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Recently,GenFleet announced the latest phase II data of KROCUS study, fulzerasib (GFH925, KRAS G12C inhibitor) in combination with cetuximab for first-line non-small cell lung cancer (NSCLC) treatment,in a late-breaking abstract at the mini oral presentation of the 2025 European Lung Cancer Conf...Read more »
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PLB1004, developed by Beijing Avistone Biotechnology Co., Ltd., is a safe, highly selective, and efficient irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) employed in treating non-small-cell-lung-cancer (NSCLC). On April 9th, 2025, National Medical Products Admi...Read more »
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On March 13, 2025, the top international journal Nature Medicine published MediLink’s B7-H3 targeting antibody drug conjugate (ADC) YL201 Phase 1/1b trial. The trial included a dose-escalation part (phase 1) and a dose-expansion part (phase 1b). A total of 312 patients were enrolled across...Read more »
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On March 21, 2025,Immunofoco announced that its independently developed EpCAM-targeting autologous CAR-T cell therapy, IMC001, has been granted clearance by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its second Investigational New D...Read more »
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On March 31, 2025,Innovent Biologics announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy fo...Read more »
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On March 21, 2025, Junshi Biosciences announced that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for the company’s product, toripalimab, in combination with bevacizumab for the first-line treatment of unresectable or metastatic...Read more »
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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 »
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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 »
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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 »
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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 »
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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 »
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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 »