VOLUNTARY ANNOUNCEMENT - HIGHLY SELECTIVE PDE4B INHIBITOR (SYH2059 POWDER FOR INHALATION) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.
2026-03-06 · 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 HIGHLY SELECTIVE PDE4B INHIBITOR (SYH2059 POWDER FOR INHAL ATION) 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 powder for inhalation (the ‘‘Product ’’), a new Class 1 chemical drug developed by the Group, has obta ined approved from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the U.S. The Product is a novel, highly active and highly selective ph osphodiesterase 4B (PDE4B) inhibitor developed by the Group with complete independent intellect ual property rights. The approved dosage form for this clinical trial is powder for inhalation. Precl inical studies demonstrated that the Product could significantly increase pulmonary drug concentratio ns and reduce systemic exposure, thereby reducing gastrointestinal side effects. Its efficacy in an imal models of human disease was distinctly better than the existing drugs, with good pharmacokinetic c haracteristics and a broad safety margin. The indication for this approved clinical trial is pulmonar y fibrosis (PF), encompassing idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibros is (PPF). Currently, there are few drugs on the market available for the treatment of these diseases, an d patients have limited benefit from these treatments. The Product has the potential to become an effec tive drug for the treatment for these disease, providing a promising clinical development value . The approval of the Product for clinical trials represents a key achievement of the Group ’s high-end innovative inhalation technology platform, and lays a solid foundation for the development of subsequen t innovative inhalation formulations within the Group ’s pipeline. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 6 March 2026 – 1 – As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. WANG Huaiy u, Dr. LI Chunlei, Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiw ei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Dir ectors. – 2 –
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