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.
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.
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.