US Edition
Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT
- On June 10, 2025, Abbisko Therapeutics announced that the China NMPA has accepted the submission of regulatory approval documents for pimicotinib in Shanghai.
- This submission follows the Priority Review granted in May 2025 by the NMPA’s Center for Drug Evaluation for pimicotinib to treat TGCT patients.
- The application is supported by findings from the initial segment of the international Phase 3 MANEUVER trial, which reported a 54.0% objective response rate at week 25 for pimicotinib compared to placebo.
- Abbisko CEO Yao-Chang Xu highlighted pimicotinib’s significant clinical effectiveness and safety, while Merck is striving to introduce the inaugural authorized systemic treatment for TGCT patients in China.
- The acceptance marks a key milestone, with pimicotinib potentially becoming a best-in-class treatment addressing unmet needs for TGCT patients in China and globally.
Insights by Ground AI
Does this summary seem wrong?
77 Articles
77 Articles
All
Left
10
Center
27
Right
8
Bennington Banner+76 Reposted by 76 other sources
Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT
SHANGHAI, June 10, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1…
Coverage Details
Total News Sources77
Leaning Left10Leaning Right8Center27Last UpdatedBias Distribution60% Center
Bias Distribution
- 60% of the sources are Center
60% Center
L 22%
C 60%
R 18%
Factuality
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage
