China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has signed an exclusive licensing deal with compatriot firm Jiangsu Carephar Pharmaceutical Co., Ltd to develop H008 globally, including its oral preparation and injection forms, and covering all plausible indications.
Agreement Details and Rights Allocation
Under the agreement, Carephar will be the Marketing Authorization Holder (MAH) of the product in mainland China, while Fosun will exclusively enjoy commercialization rights, including market promotion and distribution. Outside of China, Fosun will act as the MAH, owning exclusive product rights, including but not limited to clinical studies, regulatory filing, commercialization, sub-licensing rights, and more. Financial details of the deal were not disclosed.
Product Overview and Development
H008 is China’s first domestically developed potassium competitive acid blocker (P-CAB), designed for use in treating duodenal ulcer, reflux esophagitis, and Helicobacter pylori infection, among other conditions. Carephar filed the tablets for approval in duodenal ulcer and reflux esophagitis in China in September 2021. Meanwhile, in the US, the drug has concluded a Phase I clinical study.
Future Outlook
The exclusive licensing deal between Fosun and Carephar marks a significant step in advancing the global development of H008. By leveraging their respective strengths, the companies aim to bring this innovative P-CAB to patients worldwide, addressing significant unmet needs in gastrointestinal health.-Fineline Info & Tech
