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股票

华东医药: 2026年第一季度报告(英文版)

来源:证券之星

2026-07-08 17:05:06

                                                                            First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
Stock code: 000963                  Stock abbreviation: Huadong Medicine                     Announcement No.: 2026-030
                                        Huadong Medicine Co., Ltd.
                                        First Quarterly Report 2026
     The Company and all members of the Board of Directors hereby guarantee that the information presented in this report is
authentic, accurate and complete and free of any false records, misleading statements or material omissions.
Important Declaration:
"Company") hereby guarantee that the information presented in the Report is authentic, accurate and complete and free of false
records, misleading statements or material omissions, and shall undertake individual and joint legal liabilities.
manager) hereby declare that the financial information in this quarterly report is authentic, accurate and complete.
□Yes No
According to “Stock Listing Rules of the Shenzhen Stock Exchange”, if listed companies have both Chinese and other language
version of public notice, they should ensure the content of both versions are the same. In the case of discrepancy, the original
version in Chinese shall prevail.
                                                                           First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
I. Key Financial Data
(I) Key accounting data and financial indicators
Whether the Company needs to perform a retroactive adjustment or restatement of previous accounting data
□Yes No
                                                                                                      Year-on-year change for the
                                       Current reporting period           Same period last year
                                                                                                         reporting period (%)
 Operating revenue (RMB)                        11,183,450,824.27                 10,735,787,899.82                         4.17%
 Net profits attributable to
 shareholders of the listed                      1,002,189,357.16                    914,708,484.70                         9.56%
 company (RMB)
 Net profits attributable to
 shareholders of the listed
 company after deduction of                        989,719,668.99                    897,337,982.42                        10.30%
 non-recurring profit and loss
 (RMB)
 Net cash flow from operating
                                                  -852,335,762.63                   -832,728,693.88                        -2.35%
 activities (RMB)
 Basic earnings per share
 (RMB/share)
 Diluted earnings per share
 (RMB/share)
 Weighted average return on
 equity
                                     End of the current reporting                                     Change from prior year-end
                                                                           End of the last year
                                                period                                                          (%)
 Total assets (RMB)                            39,908,042,564.94                  39,038,036,320.92                        2.23%
 Owners' equity attributable to
 shareholders of listed                         25,733,074,032.10                 24,811,339,992.99                         3.71%
 companies (RMB)
The Company's total share capital as of the trading day prior to disclosure:
 The Company’s total share capital as of the trading day prior to
 disclosure (shares)
Fully diluted earnings per share based on the latest share capital:
 Preferred dividends paid (RMB)                                                                                               0.00
 Paid perpetual bond interest (RMB)                                                                                           0.00
 Fully diluted earnings per share based on the latest share capital
 (RMB/share)
(II) Non-recurring profit and loss items and amounts
Applicable □Not applicable
                                                                                                                       Unit: RMB
                                                  Amount during the current reporting
                    Item                                                                                 Description
                                                               period
 Profits/losses on disposal of non-current
 assets (including the written-off part of
 the accrued impairment provision of
 assets)
 Government grants included in the                                        22,334,120.97
                                                                            First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
 current profits and losses (except those
 that are closely related to the normal
 business operation of the Company,
 comply with national policies and
 regulations, are enjoyed in accordance
 with the defined criteria, and have a
 lasting impact on the Company's profits
 and losses)
 Other non-operating revenue and
 expenses other than those mentioned                                        -7,779,473.38
 above
 Less: Amount affected by income tax                                        1,182,827.86
      Amount affected by minority
 interests (after tax)
 Total                                                                     12,469,688.17                           --
Details of other profit and loss items conforming to the definition of non-recurring profits and losses
□Applicable Not applicable
There are no other profit and loss items that meet the definition of non-recurring profits and losses.
Explanation for recognizing an item listed as a non-recurring profit and loss in the Interpretative Announcement No. 1 on
Information Disclosure Criteria for Public Listed Companies - Non-Recurring Profits and Losses as an item of recurring profit and
loss
□Applicable Not applicable
The Company did not recognize any item of non-recurring profit and loss items listed in the Interpretative Announcement No. 1 on
Information Disclosure Criteria for Public Listed Companies - Non-Recurring Profits and Losses as an item of recurring profit and
loss.
