China’s Pharma Firms Collaborate on Generic Version of Sun Pharma’s Carbamazepine

Several China-based pharmaceutical companies, including Shanghai Zhongxi Sunve Pharmaceutical Co. Ltd, Shanghai Anbison Lab Co., Ltd, Qingdao BAHEAL Pharmaceutical Co., Ltd, and SPH Pharmaceutical Sales Co., Ltd, have agreed to collaborate on the development and marketing of Anbison Lab’s first generic version of carbamazepine sustained-release tablets (II) in China. The drug is a dibenzodiazepine used to treat epilepsy and peripheral neuralgia.

Market and Regulatory Context
Carbamazepine sustained-release tablets (II) are a first-line treatment for epilepsy and a recommended treatment for trigeminal neuralgia. The market for these tablets was initially dominated by Novartis’s Tegretol, the first carbamazepine sustained-release tablets to be launched. Anbison Lab’s generic version, which was first approved in the US in 2021, received regulatory approval in China in 2022 with three different specifications.

Collaboration Details
Under the agreement, marketing approval for the generic carbamazepine sustained-release tablets will be transferred to Sunve Pharmaceutical. BAHEAL will handle the supply chain, while SPH Pharmaceutical Sales will be responsible for marketing and promotional activities in China. Financial details of the collaboration were not disclosed.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry