drugset / Press release

VOLUNTARY ANNOUNCEMENT - OCTREOTIDE LONG-ACTING INJECTION (SYHX2008) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2026-06-18 · 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 OCTREOTIDE LONG-ACTING INJECTION (SYHX2008) 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 the Octreotide Long-acting Injection (SYHX2008) (the ‘‘Product ’’) developed by the Group has obtained approval from the U.S. Food and Drug Administration (FDA) to conduct clinical tria ls in the U.S. Octreotide is used for the first-line treatment of acromega ly and gastroenteropancreatic neuroendocrine tumors. Leveraging the Group ’s long-acting delivery technology platform, the Product ut ilizes highly biocompatible excipients to form a gel depot following subc utaneous injection. This enables long- acting drug delivery, requiring administration only once a month. Currently, the Product has entered Phase III clinical trials in China. Clinical studies have sh own that the Product takes effect within one week of administration and does not require prior administr ation of short-acting octreotide acetate injections, and its biochemical control rate demonstrates a trend of being significantly superior to currently marketed octreotide microsphere formulations. In addition, the Product features a pre-filled syringe design that allows for subcutaneous self-administ ration by patients, reducing the risk of nerve injury associated with intramuscular injections and signi ficantly improving patients ’ convenience of administration and treatment adherence. The indication for this clinical trial approval is acromega ly. The approval of this clinical trial will effectively expand the coverage of the Group ’s product lines in the global market, reinforce the advantages of the Group ’s long-acting injection technology platform and significa ntly enhance the Group ’s competitive position and industry impact in the internati onal peptide therapeutics sector. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 18 June 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, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors. – 2 –

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