Hong Kong-listed Shanghai Henlius Biotech Co. Ltd. is set to renew Chinese biotechs’ efforts to land an immuno-oncology antibody onto the US market, with a regulatory pathway now set for its anti-PD-1 drug serplulimab (HLX10, already marketed as Hansizhuang in China).
Henlius Forges Ahead With US PD-1 Plans Despite Peers' Setbacks
Bridging Study Planned
The latest step by the Chinese drug maker to support its international ambitions is a bridging study in the US, which will evaluate its PD-1 contender serplulimab against Roche’s PD-L1-targeted Tecentriq.
More from China
• By
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.
• By
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.
• By
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.
• By
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.
More from Focus On Asia
• By
Plus deals involving GV20/Mitsubishi Tanabe, Kaken/Alumis, AstraZeneca/Alteogen and deal terminations involving Clover/Gavi Alliance and Rhythm/RareStone.
• By
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.
• By
Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.