1. 乐鱼(中国)leyu·官方网站

      Centennial HEC
      Centennial HEC

      Biomedicine Industry

      The biomedical industry mainly includes Sunshine Lake Pharma Co., Ltd. and HEC Pharm Co., Ltd. two business systems. Sunshine Lake Pharma Co., Ltd. includes HEC Pharmaceutical Research Institute, domestic preparation business ("HEC Changjiang Pharmaceutical", which has been listed in Hong Kong stock market) and pharmaceutical business for foreign markets; HEC Pharm Co., Ltd. is mainly engaged in bio-fermentation API.

      Pharmaceutical Research Institute

      HEC Research Institute

      Research Institute
      The Pharmaceutical Research Institute was established in 2005, driven by the twin engines of "innovation" and "internationalization" to develop and commercialize small molecule innovative drugs, biological innovative drugs and similar drugs, first generic drugs and innovative preparations around the world, involving infectious diseases such as hepatitis B and C, tumor diseases such as esophageal cancer, endocrine and metabolic diseases such as diabetes and other fields; the cumulative investment in research and development exceeds 20 billion yuan.
      Research Scale
      • 1 National key laboratory
        1 National key laboratory
        A national key laboratory for the R&D of new anti-infective drugs is approved to establish, undertaking and participating in the R&D of 25 major national projects.
      • 3 Platforms
        3 Platforms
        Small molecule R&D platform, macromolecule R&D platform, generic drug and innovative formulation platform, with complete independent R&D capability
      • 100+ Research projects
        100+ Research projects
        43 Class 1 new drugs (33 chemical innovative drugs, 10 biological innovative drugs), 8 biosimilar drugs, 50+ generic drugs & improved new drug projects
      • 50 Class 1 new drug products
        50 Class 1 new drug products
        28 Products are in the clinical stage, 6 are in the clinical phase III, 4 have completed the overseas clinical phase I, and 1 has FDA orphan drug qualification.
      • 1500+ Researchers
        1500+ Researchers
        There are 1500+ R&D personnel, and the proportion of masters and doctors is more than 60%.
      • 2000+ Patents
        2000+ Patents
        There are 2000+ patents in the biomedical sector, in which 800+ are overseas patents.
      • 6-Fold GMP certification
        6-Fold GMP certification
        Possess 6-fold GMP certification from the United States, the European Union, China, WHO, Australia, and Belarus, forming an international standard pharmaceutical production system
      • 15+ Countries and Regions
        15+ Countries and Regions
        Serve customers covering five continents, accumulatively enter 15+ countries and regions, create a global sales network layout
      • Advantages of the research institute
        Advantages of the research institute
        It is equipped with advanced R&D software, hardware and environment, 50,000 square meters of laboratories, completely independent R&D capabilities, and a complete R&D system, which can quickly realize industrialization; it conducts R&D cooperation with international top pharmaceutical companies. It has the ability to develop generic drugs and innovative preparations and clinical trials that meet European and American standards.
      • Strength of the research institute
        Strength of the research institute
        It has abundant product clusters, and the R&D strength ranks first in the domestic echelon. It focuses on infection, tumor, chronic disease (metabolism) and other market fields. There are 100 products on the market, including 1 Class 1 new drug. 50 Class 1 new drugs are under development, 11 of which are in clinical phase II/III. Research institute has entered the forefront of China's new drug R&D pipeline and innovative chemical drugs.
      The echelon of innovative drug pipeline is clearly stratified and competitive
      Therapeutic field Medicine name Indication Clinical phase Ⅰ Clinical phase Ⅱ Clinical phase Ⅲ Come into the market
      Infection field
      Emitasvir Hepatitis C
      Antaitasvir Hepatitis C
      Yiqibuvir Hepatitis C
      Morphothiadine Hepatitis B
      Forethiadine Hepatitis B
      HEC116094 Influenza
      Tumor/ Immune field
      Larotinib Esophageal Cancer
      Clifutinib AML
      HEC169096 Solid Tumor
      HEC81885 Solid Tumor
      Metabolic/chronic disease
      Rongliflozin Diabetes
      Yinfenidone IPF/PF-ILD
      HEC96719 NASH
      HEC93077 Gout
      HEC73077 Diabetic nephropathy
      HEC95468 Pulmonary hypertension
      HEC53856 Renal anemia
      HEC126764 Diabetic nephropathy
      Neuropsychiatric field
      Mitizodone Depression
      HEC137076 Migraine
      Note: Products in the early stages of development are not listed in the product pipeline above    Conduct overseas clinical trials    Foreign cooperation

