Hutchmed Ltd., already listed in the U.S. and London, returned to home soil June 30 for a third IPO on the Hong Kong Stock Exchange that reaped HK$4.17 billion (US$537.2 million). The Hong Kong-based company is currently looking to score its first FDA approval to tap the U.S. market after three China approvals.
Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
CAR T specialist Carsgen Therapeutics Holdings Ltd.’s shares started trading on the Hong Kong Stock Exchange on June 18, helping the company raise HK$3.1 billion (US$400 million) from an IPO that will allow it to advance its phase II-stage BCMA CAR T therapy candidate, CT-053, in multiple markets.
Multinational antibody specialist Hifibio Therapeutics Inc. closed an oversubscribed $75 million series D financing round to move its anti-TNFR2 antibody HFB-200301 and the anti-OX-40 antibody HFB-301001 to phase I trials by the end of this year.