Microport Neurotech Ltd.’s intracranial visualized stent Rebridge has been included in the green channel, a priority review for medical devices, by China’s NMPA.

Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms.

Tenacia Biotechnology Co. Ltd. has acquired exclusive greater China rights to certain formulations of Marinus Pharmaceuticals Inc.’s seizure therapy, ganaxolone (Ztalmy), in a deal worth up to $266 million. Under the terms, Shanghai-based Tenacia now has the rights to develop and commercialize current oral and intravenous dose formulations of ganaxolone in mainland China, Hong Kong, Macao and Taiwan. It also gained the right to the first negotiation for a new formulation of the drug in the future.

Reistone Biopharma Co. Ltd. said both doses of the JAK1 inhibitor ivarmacitinib, tested against moderate to severe atopic dermatitis (AD) in a multinational phase III trial, met the study’s co-primary endpoints, delivering significant improvements on a common measure of disease severity vs. placebo. It’s the first National Class A new drug for AD that is designed and developed in China, according to the company.

Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.

Tenacia Biotechnology Co. Ltd. has acquired exclusive greater China rights to certain formulations of Marinus Pharmaceuticals Inc.’s seizure therapy, ganaxolone (Ztalmy), in a deal worth up to $266 million.

As China seeks to be more independent in medical device development, authorities have released several guidelines to enhance the quality of its medical devices, as well as accelerate their registration.