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Lee's Pharmaceutical Holdings Limited 李氏大藥廠控股有限公司 Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. Lee’s Pharmaceutical Holdings Limited 李氏大藥廠控股有限公司* (Incorporated in the Cayman Islands with limited liability) (Stock code: 950) VOLUNTARY ANNOUNCEMENT NADROPARIN CALCIUM FOR INJECTION OBTAINED DRUG REGISTRATION APPROVAL This announcement is made by the board of directors (the “Board”) of Lee’s Pharmaceutical Holdings Limited (the “Company” or “Lee’s Pharm”, together with its subsidiaries as the “Group”) on a voluntary basis. The Board of the Company is pleased to announce that, on 24 July 2020, Nadroparin Calcium for Injection (brand name: Livaracine), a low molecular weight heparin (“LMWH”) product developed by Zhaoke Pharmaceutical (Hefei) Company Limited, a wholly-owned subsidiary of the Company, has obtained drug registration approval from the National Medical Products Administration (the “NMPA”) of the People’s Republic of China. The Group had conducted a bio-equivalency study of Livarcine for the application of drug registration approval. The application results concluded that, based on the Drug Administration Law of the People’s Republic of China and relevant requirements, Livaracine is proven to have fulfilled the relevant drug registration requirements, the conclusion of Livaracine being bioequivalent to the original import drug of nadroparin calcium for injection (brand name: Fraxiparine) has been accepted, two additional specifications of Livaracine: 0.6ml:6150IU and 0.4ml:4100IU have been approved and relevant drug approval numbers have been issued. The Group’s Livaracine was first launched in 1998 and is one of the leading LMWH brands in China. The classification of Livaracine as Nadroparin is a validation and confirmation of Livaracine’s quality, safety and efficacy profile and, significantly expanding its current indications. Nadroparin is an anticoagulant and is a specific class of LMWH. It is indicated to prevent deep vein thrombosis after surgery and treat the formation of deep vein thrombosis. It is also indicated in the treatment of ischemic complications in unstable angina and non-q-wave myocardial infarction in combination with aspirin and prevention of clotting during hemodialysis. According to the data from SZYY.COM.CN (數字醫藥網), the sales revenue of LMWH products in China was approximately RMB5.843 billion in 2018, Nadroparin ranked third among all LMWH products, with the sales revenue of approximately RMB1.0 billion. The Group is currently the market leader in anti-thrombotic area in China, besides Nadroparin Calcium for Injection, it has a robust pipeline of anti-thrombotic products, such as a Phase II anti-platelet drug, Anfibatide; a Phase III Warfarin like anticoagulant, Tecarfarin; a synthetic anti-thrombotic agent, Fondaparinux; and a Factor Xa inhibitor anticoagulant, GCC-4401C. ABOUT LEE'S PHARM Lee’s Pharm is a research-driven and market-oriented biopharmaceutical company with more than 25 years of operation in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with over 20 international companies and currently markets 23 proprietary and licensed- in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease areas such as cardiovascular, woman health, paediatrics, rare diseases, oncology, ophthalmology, dermatology, obstetrics and urology. It has more than 60 products under different development stages stemming from both internal research and development as well as from the licensing and development, commercialisation, and manufacturing rights from various United States, European and Japanese companies. By order of the Board Lee’s Pharmaceutical Holdings Limited Lee Siu Fong Chairman Hong Kong, 6 August 2020 * For identification purpose only As at the date of this announcement, Ms. Lee Siu Fong (Chairman), Ms. Leelalertsuphakun Wanee and Dr. Li Xiaoyi are executive directors of the Company, Mr. Simon Miles Ball is a non-executive director of the Company, Dr. Chan Yau Ching, Bob, Mr. Lam Yat Cheong and Dr. Tsim Wah Keung, Karl are independent non-executive directors of the Company. .
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