Slightly ahead of the assigned June 23 PDUFA date, Nuvation Bio Inc. scored the U.S. FDA’s go-ahead for Ibtrozi (taletrectinib) to treat adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
Nuvation Bio Inc. said on March 25 it will acquire Anheart Therapeutics Ltd., a U.S.- and China-based precision oncology company, in an all-stock transaction, adding Anheart’s ROS1-inhibiting lung cancer drug, taletrectinib (AB-106), to its pipeline.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
Anheart Therapeutics Co. Ltd. raised $61 million in a series B round to support the development of a slate of precision oncology pipeline in-licensed by the company from Daiichi Sankyo Co. Ltd. Toward that end, funds will support phase II testing of the Hangzhou, China-based firm’s lead asset, the ROS1 inhibitor taletrectinib, for the potential treatment of non-small-cell lung cancer.
Anheart Therapeutics Co. Ltd. raised $61 million in a series B round to support the development of a slate of precision oncology pipeline in-licensed by the company from Daiichi Sankyo Co. Ltd. Toward that end, funds will support phase II testing of the Hangzhou, China-based firm’s lead asset, the ROS1 inhibitor taletrectinib, for the potential treatment of non-small-cell lung cancer.
