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Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug HRS-5965. The designation is for the treatment of primary IgA nephropathy, the most common primary…
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Hengrui Pharmaceuticals Reports 22.63% Revenue Growth in 2024 with Strong Innovative Drug Sales
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) released its 2024 financial report, recording RMB 27.985 billion (USD 3.86 billion) in revenues, a 22.63% year-on-year (YOY) increase. The net profit attributable to shareholders of the listed company was RMB 6.337 billion (USD 873.7 million), up 47.28% YOY. Sales of innovative…
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Shanghai Designates Backup Suppliers and Specialized Drug Formulations in GY-YD2024-2 Procurement
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Shanghai has finalized its list of second-tier backup suppliers and manufacturers for specialized drug formulations under the 10th National VBP (Volume-Based Procurement) Program (GY-YD2024-2). The move aims to stabilize supply chains, address market shortages of irregular drug specifications, and ensure cost-effective access to critical medications. Key suppliers include domestic pharmaceutical…
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Hengrui Pharmaceuticals Gets NMPA Green Light for HRS-1738 and HRS-5817 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its two Category 1 chemical drugs, HRS-1738 and HRS-5817, targeting prostate cancer and overweight/obesity respectively. HRS-1738: Prostate Cancer Diagnostic InnovationHRS-1738 is an internally developed radiopharmaceutical designed for in…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-9803 and SHR-A2102 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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Jiangsu Hengrui Pharmaceuticals Inks Global License Deal with Merck for HRS-5346
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced a license agreement with US-based giant Merck & Co., Inc. (NYSE: MRK). Under the terms, Merck gains exclusive global development, manufacturing, and commercialization rights to Hengrui’s HRS-5346, excluding the Greater China region. Financial TermsMerck will provide an upfront payment of USD 200…
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Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or…
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FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
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The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL) to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) regarding its application for the combination of programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab with small-molecule targeted cancer therapy apatinib as a first-line treatment for irresectable…
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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its HRS-6213. This novel agent is designed for PET imaging to diagnose and evaluate solid tumors, marking a significant step forward in oncology diagnostics. Mechanism and ApplicationHRS-6213…
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Jiangsu Hengrui Pharmaceuticals’ Tegileridine Approved for Postoperative Pain Management
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its tegileridine. The Category 1 drug is now approved to treat postoperative moderate to severe pain. Drug Profile and MechanismTegileridine is a μ opioid receptor (MOR)-biased small-molecule agonist. It…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for HRS-4029. The novel neuroprotective agent will now be assessed in a clinical study as a treatment for acute ischemic stroke (AIS). Preclinical FindingsPreclinical studies have demonstrated that HRS-4029 can…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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NewCo Model: China’s Innovative Drug Companies’ New Transaction Mode in Capital Winter
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NewCo is a new transaction model developed by Chinese innovative drug companies in response to capital winter and internationalization needs. It involves licensing overseas rights of early-stage R&D pipelines to newly established independent companies, bringing in overseas capital and management teams to accelerate development and share risks. This model combines…
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Hengrui Pharmaceuticals Gets NMPA Green Light for SHR-A2009 Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II clinical study for its drug candidate SHR-A2009. The study will assess the safety, tolerability, and efficacy of SHR-A2009 as a treatment for advanced solid tumors in…
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Jiangsu Hengrui’s HRS-1301 Receives NMPA Approval for Hyperlipidemia
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its Category 1 chemical drug HRS-1301 has received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of hyperlipidemia. Clinical Approval DetailsThe approval marks a significant milestone for HRS-1301, a novel drug designed to address hyperlipidemia.…
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Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye drops, designed to delay myopia progression in children aged 6-12, has been accepted by the National Medical Products Administration (NMPA). The product targets children with spherical diopters ranging from -0.50D to -4.00D and astigmatism/anisometropia ≤…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Pharmaceutical Giants Race to Integrate DeepSeek AI for Efficiency Gains
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On February 14, China’s stock market saw a significant upsurge in the AI pharmaceuticals sector, with healthcare stocks across the board performing strongly. The rally was particularly driven by AI Pharmaceuticals, medical services, and DRG/DIP segments, with companies like Shanghai Runda Medical Technology Co., Ltd. leading the charge, resulting in…
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Hengrui’s Vunakizumab Receives NMPA Approval for nr-axSpA Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its IL-17A monoclonal antibody (mAb), vunakizumab. The Chinese company plans to study the drug as a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). Drug BackgroundVunakizumab is intended…
