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Company Profile


Founded in 1985, Tonghua Dongbao Pharmaceutical Co., Ltd. has built a solid reputation as a pharmaceutical manufacturer that boasts strengths in the R&D, production, and marketing of pharmaceuticals, particularly Chinese patent medicines, chemical medicines, and biological products. Our most lauded products include Zhennaoning Capsules, Dongbao Gantai Tablets, Tangjierui Repaglinide Tablets, Tangjieen Engagliflozin Tablets, Gansulin® Recombinant Human Insulin, and Pingsulin® Insulin Glargine, and Ruisulin® Insulin Aspart, and Tongboli Liraglutide. Tonghua Dongbao was listed on the Shanghai Stock Exchange in August 1994.


Over the years, we have maintained our philosophy of establishing a global brand through consistent innovation. Tonghua Dongbao developed the first Chinese made human insulin, with the trade name Gansulin, in 1998. Gansulin thus established China as the world’s third producer of recombinant human insulin following the United States and Denmark, and helped China overcome years of dependence on imports of the medicine. This achievement won the second prize of the National Science and Technology Progress Award and was listed in the "Top 10 Scientific Breakthroughs 1998". Tonghua Dongbao was also awarded many honorary titles such as National Technology Innovation Demonstration Enterprise and National High-tech Enterprise, and Dongbao® and Gansulin® were recognized as China’s well-known trademarks.


In June 2008, Tonghua Dongbao successfully commercialized the research results to expand the annual production capacity of recombinant human insulin drug substances to 3,000 kg and became the first EU cGMP-certified biopharmaceutical manufacturer in China. Tonghua Dongbao began to build the third manufacturing plant of recombinant human insulin and the production lines of insulin glargine and insulin aspart in 2012 and 2014 respectively. We have an annual production capacity of over 300 million cartridges & vials now. In 2016, we started to invest in the construction of the Biopharmaceutical Industrial Park, which includes: Pharmaceutical Research Institute of Tonghua Dongbao and Quality Testing Center, production bases of insulin degludec, liraglutide drug substances and injection, wastewater treatment plant, acetonitrile recycling station, etc. Tonghua Dongbao Pharmaceutical Research Institute has begun operations since March 2021.


Our insulin analog: insulin glargine, insulin aspart, insulin aspart mix 70/30 and mix 50/50 have been available on the market since February 2020, December 2021, and December 2022 respectively. GLP-1RA Liraglutide injection approved for marketing in December 2023. In addition, we have 4 oral anti-diabetic hypoglycemic drugs obtained the Pharmaceutical Product Registration Certificate issued by NMPA: sitagliptin phosphate tablets, sitagliptin phosphate/metformin hydrochloride tablets, repaglinide tablets, engagliflozin tablets. Besides, etoricoxib tablets received the notice of acceptance from the NMPA on the NDA application in September 2023.

Today, Tonghua Dongbao provides the world with five novel drugs, including three for diabetes and two for gout. Among them, first subject enrolled in Phase I clinical trial on first Chinese-made dual-target inhibitor for gout (THDBH151 Tablets) in May 2023, novel URAT1 inhibitor for gout meets primary endpoint in phase II clinical trial in January 2024. In diabetes therapy area, first subject enrolled in Phase I clinical trial on GLP-1/GIP receptor agonist (THDBH120 Injections) and oral small-molecule GLP-1 receptor agonist (THDBH110 Capsules) in December 2023.

Tonghua Dongbao advances its international strategy continuously. Based upon domestic market, while further expanding overseas markets. Tonghua Dongbao has an international registration team and an overseas sales team for international business expansion. We have already established business contacts with key regional clients in Southeast Asia, the Middle East, East Asia, South America, and Africa, and have established strategic cooperation with multiple well-known domestic enterprises, to explore overseas market jointly. Besides, in early 2020, we started filing for the registration of insulin glargine and insulin lispro in the European Union and other developing countries.

In the days to come, we will stay true to our philosophy of establishing a global brand through consistent innovation. We will enhance our capabilities in innovation-driven biopharmaceutical R&D and scale up the commercialization of research results to contribute toward achieving the goal of health for all.

Milestones

2024

  • 1 January 2024

    Tonghua Dongbao's project "Key Technology Development for the Production of Insulin Degludec and Its Combination Drug Products" has secured a special fund of CNY 1.5 million from the 2024 Jilin Province Major Science and Technology Special Funding Program in the Biopharmaceutical Industry after review, defense, and on-site verification.


  • 16 January 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd., recently completed a multicenter, randomized, double-blind, placebo-and-benzbromarone-controlled Phase IIa clinical study of THDBH130 Tablets in treating adult hyperuricemic patients with or without gout. The results demonstrate that the trial has reached its primary endpoint.


  • 6 February 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. received a notice of acceptance from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the clinical trial of the dual GLP-1/GIP receptor agonist (THDBH120 injection) intended for weight loss indications.


