On May 8, 2023, Trevena, Inc. announced that its partner in China, Jiangsu Nhwa Pharmaceutical Co. Ltd., received formal approval from the National Medical Products Administration for OLINVYK. The Chinese regulatory agency (NMPA) accepted the NDA in January 2022.

The approval is based on results of two bridging trials conducted in China and also leveraged US clinical data. Results from the bridging studies demonstrated that the safety, tolerability and pharmacokinetic profile of OLINVYK in Chinese patients is consistent with what has been seen in other OLINVYK clinical trials. Jiangsu Nhwa has an exclusive license agreement for the development and commercialization of OLINVYK In China.

Trevena is due to receive a $3 million milestone payment from Jiangsu Nhwa with the approval. The Company is also eligible to receive $15 million upon first commercial sale of OLINVYKin China, in connection with its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund (the R-Bridge Financing). As part of the R-Bridge Financing, Trevena previously received a $15 million upfront payment and may receive an additional $10 million upon achievement of either a commercial or financing milestone.