Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting.
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.
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.
Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.
Beigene Ltd. struck a global licensing deal with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. worth up to $1.5 billion for its phase I selective methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH-2039, which is being explored for solid tumors.
SK Biopharmaceuticals Co. Ltd. and Proen Therapeutics Co. Ltd. joined hands in a research collaboration to advance up to two preclinical small protein-based radiopharmaceuticals by 2027 – the year SK Biopharmaceuticals aims to “become a leading radiopharma player” worldwide.
Beijing Hanmi Pharm. Co. Ltd. broke ground on a ₩140 billion (US$98.65 million) large-scale project to build a near-500,000-square-foot China base near Beijing Capital International Airport in efforts to increase the company’s local production, R&D and office capabilities.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
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