The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
Taiwan’s Bora Pharmaceuticals Co. Ltd. is acquiring Upsher-Smith Laboratories Inc. from Sawai Group Holdings Co. Ltd. and Sumitomo Corp. of Americas for $210 million to boost its commercial presence in the U.S.
As gene therapies gain unprecedented traction into 2024, preclinical-stage South Korean biotech Genecraft Inc. said it raised ₩10 billion (US$7.48 million) in a series A financing to further R&D for its therapy against lung cancer.
A tire company is the latest to test out the waters of the biopharmaceutical industry with Tirebank Co. Ltd. and 13 affiliated individuals becoming the largest shareholders in flailing Korean antibody biotech Pharmabcine Inc. with a 13.31% stake.
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.
Korean confectionary company Orion Holdings Inc. is growing its biotech presence by purchasing a majority stake of 25% in one of the hottest Korean antibody-drug conjugate developers, Legochem Biosciences Inc., although stocks dropped on the news. Under the contract announced Jan. 15, Seoul-headquartered Orion agreed to acquire a 25.73% stake in Daejeon-based Legochem by securing about 9.36 million shares for a total of ₩548.7 billion (US$412.11 million) by the deadline of March 29, 2024.
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees.
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc.
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