Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Ivonescimab Receives NMPA Approval for First-Line Treatment of PD-L1-Positive NSCLC, Based on Breakthrough Head to Head Phase III Trial Demonstrating Superior Efficacy Over Pembrolizumab

HONG KONG, April 25, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New…

Akeso wins Chinese approval for cancer drug positioned to rival Merck’s Keytruda

New data show early hints of the medicine improving patient survival — the gold standard outcome of any cancer study

Akeso PD-1 inhibitor cleared as Keytruda challenger advances

Akeso has bagged an FDA approval for its PD-1 inhibitor penpulimab and reported new data on highly-touted PD-1/VEGF bispecific ivonescimab

# Positive Interim Analysis of Ivonescimab vs. Pembrolizumab in PD-L1 Positive Advanced NSCLC HARMONi-2 Trial Finding...

Abstract The advancement of biotherapeutics has significantly altered the landscape of oncological therapies, particularly in the realm of immune checkpoint inhibitors. This article examines intravenous ivonescimab, a potential first-in-class bispecific antibody, through the lens of recent developments in clinical trials assessing its efficacy and safety in advanced non-small cell lung cancer (NSCLC). In light of the promising overall survival t…

Ivonescimab Approved in China as First-Line Treatment for PD-L1+ Lung Cancer

HONG KONG, April 26, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) in patients…

Interim Overall Survival Analysis Requested from Chinese Health Authorities Shows a Clinically Meaningful, Positive Trend Favoring Ivonescimab Compared to Pembrolizumab in PD-L1 Positive Advanced NSCLC from HARMONi-2 Study Conducted by Akeso in China

Interim Analysis of HARMONi-2 Shows an Overall Survival Hazard Ratio of 0.777 Favoring Ivonescimab at 39% Data Maturity, Implying a Potential Numerical 22% Reduction in the Risk of Death Compared to Pembrolizumab Ivonescimab Monotherapy Approved by NMPA in China for Front-Line PD-L1 Positive Advanced NSCLC MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today noted that Akeso, Inc. (Akeso, …