News | May 07, 2026
CARBOGEN AMCIS Shanghai site clears unannounced NMPA GMP inspection
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
As per GlobalData, CARsgen’s satri-cel could mark a major breakthrough in solid tumor treatment as competition intensifies
The decision is based on the phase 3 DESTINY-Breast11 trial
Desidustat tablets are a novel oral HIF-PHI approved for treating anaemia in non-dialysis adult CKD patients
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
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
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
This marks the second indication for which gumokimab has gained NDA review acceptance
Myqorzo, a selective small-molecule cardiac myosin inhibitor, is designed to improve functional capacity and relieve symptoms in oHCM
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
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