The next-generation P-CAB drug, "Linaprazan Glurate Capsules," has been approved for market launch.

On December 3, 2024, Shanghai Sinorda Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Guizhou Sinorda Pharmaceutical Co., Ltd. (hereinafter referred to as "Sinorda"), received the Drug Registration Certificate from the National Medical Products Administration for Linaprazan Glurate Capsules, a Class 1 new chemical drug approved for the treatment of reflux esophagitis.

Screenshot source: NMPA official website

Linaprazan Glurate is a globally innovative drug jointly developed by Sinorda and Cinclus. Sinorda initiated independent preclinical research in China in 2014 to support regulatory submissions in China, the U.S., and Europe, ultimately aiming for a global first launch. Currently, Sinorda has independently completed Phase I clinical trials involving healthy volunteers and Phase II–III clinical trials targeting patients with reflux esophagitis in China. The company is now preparing for Phase III clinical trials focusing on new indications—duodenal ulcers—as well as the combination therapy of linagrelate with appropriate antibiotics for the eradication of Helicobacter pylori. Meanwhile, in Europe and the U.S., Cinclus Pharma has already independently completed Phase I–II clinical trials for refractory gastroesophageal reflux disease (RGERD), with Phase III trials currently in preparation. The approval of Linaprazan Glurate in China will provide patients with a fresh treatment option, benefiting more individuals in need.

About Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease (GERD) is a common chronic digestive disorder caused by the reflux of stomach and duodenal contents into the esophagus or mouth, leading to uncomfortable symptoms and/or complications. GERD has a high prevalence that continues to rise, significantly impacting health and quality of life—and it may even progress to esophageal cancer. Proton Pump Inhibitors (PPIs) are widely used as standard treatments, yet they have limitations such as a short half-life, slow onset of action, instability in acidic environments, and variability influenced by genetic polymorphisms. As a result, approximately 30% of GERD patients show an inadequate response to standard-dose PPI therapy.

Linaprazan Glurate is a next-generation potassium-competitive acid blocker (P-CAB) drug. Unlike proton pump inhibitors (PPIs), P-CAB competitively blocks the activity of potassium ions at the H+/K+-ATPase enzyme—the "proton pump"—thereby effectively inhibiting gastric acid secretion. Studies have shown that Linaprazan Glurate exhibits rapid onset of action when taken orally, providing long-lasting, high-intensity suppression of gastric acid production with excellent safety profiles. P-CAB has been recommended as the preferred treatment option for GERD in clinical guidelines such as the "Chinese Expert Consensus on Gastroesophageal Reflux Disease (2020 Edition)" and the "Chinese Guidelines for Diagnosis and Management of Gastroesophageal Reflux Disease (2023 Edition)."

About Sinorda

Sinorda was established in 2010 and is a biopharmaceutical company dedicated to the research, development, and commercialization of innovative drugs targeting gastrointestinal diseases, oncology immunotherapy, and autoimmune disorders. The company boasts a cutting-edge bio-innovative drug technology platform, a robust clinical research and development infrastructure, an experienced technical and management team, and an internationally renowned scientific advisory board—all equipped with the capability to pioneer original drug discoveries. Rooted in China’s domestic innovation ecosystem, Sinorda has successfully navigated the complex landscape of drug development and regulatory submissions in both China and key global markets like Europe and the U.S. Through extensive collaborations with pharmaceutical companies and R&D institutions at home and abroad, the company is rapidly advancing toward its vision of becoming one of China’s most valuable and impactful innovator-driven pharmaceutical enterprises.