(III) Details and reasons for changes in key accounting data and financial indicators
Applicable □Not applicable
                                                                                                                        Unit: RMB 10,000
                                                                         Opening        Percentag
         Items in the balance sheet             Closing balance                                               Reasons for changes
                                                                         balance        e change
                                                                                                         Mainly attributable to the
                                                                                                         decrease in commercial
Notes receivable                                                   -          621.34      -100.00%
                                                                                                         acceptance bills receivable
                                                                                                         during the current period
                                                                                                         Mainly attributable to the
Other current assets                                     13,927.49         22,234.33        -37.36%      decrease in creditable VAT input
                                                                                                         tax at the end of the period
                                                                                                         Mainly attributable to the
                                                                                                         increase in VAT output tax
Other current liabilities                                  3,494.29         1,044.36        234.59%
                                                                                                         pending carryover during the
                                                                                                         current period
                                                                                                         Mainly attributable to
Employee compensation payable                            23,713.85         41,159.88        -42.39%      remuneration paid during the
                                                                                                         current period
                                                                                                         Mainly attributable to changes in
                                                                                                         foreign currency translation
Other comprehensive income                                -7,483.69           577.07    -1396.85%
                                                                                                         differences during the current
                                                                                                         period
                                                                        Amount in
                                                 Amount in the                          Percentag
     Items in the income statement                                     the previous                           Reasons for changes
                                                 current period                         e change
                                                                          period
                                                                                                         Key programs were progressed
R&D expenses                                             35,036.53         51,537.69        -32.02%
                                                                                                         smoothly in clinical studies
                                                                           First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
                                                                                                      during the period. Expenditures
                                                                                                      related to Phase III clinical
                                                                                                      programs met the capitalization
                                                                                                      criteria and were capitalized
                                                                                                      during the current period,
                                                                                                      resulting in a corresponding
                                                                                                      decrease in R&D expenses
                                                                                                      Mainly attributable to the
Financial expenses                                         -472.53         1,461.80      -132.33%     increase in exchange earning in
                                                                                                      the current period
                                                                                                      Mainly attributable to the
                                                                                                      increase in investment income
Investment income                                        -2,231.03        -4,262.41        47.66%
                                                                                                      recognized from associates in the
                                                                                                      current period
                                                                                                      Mainly attributable to the
Other income                                              3,123.03         7,364.16       -57.59%     decrease in government grants
                                                                                                      during the current period
                                                                                                      Mainly attributable to the
                                                                                                      decrease in net losses from asset
Proceeds from disposal of assets                             53.49        -1,454.10      103.68%
                                                                                                      disposal during the current
                                                                                                      period
                                                                                                      Mainly attributable to the
Non-operating expenses                                      909.54         2,807.54       -67.60%     decrease in external donations
                                                                                                      made during the current period
                                                                        Amount in
                                                Amount in the                           Percentag
    Items in the cash flow statement                                  the previous                          Reasons for changes
                                                current period                           e change
                                                                            period
                                                                                                      Mainly attributable to the
Net cash flows from investing activities                -39,140.04       -64,583.94        39.40%     decrease in investment in the
                                                                                                      current period
                                                                                                      Mainly attributable to the
Net cash flow from financing                                                                          year-on-year decrease in the
activities                                                                                            repayment of interest-bearing
                                                                                                      liabilities
II. Shareholder Information
(I) Total number of common shareholders, number of preferred shareholders with restored voting rights
and shareholdings of top 10 shareholders
                                                                                                                         Unit: Shares
 Total number of common
                                                             Total number of preferred shareholders with restored
 shareholders at the end of the                     84,304                                                                            0
                                                             voting rights at the end of the reporting period (if any)
 reporting period
                          Particulars about the top 10 shareholders (excluding shares lent through refinancing)
                                                                                    Number of           Pledged, marked or locked-up
     Name of             Nature of         Shareholding        Number of            shares held                      status
   shareholder          shareholder          ratio (%)         shares held         with trading
                                                                                                     Status of shares       Quantity
                                                                                    restrictions
 China Grand         Domestic non-
 Enterprises,        state-owned                  41.68%         730,938,157                     0 Pledged                  138,640,000
 Inc.                corporation
 Hangzhou
 Huadong             State-owned
 Medicine            corporation
 Group Co., Ltd.
 Hong Kong           Overseas
 Securities          corporation
                                                   First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
Clearing
Company
Limited
New China Life
Insurance Co.,
Ltd. - Dividend
- Individual      Others          2.05%   35,903,842                 0   Not applicable                  0
Dividend -
Shenzhen
New China Life
Insurance Co.,
Ltd. -
Traditional -
General           Others          1.32%   23,204,014                 0   Not applicable                  0
Insurance
Products -
Shenzhen
Industrial and
Commercial
Bank of China
Limited -
Zhong Ou
AMC Medical       Others          1.21%   21,182,329                 0   Not applicable                  0
and Health
Hybrid
Securities
Investment
Fund
China
Securities        Domestic non-
Finance           state-owned     1.09%   19,095,344                 0   Not applicable                  0
Corporation       corporation
Limited
National Social
Security Fund -   Others          1.00%   17,589,744                 0   Not applicable                  0
Portfolio 112
Bank of
Shanghai Co.,
Ltd. - Yinhua
CSI Innovative
Pharmaceutical
Industry Traded   Others          0.74%   13,013,898                 0   Not applicable                  0
Open-ended
Index
Securities
Investment
Fund
China
Construction
Bank
Corporation - E
                  Others          0.70%   12,343,870                 0   Not applicable                  0
Fund CSI 300
Medical and
Health Trading
Open Index
                                                                           First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
 Securities
 Investment
 Fund
   Information about the top 10 shareholders without trading restrictions (excluding shares lent through conversions and locked-up
                                                     shares for senior management)
                                                                                                               Type of shares
         Name of shareholder               Number of shares held without trading restrictions
                                                                                                      Type of shares        Quantity
                                                                                                     RMB common
 China Grand Enterprises, Inc.                                                       730,938,157                            730,938,157
                                                                                                     shares
 Hangzhou Huadong Medicine                                                                           RMB common
 Group Co., Ltd.                                                                                     shares
 Hong Kong Securities Clearing                                                                       RMB common
 Company Limited                                                                                     shares
 New China Life Insurance Co.,
                                                                                                     RMB common
 Ltd. - Dividend - Individual                                                         35,903,842                             35,903,842
                                                                                                     shares
 Dividend - 018L-FH002 Shenzhen
 New China Life Insurance Co.,
 Ltd. - Traditional - General                                                                        RMB common
 Insurance Products - 018L-CT001                                                                     shares
 Shenzhen
 Industrial and Commercial Bank
 of China Limited - Zhong Ou                                                                         RMB common
 AMC Medical and Health Hybrid                                                                       shares
 Securities Investment Fund
 China Securities Finance                                                                            RMB common
 Corporation Limited                                                                                 shares
 National Social Security Fund -                                                                     RMB common
 Portfolio 112                                                                                       shares
 Bank of Shanghai Co., Ltd. -
 Yinhua CSI Innovative
                                                                                                     RMB common
 Pharmaceutical Industry Traded                                                       13,013,898                             13,013,898
                                                                                                     shares
 Open-ended Index Securities
 Investment Fund
 China Construction Bank
 Corporation - E Fund CSI 300                                                                        RMB common
 Medical and Health Trading Open                                                                     shares
 Index Securities Investment Fund
 Explanation on associated relationships or concerted        The Company is unaware of whether the above-mentioned shareholders
 actions among the above-mentioned shareholders              are related parties or whether they are concert parties with one another.
