Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.

China’s Jiangsu Hengrui Pharmaceuticals Co. Ltd. is launching a new biotech company called Luzsana Biotechnology that will develop and commercialize Hengrui assets in the U.S., Europe and Japan. A wholly owned subsidiary of Hengrui, Luzsana, which means “healing light,” will develop innovative products from Hengrui’s pipeline.

Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.

Just in case the U.S. FDA didn’t get the message from its advisory committee about drug applications based solely on clinical trial data from China, a trio of U.S. lawmakers wrote to FDA Commissioner Robert Califf to voice their concerns about the “current ‘East to West’ movement of clinical data” to support the approval of me-too drugs.

Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.

In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.

Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market.

Orion Corp. has secured exclusive global rights, outside China, to a non-opioid pain drug candidate from Jiangxi Jemincare Group Co. Ltd. The deal, for oral sodium channel inhibitor JMKX-000623, brought Jemincare €15 million (US$15.6 million) up front. 

Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.