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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

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

Small molecule R&D platform, macromolecule R&D platform, generic drug and innovative formulation platform, with complete independent R&D capability
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

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

There are 1500+ R&D personnel, and the proportion of masters and doctors is more than 60%.
2000+ Patents

There are 2000+ patents in the biomedical sector, in which 800+ are overseas patents.
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

Serve customers covering five continents, accumulatively enter 15+ countries and regions, create a global sales network layout

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

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
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 2024新澳门历史记录查询

Conduct overseas clinical trials 2024新澳门历史记录查询

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.

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 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

Branches under the sales department