drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYH2059 TABLETS OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2025-02-10 · 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 whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT SYH2059 TABLETS OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that SYH2059 Tablets (the ‘‘Product ’’), a new Class 1 chemical drug developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical tria ls in the U.S. Previously, the Product obtained approval from the National Medical Products Admin istration of the People ’s Republic of China to conduct clinical trials in China in January 2025. The Product developed by the Group ’s innovative small molecule drug design platform is a novel, highly active and highly selective cyclic nucleotide phosp hodiesterase 4B (PDE4B) inhibitor with complete independent intellectual property rights. The in dication for this clinical trial approval is interstitial lung disease. Preclinical studies demonstra ted that the selectivity and activity of the Product for the PDE4B target were significantly better than other dr ugs with the same target, and its efficacy in animal models of human disease was also distinctly better th an the existing drugs, with good pharmacokinetic characteristics and safety profile. Currently, there are few drugs on the market available for th e treatment of interstitial lung disease, and patients have limited benefit from these treatments. The Pr oduct has the potential to become an effective drug for the treatment for this disease, providin g a promising clinical development value. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 10 February 2025 – 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 Chu nlei, Dr. YAO Bing, Mr. CAI Xin and Mr. CHEN Weiping as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Steph en and Ms. LI Quan as independent non-executive directors. – 2 –

The release as fetched from its publisher. irasia.com ↗