                                                             As of the end of the current reporting period, none of the top 10 common
 Description of the participation in securities margin
                                                             shareholders of the Company held shares of the Company through
 trading business of top 10 shareholders (if any)
                                                             securities margin trading accounts.
Participation in the lending of shares through refinancing business of shareholders holding more than 5% of shares, top 10
shareholders and top 10 shareholders holding tradable shares without trading restriction
□Applicable Not applicable
Change in top 10 shareholders and top 10 shareholders holding tradable shares without trading restriction due to lending/returning
of shares through refinancing as compared to the previous period
□Applicable Not applicable
(II) Total number of preferred shareholders and shareholding list of top 10 preferred shareholders of the
Company
□Applicable Not applicable
                                                          First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
Ⅲ. Other Important Matters
Applicable □Not applicable
(I) Overview of the Company's overall operations during the reporting period
      In 2026, external competition is expected to continue intensifying, and the policy environment
has become increasingly complex and volatile. Corporate development faces mounting pressures.
Competition driven by market share will enter a new stage. During the reporting period, in the face
of these challenges, the Company has remained firmly aligned with its overall strategic roadmap
and annual operational objectives. Guided by the business priorities of "exploring new markets,
focusing on new products, strengthening organizational capabilities, and building new
competencies", the Company has upheld the management philosophy of "problem-solving and
value creation", and integrated the principles of "innovation-driven development, resource
integration, and enterprise-wide collaboration" throughout all operational processes; staying
committed to its innovation, the Company has systematically advanced comprehensive upgrades
across its product portfolio, management systems, and talent development. It concentrated resources
on tackling key R&D and clinical study programs, deepened collaboration across sectors such as
pharmaceuticals, medical aesthetics, and commercial operations, continuously activated growth
drivers for innovative business, and realized steady improvements in operational quality and
management efficiency, ensuring the orderly execution of various tasks.
      During the reporting period, the Company achieved operating revenue of RMB 11.183 billion,
representing a YoY increase of 4.17% and a quarter-on-quarter increase of 2.15% compared with
Q4 2025. Net profit attributable to shareholders of the listed company reached RMB 1.002 billion,
up 9.56% year-on-year. Net profit attributable to shareholders excluding non-recurring profit and
loss items was RMB 990 million, marking a YoY increase of 10.30% and reaching a historical high
for the same period.
      During the reporting period, Zhongmei Huadong, the Company's core subsidiary in the field of
pharmaceutical industry, maintained steady growth in overall operations. It achieved operating
revenue (including CSO business) of RMB 4.048 billion, representing an 11.82% YoY increase.
The consolidated net profit attributable to the parent company reached RMB 931 million, up
recorded the growth exceeding 10%.
      During the reporting period, the revenue contribution of innovative products continued to
increase. Sales and agency service revenue generated from innovative products reached RMB 810
                                                        First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
million, representing a year-on-year growth of 61.8% and accounting for 20.05% of the operating
revenue of the pharmaceutical industry segment (including the CSO business). The overall business
of the Company has entered a strong growth trajectory, further demonstrating the effectiveness of
the Company’s R&D achievement transformation and the professionalism of its commercialization
operations. By the end of the first quarter of 2026, medical institutions that were certified and
registered to administer the CAR-T therapy Zevorcabtagene Autoleucel Injection (zevor-cel) had
expanded to more than 20 provinces and municipalities across the country. Zevor-cel has also been
included in the Commercial Health Insurance Innovative Drug List. As of the date of this Report,
more than 100 commercial and Huiminbao (a city-specific supplemental medical insurance program)
programs have incorporated zevor-cel into their reimbursement coverage. Since its launch,
Sailexin, the biosimilar of Ustekinumab Injection, has demonstrated outstanding market
performance. To date, it has been prescribed in over 2,000 hospitals, and its sales revenue in the
first quarter of 2026 increased by nearly 200% year on year.
     In the diabetes field, Huiyoujing, i.e., Ganagliflozin Proline Tablets, which is the Class 1 new
drug, has now been adopted by over 1,900 tiered hospitals. Its sales revenue in the first quarter of
period after inclusion in the national reimbursement drug list).
     By the end of the first quarter, Mirvetuximab Soravtansine Injection (trade name: ELAHERE)
had been listed on drug procurement platforms in 29 provinces, prescribed in over 200 hospitals,
and made available in more than 400 medical institutions and over 200 DTP pharmacies. Currently,
Elahere has also been successfully incorporated in multiple Huiminbao (a city-specific
supplemental medical insurance program) programs and commercial insurance programs, such as
Beijing Inclusive Medical Insurance Program, Jiangxi Ganhuibao (inclusive commercial health
insurance program), Leshan Huijiabao (city-customized insurance program), and Shaanxi Universal
Health Insurance. From 2025 to the end of the reporting period, cumulative sales of Elahere
exceeded RMB 100 million. The novel PARP inhibitor, Senaparib Capsules (trade name:
Paishuning), exclusively promoted by the Company, has delivered outstanding market
performance. Currently, it is available in over 300 DTP pharmacies and more than 900 medical
institutions, supported by a multi-tier distribution network; at the same time, the Company actively
promoted the inclusion of its product in reimbursement coverage of insurance programs. The
product has been incorporated into multiple regional Huiminbao programs (e.g., West Lake
Yilianbao, Huhuibao, Chonghuibao, Jiaxing Huiminbao, and CPIC-Huxiangbao), as well as other
commercial insurance programs, effectively reducing the financial burden of patients.
