VOLUNTARY ANNOUNCEMENT - "Q101-PEGYLATED RECOMBINANT HUMAN INTERFERON-alpha2a FOR INJECTION" FOR THE TREATMENT OF HEPATITIS WAS GRANTED CLINICAL TRIAL APPROVAL
2018-05-10 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
— 1 — 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. CSPC PHARMACEUTICAL GROUP LIMITED ʮ ̡ (Incorporated in Hong Kong under the Companies Ordinance) (Stock Code: 1093) VOLUNTARY ANNOUNCEMENT “Q101-PEGYLATED RECOMBINANT HUMAN INTERFERON-α2a FOR INJECTION” FOR THE TREATMENT OF HEPATITIS WAS GRANTED CLINICAL TRIAL APPROVAL The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “Group”) announces that the “Q101-Pegylated Recombinant Human Interferon-α2a for Injection” (the “ Product ”) developed by the Group was recently granted clinical trial approval by China Food and Drug Administration of the People’s Republic of China (“China ”) for carrying out clinical trials. The Product is a site-specific mono-pegylated recombinant human interferon-α2a formed by the connection of 40KDa Y-PEG-NH 2 and recombinant human interferon-α2a through a stable covalent bond. Clinically, it is used alone or in combination with other drugs for the treatment of adults with chronic hepatitis B; and used in combination with ribavirin for the treatment of adults with chronic hepatitis C with no previous treatment. The Product is developed by the Group and has demonstrated to have significant advantages over the conventional preparations in pre-clinical studies: significantly prolonged time of peak concentration in the body, significantly higher peak concentration, significantly less fluctuations in blood concentration, low elimination rate, and half-life extension by at least tenfold. Moreover, results of animal safety assessments have shown that the Product has good safety and tolerance. — 2 — Currently, there are similar products available in China. Given the favourable results in the pre-clinical studies, the Group will endeavor to launch the Product expeditiously. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 10 May 2018 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. PAN Weidong, Mr. WANG Huaiyu, Mr. WANG Zhenguo, Mr. WANG Jinxu, Mr. LU Hua, Mr. LI Chunlei and Mr. CHAK Kin Man as executive directors; Mr. LEE Ka Sze, Carmelo as non-executive director; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Mr. LO Yuk Lam, Mr. YU Jinming and Mr. CHEN Chuan as independent non-executive directors.
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