Nearing the end of 2022, the COVID-19 pandemic clearly no longer dominates the clinical activity reported by biopharma companies. Overall clinical data tracked by BioWorld is down significantly, as is the proportion focused on the SARS-Cov-2 virus. Therapeutics and vaccines targeting cancer, infectious diseases and neurological disorders, however, remain a stronghold.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Clarity, Immorna, Innocare, Junshi, Revive, Takeda, Triastek.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Bristol Myers Squibb, Grünenthal, Kyowa Kirin, Lyvgen, Sumitomo.
A computational platform that used single-cell RNA sequencing (scRNA-seq) data could quickly predict the best chemical compounds to use to convert cells from one type into another for use in research or cell therapies. The work, published in the Nov. 17, 2022, issue of Stem Cell Reports, was a collaboration between the lab of Hongkui Deng, a professor and director of the Key Laboratory of Cell Proliferation and Differentiation at Peking University in Beijing, and the lab of Antonio del Sol, a professor at the Luxembourg Centre for Systems Biomedicine at the University of Luxembourg.
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.
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.
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.
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.
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