     MediBeacon TGFR, the world’s first bedside renal function assessment device applicable to
                                                         First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
patients with normal or impaired renal function , has officially commenced commercial sales in the
Chinese market. To date, consumables of MediBeacon TGFR have been listed in 25 provinces,
while Relmapirazin Injection has been listed in 21 provinces.
     During the reporting period, the pharmaceutical distribution segment of the Company
sustained stable operations, yielding an aggregate operating revenue of RMB 7.181 billion, marking
a year-on-year (YoY) uptick of 3.57%, and a net profit of RMB 119 million, representing a 3.16%
YoY increase. Overall, it demonstrated a robust developmental trajectory.
     Affected by multiple factors such as the cyclical fluctuations in the global economy, intensified
industry competition, and slower-than-expected recovery in domestic aesthetic medicine
consumption, the Company's aesthetic medicine segment continued to confront growth headwinds.
Throughout the reporting period, it achieved a total operating revenue of RMB 361 million
(excluding internal offsets), reflecting a YoY decline of 30.38%.
     On March 25, 2026, the Company's exclusively distributed product, Recombinant Botulinum
Toxin Type A for Injection (R&D code: YY001; trade name: Retoxin), received marketing
approval from the National Medical Products Administration (NMPA). This product is indicated for
the temporary amelioration of moderate-to-severe glabellar lines in adults aged 65 and under,
resulting from the activity of the corrugator supercilii and/or procerus muscles. This product is
poised to initiate formal commercial sales in the near future.
     During the reporting period, the Company's industrial microbiology segment continued to
experience relatively rapid revenue growth, with a YoY increase of 21.82%. Given the proactive
expansion into overseas markets and a consistent uptick in orders, this segment is anticipated to
uphold its favorable developmental momentum.
    (II) Important R&D progress of the Company during the reporting period
     Oncology
     HDM2005, an antibody-drug conjugate (ADC) targeting ROR1, has maintained its leading
position within the global first echelon of clinical development for ROR1 ADCs. Presently, three
clinical studies are being conducted in China: a Phase I clinical study evaluating monotherapy for
advanced hematologic malignancies, including mantle cell lymphoma (MCL), diffuse large B-cell
lymphoma (DLBCL), and classical Hodgkin lymphoma (cHL). This study has completed Phase Ia
monotherapy dose escalation and is currently performing dose expansion studies for MCL and cHL.
Another Phase I study, assessing monotherapy for advanced solid tumors, has enrolled 17 patients
and is conducting dose expansion at a dosage of 2.5 mg/kg. Additionally, a Phase Ib &II clinical
                                                          First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
study investigating combination therapy for DLBCL patients is currently undergoing combination
therapy dose escalation. In addition, the Company has submitted communication and meeting
requests to the CDE, respectively, for combination therapy in MCL and cHL.
     The clinical study for dose escalation of monotherapy involving HDM2020, an ADC targeting
FGFR2b, has advanced to the fourth dose cohort. Furthermore, a Phase Ia study for lung squamous
cell carcinoma has officially commenced, with subject screening currently in progress. In February
(including gastroesophageal junction cancer).
     HDM2012, an ADC targeting MUC17, has reached the fourth dose cohort in its Phase I
clinical study aimed at treating advanced solid tumors.
     HDM2017, targeting CDH17, has progressed to the fourth dose cohort in its Phase Ia
monotherapy trial in China, with concurrent dose expansion at a dosage of 3.2 mg/kg. The first
Australian site was activated in February 2026, and subject screening is ongoing. In addition, in
March 2026, HDM2017 received ODD from the U.S. FDA for three indications: biliary tract cancer,
gastric cancer, and pancreatic cancer.
     HDM2024, an EGFR/HER3-targeting bispecific ADC, received IND approvals in the United
States and China in March 2026 for the treatment of advanced solid tumors. The first subject
administration in a Phase I clinical study in China was completed in April 2026.
     HDP-101 (HDM2027), a BCMA-targeting amanitin ADC, enrolled its first patient in China in
March 2026 for the treatment of plasma-cell disorders, including multiple myeloma.
     The small-molecule antineoplastic agent HPK-1 PROTAC (hematopoietic progenitor kinase 1
proteolysis-targeting chimera), HDM2006 tablets, is currently undergoing a Phase I clinical study in
China for the treatment of advanced solid tumors, with enrollment for the third dose cohort
underway.
     DR30206 for injection, a proprietary PD-L1/VEGF/TGF-β tri-specific antibody fusion protein,
developed by Doer Biologics, a controlled subsidiary of the Company, is nearing the completion of
dose expansion studies in its Phase Ib trial for the first-line treatment of non-small cell lung cancer,
demonstrating promising overall efficacy. The program is advancing its combination therapy study.
Phase Ib/IIa clinical studies evaluating combination therapy with standard chemotherapy for
advanced or metastatic gastrointestinal tumors, as well as Phase Ib monotherapy expansion studies
for head and neck squamous cell carcinoma cohorts, are currently underway. In January 2026, the
DR30206 was administered to the first subject in the monotherapy expansion cohort for platinum-
resistant ovarian cancer during its Phase Ib trial. In March 2026, DR30206 received IND approval
in China for its combination with standard chemotherapy in patients with locally advanced or
                                                        First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
metastatic non-small cell lung cancer.
     Endocrinology
     HDM1002 (conveglipron), the oral small-molecule GLP-1 receptor agonist, has completed
enrollment of all subjects for its Phase III clinical study in China for the weight management
indication. The study is currently in the stage of treatment follow-up and data collection. The NDA
application is expected to be submitted in Q4 2026. Both Phase III clinical studies for the type 2
diabetes mellitus indication of this product have completed full enrollment. Pre-NDA
communication application is expected to be submitted in Q4 2026.
     HDM1005 (poterepatide) Injection, a GLP-1R/GIPR long-acting polypeptide dual-target
agonist, enrolled all subjects in the Phase III clinical study for the weight management indication.
