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Tonghua Dongbao's application of human insulin injection accepted by EMA
Date：2023-02-02
Author：東寶
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On February 1, 2023, Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao") and Rechon Life Science AB ("Rechon") announced that the marketing authorization application (MAA) for their human insulin injection was recently accepted by the European Medicines Agency (EMA).
Human insulin injections are poised for overseas marketing
Tonghua Dongbao's human insulin drug substances were EU GMP-certified in 2013. To expand its overseas market presence, the Company began the registration process for a human insulin injection in the EU and entrusted Rechon with a clinical trial on the human insulin injection in the EU. According to the partnership agreement, Tonghua Dongbao would furnish the insulin drug substances, and Rechon would use those drug substances to make human insulin injections and register the product in the EU in compliance with the EU's biosimilar registration procedure. Tonghua Dongbao's MAA for the human insulin injection was accepted by the EMA in January 2023, following the conclusion of the Phase III clinical trial in the EU.
The Company has been consistently pushing ahead with the international registration of human insulin and insulin analogs in recent years. If the MAA is approved, the Company will mark a significant milestone in expanding into developed markets for its insulin products, and the registration of its insulin products in many countries will be fast-tracked, thus boosting the international market presence of its insulin products.
Global expansion strategy makes steady progress
With the expansion and diversification of the Company's product pipelines and portfolio, in addition to human insulin, the Company is bringing more high-quality products such as insulin analogs, GLP-1RA, and Class 1 novel drugs to the international market.
Over the past decade, the Company has been exporting human insulin drug substances for many years by virtue of its superior product and production quality, as well as its established brand advantages. In 2021, the Company's international business achieved sales revenue of more than RMB 80 million, a YoY increase of more than 50%.
At the same time, the Company is steadily advancing the registration of insulin analogs (insulin glargine, rapid-acting, and premixed insulin aspart) in overseas markets. In recent years, with the approval of insulin glargine and insulin aspart products in China, the Company has initiated the registration process of these products in a number of developing countries and plans to register them in developed countries.
For GLP-1RA, after the MAA for the liraglutide injections produced in China was accepted, the Company reached a cooperation agreement with Kexing Biopharm in December 2022 to market liraglutide injections in 17 overseas emerging markets.
In addition, the Company has a number of proprietary Class 1 novel drugs that have entered or will soon enter clinical trials, including the potential best-in-class innovative products. As the clinical trials of these novel drugs move forward and reach primary endpoints in phases, the Company is seeking overseas partners and approaching large overseas pharmaceutical companies to make a foray into the vast international market.
The international market is a blue ocean
The vast and lucrative international market for diabetes treatment is a magnet for pharmaceutical companies. According to the International Diabetes Federation (IDF) Diabetes Atlas 10th edition, 537 million adults aged 20-79 had diabetes in 2021, representing 10.5% of the world's population in this age group. According to a Statista survey, the global diabetes drugs market was estimated at USD 59.04 billion in 2021 and will keep growing in the long run.
The EMA's acceptance of the MAA for the human insulin injection marks the Company's another solid step towards the large-scale commercialization of its products worldwide. Tonghua Dongbao is expected to be the pioneer that brings Chinese insulin products to the developed countries, plunges into the global competition, and provides overseas diabetic patients with high-quality drugs after it developed the first Chinese recombinant human insulin that breaks the monopoly of foreign pharmaceutical companies.
About human insulin injection
Tonghua Dongbao, a leading insulin maker in China, developed China's first recombinant human insulin in 1998, making it the third country after the United States and Denmark to produce a recombinant human insulin, which is used for the treatment of diabetes. The Company has been focusing on the development and production of products for the treatment of diabetes for many years. Its recombinant human insulin injection products (registered trademark "Gansulin") include Gansulin R, Gansulin 30R, Gansulin N, Gansulin 40R, and Gansulin 50R. Its recombinant human insulin drug substances and injection products attained revenue of RMB 2.214 billion in 2019, RMB 2.264 billion in 2020, and RMB 2.419 billion in 2021.
About Rechon Life Science AB
Rechon Life Science AB is a pharmaceutical company based out of Limhamn, Sweden. Rechon provides services for pharmaceutical, biotech, and life science companies in the development and manufacturing of pharmaceutical products such as sterile vials, ampules, cartridges, and pre-filled syringes. Rechon focuses on contract pharmaceutical services and works with companies of all sizes, from startups to industry leaders.
