Tonghua Dongbao Medicines Co. Ltd.

Tonghua Dongbao Pharmaceutical Co., Ltd. was established in 1985. It is a well-known domestic pharmaceutical manufacturer integrating pharmaceutical R&D, production and sales. It mainly develops Chinese patent medicines, chemical drugs and biological products. The main products are Zhennaoning Capsules, Dongbao Gantai tablets, recombinant human insulin - "Gansulin", insulin glargine - "Pingsulin", insulin aspart - "Risulin" and other products. In August 1994, the company was listed on the Shanghai Stock Exchange.

Over the years, the company has established a scientific and technological research and development team with the development concept of "adhering to independent innovation and creating a world brand", and is committed to the research and development of drugs in the fields of diabetes and other therapeutic areas. In 1998, my country's first recombinant human insulin - "Gansulin" was successfully developed, which not only filled the domestic gap, but also made my country the third country in the world that can produce recombinant human insulin after the United States and Denmark. Recombinant human insulin in my country has long been dependent on foreign imports. This achievement won the second prize of the National Science and Technology Progress Award and was selected as one of the "Top Ten Science and Technology Progress News in China in 1998". The company has successively won the titles of National Technology Innovation Demonstration Enterprise and National High-tech Enterprise. The trademarks "Dongbao" and "Ganshulin" were recognized as China's Famous Brands in 2002 and 2013 respectively.

In June 2008, it completed the transformation of the technical achievements of recombinant human insulin API with an annual output of 3,000 kg, and became the first biopharmaceutical enterprise in China to pass the EU cGMP certification. In 2011, the company started the research and development of third-generation insulin. In 2012, the company invested in the construction of the third-phase project with an annual output of 126 million recombinant human insulin injections. In 2014, invested in the construction of insulin glargine and insulin aspart production lines. In 2016, it began to invest in the construction of Dongbao Biomedical Industrial Park. The park includes: Tonghua Dongbao Pharmaceutical Research Institute and Quality Inspection Center, Insulin Degludec, Liraglutide API and Injection Production Base, Sewage Treatment Station, and Acetonitrile Recovery Workshop Etc., Tonghua Dongbao Pharmaceutical Research Institute has been officially put into use in March 2021.

At present, the company's third-generation insulin, insulin glargine, has been launched on the market in February 2020, and insulin aspart will also be launched in December 2021. The oral hypoglycemic drug "Sitagliptin Phosphate Tablets" obtained the drug registration certificate in August 2021, "Sitagliptin Metformin Tablets" obtained the drug registration certificate in October 2021, and repaglinide tablets obtained the drug registration certificate in June 2021 Obtain the notification of acceptance of the declaration. At the same time, the company pays attention to connecting with the world, and cooperates with the French company Adocia to jointly promote the research and development of the fourth-generation insulin - super fast-acting insulin lispro. In November 2020, it received the approval notice for drug clinical trials approved and issued by the State Drug Administration. In October 2021, the application for parallel Phase I and Phase III clinical trials was approved. This product is the first fourth-generation insulin that has obtained clinical approval to enter the clinical trial stage in my country, and the first clinical trial in China will be conducted in May 2022. Subjects were enrolled. Soluble glargine lispro diinsulin injection was approved in March 2022 for the domestic clinical trial application, and in April 2022, the German phase I clinical trial application was approved. This injection is currently the only one that can treat long-acting glargine. A compound preparation of a successful combination of insulin and fast-acting insulin lispro. The company started the registration and certification of insulin glargine and insulin aspart in the EU and developing countries in early 2020.

The company currently has five global first-class innovative drugs, namely three innovative drugs in the field of diabetes treatment and two in the field of gout treatment, of which the world's first SGLT1/ SGLT2/ DPP4 triple-target inhibitor has been released in China Phase I in February 2022. The first subject of the clinical trial was enrolled; the first class of gout/hyperuricemia drug URAT1 inhibitor (THDBH130 tablets) was clinically approved in December 2021, and the first subject of the China Phase I clinical trial was enrolled in April 2022 group, which will inject a strong impetus into the company's innovative development.

In the future, the company will continue to adhere to the development concept of "adhering to independent innovation and creating a world brand", guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, seize the favorable opportunities for the state to encourage innovative drugs and biological drugs, and be driven by technological innovation. Continuously improve the research and development capabilities of biopharmaceuticals, speed up the transformation of technological achievements, and make new and greater contributions to the cause of human health.