Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: AFT, Alexion, Allay Therapeutics, Astrazeneca, Astellas, Biocytogen, Biomed X Institute, Cstone, CTM, Escugen Biotechnology, Hyloris, Immunoscape, Innovent, Inxmed, JCR, Juniper, Maruishi, Pharmaceutical, Mink Therapeutics Neurocrine, Ono Pharmaceutical, Ping-An Shinonogi, Polaris, Propella, Servier, Takeda, Xuanzhu.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: .
South Korean biotech Pinotbio Co. Ltd. inked a $250 million (₩320 billion) licensing deal with Princeton, N.J.-based Conjugatebio Inc. to develop 10 antibody-drug conjugate (ADC) targets with Pinotbio’s ADC platform technology. The deal announced on Dec. 21 adds to a previous agreement between the two companies last year. Pinotbio and Conjugate first teamed up to discover and develop five ADC targets in June 2022.
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
Taiwan’s Caliway Biopharmaceuticals Co. Ltd. said it secured more than $100 million in an oversubscribed capital raise to advance CBL-514, its lead asset for subcutaneous fat reduction nearing phase III studies.
If the COVID-19 pandemic shocked countries to build self-reliance in biomedical ecosystems, the re-opening of borders in 2023 kickstarted international collaborations to grow major biohubs in Asia. Countries in the Asia Pacific region – including Singapore, China, Japan, Korea and Australia – increasingly drew overseas investors and collaborators, helping each country grow national biotech capabilities and expertise.
Neuren Pharmaceuticals Ltd. plans to progress NNZ-2591 to phase III trials following positive top-line phase II results in children with Phelan-McDermid syndrome, a genetic neurodevelopmental disorder for which there are no approved treatments.
Biopharma deals totaled $18.97 billion in November, marking a notable decrease from October’s historic deal value of $44.91 billion. Even still, through the first 11 months of 2023 cumulative deal value reached $194.26 billion, an 18.65% gain over the $163.73 billion recorded in the same period in 2022.
Compugen Ltd. has entered another collaboration, this time exclusively licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million.
South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024.
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