Top-line results for the Phase II clinical study for diabetes were obtained in February 2026. The first
subjects have been enrolled in both Phase III studies for diabetes. Two Phase III studies for the
obstructive sleep apnea hypopnea syndrome (OSAS) indication are currently in preparation.
     DR10624, a first-in-class therapeutic candidate targeting FGF21R/GCGR/GLP-1R and
developed by Doer Biologics, a controlled subsidiary of the Company, is currently progressing with
preparations for its Phase III clinical study aimed at treating severe hypertriglyceridemia. In January
hypertriglyceridemia. The Phase II clinical study targeting patients with metabolic dysfunction-
associated steatotic liver disease with high risk of liver fibrosis is currently being conducted
concurrently. Top-line results are expected to be obtained in Q3 2026.
     HDM1014 injection, which is the GalNAc-siRNA weight-loss drug self-developed by the
Company, is undergoing IND development work. It is expected to submit IND application in China
in Q4 2026.
     The IND application for HDM1010 tablets (a fixed-dose oral combination formulation of
HDM1002) intended for the treatment of type 2 diabetes mellitus has received approval from the
U.S. FDA. Clinical study preparations are currently in full swing.
     The NDA for the diabetes indication of Semaglutide Injection was submitted and accepted in
March 2025 and successfully passed clinical inspection; the NDA for the weight management
indication was accepted in April 2026.
     The NDA for Insulin Degludec Injection was submitted and accepted in February 2025; the
on-site inspection has been completed, and the application is currently under technical review.
     The top-line results from the Phase III clinical study of Insulin Degludec and Insulin Aspart
Injection have been obtained. It is expected to submit NDA in the Q2 of 2026.
     Autoimmunity
                                                           First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
     The Marketing Authorization Application (MAA) and supplemental application for HDM3001
(QX001S), a ustekinumab biosimilar developed in collaboration with Qyuns Therapeutics for the
treatment of Crohn's disease, are expected to receive approval in the Q2 of 2026.
     The Phase III clinical studies for the innovative drug Oturkibart (R&D code:
HDM3016/QX005N), which was developed by the Company in collaboration with Qyuns
Therapeutics for the treatment of prurigo nodularis (PN) and atopic dermatitis (AD) have reached
their primary endpoints. The NDAs for the PN and AD indications are expected to be submitted in
the first and second halves of 2026, respectively.
     The Chinese NDA applications for HDM3014 (Roflumilast Cream), developed in
collaboration with Arcutis in the United States for two indications—plaque psoriasis in patients
aged 6 and above, and atopic dermatitis in patients aged 6 and above—have successfully passed the
clinical on-site inspection conducted by the National Medical Products Administration. In addition,
the Chinese NDA application for Roflumilast Cream for atopic dermatitis indication in patients
aged 2 to 5 was accepted in February 2026.
     The Phase I/II clinical study evaluating Ruxolitinib Gel (HDM3010), a modified new drug
developed by the Company, for the treatment of prurigo nodularis has yielded top-line results. The
Company has received feedback from the Center for Drug Evaluation (CDE) and are currently
making preparations for subsequent studies based on this feedback. In addition, a Phase III clinical
study in vitiligo is currently ongoing.
     The Phase III clinical study of MC2-01 Cream, developed through a collaboration between the
Company and MC2 Therapeutics for the treatment of plaque psoriasis, has enrolled more than 120
subjects in China to date.
     HDM4002 Injection, the first-in-class bispecific antibody candidate independently developed
by the Company, is currently undergoing IND-enabling development. It is anticipated that IND
applications will be submitted in both China and the United States in 2026.
     Other segments
     The NDA for Ranibizumab Injection was submitted and accepted in May 2025. Subsequently,
the on-site inspection has been completed for the production. Ranibizumab Injection has
successfully passed the clinical on-site inspection conducted by the National Medical Products
Administration.
                                                     China
   Type             Item          Category                                         Milestone Event
                                               Registration Class
                  SAILEXIN   
                                  Biosimilar       Class 3.3        Supplemental application for new strengths
   NDA
                                                                First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
 acceptance       (Ustekinumab                         therapeutic       of Crohn's disease was accepted in January
                    Injection)                     biological product    2026
                                                                         NDA was accepted in February 2026
                      Cream              drug             drug
                                                        Class 3.3
                   Semaglutide                                           NDA for weight management indication was
                                      Biosimilar       therapeutic
                    Injection                                            accepted in April 2026
                                                   biological product
                 Budesonide and
               Fomoterol Powder       Modified     Class 2.2 chemical
                                                                         NDA accepted in April 2026
               for Inhalation (IV),   new drug            drug
                  Capsule type
                                                                      The IND for metabolic dysfunction-
                                      Innovative   Class 1 therapeutic
                    DR10624                                           associated steatotic liver disease was
                                         drug      biological product
                                                                      approved in the U.S. in January 2026
                                                                      The IND for the combination therapy with
                                                                      Rituximab and Lenalidomide for the
                                    Innovative Class 1 therapeutic
                   HDM2005                                            treatment of relapsed/refractory mantle cell
                                        drug    biological product
                                                                      lymphoma was approved in China in
                                                                      January 2026
                                    Innovative Class 1 therapeutic IND for hypertriglyceridemia approved in
                    DR10624
                                        drug    biological product    China in February 2026
     IND
                                                                      The IND for combination with standard
  approved
                                                                      chemotherapy in locally advanced or
                                    Innovative Class 1 therapeutic
                    DR30206                                           metastatic non-small cell lung cancer
                                        drug    biological product
                                                                      patients was approved in China in February
                                                                      The IND for advanced malignant solid
                                    Innovative Class 1 therapeutic
                   HDM2024                                            tumors was approved in China in March
                                        drug    biological product
                                                                      The IND for advanced malignant solid
                                    Innovative Class 1 therapeutic
                   HDM2024                                            tumors was approved in the U.S. in March
                                        drug    biological product
                                                                      Orphan drug designation was granted in the
                                    Innovative Class 1 therapeutic U.S. in February 2026 for indications of
                   HDM2020
                                        drug    biological product    gastric cancer and gastroesophageal junction
                                                                      cancer
                                                                      Orphan drug designation was granted in the
                                    Innovative Class 1 therapeutic
                   HDM2017                                            U.S. in March 2026 for biliary tract cancer
Orphan drug                             drug    biological product
                                                                      indication
 designation
                                                                      Orphan drug designation was granted in the
                                    Innovative Class 1 therapeutic
                   HDM2017                                            U.S. in March 2026 for gastric cancer
                                        drug    biological product
                                                                      indication
                                                                      Orphan drug designation was granted in the
                                    Innovative Class 1 therapeutic
                   HDM2017                                            U.S. in March 2026 for pancreatic cancer
                                        drug    biological product
                                                                      indication
                                                                      Chinese breakthrough therapy designation
Breakthrough                        Innovative Class 1 therapeutic
                    DR10624                                           was obtained in January 2026 for severe
   therapy                              drug    biological product
                                                                      hypertriglyceridemia
Note: Budesonide and Fomoterol Powder for Inhalation (IV)(capsule type) is the product exclusively commercialized
by the Company in the Chinese mainland.
