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China’s Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HLX79 (E-602) in combination with Hanlikang (rituximab biosimilar) for the treatment of active glomerulonephritis. Innovation and MechanismHLX79 is a first-in-class human sialidase fusion…
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Shanghai Henlius Biotech Inc. (HKG: 2696) has published its 2024 financial results, recording revenues of RMB 5.72 billion (USD 788 million), representing a 6.1% year-on-year (YOY) increase. Net profits reached RMB 820.5 million (USD 114 million), up 50.3% YOY, reflecting strong performance across its product portfolio. Core Product PerformanceHenlius Biotech…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial for its small molecule drug HLX99 in amyotrophic lateral sclerosis (ALS). The trial will assess the drug’s potential to treat this neurodegenerative disease through neuroprotective mechanisms. Drug ProfileHLX99 is an…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II study of HLX43, its antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. The drug, designed for advanced/metastatic solid tumors, has no comparable approved products…
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a licensing deal with India-headquartered Dr. Reddy’s Laboratories Ltd. (BOM: 500124) for its HLX15, a biosimilar version of Johnson & Johnson’s Darzalex (daratumumab). Under the agreement, Dr. Reddy’s will obtain exclusive commercialization rights to the anti-CD38 monoclonal antibody (mAb), including both intravenous…
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced that it has received marketing approval from the European Commission (EC) for its serplulimab, combined with carboplatin and etoposide, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) under the trade name Hetronifly. This approval marks serplulimab…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its plan to take its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) private has fallen through after the shareholder vote did not pass in accordance with the terms. As a result, the listing of Henlius’ H Shares…
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic license agreement with Abbott Laboratories (NYSE: ABT). The agreement grants the US multinational company exclusive or semi-exclusive development and commercialization rights to four biosimilars and one novel biologic drug in 69 emerging countries and regions. The deal, for which…
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biotechnology company based in China, has announced an expansion of its alliance with Palleon Pharmaceuticals Inc. This partnership, originally established in June 2022, now includes the US firm in the development and commercialization of a combination therapy using Palleon’s E-602 and Henlius’…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biopharmaceutical company, has announced its membership in the Biosimilars Forum, a nonprofit organization dedicated to advancing the biosimilars industry in the United States. The membership aims to expand access to biological medicines and improve healthcare outcomes. Henlius anticipates that this membership…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase…
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the initiation of commercial supply of its biosimilar product, Hanquyou (trastuzumab; HLX02), in the US market. This move marks the expansion of the company’s commercial supply network to include China, South Asia, North America, Europe, the Middle East, and Latin America. Herceptin…
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biotech company, has entered into a strategic partnership with AL-TIRYAQ AL-KHALAWI Medical Company (SVAX), a healthcare unit owned by the prominent Fakeeh family in Saudi Arabia, during the 2024 China International Import Expo (CIIE). This collaboration aims to leverage Henlius Bio’s…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…