In a deal worth as much as $600 million, Lanova Medicines Ltd. licensed exclusive global rights to Astrazeneca plc for LM-305, an antibody-drug conjugate (ADC) targeting GPRC5D, for multiple myeloma (MM). Lanova will receive up-front and near-term payments of up to $55 million and development and commercial milestone payments of up to $545 million, as well as tiered royalties on net sales worldwide. Read More
Angelini Pharma SpA and JCR Pharmaceuticals Co. Ltd. signed an exclusive worldwide agreement for the development and commercialization of biologic therapies for epilepsy based on the J-Brain Cargo technology. Read More
Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease. Read More
Lianbio Co. Ltd. gained its first Asian approval in Macau for Camzyos (mavacamten/Myokardia Inc.) for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The company in-licensed mavacamten rights from Myokardia, now a wholly owned subsidiary of Bristol Myers Squibb Co., in August 2020 for developing and commercializing mavacamten in mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten was granted breakthrough therapy designation in China in February 2022 for patients with oHCM. Read More
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June. Read More
Korean biopharmas in the antibody-drug conjugate (ADC) space can leverage the strength of the Korean ecosystem when partnering with global pharma companies, said investors during the BIO Korea 2023 conference in Seoul on May 12. Read More
Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the BIO Korea 2023 conference in Seoul on May 11. Read More
When it comes to CAR T therapies, South Korea is trailing behind the U.S. and China, but the South Korean government sees cell and gene therapies as a space where the country can draw international investors, speakers said during the Bio Korea 2023 conference in Seoul on May 10. Read More
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication. Read More
Chance Pharmaceuticals Co. Ltd. acquired greater China rights to Inbrija (levodopa inhalation powder), used to manage Parkinson’s disease (PD), from Acorda Therapeutics Inc. in a deal worth as much as $140 million. Read More
Biopharma financings are pacing more than $300 million higher than at the end of April last year, but are well behind the total through April 2021 when the value of financings more than doubled any recent year due to the response to the COVID-19 pandemic. Through the end of April, biopharmas have raised $19.83 billion this year, compared to $17.5 billion through the same month in 2022, $53.7 billion in 2021, $24.04 billion in 2020 and $19.53 billion in 2019. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alterity, Enanta, Innovent, Kintor, Novavax, Onocross, Qilu. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aligos, Amoytop, Angelini, Astrazeneca, Bayer, CSL, Cytomed, Dynamicure, Geneone, Hummingbird, JCR, Lanova, Merck, Olix, Takeda, Telix, Uniqure. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alphamab, Ascletis, Astrazeneca, Biophytis, Eli Lilly, Genassist, H. Lundbeck, Hefei Tianhui, Innovent, Lianbio, Novavax, Oramed, Otsuka, Radiopharm, Specialized. Read More
