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History

Course of Development

Since its establishment in 1995, Hansoh Pharma has been working to address unmet clinical needs, accelerating the pace of technological innovation, and making unremitting efforts to improve human health and quality of life.

  • 2025
    The second indication of XINYUE was approved for immunoglobulin G4-related disease (IgG4-RD) in adult patients Ameile ( trade name: Aumseqa in UK) has been granted marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, making it the first innovative drug from Hansoh Pharma to be approved for the overseas market Ameile's fourth indication approved for marketing, targeting post-operative adjuvant therapy for EGFR mutation-positive non-small cell lung cancer The third New Drug Application of Ameile has been approved for maintenance therapy in patients with unresectable stage III NSCLC following chemoradiotherapy
  • 2024
    2024 National May 1 Labor Medal Aumolertinib project won first prize among the Jiangsu Science and Technology Awards for 2023
  • 2023
    Saint Luolai (Pegmolesatide Injection）, was included in the National Reimbursable Drug List The invention patent "EGFR Inhibitor and Preparation and Application Thereof" for Ameile won the 24th China Patent Gold Award Saint Luolai, Hansoh’s seventh innovative drug and the only globally approved and marketed innovative small-molecule peptide-based compound for the treatment of renal anemia, granted approval for marketing Ameile（Aumolertinib Mesylate Tablets）was included in the National Reimbursable Drug List XINYUE (Inelizumab Injections), was included in the National Reimbursable Drug List Mailingda (Morinidazole Sodium Chloride for Injection) has been included in the general list of the 2023 NRDL.
  • 2022
    The Journal of Clinical Oncology (JCO), an internationally renowned oncology journal, published a paper on the AENEAS study of Ameile（Aumolertinib Mesylate Tablets）, which was the first publication of the clinical data of an original Chinese third-generation EGFR-TKI in the official ASCO journal 21 full-text papers on Ameile were published in SCI journals, with a cumulative impact factor of 153.1 points 34 Ameile studies gained spotlight at WCLC, ESMO, ESMO ASIA, ASCO and other international academic events of oncology The 96-week data from the large-scale Phase III clinical study of Hengmu (Tenofovir Amibufenamide Tablets) was published in the Journal of Clinical and Translational Hepatology (JCTH), an internationally renowned academic journal of hepatology
  • 2021
    Ranked 1,616th in Forbes Global 2000 Ameile（Aumolertinib Mesylate Tablets） received approval for first-line indication Hengmu, China's first original oral anti-HBV drug, came into the market Hengmu（Tenofovir Amibufenamide Tablets）was included in the National Reimbursable Drug List
  • 2020
    Ranked 37th among pharmaceutical companies worldwide Recognized as Green Supply Chain Management Enterprise by MIIT China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline and China Pharmaceutical Enterprise CSR Leading Enterprise Award The "National Category 1 Long-acting GLP-1 Hypoglycemic Drug Polyethylene Glycol Loxenatide and Its Formualtions R&D and Industrialization Project" was awarded the Commendation Award of China’s Grand Industrial Awards by China’s Federation of Industrial Economics Ameile(Aumolertinib Mesylate Tablets), China's first original third-generation EGFR-TKI innovative drug, hit the market Three innovative drugs，Ameile（Aumolertinib Mesylate Tablets）, Hansoh Xinfu（Flumatinib Mesylate Tablets） and Fulaimei（PEG-Loxenatide for Injection） entered the National Reimbursable Drug List Morinidazole invention patent and Tigecycline invention patent were awarded China Patent Excellence Award and China Patent Silver Award by China National Intellectual Property Administration respectively
  • 2019
    The parent company was listed on the Hong Kong Stock Exchange (Hansoh Pharma 03692. HK) China Pharmaceutical Enterprise CSR Leading Enterprise Award Green Enterprise Management Award China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline (2rd place) Hansoh Xinfu( Flumatinib Mesylate Tablets), China's first independently developed second-generation Class 1 innovative drug for CML, came into the market Fulaimei(PEG-Loxenatide for Injection), the world's first PEGylated long-acting hypoglycemic drug and China's first long-acting GLP-1 hypoglycemic drug, hit the market
  • 2018
    China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline (2rd place) Oulanning (Olanzapine Tablets) was the first to pass the consistency evaluation Xinwei (Imatinib Mesylate Tablets) was the first to pass the consistency evaluation Fulaidi (Repaglinide Tablets) was the first to pass the consistency evaluation Hengsen (Micafungin Sodium for Injection) came into the market
  • 2017
    National Intellectual Property Exemplary Enterprise Ranked 19th in the Top 100 Ranking of China's Pharmaceutical Industry Ranked 23rd in Top 100 Pharmaceutical Companies in China 2016 Recognized as a Contract-abiding and Trustworthy Company at the provincial level for six consecutive years Xinwei (Imatinib Mesylate Tablets) was named to the "China Pharmaceuticals • Top Brands" list Mailingda（Morinidazole Sodium Chlorride for Injection） entered the National Reimbursable Drug List
  • 2016
    Recognized as an Intellectual Property Exemplary Enterprise by China National Intellectual Property Administration Oulanning (Olanzapine Tablets) received China Patent Excellence Award from China National Intellectual Property Administration Xinwei (Imatinib Mesylate Tablets) received the first prize for the Advancement of Science and Technology from the National Federation of Industry & Commerce Pulaile (Pemetrexed Disodium for Injection), was approved by the PMDA,Japan
  • 2014
    The patent of "New Synthetic Process of Important Intermediate of New Oncology Drug Gemcitabine" won China Patent Gold Award The first Class 1.1 innovative drug, Mailingda, came into the market, which was the world's first innovative nitroimidazole anti-anaerobic drug in 40 years "Development and Application of New Antipsychotic Drug Olanzapine and Its Formulations" won the second prize of the National Science and Technology Progress Award
  • 2013
    All production lines in Hansoh obtained GMP certificate "Development and Industrialization of Gemcitabine Hydrochloride for Injection, a New Oncology Drug" won the second prize of the National Science and Technology Progress Award Zefei (Gemcitabine Hydrochloride for Injection) was approved by the FDA
  • 2012
    Recognized as a National Technology Innovation Exemplary Enterprise The Administrative R&D Center at Lianyungang Headquarters was put into use Gainuo （Vinorelbine Tartrate Injection）and Zefei（Gemcitabine Hydrochloride for Injection） passed the FDA certification, embarking on a new international journey
  • 2011
    Shanghai R&D Center, i.e. Shanghai Hansoh BioMedical Co., Ltd., was established
  • 2009
    Managed as a group and changed into Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
  • 2006
    Approved to establish a postdoctoral research station
  • 2003
    Passed the FDA certification with "zero defect", starting the new international journey
  • 2002
    Recognized as a Key National High-tech Enterprise Started the research and development of Class 1.1 innovative drugs, becoming one of the first companies in China to tap the potential of innovative drugs
  • 2001
    Zefei( Gemcitabine Hydrochloride for Injection) and Oulanning （Olanzapine Tablets） came into the market successively, establishing a leading role in the development and production of oncology and psychotropic drugs in China
  • 2000
    Launched first GMP production workshop in Lianyungang, Jiangsu Province and commenced production of solid oral formulations.
  • 1999
    Gainuo ( Vinorelbine Tartrate Injection) came into the market, becoming an important milestone in the domestic oncology field
  • 1997
    Meifeng（Tabellae Cefalexini Lente Liberantes） hit the market, marking the exclusive launch of new dosage form in China and becoming the first blockbuster product
  • 1995
    Establishment of Lianyungang Haosen Pharmaceutical