Tag Archives: National Medical Products Administration

GSK Advances Hepatitis B Treatment Pipeline with China NDA Submission for Bepirovirsen Based on Phase III Trial Success

(IN BRIEF) GSK has announced that China’s National Medical Products Administration has accepted for review a New Drug Application for bepirovirsen, an investigational antisense oligonucleotide designed to treat adults with chronic hepatitis B. The submission is supported by Phase III … Read the full press release

GSK Expands Respiratory Portfolio with China Approval of Long-Acting Exdensur Therapy for Severe Asthma Patients

(IN BRIEF) GSK has secured approval in China for Exdensur (depemokimab), a first-of-its-kind ultra-long-acting biologic for treating severe eosinophilic asthma in patients aged 12 and above. Approved by China’s National Medical Products Administration, the therapy offers a novel treatment approach … Read the full press release

GSK Secures China Approval for Trelegy Ellipta in Asthma, Expanding Single Inhaler Triple Therapy Use

(IN BRIEF) GSK has secured approval in China for Trelegy Ellipta as a maintenance treatment for adults with asthma, adding to its existing indication in COPD and making it the only single inhaler triple therapy approved for both conditions in … Read the full press release

Sarclisa Receives First Approval in China for Treatment of Relapsed or Refractory Multiple Myeloma

(IN BRIEF) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release