(Yicai) Aug. 8 -- Shares in Zhejiang Jingxin Pharmaceutical reached a record high today after the Chinese drugmaker said that, four years after failing to overturn Hungarian biotech firm Gedeon Richter’s China patent for an innovative antipsychotic drug, it has secured the exclusive license to use that patent in mainland China, paving the way for Jingxin to launch and commercialize its generic version in the domestic market.

Jingxin’s share price [SHE:002020] closed up 3.4 percent at CNY19.12 (USD2.60). Earlier in the day it hit CNY19.90. The stock has gained 58 percent in value over the past month.

Gedeon Richter, the developer of the original drug, will grant Jingxin the exclusive rights to develop, manufacture and commercialize formulations of cariprazine hydrochloride, which is a treatment for mental disorders, and its active pharmaceutical ingredient on the Chinese mainland, Jingxin said yesterday, citing the patent licensing agreement the two parties penned that day.

Once the generic drug gets the green light from Chinese regulators, Jingxin will produce this new medicine in-house and sell it under its own brand. The Xinchang-based company has already filed an application with Chinese authorities to take the generic medicine to market.

On gaining regulatory approval, Jingxin will pay Budapest-based Gedeon Richter up to EUR530,000 (USD616,730) in milestone payments, and, once sales begin, Jingxin will also pay a portion of net sales revenue to Gedeon Richter based on an agreed percentage.

Gedeon Richter’s patents for cariprazine hydrochloride in China include a compound patent and a crystal-form patent. The compound patent expired last year, while the crystal-form patent is valid until May 2028.

Back in 2020, Jingxin challenged the validity of the crystal-form patent but lost the case in June 2021 when the National Intellectual Property Administration ruled against it.

Cariprazine hydrochloride, which is sold under the brand name Vraylar, is a non-typical antipsychotic drug that is mainly used to treat or support the treatment of schizophrenia and depression in adults. It has already been approved by the US Food and Drug Administration and the European Medicines Agency for multiple indications.

Editor: Kim Taylor