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CSPC Pharmaceutical Group Limited — Regulatory Filings 2021
May 11, 2021
49680_rns_2021-05-11_631ab305-43db-4eba-bd10-a91f72791268.pdf
Regulatory Filings
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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.
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CSPC PHARMACEUTICAL GROUP LIMITED 石藥集團有限公司
(Incorporated in Hong Kong with limited liability)
(Stock code: 1093)
VOLUNTARY ANNOUNCEMENT
PASSING OF CONSISTENCY EVALUATION FOR “DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION”
The board of directors (the “ Board ”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “ Group ”) is pleased to announce that the “Doxorubicin Hydrochloride Liposome Injection (10ml:20mg)” (brand name: Duomeisu (多美素)) (the “ Product ”) developed by CSPC Ouyi Pharmaceutical Co., Ltd.*(石藥集團歐意藥業有限公司), a subsidiary of the Company, has been granted approval by the National Medical Products Administration of the People’s Republic of China for passing the consistency of quality and efficacy evaluation of generic drugs (the “ Consistency Evaluation ”), being the first product of this type passing the Consistency Evaluation in China.
Doxorubicin hydrochloride, an anthracycline antibiotic, is a broad-spectrum anti-tumor drug with cytotoxic effects by the inhibition of DNA, RNA and protein synthesis. It can be indicated for the treatment of AIDS-related Kaposi’s sarcoma (AIDS-KS) in patients with low CD4 count (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. The Product can be used as first-line systemic chemotherapy or as second-line chemotherapy in AIDS-KS patients with progression or in patents intolerant to prior combination chemotherapy comprising at least two of the following agents: vincristine, bleomycin and standard doxorubicin (or other anthracycline antibiotics).
Duomeisu is one of the key anti-tumor products of the Group. The passing of the Consistency Evaluation signifies that the Group’s high-end nano-preparation technology has reached the advanced international standard.
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By Order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen
Chairman
Hong Kong, 11 May 2021
As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.
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