      Domestic preparation business [HEC Changjiang Pharmaceutical (01558.HK)]

      HEC Pharmaceutical (01558.HK) is listed on the main board of Hong Kong. Its main products include anti-influenza drug Kewei (oseltamivir phosphate capsules and granules), insulin series products, emitavir phosphate cap

      Kewei
      Kewei is the recommended drug for the prevention and treatment of influenza in the world, and it is also a safer and more effective drug for the treatment of influenza in children at this stage; HEC holds a patent for the professional Kewei granule process that is more suitable for children.

      Insulin

      There are 120 million people with diabetes in China, and the market space for new and alternative markets is vast. HEC drug recombinant human insulin injection and insulin glargine injection have been approved for marketing, and won the bid for national centralized procurement. Insulin Aspart Injection and Insulin Aspart 30 Injection have been approved for marketing in China in 2022, and a series of diabetes products such as liraglutide will be launched in the future; the clinical development of insulin glargine and insulin aspart in the United States is progressing smoothly, and it is expected that it will be approved for listing in the United States in 2023 and 2024, respectively, entering the US$15 billion insulin market.

       

      Emitasvir Phosphate Capsules

      Emitasvir phosphate, launched in December 2020, is China's first fully self-developed oral small molecule anti-hepatitis C drug. Emitasvir phosphate has a cure rate of 99.8% in the treatment of Chinese hepatitis C genotype 1 patients. It has won the National Twelfth Five-Year Plan and the Thirteenth Five-Year Plan for Major New Drug Creation Projects. It has entered the National Medical Insurance Catalogue in December 2021, and is currently in rapid volume.

       

      Centralized procurement products

      HEC pharmaceutial have been approved for 38 domestic consistency evaluation drugs, and 17 varieties of centralized procurement have been won the bid, and the varieties of centralized procurement have become the rapid growth point of HEC drugs. 

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      Pharmaceutical business for foreign markets

      Internationalization of biomedicine
      HEC is an advanced preparation international enterprise in China, possessing strong international R&D and clinical promotion capabilities, drug registration capabilities and intellectual property rights layout capabilities. At present, more than 30 varieties of generic drugs have been approved in the United States and Europe, and 4 new drugs and 1 biosimilar drug have been clinically launched overseas, and another biosimilar drug is planned to be clinically launched overseas. In 2022, HEC successfully invalidated the US patent of Novartis fingolimod, becoming the first Chinese company to successfully challenge the patent of an original drug in the US. Sunshine Lake Pharma has established sales branches in 15 countries including Singapore, Japan, the United States, and Germany. At present, the German company has a complete and mature operating system, and has the qualifications to sell medicines throughout Europe, which ranks 14th in the number of bids won by the insurance company AOK.
      HEC international product line of new drugs and biological drugs
      Drug classificationDrug nameTherapeutic fieldHighlights of the drug
      Small molecule new drug
      HEC68498Physical painTarget differentiation
      HEC96719Non-alcoholic fatty liver diseasePotential best-in-class, diverse potential indications
      Yinfenidone hydrochlorideIdiopathic pulmonary fibrosis IPFPotential best-in-class, broad market in China and the United States
      Biological new drugs and biosimilars
      Insulin glargineDiabetesQuality comparable to original research, planned to be listed in the United States
      Insulin aspartDiabetesQuality comparable to original research, planned to be listed in the United States
      GLP-1/FGF21 Dual-target biological drugType 2 diabetes, NASHExpected to become a global First-in-class

      Fermentation Raw Materials

      HEC's biochemical fermentation raw materials are mainly macrolide products (the raw materials of broad-spectrum antibiotics), the technology level and product quality are among the best in the world, and the output accounts for more than 65% of the global standard market.

      Core customer:

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      HEC Medicine—Production System

      Shaoguan, Guangdong

      API factory

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      Dongguan, Guangdong

      Oral solid dosage production base

      Yichang, Hubei

      Domestic preparation factory

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      Yichang, Hubei

      API factory

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