VOLUNTARY ANNOUNCEMENT-THE GROUP'S GASTRIC CANCER DRUG "DP303c" WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA
2018-02-06 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
—1 — Hong Kong Exchanges and Clearing Limited and The St ock Exchange of Hong Kong Limited take no responsibilit y for the contents of th is announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoeve r arising from or in reliance upon the whole or any part of the contents of this announcement. VOLUNTARY ANNOUNCEMENT THE GROUP’S GASTRIC CANCER DRUG “DP303c” WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA The Board of Directors (the “ Board ”) of CSPC Pharmaceutical Group Limited (the “Company ”, together with its subsidiaries, the “ Group ”) i s p le a s e d t o announce that the antibody-drug conjugate drug “ DP303c” (the “ Product ”) developed by the Group was granted orphan-drug designation by the U.S. Food and Drug Administration (the “ U.S. FDA ”) for the treatment of gastric cancer incl uding cancer of gastroesophageal junction. Approximately 15%-20% patients with gastric can cer are HER2 (Human Epidermal Growth Factor Receptor 2) positive. The incidence of HER2 pos itive is even higher in patients with cancer of gastroesophageal junction. In th e U.S., there are fewer than 200, 000 patients with gastric cancer, thus can be classified as a rare disease. However, the prevalence rate of gastric cancer is relatively high in Asian countries including China, Japan and South Korea. DP303c consists of an antibody that selectively binds to HER2 and a cytotoxic agent, representing a new type of targeted drug for the treatment of HER2 positive gastric cancer. DP303c has shown potent anti-tumor effects in a mouse NCI-N87 m odel for HER2 positive human gastric cancer and in an in-vitro assay with HER2 positive SK-BR-3 cell line. Therefore, we believe that DP303c can achieve better efficacy for the treatment of gast ric cancer with less si de effects and prolonged survival. —2 — DP303c is developed by the Group with independent intellectual property rights. Multiple patent applications have been filed in vari ous counties including U.S. and China. The orphan-drug designation implies that more guidance will be given by the U.S. FDA and there will be more opportunity to communicate with the U.S. FDA . Under certain circumstances, part of the clinical trials can be waived to speed up the product launch. In addition, orphan drugs in the U.S. are entitled to 7 years of ex clusive marketing rights and tax credits of up to 50% of the research and development cost. The Group is now push ing forward with the clinical development of the Product in both U.S. and China. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 6 February 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 di rector; and Mr. CHAN Siu Keung, Leonard, Mr. WANG Bo, Mr. LO Yuk Lam, Mr. YU Jinming and Mr. CHEN Chuan as independent non-executive director
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