Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house.
Seoul, South Korea-headquartered Boryung Co. Ltd. grabbed headlines in 2022 with its strategic redesign to move beyond drug development, announcing that it would invest $10 million in Axiom Space Inc. for a 0.4% stake in the U.S. commercial space station developer. The investment ramped up over the course of a year, with Boryung pouring a total of $60 million into Axiom Space over two financing rounds for a 2.7% stake. Axiom is set to build the world’s first commercial space station.
SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
Verismo Therapeutics Inc., the U.S. subsidiary of South Korea’s HLB Co. Ltd., inked a license agreement with the University of Pennsylvania for two newly discovered CD19 binders – one of which will be used to develop Synkir-310, its investigative CAR T therapy for blood cancers.
Hutchmed (China) Ltd.’s sovleplenib (HMPL-523) met the primary endpoint of durable response rate and all secondary endpoints in the pivotal phase III trial in adults with primary immune thrombocytopenia (ITP) in China.
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Jyong Biotech Ltd. filed for an IPO that could raise as much as $40 million to advance a pipeline that includes several prospects for urinary system disorders, including one that has reached the NDA stage in the U.S.
Immuno-oncology company Imugene Ltd. has acquired a worldwide exclusive license to Precision Biosciences Inc.’s allogeneic CD19 CAR T-cell therapy program in a deal worth more than $227 million. The off-the-shelf CD19 CAR T-cell therapy, azercabtagene zapreleucel (azer-cel), could potentially be the first allogeneic CAR T to be approved, Imugene CEO Leslie Chong told BioWorld.
South Korean pharmaceutical firms LG Chem Ltd. and JW Pharmaceutical Corp. are recouping and pressing on with their respective novel gout drugs internationally, with each having faced regulatory setbacks from IND rejections overseas.