China’s top drug regulator granted on 29 June a marketing green light to what appears set to be the world’s first immune checkpoint inhibitor-based bispecific antibody to be commercialized, as other pharma firms in the country remain mired in an increasingly overcrowded domestic market for anti-PD-1/L1 antibodies.
China Approves World’s First Bispecific IO Drug Amid PD-1/L1 Glut
But Competition Looms
Akeso’s PD-1/CTLA-4-targeting therapy cadonilimab has been the front-runner in the bispecific antibody field in China, leading about 50 other similar agents under development by domestic pharma firms. With a new conditional approval, it has also gained a head start over home-grown PD-1/L1 antibody rivals in the cervical cancer space.
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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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The latest in a long line of restructuring measures will see Sumitomo Pharma making a stepped sale of its pharma operations in Asia to major Japanese trading house Marubeni.
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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.