VOLUNTARY ANNOUNCEMENT - CRB-701 (SYS6002) GRANTED FAST TRACK DESIGNATION BY THE U.S. FDA
2024-12-04 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
Hong Kong Exchanges and Clearing Limited and The Stock Excha nge 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 (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT CRB-701 (SYS6002) GRANTED FAST TRACK 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 ’’) is pleased to announce that CRB-701 (SYS6002) (the ‘‘Product ’’), developed by Corbus Pharmaceuticals, Inc. ( ‘‘Corbus Pharmaceuticals ’’) under a license from the Group, has been granted Fast Track designation by th e U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory metastati c cervical cancer. The product is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4 that contains a site- specific, cleavable linker and a precise drug antibody rati o of 2 using MMAE as the payload. The FDA’s Fast Track designation is designed to facilitate the devel opment of drugs intended to treat serious conditions that demonstrate the potential to fill u nmet medical needs, and expedite the review. The Product has recently completed enrollment of the dose es calation part of its Phase I clinical trial (NCT06265727) that is being conducted in the U.S. and Europe . The three-part Phase I trial is evaluating the safety, pharmacokinetics and efficacy of th e Product in patients with advanced solid tumors known to be associated with high Nectin-4 expression . By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 4 December 2024 As at the date of this announcement, the Board comprises Mr. C AI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. JIANG Ha o, Dr. YAO Bing and Mr. CAI Xin as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Honggu ang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors.
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