The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

China's Duality Biologics, founded in 2020, has developed two-thirds of its clinical-stage antibody-drug conjugates by combining antibodies acquired from domestic peers with its proprietary linker-payload platform.

The changes mark the second major revision to the 2022 antibody-drug conjugate-focused alliance between the US and Chinese firms, which is now focusing on ADCs against Trop2, Nectin-4 and other undisclosed targets. Meanwhile, the results from other trials with Claudin 18.2 ADCs have used varying definitions of high expression, with differing results. 

Being the Chinese biotech’s backbone asset in the autoimmune disease area, telitacicept, a BlyS/APRIL dual targeting fusion protein, has hit its target in a China-only Phase III study in generalized myasthenia gravis. The candidate is also being investigated in global Phase III trials in systemic lupus erythematosus and Sjögren's syndrome.

Also deals involving WuXi/Medigene, Eisai/Seed, Genor/Two River/Third Rock Ventures, ImmuneOnco/Instil, Biocytogen/Ideaya, Takeda/Dr Reddy’s/Zydus/Mankind and deals in brief.

If closed successfully, the traditional producer of active pharmaceutical ingredients and generic drugs will scoop up the world’s second advanced KRAS G12D-targeting T-cell receptor (TCR) T cell therapy candidate, as well as an EGFR variant III-targeting chimeric antigen (CAR) receptor T-cell agent. Out-licensing efforts are already under way.