  • 27 March 2024

    The Fourth Meeting of the Eleventh Board of Directors of Tonghua Dongbao Pharmaceutical Co., Ltd. has appointed Mr. Li Jiahong as the Chairman of the Company and Mr. Leng Chunsheng as the Vice Chairman and General Manager.


  • 23 April 2024

    China's Joint Procurement Office (JPO) announced the preliminarily selected bids from a continued round of the national volume-based procurement (VBP) program for insulin. This VBP cycle is set to run from the date of tender implementation until December 31, 2027. Tonghua Dongbao Pharmaceutical Co., Ltd. successfully secured a Category A designation for its entire lineup of insulin products. Insulin Glargine and two other products were both categorized as A1. These results meet management expectations and align with the Company's development planning.


  • 24 April 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. received a notice of approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the clinical trial of the dual GLP-1/GIP receptor agonist (THDBH120 injection) intended for weight loss indications.


  • 29 April 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. obtained clinical trial approval for the combination of insulin degludec and liraglutide injection, marking a significant milestone in the development of a fixed combination of insulin analogs and GLP-1RA, which will enhance its market competitiveness.


  • 6 May 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. successfully dosed the first patient in the Phase IIa clinical trial of the dual inhibitor for gout (THDBH151 tablets), the first XO/URAT1 dual inhibitor for gout that has entered the Phase II clinical trial stage in China.


  • 7 May 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. signed the Commercialization Licensing and Marketing Authorization Holder (MAH) Agreement with Beijing Quality Peptide Biopharmaceutical Technology Co., Ltd. for the GLP-1 Semaglutide injections. The Company will obtain exclusive commercial rights to QL Biopharm's clinical investigational drug in the Chinese Mainland, namely ZT001 Semaglutide Injection, and will also have rights to joint overseas market development with QL Biopharm.


  • 7 May 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. entered into a Capital Increase Agreement with JHM Biopharm (Hangzhou) Co., Ltd. and its founding shareholders.


  • 14 May 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. has initiated the Phase I clinical trials in China for the combination of insulin degludec and liraglutide injection and successfully dosed the first patient, following the receipt of a clinical trial approval notification from the National Medical Products Administration (NMPA).


  • 20 June 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd., has initiated the Phase Ib clinical trial of THDBH120 injection for diabetes indications, and the first patient was dosed, following the receipt of a clinical trial approval notification from the National Medical Products Administration (NMPA).


  • 24 June2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. and Sinopharm Group Co., Ltd. have signed a Strategic Cooperation Framework Agreement in Shanghai.


  • 4 July 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. underwent an on-site inspection by the European Medicines Agency (EMA) in April 2024. In July 2024, the Company received a notice that its human insulin drug substance (DS) production facilities comply with the European Union (EU) GMP regulations and are ready for commercial manufacturing in the EU.


  • 25 July 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd., has initiated the Phase Ib clinical trial of THDBH120 injection for weight loss indications, and the first patient was dosed, following the receipt of a clinical trial approval notification from the National Medical Products Administration (NMPA).


  • 31 July 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. has initiated the Phase III clinical trial of semaglutide injections (THDB0225) jointly developed with Beijing Quality Peptide Biopharmaceutical Technology Co., Ltd. in China and completed the dosing of the first patient.


  • 8 November 2024

    Tonghua Dongbao Pharmaceutical Co., Ltd. has completed the key Phase I clinical trials for the combination of insulin degludec and liraglutide injection and generated the final report following the receipt of a clinical trial approval notice from the National Medical Products Administration (NMPA).


  • 6 December 2024

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. has completed the Phase I clinical study on evaluating the safety and other characteristics of THDBH120 injection in healthy Chinese adults following the receipt of the clinical trial approval, with the result meeting the primary endpoint.


  • 17 December 2024

    The "Jilin Provincial Key Laboratory for Novel Drugs Targeting Metabolic Diseases" co-founded by Tonghua Dongbao Pharmaceutical Co., Ltd. and Tonghua Normal University has been officially approved for construction.


2023

  • February 2023

    The marketing authorization application for human insulin injection has been accepted by the European Medicines Agency (EMA).


  • May 2023

    First subject enrolled in Phase I clinical trial on first Chinese-made dual-target inhibitor for gout (THDBH151 Tablets).


  • September 2023

    The NDA application for Etoricoxib Tablets has been accepted.


  • September 2023

    A strategic partnership with Nanjing Kingfriend Biochemical Pharmaceutical Co., Ltd. to introduce their insulin injections, including insulin glargine, insulin aspart, and insulin lispro, to the US market.


  • October 2023

    Obtained the Pharmaceutical Product Registration Certificate for empagliflozin tablets


  • December 2023

    Liraglutide injection (Trade name: Tongboli) approved for marketing


  • December 2023

    The first subject enrolled in Phase I clinical trial of novel oral small-molecule GLP-1 receptor agonist (THDBH110 Capsules).


