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BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
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FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
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The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the…
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Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
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Yunnan Baiyao Group Co., Ltd (SHE: 000538), a traditional Chinese medicine (TCM) company based in Kunming, has received approval from the National Medical Products Administration (NMPA) in China to conduct a clinical study for its Category 1 chemical drug, INR101. The study will initially assess the drug in healthy volunteers…
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Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
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Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
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Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a regulatory Phase III clinical study. The study will evaluate the combination of the company’s KRAS G12C inhibitor, glecirasib, with Erbitux (cetuximab) for…
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Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
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MSD’s Keytruda Adjuvant Treatment for High-Risk Endometrial Cancer Fails to Meet Primary Endpoint
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its blockbuster drug Keytruda (pembrolizumab) as an adjuvant treatment in newly diagnosed, high-risk endometrial cancer failed to meet the primary endpoint of disease-free survival (DFS). Although the analysis of the co-primary endpoint of overall survival (OS)…
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WestGene Biopharma’s Groundbreaking mRNA Vaccine for EB Virus Tumors Gets FDA Green Light
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WestGene Biopharma Co., Ltd., a biopharmaceutical company based in Chengdu, has announced that its drug candidate WGc-043 has been approved for clinical trials by the US Food and Drug Administration (FDA). WGc-043 is recognized as the world’s first clinically approved mRNA therapeutic vaccine targeting Epstein-Barr (EB) virus-related tumors. The vaccine…
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RJK Biopharma’s RJK002 Earns Tacit Approval for Amyotrophic Lateral Sclerosis Clinical Trial
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Shanghai-based RJK Biopharma Ltd. has announced that its Category 1 drug RJK002 has received tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for the treatment of amyotrophic lateral sclerosis (ALS). RJK002 is recognized as the first clinically approved adeno-associated virus (AAV) gene therapy for ALS in China…
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BioNTech Secures Global Rights to Biotheus Inc.’s Pre-Clinical Bispecific Antibody
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Biotheus Inc., a biopharmaceutical company based in China, has announced that its German partner BioNTech (NASDAQ: BNTX) has exercised a global exclusive option right, securing the rights to globally develop, manufacture, and commercialize Biotheus’s in-house developed pre-clinical bispecific antibody (BsAb) candidate drug. Upon the option exercise, Biotheus will receive option…
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China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction
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Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle, has been granted marketing approval in China. This product, a recombinant follicle stimulating hormone (rFSH) known as follitropin delta derived from human cell lines, has already received approvals across numerous countries and regions. It is…
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Chia Tai Tianqing’s PD-L1 Antibody Benmelstobart Wins NMPA Nod for ES-SCLC
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China-based Chia Tai Tianqing has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is approved as a first-line treatment for extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib…
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Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-B16D1, in patients with advanced solid tumors. Biokin Pharma,…
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Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
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Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
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Sandoz Q1 2024 Results Highlight 6% Growth, Led by Biosimilars and European Strength
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Switzerland-based Sandoz (SWX: SDZ) has reported its financial results for the first quarter of 2024, announcing sales of USD 2.5 billion, marking a 6% year-on-year (YOY) increase in constant currency terms. This growth was driven by contributions from all regions. Generics sales experienced a modest 1% YOY increase to USD…
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Jiangsu QYuns Therapeutics Gets NMPA Green Light for CSU Treatment QX013N
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its monoclonal antibody (mAb), QX013N. The drug is intended to treat chronic spontaneous urticaria (CSU), a common…
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Laekna’s ActRIIA Monoclonal Antibody LAE102 Gets Green Light from China’s CDE for Obesity Treatment
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Sino-US biotech firm Laekna has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its monoclonal antibody drug candidate, LAE102, intended for the treatment of obesity. This development follows the drug’s previous clinical trial approval in the US last month. In-house developed, LAE102…
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Novo Nordisk’s Q1 2024 Global Sales Surge 24% YOY on Strength of GLP-1 Therapies
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Denmark-based pharmaceutical giant Novo Nordisk (CPH: NOVO-B) reported a substantial 24% year-on-year (YOY) increase in global sales for the first quarter of 2024, reaching DKK 65.3 billion (USD 9.4 billion) at constant exchange rates (CER). The growth was primarily attributed to strong performances in glucagon-like peptide-1 (GLP-1)-based drugs and obesity…
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Jiangsu Hengrui Pharmaceuticals Advances HRS-5965 with NMPA Clinical Trial Approval for Glomerular Diseases
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has been granted approval by the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-5965, a novel therapeutic targeting primary or secondary glomerular diseases. The conditions include IgA nephropathy, idiopathic membranous nephropathy, C3…