academic conferences since 2026
         Date of                      Conference/journal      Presentation
No.                      Item                                                                    Title
         release                            name                format
                                      American Academy                         Efficacy and Safety of Roflumilast
                                        of Dermatology                         Cream 0.3% in Chinese Adult and
                                                                      First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
                                               (AAD)                                 Pediatric    Patients    with    Plaque
                                                                                     Psoriasis: Results From a Phase 3 Trial
                                                                                     Roflumilast Cream 0.15% for Mild-to-
                                          American Academy
                                                                     Poster          Moderate Atopic Dermatitis: A
                                                                  presentation       Multicenter, vehicle-Controlled Phase
                                               (AAD)
                                          Society of Critical                        Clinical Validation of a Transdermal
                                              (SCCM)                                 Individuals
                                          Society of Critical                        Bioequivalence and Efficacy Study of
                                              (SCCM)                                 Measurement in Chinese Subjects
                                              American                               HDM2021, a potent and selective
                                           Association for           Poster          CBL-B inhibitor exhibits robust
                                           Cancer Research        presentation       immunomodulatory efficacy for anti-
                                              (AACR)                                 tumor therapy
                                              American                               A novel EGFR and HER3 bispecific
                                           Association for           Poster          antibody-drug      conjugate    exhibits
                                           Cancer Research        presentation       superior antitumor activity and
                                              (AACR)                                 favorable toxicological profile
                                              American
                                                                                     DR319-DP:      A     Nectin-4/Trop-2
                                           Association for           Poster
                                           Cancer Research        presentation
                                                                                     VHH design and dual-MOA payloads
                                              (AACR)
(III) Activities such as research, communication, and interviews conducted during the reporting period
                                                                                  Main content
                                                                                  of discussion         Index of basic
     Reception        Reception      Reception       Type of
                                                                   Visitors            and            information of the
       date            address        method         visitor
                                                                                  information              research
                                                                                    provided
                                                                                                     For details, please
                                                                 Guotai                              refer to the Record
                                                                 Haitong                             Sheet of Investor
                                                    Institutio   Securities,                         Relations Activities
                   Conference                                                     Investor
 January 21                                         ns and       TF                                  on January 21 and
                   room of the      Field visits                                  communicati
 and 22, 2026                                       individu     Securities,                         22, 2026 published
                   Company                                                        on
                                                    als          Zheshang                            by the Company at
                                                                 Securities,                         https://irm.cninfo.co
                                                                 etc.                                m.cn/       and     at
                                                                                                     www.cninfo.com.cn.
IV. Quarterly Financial Statements
(I) Financial statements
Prepared by: Huadong Medicine Co., Ltd.
                                                     March 31, 2026
                                                                                                                 Unit: RMB
                                                         First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
                     Item                  Closing balance                          Opening balance
Current assets:
   Monetary funds                                    3,734,865,777.19                          4,978,052,188.84
   Deposit reservation for balance
   Lendings to banks and other financial
institutions
   Trading financial assets
   Derivative financial assets
   Notes receivable                                                                                6,213,394.05
   Accounts receivable                              11,076,591,135.34                          8,985,587,945.31
   Receivables financing                               332,387,014.92                            460,578,206.16
   Prepayments                                         508,155,787.14                            445,803,941.09
   Premium receivable
   Reinsurance accounts receivable
   Reinsurance contract reserve
receivable
   Other receivables                                   609,897,223.80                            517,535,129.39
      Incl.: Interest receivable
               Dividends receivable                          223,608.84                               223,608.84
   Financial assets purchased for resale
   Inventory                                         5,327,579,147.01                          5,535,765,919.86
    Incl.: Data resources
  Contract assets
  Assets held for sale
  Non-current assets due within one year                75,464,880.54                             75,464,880.54
  Other current assets                                 139,274,907.01                            222,343,329.23
Total current assets                                21,804,215,872.95                         21,227,344,934.47
Non-current assets:
  Loans and advances issued
  Debt investments
  Other debt investments
  Long-term receivables
  Long-term equity investment                        1,629,415,091.83                          1,509,122,017.22
  Investment in other equity instruments               682,132,315.02                            681,006,253.76
  Other non-current financial assets
  Investment property                                   10,694,501.05                             10,946,776.47
  Fixed assets                                       4,389,958,201.12                          4,470,264,264.88
  Construction in progress                             931,509,517.77                            832,431,516.18
  Productive biological assets
  Oil and gas assets
