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Shanghai Henlius Biotech Partners with SVAX to Boost MENAT Region’s Access to Biological Drugs
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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 and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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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…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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Shanghai Henlius Biotech Reports 9.8% YOY Revenue Growth and Continued Profitability in 2024H1 Financial Report
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Shanghai Henlius Biotech Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has reported its financial results for the first half of 2024, with a 9.8% year-on-year (YOY) increase in revenue, amounting to RMB 2.7461 billion. The company has sustained profitability, building…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. Henlius has secured the exclusive commercialization rights for Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing…
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Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
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SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional…
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Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
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China’s Henlius Biotech Partners with Sermonix for Japan Development of Breast Cancer Drug
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Shanghai Henlius Biotech Inc. (HKG: 2696), a prominent biopharmaceutical company based in China, has announced an expansion of its licensing agreement with Sermonix Pharmaceuticals Inc., to include additional territories in Asia for the development and commercialization of HLX78 (oral lasofoxifene). This supplementary agreement facilitates a co-development partnership between Henlius and…
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Henlius Pharmaceutical’s HLX15 Biosimilar Meets Phase I Clinical Endpoints
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the successful completion of a Phase I clinical study for HLX15, its biosimilar candidate for Johnson & Johnson’s Darzalex (daratumumab). The trial involved healthy Chinese male subjects and met all pre-set endpoints. Daratumumab is a monoclonal antibody therapy indicated for the…
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Fosun Pharma to Take Henlius Private in Deal Valued at HKD 5.407 Billion
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced plans to take its subsidiary Shanghai Henlius Biotech Co., Ltd (HKG: 2696) private. According to a stock exchange announcement from the China-based firm, Fosun currently holds 323.7 million shares of Henlius, representing 59.56% of the company’s total shares.…
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Fosun Pharma Rumored to Fully Acquire Subsidiary Henlius Pharmaceutical, Shares Suspended
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Rumors are circulating, as reported by Bloomberg citing insiders, that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) is planning to fully acquire its subsidiary Shanghai Henlius Biotech Co., Ltd (HKG: 2696). This strategic move comes as Henlius, a Hong Kong-listed company, has suspended its shares from trading…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Henlius Biotech and Palleon Pharmaceuticals Modify Licensing Agreement for Bifunctional Antibody
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the revision of a cooperation and licensing agreement initially signed with Palleon Pharmaceuticals Inc. in June 2022. The original agreement was centered around the development of a bifunctional anti-HER2 antibody-sialidase fusion protein and a second…
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Fosun Pharmaceutical Advances Lasofocine Clinical Trials for Breast Cancer after NMPA Nod
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct two clinical studies for lasofociene. The first trial is a Phase I study in healthy subjects, while the second is a global multi-center Phase…
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Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Henlius Biotech Posts 67.8% YOY Revenue Growth and First Annual Profit in 2023 Financials
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Shanghai Henlius Biotech Inc., (HKG: 2696) has released its financial results for 2023, reporting revenues of RMB 5.395 billion (USD 749 million), marking a 67.8% year-on-year (YOY) increase. The company achieved its first profitable full year with net profits reaching RMB 546 million (USD 76 million). The strong financial performance…
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Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
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Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
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Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these…
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Henlius Biotech Forecasts First-Ever Profit in 2023 Driven by Sales Growth and Efficient Management
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Shanghai Henlius Biotech Inc., (HKG: 2696), a China-based biopharmaceutical company, has released a positive profit forecast, anticipating a minimum profit of RMB 500 million (USD 72.4 million) in 2023, marking the company’s first profitable year. This forecast is attributed to the sustained sales growth of its products Hanquyou (trastuzumab injection,…
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MindRank Ltd Partners with Henlius Biotech to Pioneer AI-Powered Drug Therapies
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MindRank Ltd, a China-based frontier in AI-enabled drug development, has inked a strategic partnership with Shanghai Henlius Biotech Inc. (HKG: 2696), a fellow Chinese firm, to co-develop AI-driven antibody drug conjugate (ADC) and anti-aging therapy platforms. This alliance combines Henlius’s comprehensive biopharmaceutical platform, specialized in antibody and Linker Payload technologies,…
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Henlius Biotech Ships First International Batch of HanSiZhuang for Cancer Treatment to Indonesia
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biotech company from China, has announced the first international shipment of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab), from Shanghai Pudong Airport to Indonesia. HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has gained approval from the National Medical Products…
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Henlius Biotech Secures Exclusive Rights to Sermonix’s Lasofoxifene for Breast Cancer Treatment in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) has entered into a partnership and licensing agreement with U.S.-based Sermonix Pharmaceuticals Inc. for exclusive development, manufacturing, and commercialization rights in China for the investigational drug lasofoxifene. This ESR1 antagonist is being developed as a treatment for breast cancer. Under the terms of the…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
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Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Zhiyi Biotechnology and Henlius Biotech Partner to Develop Novel Drug Products and Platforms
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Guangzhou-based Zhiyi Biotechnology has entered into a strategic partnership with Shanghai Henlius Biotech Inc. (HKG: 2696), a fellow Chinese firm. The collaboration aims to develop innovative drug products and technology platforms, with a particular focus on the advancement of engineered bacterial drugs and new functional strains. The joint efforts will…
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Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
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Shanghai Henlius Partners with China Resource Medicine to Enhance Product Accessibility
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic partnership with China Resource Medicine Commercial Holdings Ltd. aimed at enhancing product accessibility across the market. Under the terms of the agreement, the two companies will collaborate on product marketing promotion, channel expansion, and supply chain management, although financial details…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
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Fosun Pharmaceutical Gets FDA Green Light for HLX42 ADC Clinical Study
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for HLX42, an antibody drug conjugate (ADC) co-developed with Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics. The study targets advanced/metastatic…
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Shanghai Henlius Biotech Reports 84.0% YOY Revenue Growth in Q3 2023 Financials
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Shanghai Henlius Biotech Inc., (HKG: 2696) a prominent player in the biopharmaceutical industry, has published its financial results for the third quarter of 2023. The company reported revenues of RMB 3.9278 billion (USD 542 million) for the nine months ending September 30, 2023, marking an impressive 84.0% year-on-year (YOY) increase.…
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Shanghai Henlius Biotech’s HanSiZhuang Shows Positive Results in Phase III ASTRUM-002 Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The…
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Shanghai Henlius Biotech and Intas Pharmaceuticals Ink New Licensing Deal for PD-1 mAb
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China’s Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new licensing agreement with India-based Intas Pharmaceuticals Ltd, granting Intas exclusive development and commercialization rights to its anti-programmed death-1 (PD-1) monoclonal antibody (mAb) HanSiZhuang (serplulimab) in Europe and India. This strategic partnership further expands the global reach of Henlius’s innovative…
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Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
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China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
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Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of…
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Henlius Pharmaceutical Secures GMP Compliance for PD-1 Inhibitor Serplulimab in Indonesia
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced that its partner, PT Kalbe Genexine Biologics (KGbio), through its subsidiary PT Kalbio Global Medika, has received a GMP inspection completion letter from the Badan Pengawas Obat dan Makanan (BPOM), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Indonesia.…
