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Huadong Medicine’s Mirvetuximab Soravtansine Heads for Priority Review by China’s CDE
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The China’s Center for Drug Evaluation (CDE) website has indicated that Huadong Medicine Co., Ltd (SHE: 000963) is moving forward with a priority review for its mirvetuximab soravtansine, an antibody drug conjugate (ADC), for potential use in folate receptor α (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or…
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Transcenta’s Osemitamab Combo Shows Promising PFS Data in Advanced GC/GEJ Cancer Study
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Transcenta Holding Ltd (HKG: 6628), a China-based biopharmaceutical company, has presented progression-free survival (PFS) data based on CLDN18.2 expression levels from a Phase I/II study of osemitamab (TST001) in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for advanced gastric/gastroesophageal junction (GC/GEJ) carcinoma at the ESMO World Congress…
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Hybio Pharmaceutical’s Liraglutide Biosimilar Withdrawn from NMPA Filing
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has approved its application to withdraw the market filing for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This decision comes as part of a strategic adjustment in response to policy and…
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Innovent Biologics and IASO Biotherapeutics’ Fucaso Approved for Multiple Myeloma Treatment in China
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Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved…
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SciClone Pharmaceuticals’ Danyelza Officially Launched in China for Neuroblastoma Treatment
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) has reached a significant milestone with the first prescription of Danyelza (naxitamab) in China, signifying its official commercial launch. Danyelza, a GD2-targeted monoclonal antibody, was originally developed by Y-mAbs Therapeutics Inc. and was fast-tracked for marketing approval in China in November 2020. Licensing Agreement and…
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Zai Lab’s Vyvgart Receives NMPA Approval as First-in-Class FcRn Antagonist for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard…
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InnoCare Pharma and Keymed Biosciences Initiate Clinical Trial for ICP-B02 with First Subcutaneous Injection
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InnoCare Pharma (HKG: 9969; SHA: 688428) and Keymed Biosciences Inc., (HKG: 2162) have announced a significant milestone in their joint development of ICP-B02 (CM355), a bispecific antibody (BsAb) targeting CD20 and CD3. The first subcutaneous injection administration has been successfully administered to a Chinese patient, marking a new route of…
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Jiangsu Hengrui Medicine Gets NMPA Approval for HRS-4357 Clinical Study in Prostate Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 radiotherapeutic drug, HRS-4357. This novel molecule is under development for the treatment of prostate specific…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for BL-B01D1 Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its drug candidate, BL-B01D1. This in-house developed antibody-drug conjugate (ADC) targets EGFR and HER3, key drivers…
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RareStone Group’s Pitolisant Earns Priority Review Status for Narcolepsy Treatment in China
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The Center for Drug Evaluation (CDE) website in China has indicated that RareStone Group, a China-based rare disease specialist formerly known as Citrine Medicine, has secured priority review status for its in-licensed drug candidate, pitolisant. This status is awarded for the drug’s potential as a treatment for excessive daytime drowsiness…
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Joincare Pharmaceutical Initiates Phase III Study for Anti-IL-17A mAb in Plaque Psoriasis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced the initiation of a Phase III clinical study for its anti-IL-17A monoclonal antibody (mAb) in the treatment of moderate to severe plaque psoriasis. The study, which was approved in China in February 2020, marks a significant step forward in…
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ZSP1273 by Guangdong Zhongsheng Pharma Shows Promise in Phase III Flu Treatment Study
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced preliminary top-line data from a Phase III clinical study for its Category 1 drug, ZSP1273, in adults with simple influenza A. The randomized, double-blind study, conducted across over 80 centers in China, compared the effects of ZSP1273…
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Hansoh Pharmaceutical’s Phenylheptal Peptide Receives NMPA Approval for Anemia Treatment
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The National Medical Products Administration (NMPA) has issued a marketing approval for China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Category 1 product, phenylheptal peptide. This drug is indicated for the treatment of anemia in adult non-dialysis patients who are not receiving erythropoiesis stimulator (ESA) treatment, and in adult dialysis…
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Sinocelltech Group Receives NMPA Approval for Bevacizumab Biosimilar for Multiple Cancers
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its bevacizumab biosimilar. This biosimilar will be used to treat a range of cancers including metastatic colorectal cancer (CRC), recurrent glioblastoma, advanced metastatic or recurrent non-small cell lung…
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Huadong Medicine Receives NMPA Approval for DR30206 Clinical Study in Advanced Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable DR30206, a Category 1 biologic product, in the treatment of advanced solid tumors. DR30206: A Promising Antibody Fusion Protein Targeting PD-L1,…
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Sinocelltech Group Receives NMPA Approval for COVID-19 Vaccine Bridging Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study. The study will assess the safety and immunogenicity of SCTV01E-2, an S trimer protein vaccine developed to combat COVID-19. This vaccine is designed for individuals…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase III Studies of Gallium Edotreotide Injection
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with Phase III clinical studies for its gallium [68Ga] edotreotide injection and gallium [68Ga] edotreotide injection preparation kit. Gallium [68Ga]…
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Jacobio Pharma Reports Promising Clinical Results for KRAS G12C Inhibitor Gecirasib in CRC
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China-based Jacobio Pharma (HKG: 1167) has announced clinical results for its novel KRAS G12C inhibitor, glecirasib, in the treatment of KRAS G12C mutant advanced colorectal cancer (CRC). The findings were presented at the Second JCA-AACR Precision Medicine International Conference, showcasing the potential of glecirasib as both a monotherapy and in…
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Harbour BioMed’s Batoclimab for Generalized Myasthenia Gravis Accepted for NMPA Review
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Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced that the National Medical Products Administration (NMPA) has accepted a biological license application for its batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This development follows the positive…
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Hansoh Pharmaceutical Gets NMPA Approval for HS-10518 Clinical Study in Endometriosis Pain
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug HS-10518 (TU2670). The study will focus on the treatment of moderate to severe pain associated with endometriosis and menorrhagia associated with…
