Pharmaceutical Research Institute
The Pharmaceutical Research Institute was established in 2005. Driven by the dual engines of "innovation" and "internationalization", it develops and commercializes small-molecule innovative drugs, biological innovative drugs, biosimilars, first generic drugs, and innovative formulations globally. Its research covers multiple fields such as infectious diseases (e.g., hepatitis B and hepatitis C), tumor diseases (e.g., esophageal cancer), endocrine and metabolic diseases (e.g., diabetes), etc. The cumulative R&D investment has exceeded 20 billion yuan.
Advantage and strength
Equipped with advanced R&D software, hardware and environment, a 50,000-square-meter laboratory, completely independent R&D capabilities, and a complete R&D system, it can quickly realize industrialization; conduct R&D cooperation with international high-quality pharmaceutical companies. Capabilities in the development and clinical trials of generic drugs and innovative preparations that meet European and American standards A rich product cluster, with R&D strength ranking among the domestic best-selling echelons, focusing on market areas such as infection, oncology, and chronic diseases (metabolism). There are 100 listed products, including 1 Class 1 new drug, and 50 Class 1 new drugs under research, 11 of which are in Phase II/III clinical trials. The Pharmaceutical Research Institute ranks among the forefront of China's new drug R&D pipelines and innovative chemical drugs
1 national key laboratory
A national key laboratory for anti-infective new drug research and development was established in batches, and it has undertaken and participated in the research and development of 25 national major projects.
3 major platforms
Small molecule R&D platform, large molecule development platform, generic drug and innovative preparation platform, with fully independent R&D capabilities
100+ research projects in progress
43 Class 1 new drugs (33 chemical innovative drugs, 10 biological innovative drugs), 8 biosimilars, and over 50 generic drugs & improved new drug projects
50 Class 1 new drug products
28 products are in the clinical stage, 6 in Phase III clinical trials, 4 have completed overseas Phase I clinical trials, and 1 has received FDA orphan drug designation.
1500 researchers
More than 1,500 R&D personnel, with a proportion of master's and doctoral degrees exceeding 60%
2800+ special items
Biomedical sector patents: over 2,000, overseas patents: over 800
6-layer GMP
A pharmaceutical production system with six GMP certifications from the United States, the European Union, China, WHO, Australia, and Belarus
15+ countries and regions
Our service clients cover five continents, having entered more than 15 countries and regions in total, creating a global sales network layout.
Domestic-oriented
preparation business
【Dongyangguang Pharmaceutical (06887.HK)】
Guangdong Dongyangguang Pharmaceutical Co., Ltd. (06887.HK) is listed on the Main Board of the Hong Kong Stock Exchange. Its main products include the anti-influenza drug Kewei (Oseltamivir Phosphate Capsules and Granules), insulin series products, Imidavir Phosphate Capsules, and centralized procurement products.
Kewei
Kewei is a globally recommended medication for the prevention and treatment of influenza, and it is also a relatively safe and effective drug for treating children's influenza at this stage; Dongyangguang holds the patent for the professional Kewei granule process, which is more suitable for children.
Insulin
There are 120 million diabetes patients in China, with a vast market space for new additions and replacements. Dongyangguang Pharmaceutical's recombinant human insulin injection and insulin glargine injection have been approved for marketing and immediately won the national centralized procurement bid. Insulin aspart injection and insulin aspart 30 injection were approved for marketing in China in 2022, and subsequent diabetes series products such as liraglutide will also be launched; the clinical progress of insulin glargine and insulin aspart in the United States is going smoothly, and they are expected to be approved for marketing in the United States in 2024, entering the 15 billion US dollar insulin market in the United States.
Imiprevir Phosphate Capsules
Imitapivir Phosphate, launched in December 2020, is a new oral small-molecule anti-hepatitis C drug completely independently developed in China. It is a breakthrough achieved by Dongyangguang after 10 years of efforts, realizing the innovation of a new drug from 0 to 1. The cure rate of Imitapivir Phosphate in treating Chinese patients with hepatitis C genotype 1 is as high as 99.8%. It has won the national major new drug creation special projects during the 12th and 13th Five-Year Plans. In December 2021, it was included in the National Medical Insurance Catalog and is currently in a stage of rapid sales growth.
Centralized procurement products
Dongyangguang Yangtze River Pharmaceutical has been approved for 38 domestic consistency evaluation drugs. At present, it has won bids for 17 centralized procurement varieties, which have become a rapid growth driver for Dongyangguang Pharmaceutical.
Pharmaceutical business oriented to foreign markets
Internationalization of biomedicine
Dongyangguang is a domestically advanced international pharmaceutical preparation enterprise in China, with strong capabilities in international R&D, clinical advancement, drug registration, and intellectual property layout. Currently, it has over 30 generic drug varieties approved in both the United States and Europe. There are 4 new drugs and 1 biosimilar already undergoing clinical trials overseas, and another 1 biosimilar is planned to start clinical trials abroad. In 2022, it successfully invalidated Novartis' U.S. patent for fingolimod, becoming a Chinese enterprise that successfully challenged the patent of an original drug in the United States. Guangdong Dongyangguang Pharmaceutical 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 operational system, holds the qualification for pharmaceutical sales throughout Europe, and ranks 14th in the number of winning bids from insurance company AOK.
The company's international product line of new drugs and biological drugs
Classification of DrugsDrug nameTherapeutic fieldHighlights of the Medicine
Small molecule new drugsHEC68498
Physical painTarget differentiation
HEC96719Non-alcoholic fatty liver diseasePotentially better than similar products, with diverse potential indications

HEC68498

Pirfenidone Hydrochloride

Entity pain idiopathic pulmonary fibrosis IPFPotential peers are better, and the Chinese and American markets are vast.

Biological new drugs

and biosimilars

Insulin GlargineDiabetesIts quality is comparable to that of the original research, and it is planned to be launched in the United States.
Insulin AspartDiabetesIts quality is comparable to that of the original research, and it is planned to be launched in the United States.

GLP-1/FGF21

dual-target biological drug

Type 2 diabetes, NASHExpected to become the global First-in-class
Branch companies under the Sales Division

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Bio-fermented active pharmaceutical ingredients
Dongyangguang's biochemical fermentation APIs are mainly macrolide products (APIs for broad-spectrum antibiotics). Its technological level and product quality rank among the world's top, and its output accounts for more than 65% of the global regulated market.
Core customers
Production system
Guangdong Shaoguan —— API Factory
Guangdong Dongguan —— Oral Solid Preparation Production Base
Hubei Yichang —— Domestic Pharmaceutical Preparation Factory
Hubei Yichang — Active Pharmaceutical Ingredient Factory