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.
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.
Zai Lab Ltd. and Macrogenics Inc. have announced a collaboration and license agreement involving up to four immuno-oncology molecules in a deal potentially worth upward of $1.5 billion. The deal makes sense as both are upcoming companies at around the same stage in development – making progress in oncology with first products recently approved by regulators.
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.
Inmagene Biopharmaceuticals Co. Ltd. has raised $100 million in a series C financing to move its IL-17 inhibitor to phase II trials in the U.S. and China.
Jacobio Pharmaceuticals Group Co. Ltd. has received a milestone payment of $20 million from Abbvie Inc. for dosing the first two patients in the U.S. for a global phase I/IIa study of JAB-3312 in combination with pembrolizumab and binimetinib, taking another step forward in the global SHP2 race.
Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration at the 2021 American Society of Clinical Oncology meeting, drawing attention to oncolytic viruses developed by Chinese scientists.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Genhouse Bio Co. Ltd. closed a series A financing round to raise more than ¥200 million (US$31 million) to support phase I studies of KRAS inhibitor GH-35 and SHP2 inhibitor GH-21 in China. The startup expects to enroll patients in trials testing the two compounds in the second half of this year, CEO Wang Kuifeng told BioWorld in an exclusive interview.
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