  Right-of-use assets                                  158,409,996.23                            170,395,474.59
  Intangible assets                                  3,922,211,412.97                          3,849,691,624.59
    Incl.: Data resources
  Development expenditure                            1,943,582,627.60                          1,757,196,902.53
    Incl.: Data resources
  Goodwill                                           2,848,210,102.92                          2,860,135,566.37
  Long-term deferred expenses                           18,776,159.14                             19,541,767.43
  Deferred income tax assets                           385,084,524.44                            385,084,524.45
  Other non-current assets                           1,183,842,241.90                          1,264,874,697.98
Total non-current assets                            18,103,826,691.99                         17,810,691,386.45
Total assets                                        39,908,042,564.94                         39,038,036,320.92
Current liabilities:
  Short-term borrowings                              1,714,508,902.52                          1,621,903,523.77
  Borrowings from the central bank
  Borrowings from other banks and
other financial institutions
                                               First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
  Trading financial liabilities
  Derivative financial liabilities
  Notes payable                             3,017,614,936.17                         2,910,051,094.08
  Accounts payable                          4,591,952,103.81                         5,059,850,765.02
  Advance receipts                                502,191.65                               797,358.84
  Contract liabilities                        232,364,085.08                           188,554,462.61
  Expense for financial assets sold for
repurchase
  Deposits taken and interbank deposits
  Receivings from vicariously traded
securities
  Receivings from vicariously sold
securities
  Employee compensation payable               237,138,507.68                            411,598,841.94
  Taxes and dues payable                      553,756,331.70                            563,317,023.92
  Other payables                            2,567,376,516.56                          2,215,275,211.55
     Incl.: Interests payable
              Dividends payable              101,810,219.60                            102,560,219.60
  Handling charges and commissions
payable
  Reinsurance accounts payable
  Liabilities held for sale
  Non-current liabilities due within one
year
  Other current liabilities                    34,942,891.80                            10,443,641.94
Total current liabilities                  13,033,135,267.46                        13,090,663,656.22
Non-current liabilities:
  Provision for insurance contracts
  Long-term borrowings                       251,619,962.82                            252,034,854.55
  Bonds payable
     Incl.: Preferred share
              Perpetual bonds
  Lease liabilities                           111,057,382.92                            88,813,504.20
  Long-term payables
  Long-term employee compensation
payable
  Estimated liabilities                       19,922,759.61                             20,617,015.41
  Deferred revenue                           187,359,036.43                            190,942,291.61
  Deferred income tax liabilities            217,236,393.17                            223,959,318.75
  Other non-current liabilities
Total non-current liabilities                 787,195,534.95                           776,366,984.52
Total liabilities                          13,820,330,802.41                        13,867,030,640.74
Owners' equity:
  Share capital                             1,753,736,848.00                         1,753,736,848.00
  Other equity instruments
     Incl.: Preferred share
              Perpetual bonds
  Capital reserve                           2,416,510,921.20                         2,416,358,618.64
  Less: Treasury share
  Other comprehensive income                  -74,836,933.54                              5,770,687.07
  Special reserves
  Surplus reserves                          1,616,443,486.39                         1,616,443,486.39
  General risk reserves
  Retained earnings                        20,021,219,710.05                        19,019,030,352.89
Total owners' equity attributable to the
parent company
  Minority interests                         354,637,730.43                            359,665,687.19
                                                                      First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
 Total owners' equity                                                 26,087,711,762.53                       25,171,005,680.18
 Total liabilities and owners' equity                                 39,908,042,564.94                       39,038,036,320.92
Legal representative: Lv Liang      Officer in charge of accounting: Lv Liang     Head of Accounting Department: Qiu Renbo
                                                                                                                   Unit: RMB
                      Item                    Amount incurred in the current period     Amount incurred in the previous period
 I. Total operating revenue                                       11,183,450,824.27                          10,735,787,899.82
    Incl.: Operating revenue                                      11,183,450,824.27                          10,735,787,899.82
            Interest income
            Premiums earned
            Handling charges and
 commissions revenue
 II. Total operating costs                                         9,992,872,896.34                           9,620,007,130.43
   Incl.: Operating costs                                          7,387,443,870.04                           7,206,598,136.26
               Interest expenditure
         Handling charges and
 commissions expenditure
               Surrender value
               Net payments for insurance
 claims
               Net provision for insurance
 liabilities
               Expense for insurance policy
 dividends
               Reinsurance expenses
               Taxes and surcharges                                   67,774,008.09                              57,265,200.91
               Selling expenses                                    1,820,619,488.78                           1,470,753,504.47
               Management expenses                                   371,395,501.48                             355,395,350.66
               R&D expenses                                          350,365,327.14                             515,376,918.47
               Financial expenses                                     -4,725,299.19                              14,618,019.66
                 Incl.: Interest expense                              19,176,576.84                              25,924,507.30
                         Interest income                              20,155,981.89                              27,812,843.06
   Plus: Other incomes                                                31,230,304.02                              73,641,636.88
        Investment income (loss
                                                                     -22,310,345.97                             -42,624,149.61
 expressed with "-")
              Incl.: Investment income in
                                                                      -7,510,017.34                             -28,249,462.69
 associates and joint ventures
                     Income from
 derecognition of financial assets
 measured on the basis of amortized costs
        Exchange earnings (loss
 expressed with "-")
         Net income of exposure hedge
 (loss expressed with "-")
         Income from changes in fair
 value (loss expressed with "-")
          Credit impairment loss (loss
                                                  First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
expressed with "-")
         Asset impairment loss (loss
expressed with "-")
         Proceeds from disposal of assets
(loss expressed with "-")
III. Operating profit (loss expressed with
"-")
