China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
In just its second PCT filing, Ykrita Lifesciences Private Ltd. (YLS) continues to assemble intellectual property for its development of an extracorporeal bioengineered dual-cell liver regeneration (EBDLR) system which serves as a lightweight, portable, ectopic liver device to aid in the rejuvenation of the body’s own liver and treat acute liver failure without the need for surgery.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
Opthea Ltd. announced it plans to raise up to AU$227.3 million (US$150 million) to extend its cash runway through the data readout for its two phase III pivotal trials of sozinibercept (OPT-302) in wet age-related macular degeneration.
Chinese artificial intelligence (AI)-driven drug discovery firm Quantumpharm Inc., also known as Xtalpi, began trading on the Hong Kong stock exchange June 13, listing under a new special technology listing track that lured it away from an IPO in the U.S.
A week after generating buzz with its proposed Nasdaq listing and plans to raise about $200 million, Telix Pharmaceuticals Ltd. withdrew its U.S. IPO filing, citing market conditions. The Australian radiopharma firm’s shares continue trading on the Australian Securities Exchange (TLX), where they closed June 14 at AU$16.61 (US$10.98), up AU15 cents.
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.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
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