Tenacia Biotechnology Co. Ltd. has acquired exclusive greater China rights to certain formulations of Marinus Pharmaceuticals Inc.’s seizure therapy, ganaxolone (Ztalmy), in a deal worth up to $266 million. Under the terms, Shanghai-based Tenacia now has the rights to develop and commercialize current oral and intravenous dose formulations of ganaxolone in mainland China, Hong Kong, Macao and Taiwan. It also gained the right to the first negotiation for a new formulation of the drug in the future. Read More
Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, according to top-line data. Read More
Reistone Biopharma Co. Ltd. said both doses of the JAK1 inhibitor ivarmacitinib, tested against moderate to severe atopic dermatitis (AD) in a multinational phase III trial, met the study’s co-primary endpoints, delivering significant improvements on a common measure of disease severity vs. placebo. It’s the first National Class A new drug for AD that is designed and developed in China, according to the company. Read More
Biotheus Inc. out-licensed Chinese rights to its preclinical EGFR/MET bispecific antibody, PM-1080, to Hansoh Pharmaceutical Group Co. Ltd. for ¥50 million (US$359,150) up front and up to ¥1.42 billion in future development, regulatory and commercialization milestones, plus tiered sales-based royalties. Read More
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader. Read More
Simcere Pharmaceutical Group Ltd. has inked a licensing agreement picking rights to develop Idorsia Ltd.’s insomnia treatment in greater China, in exchange for a $30 million up-front payment. Read More
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aerogen, Biontech, Biotheus, Cansinobio, ERS Genomics, Hansoh, Hutchmed, Immutep, Invivyd, Legochem, Marinus, Nextcure, Pfizer, Tenacia. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: ABVC, Akeso, Amarin, Ascletis, Astrazeneca, Beigene, Canbridge, Daiichi Sankyo, Everest Medicines, Gmax, Junshi, Novavax, Nuance. Read More
