2021年华东医药股份有限公司中报

Huadong Medicine Co., Ltd. The Half Year Report 2021 August 2021 Section I. Important Declaration, Contents and Definitions The Board of Directors, Board of Supervisors, directors, supervisors and senior management of Huadong Medicine Co., Ltd. (hereinafter referred to as the “Company”) hereby guarantee that the information presented in this half year report is authentic, accurate and complete and free of any false records, misleading statements or material omissions, and shall undertake individual and joint legal liabilities. Lv Liang, the Company’s legal representative and the officer in charge of accounting, and Qiu Renbo, head of accounting department (accounting supervisor) hereby declare and guarantee that the financial statements in this half year report are authentic, accurate and complete. All directors have attended the Board of Directors meeting to review this half year report. The future plans, development strategies and other forward-looking statements in this half year report shall not be considered as substantial commitment of the Company to investor. Investors and related parties should maintain sufficient risk awareness, and should understand the difference between plans, forecasts and promises. Investors are kindly reminded to pay attention to possible investment risks. The Company faced various risks in its operations, involving industry policies, markets, R&D of new drugs, product price reduction, etc. For details, refer to “X. Risks and Countermeasures” in “Section III. Discussion and Analysis of the Management”. We thank all investors for paying attention to the Company’s operations, and we hope that you can be aware of investment risks. The company does not plan to distribute cash dividends, no bonus share will be issued; and no capital reserve will be converted to increase the share capital. According to “Stock Listing Rules of the Shenzhen Stock Exchange”, if listed companies have both Chinese or 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. Contents Section I. Important Declaration, Contents and Definitions......2 Section II. Company Profile and Key Financial Indicators ......8 Section III. Discussion andAnalysis of the Management......11 Section IV. Corporate Governance ......45 Section V. Environmental and Social Responsibility ......46 Section VI. Important Matters......59 Section VII. Share Change and Shareholders ......84 Section VIII. Preferred Shares ......89 Section IX. Information about Bonds ......90 Section X. Financial Report ......91 DocumentsAvailable for Reference I. Financial Statements carrying the signatures and stamps of the Company Principal, the Chief Financial Officer and the person in charge of accounting firm; II. Original copies of all documents and the announcements thereof disclosed in the reporting period on the designated newspaper. Definitions Term refers to Definition CSRC refers to China Securities Regulatory Commission SSE refers to Shenzhen Stock Exchange Huadong Medicine/the Company/our Company refers to Huadong Medicine Co., Ltd. CGE refers to China Grand Enterprises, Inc. Huadong Medicine Group refers to Hangzhou Huadong Medicine Group Co., Ltd. Zhongmei Huadong refers to Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Jiangdong Company refers to Hangzhou Zhongmei Huadong Pharmaceutical Jiangdong Co., Ltd. Jiuyang Bio refers to Jiangsu Jiuyang Biopharm Co., Ltd. Xi’an Bohua refers to Huadong Medicine (Xi’an) Bohua Pharmaceutical Co., Ltd. Jiuyuan Gene refers to Hangzhou Jiuyuan Gene Engineering Co., Ltd. Doer Biologics refers to Zhejiang Doer Biologics Corporation Huadong Ningbo Company refers to Huadong Ningbo Medicine Co., Ltd. Chongqing Peg-Bio refers to Chongqing Peg-Bio Biopharm Co., Ltd. Qyuns Therapeutics refers to Qyuns Therapeutics Co., Ltd. Nuoling Biomedical refers to Nuoling Biomedical Technology (Beijing) Co., Ltd. Yuanda Investment Management refers to Shanghai Yuanda Investment Management Co., Ltd. Fuguang Chengdu refers to Fuguang Chengdu Equity Investment Management Co., Ltd. Hangzhou High-Tech refers to Hangzhou High-Tech Venture Capital Management Co., Ltd. Yuanda Huachuang refers to Beijing Yuanda Huachuang Investment Co., Ltd. Hangzhou Heda refers to Hangzhou Heda Industrial Fund Investment Co., Ltd. Pharmaceutical Industry Fund/Fuguang refers to Hangzhou Fuguang Hongxin Equity Investment Partnership (L.P.) Hongxin Sinclair refers to Sinclair Pharma Limited vTv Company refers to vTv Therapeutics LLC R2 refers to R2 Technologies,Inc. MediBeacon refers to MediBeacon Inc. ImmunoGen refers to ImmunoGen, Inc. Provention Bio refers to Provention Bio, Inc. RAPT refers to RAPT Therapeutics,Inc. Kylane refers to Kylane Laboratoires SA High Tech refers to High Technology Products, S.L.U. LG refers to LG Chem Ltd Jetema refers to Jetema. Co,.ltd Exscientia refers to Exscientia Ltd. GMP refers to Good Manufacturing Practice CGMP refers to Current Good Manufacture Practices GSP refers to Good Supply Practice BE refers to Bioequivalence Center for Drug Evaluation (of National Medical Products CDE refers to Administration) MAH refers to MarketingAuthorization Holder FDA refers to (U.S.) Food and DrugAdministration NMPA refers to National Medical Products Administration NDA refers to New DrugApplication ANDA refers to Abbreviated New Drug Application International Council for Harmonisation (of Technical Requirements ICH refers to for Pharmaceuticals for Human Use) IND refers to Investigational New Drug PK/PD refers to pharmacokinetics/pharmacodynamics CMC refers to Chemistry, Manufacturing and Control CMO refers to Contract Manufacturing Organization CDMO refers to Contract Development and Manufacturing Organization PMA refers to Premarket Application QA refers to QualityAssurance (department) Catalogue of Drugs for Insurance（2020） Catalogue of Drugs for Basic National Medical refers to Insurance/Employment Injury Insurance/Birth Insurance（2020） ADC refers to Antibody-Drug Conjugate EHS refers to Environment、Health、Safety Drugs that can only be purchased and used according to prescriptions Prescription Drugs refers to issued by physicians OTC refers to Over The Counter MRCT refers to International Multi-center Clinical Trial RWS/RWR refers to Real World Study/Real World Research Section II. Company Profile and Key Financial Indicators I. Company information Stock name (abbreviation) Huadong Medicine Stock code 000963 Stock listed on Shenzhen Stock Exchange Company name in Chinese 华东医药股份有限公司 Company name in Chinese 华东医药 (abbreviation, if any) Company name in English (if HUADONG MEDICINE CO., LTD any) Company name in English (abbreviation, if any) HUADONG MEDICINE Legal representative Lv Liang II. Contact persons and contact information Secretary of the Board of Directors SecuritiesAffairs Representative Name Chen Bo / Contact address 866 Moganshan Road, Hangzhou / Tel. 0571-89903300 / Fax 0571-89903300 / Email address hz000963@126.com / III. Other information 1. Company’s contact information Whether there is any change in the Company’s registered address, office address, zip code, company website or company email address during the reporting period. □Applicable √ N/A There is no change in the Company’s registered address, office address, zip code, company website or company email addres