A Decade of Collaboration: Medicilon Supports SinoRDA in Achieving Approval for Linaprazan Glurate

On December 3, Shanghai SinoRDA Science and Technology Co., Ltd., a subsidiary of Guizhou SinoRDA Biotechnology Co., Ltd. (SinoRDA), secured approval from the National Medical Products Administration for its Linaprazan Glurate capsules. This milestone drug, a Category 1 chemical medication, is designed to treat reflux esophagitis.

Medicilon, a trusted partner of SinoRDA for over a decade, provided comprehensive R&D services for Linaprazan Glurate, covering API, formulation, pharmacodynamics, pharmacokinetics, and safety evaluations. This collaboration played a pivotal role in accelerating the drug’s journey to approval.

Linaprazan Glurate: A Next-Generation P-CAB Drug with Global Impact

Linaprazan Glurate is a next-generation P-CAB (potassium-competitive acid blocker) that inhibits gastric acid secretion by competitively blocking the potassium ion activity of H+/K+-ATPase. It demonstrates rapid onset, sustained acid suppression, and a strong safety profile. Multiple Chinese clinical guidelines recommend Linaprazan Glurate as a first-line treatment for GERD.

The drug is the result of a joint development effort between SinoRDA and Cinclus Pharma, initiated in 2014. Extensive research in China included preclinical studies, Phase I trials in healthy volunteers, and Phase II–III trials for GERD patients. Linaprazan Glurate is also preparing for Phase III trials targeting duodenal ulcer and H. pylori eradication. Meanwhile, Cinclus Pharma has conducted Phase I–II trials for RGERD in Europe and the United States, with Phase III trials planned.

This approval marks a major breakthrough in GERD treatment, laying the groundwork for global clinical expansion and solidifying Linaprazan Glurate as a potential game-changer in the field.

Beyond Linaprazan Glurate, SinoRDA’s diversified pipeline includes early-stage projects such as the sentinel lymph node T-cell vaccine SND002, the oncolytic virus drug SND005, and the bispecific antibody SND006. These programs reflect SinoRDA’s commitment to advancing treatments for gastrointestinal diseases, tumor immunology, and autoimmune conditions.

Medicilon: Driving Innovation in Preclinical Drug Development

The approval of Linaprazan Glurate underscores a decade of fruitful collaboration between Medicilon and SinoRDA. By providing seamless, integrated R&D services, Medicilon enabled the efficient progression of this therapy from discovery to regulatory approval.

As one of China’s leading preclinical R&D service platforms, Medicilon offers a full suite of capabilities—from drug discovery to pharmaceutical research and preclinical studies. To date, the company has supported 69 IND applications, with 26 successfully completed and 31 ongoing. Its comprehensive solutions have established Medicilon as a trusted partner for biopharmaceutical innovators worldwide.

Medicilon congratulates SinoRDA on this milestone and looks forward to the expanded clinical applications of Linaprazan Glurate. Medicilon reaffirms its commitment to innovation, delivering high-quality, efficient R&D services to accelerate the development of transformative therapies.

About SinoRDA

Established in 2010, SinoRDA specializes in innovative drug development for gastrointestinal diseases, oncology, and autoimmune disorders. With advanced biopharmaceutical platforms, a seasoned technical team, and an international track record, SinoRDA collaborates with global pharmaceutical companies and research institutions to drive groundbreaking drug innovations.

About Medicilon

Founded in 2004, Medicilon (Stock Code: 688202.SH) provides comprehensive preclinical drug research services for global pharmaceutical companies and institutions. With over 2,000 clients and 490 IND-approved drugs, Medicilon accelerates drug development through efficient project management and innovative solutions.