Chinese immuno-oncology specialist CARsgen Therapeutics and Huadong Medicine Co., Ltd., its domestic commercialization partner, on 1 March won regulatory approval in China for zevorcabtagene autoleucel (zevor-cel), an autologous BCMA-targeting chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma, in the fourth- and later-line setting.
CARSgen Wins China’s Fifth CAR-T Approval But Pricing Dilemma Unresolved
As China’s fifth approved CAR-T cell therapy, CARSgen/Huadong’s zevorcabtagene autoleucel is priced at $159,735 for a single infusion. Expanding patient access will become a formidable task for the companies, due to the poor prospects of reimbursement coverage by China’s public medical insurance program.
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AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.
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After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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UK pharma will invest $2.5bn in Beijing R&D hub, build a vaccine manufacturing site with BioKangtai, and partner in chronic disease with Syneron and in oncology/immunology with Harbour BioMed.
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Senior executives from AstraZeneca, BMS, Novo Nordisk, Takeda and Regeneron outline how big pharma's global capability centers (GCCs) in India are evolving beyond cost efficiency, focusing on innovation, “agile experimentation” and new technology including GenAI, virtual & augmented reality, with some positioned as COEs. Will Indian multinationals use the GCC approach?
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Plus deals involving GV20/Mitsubishi Tanabe, Kaken/Alumis, AstraZeneca/Alteogen and deal terminations involving Clover/Gavi Alliance and Rhythm/RareStone.
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RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.