VOLUNTARY ANNOUNCEMENT - CPO301 RECEIVES FAST TRACK DESIGNATION FROM THE US FDA
2024-10-08 · 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 announcemen t, make no representation as to its accuracy or completeness and expressly disclaim any lia bility whatsoever for any loss howsoever arising from or in reliance upon the whole or any pa rt of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT CPO301 RECEIVES FAST TRACK DESIGNATION FROM THE US 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 CPO301, a first-in-class antibody drug conjugate (ADC) dev eloped by the Group, has received Fast Track Designation from the US Food and Drug Adm inistration (FDA) for the treatment of patients with recurrent or metastatic squamou s non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) overe xpression that has progressed on or after treatment with platinum-based chemotherapy and anti-PD-(L1) therapy. Lung cancer is one of the leading causes of cancer incidence a nd mortality worldwide. Though many effective therapeutic treatments have been dev eloped, there are still unmet medical needs for the effective treatment of recurrent or me tastatic squamous NSCLC. CPO301 demonstrated encouraging efficacy and satisfactor y safety and tolerability in recurrent or metastatic squamous NSCLC patients enrolled i n the Phase I studies in China and the US. This is the second Fast Track Designation granted by the US FD A for CPO301. The first Fast Track Designation was granted for the treatment of pati ents with metastatic NSCLC harbouring EGFR mutations who are relapsed/refractory to o r ineligible for EGFR targeting therapy such as 3rd-generation EGFR inhibitors including O simertinib. These designations shall expedite the development of CPO301 in the US. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 8 October 2024 – 1 – 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 Hao, Dr. YAO Bing and Mr. CAI Xin as executive directors ; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. L AW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –
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