-
On March 21, 2025,announces that the New Drug Application (“NDA”) for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior ...Read more »
-
On March 10, 2025,Sichuan Kelun-Biotech announced that the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) was approved for marketing by the National Medical Products Administration (NMPA...Read more »
-
On March 18, 2025,Alphamab Oncology announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of ...Read more »
-
On March 10, 2025,Hansoh Pharma announced the third New Drug Application (“NDA”) of the Group’s innovative drug Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) has been approved by the National Medical Products Administration of China (“NMPA”) for the treatment of patients with locally advanced,...Read more »
-
On March 12, 2025,Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on...Read more »
-
On March 5th, 2025,Ascentage Pharma announced that its drug, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for combination with low-intensity chemotherapy for the first-...Read more »
-
On March 4th, 2025, BeiGene announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA(tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose ...Read more »
-
On February 25th, 2025,China’s National Medical Products Administration (NMPA) has approved finotonlimab in combination with SCT510 for the treatment of unresectable or metastatic hepatocellular carcinoma that has not received prior systemic therapy. Finotonlimab is a recombinant humanized IgG4...Read more »
-
On February 8, 2025, The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s finotonlimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb), for use in combination with platinum-based chemotherapy as a first-line treatment for recurrent and/or metas...Read more »
-
On February 21, 2025, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Satri-cel(CT041)(an autologous CAR T-cell product candidate against Claudin18.2) ,for advanced gastric/esophagogastric jun...Read more »
-
On February 22, 2025, the New Drug Application (NDA) for ipilimumab injection (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and granted Priority Review designation in com...Read more »
-
On January 22, 2025,《Nature Medicine》 published the results of the Akeso independently developed PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal j...Read more »