WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center

Clearing 19 biologics for Europe market

China greenlights Boehringer Ingelheim’s HERNEXEOS for aggressive lung cancer

The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer

Lupin enters China market with approval for Oseltamivir oral suspension

The approval has been secured in partnership with Yabao Pharmaceuticals, a major player in China’s paediatric medicine segment

China poised to launch world’s first CAR-T therapy for gastric cancer

As per GlobalData, CARsgen’s satri-cel could mark a major breakthrough in solid tumor treatment as competition intensifies

RoosterBio taps MineBio to supercharge hMSC & exosome solutions in China

ENHERTU approved in China as first HER2-targeted ADC for early breast cancer

The decision is based on the phase 3 DESTINY-Breast11 trial

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT

Trelegy Ellipta gets green light in China for adults with uncontrolled asthma

The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance

China nod to first homegrown BNCT cancer drug for human trials

The injectable borofalan (10B), developed by CNNC Headway—a subsidiary of China Isotope & Radiation Corporation (CIRC) under the China National Nuclear Corporation (CNNC)—has officially entered Phase I clinical trials