Dexter Yan is a senior writer covering China’s surging pharma industry on the APAC Pharma news team. With a keen interest in R&D and commercial activities taking place around the clock, he is always on the lookout for opportunities to keep readers better informed of any developments in the field.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
While diverging from partner Merck & Co. in its study dosage of sacituzumab tirumotecan, Kelun has garnered the world’s first approval, in China, for a TROP2-targeting antibody-drug conjugate, for the treatment of lung cancer.
Chinese biotech TYK Medicines says its EGFR inhibitor outperformed AstraZeneca’s same-class blockbuster Tagrisso in a pivotal Phase II trial for first-line use in brain metastases resulting from EGFR mutation-positive non-small cell lung cancer.
Following approvals in China, Trinomab and Keymed have become world-first movers in tetanus prophylaxis and seasonal allergic rhinitis, respectively. But Lepu and RDO Pharm have seen their hopes for approval of an EGFR-targeting antibody-drug conjugate and an imaging agent fizzle.
Shanghai-listed Amoytop will take over the non-US operations of Skyline Therapeutics for $58m in total potential payments, in a deal revealing Amoytop’s ambitions to muscle into the gene therapy field.
In one sign of renewed interest in AI tools from Chinese biotechs, Harbour BioMed has linked with InSilico Medicine for antibody discovery. Meanwhile, Antengene and AIM Vaccine will use DeepSeek's AI technology to support drug and vaccine development.