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. Read More
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. Read More
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions. Read More
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. Read More
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement. Read More
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. Read More
South Korean pharmaceutical Voronoi Inc. said that New Jersey-based Pyramid Biosciences Inc. terminated its previous $846 million deal for Voronoi’s solid and breast cancer drug candidate, VRN-08, in a letter dated Oct. 24, 2023. Read More
Ophthalmology company Polyactiva Pty Ltd.’s biodegradable ocular implant provides six months of sustained drug delivery for patients with glaucoma and is the first biodegradable ocular implant that has the potential to be used safely for repeat dosing, Polyactiva CEO Vanessa Waddell told BioWorld. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Adlai Nortye Biopharma, Aribio, Brii Biosciences, Certa Therapeutics, Neuren Pharmaceuticals, SCG Cell Therapy, Visen Pharmaceuticals. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Astellas, Chiesi Farmaceutici, Haisco Pharamceutical, Mayne Pharma, Propella, Qsam, Telix, Therapeuticsmd. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Appolomics, Aurinia, Pfizer. Read More