  • December 2023

    The first subject enrolled in Phase Ia clinical trial of novel dual GLP-1/GIP receptor agonist (THDBH120 injection).


2022

  • 14 January 2022

    Received a notification of acceptance from the National Medical Products Administration (NMPA) on the registration application for empagliflozin drug substance (DS).


  • 7 February 2022

    Tonghua Dongbao Pharmaceutical Co., Ltd. received a notification of acceptance from the National Medical Products Administration (NMPA) on the registration application for empagliflozin.


  • 28 February 2022

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. has successfully completed the enrollment of the first subject in the phase I clinical trial of its triple-target inhibitor (THDBH101 Tablets/WXSHC071 Tablets) in China, after receiving the notice of approval from the National Medical Products Administration (NMPA).


  • 25 April 2022

    Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. has completed the first subject enrollment in phase I clinical trial of novel URAT1 inhibitor (THDBH130 Tablets) for treating gout/hyperuricemia in China.


  • 6 May 2022

    Tonghua Dongbao Pharmaceutical Co., Ltd. has completed the first subject enrollment in phase III clinical trial of BC Lispro (THDB0206 Injection) in China.

2021

  • 5 March 2021

    Tonghua Dongbao and WuXi AppTec (Shanghai) signed the Memorandum of Understanding on Strategic Cooperation, specifying the intention of both parties to start extensive cooperation in the development of novel drugs for diabetes and other diseases, signaling its foray into the realm of novel drugs.


  • 8 March 2021

    Tonghua Dongbao Pharmaceutical Research Institute began operations.


  • 27 June 2021

    Tonghua Dongbao won the Best Public Service Award in the 10th Chinese Listed Companies Forum.


2020

  • 27 January 2020

    Tonghua Dongbao donated RMB 1 million to the China Red Cross Foundation for the COVID-19 pandemic control in Wuhan.


  • 4 February 2020

    Tonghua Dongbao rolled out the first lot of Changsulin® insulin glargine injections, or the insulin analog.


  • 21 February 2020

    Tonghua Dongbao donated RMB 22 million worth of drugs and RMB 1 million in cash to the Tonghua Red Cross Society to support the COVID-19 pandemic control in Tonghua.



  • 14 September 2020

    Tonghua Dongbao received the notification of acceptance by the Center for Drug Evaluation of the NMPA on the application for the clinical trial of ultra-rapid-acting insulin lispro injections.


  • 14 October 2020

    Tonghua Dongbao ranked 14th in the Top 100 Pharmaceutical Enterprises 2019 issued by the Expert Committee of China Top 100 Pharmaceutical Industry.


  • 23 November 2020

    Tonghua Dongbao received NMPA approval for the clinical trial of ultra-rapid-acting insulin lispro injections.


  • 26 November 2020

    Tonghua Dongbao was recognized as an enterprise with outstanding contributions in the fight against the pandemic in Tonghua.


2019

  • March 2019

    Mr. Li Yikui, the founder of Dongbao Group, resigned as chairman and exited the Board of Directors. Mr. Li Jiahong took over as the Chairman and General Manager of Dongbao Group, and Dr. Leng Chunsheng served as Chairman and General Manager of Tonghua Dongbao.


  • 6 December 2019

    Tonghua Dongbao received the registration approval for insulin glargine, or the insulin analog.

2018

  • 26 April 2018

    Tonghua Dongbao and Adocia SAS signed the Agreement for Cooperation and Licensing of Ultra-rapid-acting Insulin and the Agreement for Cooperation and Licensing of BioChaperone Combo.


  • May 2018

    The insulin research team led by Dr. Leng Chunsheng was awarded the honorary title of Huang Danian Research Team in Jilin Province.

2017

  • 20 October 2017

    The NMPA issued the approval for the clinical trial of insulin detemir drug substances and insulin detemir injection.


  • 9 November 2017

    Jilin Medical Products Administration issued the notification of acceptance of the application for the clinical trial of recombinant insulin lispro drug substances and recombinant insulin lispro injection.


  • 16 November 2017

    NMPA issued the notification of acceptance of the application for registration of liraglutide drug substances and liraglutide injection.


  • 16 November 2017

    Tonghua Dongbao received the notification of acceptance for the application for the phase III clinical trial of recombinant human insulin injection in the EU.


  • 25 November 2017

    Tonghua Dongbao was recognized as a national high-tech enterprise.

2016

  • 16 March 2016

    Gansulin R is named as one of the Famous Brands in Jilin.


  • April 2016

    The Biopharmaceutical Industrial Park was settled in Tonghua Pharmaceutical Hi-tech Industrial Development Zone. The groundbreaking ceremony was held on July 16.


  • 7 June 2016

    The Adverse Drug Reaction Reporting and Monitoring Center (ADR Monitoring Center) was established.

Culture

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