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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Alphamab’s KN057 Earns FDA Orphan Drug Designation for Hemophilia B Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has received another orphan drug designation (ODD) from the US FDA for its monoclonal antibody (mAb) KN057, which targets the tissue factor pathway inhibitor (TFPI). This new ODD is for the potential treatment of hemophilia B, following the initial ODD…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Hengrui Pharmaceuticals Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
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Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
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Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic, SQ-22031 eye drops. This Category 1 therapeutic biologic is intended for the treatment of dry eye syndrome and neurotrophic keratitis, with…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
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Amoytop Biotech Opts for NASH Drug Candidate KN069 in Licensing Deal with Alphamab Oncology
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Xiamen Amoytop Biotech Co., Ltd (SHA: 688278), a biopharmaceutical company based in China, has exercised its option rights for KN069, a drug candidate for non-alcoholic steatohepatitis (NASH), under a licensing agreement with fellow Chinese firm Alphamab Oncology (HKG: 9966). The original deal, signed in December 2023, granted Amoytop the choice…
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Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
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Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biopharmaceutical company based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, HP560. The molecule is being evaluated as a potential treatment for myelofibrosis,…
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Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
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Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for BBM-H901, a gene therapy for hemophilia B. This development marks a significant milestone for the treatment, which is being designed…
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Pfizer’s Hemophilia A Gene Therapy Shows Promise in Phase III AFFINE Study
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Pfizer Inc. (NYSE: PFE), a US pharmaceutical giant, has announced positive topline results from the Phase III AFFINE study for its gene therapy candidate, giroctocogene fitelparvovec, for the treatment of hemophilia A. With these results, Pfizer is now poised to prepare for regulatory submission for this one-time gene therapy, which…
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Novo Nordisk’s Wegovy Approved in the UK to Reduce Cardiovascular Risks in Overweight Adults
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Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks…
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IASO Biotherapeutics’ CAR-T Therapy Fucaso Receives FDA IND Approval for Multiple Sclerosis
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China-based IASO Biotherapeutics has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to explore the potential of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), in treating multiple sclerosis (MS). This marks the second IND nod…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
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Innorna’s Herpes Zoster mRNA Vaccine IN001 Receives Clinical Trial Approval in China
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Shenzhen-based Innorna Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to commence clinical trials for its proprietary IN001, a novel mRNA vaccine designed to combat herpes zoster. This marks a significant milestone for the company, as IN001 is the first mRNA-based herpes…
