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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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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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Beijing Cancer Hospital