The approved product was developed together with Cinclus Pharma’s partner Jiangsu Sinorda Biomedicine Co., Ltd, (“Sinorda”) in preclinical studies and independently developed in clinical phases in China by Sinorda. The approval of linaprazan glurate in China follows local clinical trials that demonstrated the drug's safety, efficacy, and ability to address a significant unmet need in GERD. Following the approval, pricing and reimbursement discussions will be initiated laying the foundation for expected product launch in China in 2025.

“We are thrilled to announce this highly significant marketing approval for linaprazan glurate in China, a market that represents an immense opportunity for expanding access to this innovative treatment. This achievement clearly reflects the strength of our partner Sinorda, our science, and takes us one important step closer to delivering a therapy meeting an unmet need in a global patient population,” said Christer Ahlberg, CEO of Cinclus Pharma.

Cinclus Pharma has a license agreement with Sinorda for the development and commercialization of linaprazan glurate in China and other selected regions of Asia. 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 company within the Shanghai Pharmaceuticals group, one of China’s leading public pharmaceutical and healthcare companies.