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On April 25, 2025,InnoCare Pharma announced that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which accepted the New Drug Application (NDA) of z...Read more »
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NMPA Approval of Limertinib, a Third-generation EGFR TKI for the First-line Treatment of Lung Cancer
On April 25, 2025,Innovent Biologics announces that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbo...Read more »
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On April 23rd, Akeso’s penpulimab obtained the Food and Drug Administration approved with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a sin...Read more »
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On March 16, 2025，Akeso announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination ...Read more »
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On April 24, 2025,GenFleet Therapeutics announced US Food and Drug Administration (FDA) cleared the investigational new drug (IND) application of GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, for clinical trial treating advanced solid tumor patients harboring KRAS G12D mutation. The study...Read more »
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On April 17,2025,Hansoh Pharmaceutical announces that the Group’s self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 for injection has obtained approval to be included as Breakthrough-Therapy-Designated Drug by the National Medical Products Administration (NMPA) of China, ...Read more »
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On April 15th, 2025, InnoCare Pharma announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent p...Read more »
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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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Beijing Cancer Hospital