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
1 National key laboratoryA 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 PlatformsSmall molecule R&D platform, macromolecule R&D platform, generic drug and innovative formulation platform, with complete independent R&D capability
100+ Research projects43 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 products28 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+ ResearchersThere are 1500+ R&D personnel, and the proportion of masters and doctors is more than 60%.
2000+ PatentsThere are 2000+ patents in the biomedical sector, in which 800+ are overseas patents.
6-Fold GMP certificationPossess 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 RegionsServe customers covering five continents, accumulatively enter 15+ countries and regions, create a global sales network layout
Advantages of the research instituteIt 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 instituteIt 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.
|Therapeutic field||Medicine name||Indication||Clinical phase Ⅰ||Clinical phase Ⅱ||Clinical phase Ⅲ||Come into the market|
|Tumor/ Immune field|
Domestic preparation business [HEC Changjiang Pharmaceutical (01558.HK)]
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.
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.
Pharmaceutical business for foreign markets
|HEC international product line of new drugs and biological drugs|
|Drug classification||Drug name||Therapeutic field||Highlights of the drug|
|Small molecule new drug|
|HEC68498||Physical pain||Target differentiation|
|HEC96719||Non-alcoholic fatty liver disease||Potential best-in-class, diverse potential indications|
|Yinfenidone hydrochloride||Idiopathic pulmonary fibrosis IPF||Potential best-in-class, broad market in China and the United States|
|Biological new drugs and biosimilars|
|Insulin glargine||Diabetes||Quality comparable to original research, planned to be listed in the United States|
|Insulin aspart||Diabetes||Quality comparable to original research, planned to be listed in the United States|
|GLP-1/FGF21 Dual-target biological drug||Type 2 diabetes, NASH||Expected 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.
HEC Medicine—Production System
Oral solid dosage production base
Domestic preparation factory