Cinclus Pharma's Linaprazan for GERD Receives NMPA Marketing Approval

Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval

Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug candidate, linaprazan, which is indicated for the treatment of gastroesophageal reflux disease (GERD). The drug is expected to be commercialized in China in 2025, marking a significant milestone for the company in the Chinese market.

Linaprazan: A Potassium Ion Competitive Acid Blocker (P-CAB)
Linaprazan is an oral potassium ion competitive acid blocker (P-CAB) that was co-developed by Cinclus Pharma’s partner, Jiangsu Sinorda Biomedicine Co., Ltd, during preclinical studies. The clinical phases of the drug’s development in China were independently carried out by Sinorda. This collaboration highlights the synergy between Swedish and Chinese pharmaceutical companies in bringing innovative treatments to market.

Development and Commercialization Rights
Sinorda initially obtained the development and commercialization rights for linaprazan glurate in China and other selected regions of Asia through a licensing deal with Cinclus Pharma. Subsequently, Sinorda sub-licensed the manufacturing and industrial sales rights for linaprazan glurate in China, Hong Kong, Macau, and Taiwan to SPH Sine Pharmaceutical Laboratories Co., Ltd, a subsidiary within the Shanghai Pharmaceuticals group, for a substantial sum of RMB 690 million (USD 95 million).-Fineline Info & Tech

Insight, China's Pharmaceutical Industry