Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne
- Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study - The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously...
Nuance Pharma Announces Acceptance for Review of the New Drug Application for Ohtuvayre® (ensifentrine) by the National Medical Products Administration of China for the maintenance treatment of chronic obstructive pulmonary disease
SHANGHAI, Jan. 27, 2026 /PRNewswire/ -- Nuance Pharma ("Nuance") today announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA) for Ohtuvayre ® (ensifentrine) for...
Alphamab Oncology Announces the Results of a Phase III Clinical Study of Anbenitamab (KN026) were Published in Annals of Oncology
SUZHOU, China, Jan. 27, 2026 /PRNewswire/ -- Alphamab Oncology (Stock Code: 9966.HK) announced that the results from a phase III clinical study for the treatment of HER2-positive gastric or gastroesophageal junction cancer (GC/GEJ) of anbenitamab...
Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment
-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter...
Renalys Pharma Announces Positive Topline Results from Phase III Study of Sparsentan in Japanese Patients with IgA Nephropathy
– In a Phase 3 clinical study evaluating the efficacy and safety of sparsentan in Japanese patients with IgA nephropathy (N=35), the percent change from baseline in the 24-hour urine protein-to-creatinine ratio at Week 36, which was the study's...
ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
SHANGHAI, June 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys...
A chronographic analysis of MSC's rollercoasting journey
TIANJIN, China, March 18, 2025 /PRNewswire/ -- On March 12, 2025, China's Center for Drug Evaluation (CDE) approved Tasly's Investigational New Drug (IND) application for NR-20201, an allogeneic adipose-derived mesenchymal stromal cell, sparking...