VOLUNTARY ANNOUNCEMENT - THE GROUP'S COUGH SUPPRESSANT PRODUCT "BENZONATATE SOFT CAPSULE" WAS GRANTED DRUG REGISTRATION APPROVAL BY THE U.S. FDA
2015-08-05 · 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. VOLUNTARY ANNOUNCEMENT THE GROUP’S COUGH SUPPRESSANT PRODUCT “BENZONATATE SOFT CAPSULE” WAS GRANTED DRUG REGISTRATION APPROV AL BY THE U.S. FDA The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company”, together with its subsidiaries (the “ Group”)) announces that the Group’s product “Benzonatate Soft Capsule” has passed the Abbreviated New Drug Application ( “ANDA”) (File no.: 202765) and was granted drug registration approval by the U.S. Food and Drug Administration (“U.S. FDA”). Benzonatate soft capsule is a non -narcotic cough suppressant used for relieving cough symptoms. Upon absorption by the body, benzonata te is distributed along the respiratory tract with significant suppressing effect on the pulmonary stretch sensors and sensory nerve endings. It is able to suppress the pulmonary vagal reflex and thereby block the input impulses of cough reflex, achieving cough suppressing effects without suppressing respiration. Clinically it is commonly used for irritable dry cough and intermittent cough caused by acute bronchitis, bronchial asthma, pneumonia and lung cancer. Benzonatate soft capsule is one of the Group’s products with ANDA submitted to the U.S. FDA. This approval signifies the Group ’s research and development and its quality control have reached international standard and adds another oral solid dosage product with approval by the U.S. FDA to the Group . This lays a solid foundation for opening up international markets such as the United States, Australia, New Zealand, South Africa and Turkey for the Group’s soft capsule products. -2- By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 5 August 2015 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. FENG Zhenying, Mr. CHAK Kin Man, Mr. P AN Weidong, Mr. WANG Shunlong, Mr. WANG Huaiyu, Mr. LU Jianmin, Mr. WANG Zhenguo and Mr. WANG Jinxu 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 Shilin as independent non-executive directors.
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