The Phase III clinical study of Linaprazan glurate—the National Investigators' Meeting—was held in Hangzhou, bringing together experts to collaboratively explore innovative treatment strategies for duodenal ulcers and Helicobacter pylori eradication.

The Phase III clinical study of Linaprazan glurate, a national investigator meeting, was held in Hangzhou.

——Focusing and pooling our efforts to jointly explore new treatment strategies for duodenal ulcers and Helicobacter pylori eradication

On November 8, 2025, in Hangzhou—The national investigator meeting for the two Phase III clinical trials of "Linaprazan glurate (X842) Capsules," hosted by Shanghai Sinorda Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Sinorda) and co-organized by Anhui CTSMED Pharmaceutical Technology Co., Ltd. (hereinafter referred to as CTSMED), was successfully held in Hangzhou. The conference brought together over 120 researchers from more than 40 centers across China, jointly discussing the clinical development plan for this domestically produced Class 1 new drug in the treatment of duodenal ulcers and Helicobacter pylori eradication.

As the leading institution, Sun Yat-sen University First Affiliated Hospital, its principal investigator, Professor Minhu Chen, delivered an opening speech that thoroughly highlighted the clinical value and industry significance of this study. He also emphasized the stringent quality standards set by the national drug regulatory authorities for clinical trials, laying a solid foundation for the smooth implementation of the research.

Lu Ming, General Manager of the sponsoring company Sinorda, elaborated on the company's development history, R&D pipeline, and core team, with a particular focus on the key advantages of the investigational drug, Linaprazan Glurate. This drug is a Class 1 new chemical entity independently developed by Sinorda over ten years. It received market approval from the National Medical Products Administration (NMPA) in December 2024 for the treatment of reflux esophagitis. Characterized by its faster onset of action, more potent acid suppression, and longer duration of effect, Linaprazan Glurate holds promise as a superior treatment option for a broader range of acid-related diseases, including duodenal ulcer and Helicobacter pylori infection.

Medical Director Li Zhen of CTSmed provided a detailed explanation of the two study protocols. The trial adopted a rigorous design of "multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group." The participating experts held in-depth discussions on key aspects such as inclusion/exclusion criteria, endoscopic evaluation, and the 13C-urea breath test, further optimizing the scientific validity and operability of the study. Subsequently, Senior Clinical Director Cui Xuefen of CTSmed presented the study execution plan. As a CRO company that has facilitated the successful market approval of 23 drugs and 7 medical device products, CTSmed possesses extensive experience in the gastroenterology field. It will strictly adhere to the project timeline and, through comprehensive training and the development of detailed data management and monitoring plans, assist investigators across all centers in completing the clinical research with high quality.

Director Xiao Yinglian from the First Affiliated Hospital of Sun Yat-sen University conducted a systematic training session on standardized procedures for endoscopic evaluation and key operational points of breath tests, providing crucial guidance to help all centers achieve uniform standards and obtain high-quality clinical data.

At the conclusion of the meeting, Professor Hu Pingsheng, founder of Sinorda, delivered a closing speech. He stated that the meeting successfully unified the research approaches and standards, and clarified the subsequent key milestones. All parties will collaborate closely, strictly control quality, and jointly advance the clinical research of Linaprazan Glurate, striving to ensure this domestic innovative achievement benefits a broad patient population at the earliest opportunity.