China-based Jingxin Pharmaceutical Co., Ltd. (SHE: 002020) announced that it has signed a Patent License Agreement with Gedeon Richter Plc. Under the agreement, Gedeon Richter will grant Jingxin Pharmaceutical an exclusive patent license to develop, manufacture, and commercialize cariprazine hydrochloride formulations and active pharmaceutical ingredients (API) within mainland China.
Drug Profile
Cariprazine hydrochloride is an atypical antipsychotic drug that acts as a partial agonist of dopamine D2 and D3 receptors. It is primarily used for the treatment of adult schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder, and as an adjunctive treatment for major depressive disorder (MDD). The drug has received regulatory approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for various indications, including schizophrenia and bipolar disorder.
Market Potential
Despite its widespread approval and use in other markets, cariprazine hydrochloride has not yet been approved in China. Jingxin Pharmaceutical has officially submitted a marketing application to China’s National Medical Products Administration (NMPA) to bring this innovative treatment option to Chinese patients.
Agreement Details
Upon fulfilling certain conditions, including regulatory approval, Jingxin Pharmaceutical will pay Gedeon Richter milestone payments totaling up to 530,000 euros. Additionally, after the market launch of cariprazine hydrochloride products in mainland China, Jingxin will pay sales royalties based on net sales.-Fineline Info & Tech
