drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYS6090 (JMT108) GRANTED FAST TRACK DESIGNATION BY U.S. FDA FOR TREATMENT OF PATIENTS WITH MSS/pMMR mCRC

2026-08-26 · 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 SYS6090 (JMT108) GRANTED FAST TRACK DESIGNATION BY U.S. FDA FOR TREATMENT OF PATIENTS WITH MSS/pMMR mCRC The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that SYS6090 (JMT108) (the ‘‘Product ’’), a first-in-class PD-1/IL-15 bispecific fusion protein d eveloped by the Group, has been granted Fast Track designation by the U.S. Food and Drug Admi nistration ( ‘‘FDA’’) for the treatment of patients with microsatellite-stable ( ‘‘MSS’’) or proficient mismatch repair ( ‘‘pMMR ’’) metastatic colorectal cancer ( ‘‘mCRC ’’) who have progressed on standard systemic therapies. In the United States, colorectal cancer ( ‘‘CRC’’) remains a major public health challenge. It is the third most commonly diagnosed cancer and the second leading cause of cancer-related death. The 5-year survival rate for patients with distant metastatic CRC is ap proximately 17% based on data from the Surveillance, Epidemiology, and End Results (SEER) progra m of the National Cancer Institute, and the median overall survival for patients with MSS/pMMR mCRC who have received third-line and subsequent therapies generally remains under 12 months, re presenting a significant unmet medical need. MSS/pMMR mCRC is typically considered as a ‘‘cold ’’ tumor with limited responsiveness to standard immunotherapy. The Product is a bispecific fusion protein t hat simultaneously blocks PD-1 and activates the IL-15 signaling pathway. Its specifically de signed asymmetric structure precisely directs IL-15 activity in a PD-1-dependent fashion, with the potent ial to selectively inflame the resistant or immunologically ‘‘cold ’’ tumor microenvironment and activate exhausted effector ce lls while minimizing immune-related toxicity. – 1 – The data supporting this Fast Track designation include pre clinical study results, and data from Phase 1 clinical studies underway in both China and the United State s. The granting of Fast Track designation by the FDA recognizes that the Product has demonstrated the p otential to treat a serious or life- threatening disease, and will facilitate and expedite its d evelopment and approval in the United States as well as globally. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 26 August 2026 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 –

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