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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Jiangsu Hengrui Pharmaceuticals Receives FDA Form 483 Following Inspection Discrepancies
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The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading drug manufacturer in China. The document, which spans eight pages, details several compliance issues observed during an inspection. Notably, it mentions an incident where an employee attempted to divert inspectors…
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Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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Hengrui Pharmaceuticals Advances Two Drug Candidates Following NMPA Clinical Trial Green Lights
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates: HRS-5346 tablets and SHR-9539 injection. HRS-5346, a small molecule drug developed in-house, is…
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Hengrui Pharmaceuticals’ Vitiligo Treatment SHR0302 and Diabetes Drug HRS9531 Get Green Light from China’s NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531. SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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Jiangsu Hengrui’s Camrelizumab/Apatinib Combo Denied FDA Approval Over Manufacturing Issues
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The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
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Hengrui Pharmaceuticals Strikes Deal with Hercules CM Newco to Supply GLP-1 Products for Global Markets
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has entered into a significant agreement to supply a range of glucagon-like peptide-1 (GLP-1) products to Hercules CM Newco Inc., a newly established US firm backed by a consortium of investors including Bain Capital Life Sciences, RTW Investments,…
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Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SHR-2173, an investigational biologic, in patients with IgA nephropathy. Developed in-house, SHR-2173 is designed to target abnormally…
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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…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Pharmaceuticals Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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Jiangsu Hengrui Pharmaceuticals Reports 7.26% Revenue Growth in 2023, Driven by Innovative Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has released its financial report for 2023, recording RMB 22.82 billion (USD 3.15 billion) in revenues for the year, marking a 7.26% increase year-on-year (YOY). The net profit attributable to shareholders, after adjustments for non-recurring gains and…
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Hengrui Pharmaceuticals Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Jiangsu Hengrui Pharmaceuticals Advances Pipeline with NMPA Approvals for Three Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received clinical trial approvals from China’s National Medical Products Administration (NMPA) for three of its pipeline drugs: HRS-9231, SHR-4597, and SHR-2173. This regulatory milestone marks a significant step forward in the company’s commitment to innovate and address unmet medical needs in China…