   Plus: Non-operating revenue                    1,256,954.75                                769,095.39
   Less: Non-operating expenses                   9,095,444.64                             28,075,417.91
IV. Total profit (total loss expressed with
"-")
   Less: Income tax expense                     195,032,945.55                            190,966,760.40
V. Net profit (net loss expressed with "-")     997,161,400.38                            913,984,183.42
   (I) Classification by continuity of
operation
operations (net loss expressed with "-")
operations (net loss expressed with "-")
   (II) Classification by ownership
owners of the parent company
VI. Other comprehensive income (net of
                                                 -80,607,620.61                            82,044,972.47
tax)
   Other comprehensive income
attributable to the owner of the parent          -80,607,620.61                            82,044,972.47
company (net of tax)
      (I) Other comprehensive income
that cannot be reclassified into the profits
and losses
of defined benefit plan
that cannot be included in the profits and
losses under the equity method
investment in other equity instruments
enterprise's credit risks
      (II) Other comprehensive income
that will be reclassified into the profits       -80,607,620.61                            82,044,972.47
and losses
that can be transferred to the profit and
loss under the equity method
investments in other debt investments
into other comprehensive income
of other debt investments
                                                 -80,607,620.61                            82,044,972.47
currency financial statements
                                                                         First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
     Other comprehensive income
  attributable to minority shareholders (net
  of tax)
  VII. Total comprehensive income                                         916,553,779.77                              996,029,155.89
     Total comprehensive income
  attributable to the owner of the parent                                 921,581,736.55                              996,753,457.17
  company
     Total comprehensive income
                                                                            -5,027,956.78                                -724,301.28
  attributable to minority shareholders
  VIII. Earnings per share:
     (I) Basic earnings per share                                                  0.5715                                     0.5224
     (II) Diluted earnings per share                                               0.5715                                     0.5213
If there is a business combination under common control in this period, the net profit of the combined party before the
combination is RMB 0.00, and the net profit of the combined party in the previous period is RMB 0.00.
Legal representative: Lv Liang       Officer in charge of accounting: Lv Liang      Head of Accounting Department: Qiu Renbo
                                                                                                                      Unit: RMB
                    Item                       Amount incurred in the current period       Amount incurred in the previous period
 I. Cash flows from operating activities:
    Cash received from selling goods and
 providing services
    Net increase in deposits from
 customers as well as banks and other
 financial institutions
   Net increase in borrowings from the
 central bank
    Net increase in borrowings from other
 financial institutions
    Cash received from the original
 insurance contract premium
   Net cash received from reinsurance
 business
   Net increase in deposits and
 investments from policyholders
   Cash received from interests, handling
 charges and commissions
   Net increase in borrowings from banks
 and other financial institutions
   Net increase in funds from repurchase
 business
    Net cash received from securities
 trading agency
   Refund of taxes and fees received                                      2,570,131.00                                2,055,460.55
   Receipt of other cash relating to
 operating activities
 Subtotal of cash inflows from operating
 activities
    Cash paid for purchase of goods and
 receipt of labor services
   Net increase in customer loans and
 advance payments
                                                 First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
  Net increase in deposits with the
central bank and interbank
   Cash for payment of the original
insurance contract
  Net increase in lendings to banks and
other financial institutions
  Cash paid for interests, handling
charges and commissions
  Cash for payment of dividends on
policies
   Cash paid to and for employees             1,542,554,152.98                         1,441,219,423.87
   Various taxes and fees paid                  709,327,509.54                           671,816,951.08
   Payment of other cash relating to
operating activities
Subtotal of cash outflows from operating
activities
Net cash flow from operating activities        -852,335,762.63                          -832,728,693.88
II. Cash flows from investing activities:
   Cash received from investment
recovery
   Cash received from obtaining
investment income
   Net cash recovered from disposal of
fixed assets, intangible assets and other           74,063.51                               9,751,907.00
long-term assets
   Net cash received from disposal of
subsidiaries and other business units
   Receipt of other cash relating to
investing activities
Subtotal of cash inflows from investing
activities
  Cash paid for the purchase and
construction of fixed assets, intangible       261,855,876.92                            637,322,382.41
assets and other long-term assets
  Cash paid for investment                     129,618,537.85                             61,618,925.00
  Net increase in pledged loans
   Net cash paid for acquisition of
subsidiaries and other business entities
   Payments of other cash relating to
investing activities
Subtotal of cash outflows from investing
activities
Net cash flows from investing activities       -391,400,351.26                          -645,839,400.41
III. Cash flows from financing activities:
   Cash received by absorbing
investment
      Incl.: Cash received by subsidiaries
from minority shareholders' investment
   Cash received from obtaining
borrowings
   Receipt of other cash relating to
financing activities
Subtotal of cash inflows from financing
activities
  Cash paid for debt repayment                1,047,678,831.32                         1,279,708,605.45
                                                                       First Quarterly Report 2026 of Huadong Medicine Co., Ltd.
    Cash paid to distribute dividends,
 profits or pay interest
      Incl.: Dividends and profits paid by
 subsidiaries to minority shareholders
    Payment of other cash relating to
 financing activities
 Subtotal of cash outflows from financing
 activities
 Net cash flow from financing activities                               35,211,994.19                            -86,838,637.84
 IV. Effect of exchange rate changes on
                                                                       -4,179,294.34                             -3,115,685.50
 cash and cash equivalents
 V. Net increase in cash and cash
                                                                   -1,212,703,414.04                         -1,568,522,417.63
 equivalents
    Plus: Opening balance of cash and
 cash equivalents
 VI. Closing balance of cash and cash
 equivalents
(II) Situation of relevant items of financial statements at the beginning of the current
year after the initial implementation of adjustment of the New Accounting Standards in
□Applicable Not applicable
(III) Audit report
Has the First Quarterly Financial Report been audited?
□Yes No
The Company’s First Quarterly Financial Report has not been audited.
                                                               Board of Directors of Huadong Medicine Co., Ltd.
                                                                                                             April 24, 2026

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2026-07-08

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