As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
Biopharma deal value surged in May to $18.76 billion, up 23% from April's $15.28 billion. This increase follows March’s $8.29 billion and February’s $7.76 billion, although represents a decline from January’s $27.9 billion. The monthly average for 2024 stands at $15.64 billion, compared to the $18.14 billion monthly average in 2023. Meanwhile, the value of biopharma M&As rose to $4.75 billion in May, an increase from April’s $1.33 billion, which was the lowest figure in nearly a year.
The Biosecure Act missed its first chance at a congressional ride June 11 when the U.S. House Rules Committee didn’t include it, as many had expected, on the list of potential riders the House will consider for its version of the National Defense Authorization Act, a must-pass defense spending bill for fiscal 2025. But that doesn’t mean the bill will be stranded by the wayside.
Fledgling biotech Ternarx Pty Ltd. has emerged from stealth mode and is the first of its kind in Australia to develop targeted protein degrader technology to destroy disease-causing proteins that cannot be targeted by conventional drugs. The Melbourne-based company will initially develop targeted protein degraders against currently undrugged transcription factors in cancers with significant unmet need, starting with neuroblastoma and prostate cancer.
South Korea’s Imbiologics Inc. scored a potential $940 million (₩1.3 trillion) technology transfer deal with U.S. biotech Navigator Medicines Inc. for its bispecific antibody drug candidate, IMB-101 (Oxtima), to treat autoimmune diseases.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ascentage, Belite, Bioarctic, GC Biopharma, Innovent, Santhera.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Deciphera, Dong-A, Hudson, Ono, Shaperon.
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