Systimmune Inc. and Bristol Myers Squibb Co. have joined hands in a co-development deal for bispecific antibody drug conjugate (ADC) BL-B01D1 in a deal worth up to $8.4 billion. The deal falls on the heels of BMS acquiring Mirati Therapeutics in October 2023 for $4.8 billion to add to its oncology pipeline.
Systimmune Inc. and Bristol Myers Squibb Co. have joined hands in a co-development deal for bispecific antibody drug conjugate (ADC) BL-B01D1 in a deal worth up to $8.4 billion. The deal falls on the heels of BMS acquiring Mirati Therapeutics in October 2023 for $4.8 billion to add to its oncology pipeline.
Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
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.
Connect Biopharma Holdings Ltd. has been seeking a partner for its atopic dermatitis candidate rademikibart, and it appears to have found the perfect partner in Simcere Pharmaceutical Group, which gains exclusive rights to develop, manufacture and commercialize rademikibart in China in a deal worth $120 million plus royalties.
Asep Medical Holdings Inc. is expanding operations into China with a joint venture (JV) with Chinese medical diagnostics firm Sansure Biotech Inc., ramping up the race to commercialize sepsis diagnostics in Asia.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
Doubling efforts to thaw the global biotech capital freeze, the U.S. branch of Shanghai-based Fosun Pharmaceutical Group Co. Ltd. will ramp up investment into U.S. clinical-stage assets through a new joint investment vehicle with American health care advisory firm Treehill Partners.
Two-year-old Ensem Therapeutics Inc. landed a deal potentially worth $1.33 billion, if all milestones are met, with Beigene Ltd. to advance its lead IND-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor. Beigene, which has a presence in Basel, Switzerland, Beijing, and Cambridge, Mass., plans to fold the inhibitor into its breast cancer efforts, which includes its internally discovered phase I CDK4 inhibitor. Rights to the Ensem product are exclusive and global.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
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