VOLUNTARY ANNOUNCEMENT - THE GROUP'S INVESTIGATIONAL NEW DRUG "CSPCHA115" WAS GRANTED CLINICAL TRIAL APPROVAL BY THE U.S. FDA
2018-07-10 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
—1 — Hong Kong Exchanges and Cl earing Limite d and The Stock Exc hange of Hong Kong Limited take no responsibility for the contents of this a nnouncement, 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 INVESTIGATIONAL NEW DRUG “CSPCHA115” WAS GRANTED CLINICAL TRIAL APPROVAL BY THE U.S. FDA 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 U.S. Food and Drug Administration (the “U.S. FDA”) has approved the Investigationa l New Drug (IND) application for “CSPCHA115” (the “Product”), a new drug developed by the Gr oup for the treatment of allergic rhinitis and asthma. Pathophysiological studies have shown that some inte rleukins (IL) such as IL-4, IL-5 and IL-13 are important in the manifestation of allergic rhinit is and asthma, which can be completely blocked by selective prostaglandin D2 (PD2) receptor anta gonists. Thus, as a highl y selective and potent antagonist for PD2 receptor,”CSPCHA115” might be be neficial for the treatmen t of allergic rhinitis and asthma. Non-clinical animal efficacy models in mice and guinea pigs have demonstrated that the Product effectively alleviated allergic rhinitis and asth ma. The completed animal safety and toxicology studies did not reveal any major or unexpected safety findings, and the overall safety profile observed in animal studies for the Product appears favorable. T hus, it is reasonable to believe that the Product is safe for human study. The IND approval obtained from the U.S. FDA will a llow the Group to start c linical trials of the Product in the United States (the “ U.S.”). The Product has also been approved to conduct clinical trials in China. Thus, the Group is now pushing forward w ith the clinical development of the Product in both the U.S. and China. —2 — “CSPCHA115” is developed by the Group with inde pendent intellectual pr operty rights. Multiple patent applications have been filed in various counties including the U.S. and China. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 10 July 2018 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG H uaiyu, Mr. WANG Jinxu, Mr. LU Hua, Mr. LI Chunlei, Mr. ZHANG Cuil ong and Mr. CHAK Kin Man as executive directors; Mr. LEE Ka Sze, Carmelo as non-executive dire ctor; 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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