Zhitai Bio's GLP-1 Product Semaglutide Injection Licensed to Tonghua Dongbao | BlueRun Ventures Headlines
It has the potential to become one of the first semaglutide biosimilars to be approved and commercially launched in China.
BlueRun Ventures stated that in the future, Zhitai Bio's GLP-1 product semaglutide biosimilar injection has the potential to become one of the first semaglutide biosimilars to be launched and sold in China. The partnership with a leading listed company in China's diabetes space will help rapidly establish a favorable market position for the product, laying important groundwork for the company's transition from R&D to commercialization.
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as "Tonghua Dongbao" or "the Company") and Beijing Zhitai Biomedical Technology Co., Ltd. (hereinafter referred to as "Zhitai Bio") signed a "Commercialization License and MAH Cooperation Agreement" (hereinafter referred to as "the Agreement") regarding the GLP-1 product semaglutide injection.
According to the Agreement, the Company will obtain exclusive commercialization rights for Zhitai Bio's clinical-stage product ZT001 semaglutide injection (indication: blood glucose control in adult patients with type 2 diabetes) (hereinafter referred to as "the Collaboration Product") in mainland China, as well as rights to jointly develop overseas markets. The Collaboration Product has completed Phase I clinical trials for the type 2 diabetes indication in mainland China and has initiated Phase III clinical studies.
In recent years, GLP-1 products have demonstrated tremendous clinical and commercial value in diabetes treatment and weight management, among other applications. Tonghua Dongbao has strategically positioned a series of GLP-1 products, including its first GLP-1 product, liraglutide injection, which was successfully approved for market launch in 2023. Two novel GLP-1 Class 1 innovative drugs — the oral small-molecule GLP-1 receptor agonist (THDBH110 capsule) and the GLP-1/GIP dual-target receptor agonist (THDBH120 for injection) — have both completed first-patient enrollment for Phase I clinical trials for diabetes indications. Additionally, the clinical trial application for the weight-loss indication of the GLP-1/GIP dual-target receptor agonist (THDBH120 for injection) has also been approved.
Building on its commitment to independent R&D, the Company is also actively seeking external high-quality projects and collaboration opportunities. This licensed introduction of semaglutide injection will create effective synergies with the Company's existing diabetes treatment products, accelerating the construction of a multi-layered, diversified GLP-1 product portfolio and further consolidating and strengthening the Company's core competitiveness in the diabetes and endocrine metabolism fields.
On the market front, in addition to obtaining exclusive commercialization rights for the Collaboration Product in mainland China, the Company will also jointly develop overseas markets with Zhitai Bio. This represents another important step in the Company's product globalization strategy, adding significant product reserves for international expansion and further opening up broader overseas market opportunities.
Jiahong Li, Chairman of Tonghua Dongbao, stated: "Zhitai Bio has an excellent R&D team and multiple technology platforms at internationally leading standards. We are very pleased to reach this cooperation with Zhitai. This licensed introduction of the Collaboration Product, semaglutide injection, will further enrich and accelerate the Company's product positioning in the GLP-1 space, and provide corresponding product reserves for advancing the Company's internationalization strategy. Leveraging years of accumulated advantages in clinical development and commercialization in the endocrine metabolism field, the Company will bring this product to patients worldwide as soon as possible."
Xujia Zhang, Chairman of Zhitai Bio, stated: "Tonghua Dongbao is a renowned domestic biopharmaceutical enterprise integrating drug R&D, manufacturing, and sales, committed to holistic solutions for diabetes and endocrine treatment. We believe that through this cooperation, we can bring the internationally leading semaglutide product to more domestic diabetic patients more quickly. Zhitai also very much looks forward to working hand-in-hand with Tonghua Dongbao to jointly develop overseas markets and collaborate on other innovative drug products."
About the Collaboration Product ZT001:
ZT001 injection belongs to semaglutide, a long-acting GLP-1 (glucagon-like peptide-1) analog. GLP-1 drugs mimic the effects of GLP-1 in the human body, not only effectively lowering blood glucose levels but also producing weight-loss effects, and have demonstrated numerous potential therapeutic values in other chronic diseases.
The originator of semaglutide injection is Danish company Novo Nordisk. Its diabetes indication product was approved by the U.S. FDA in 2017 under the trade name Ozempic, and approved by China's National Medical Products Administration (NMPA) in 2021 under the trade name Nuohatai.
In recent years, sales of semaglutide injection in China and globally have grown rapidly. According to Novo Nordisk's periodic reports, Ozempic/Nuohatai global sales in 2023 reached 95.718 billion Danish kroner (approximately RMB 100.851 billion), representing year-on-year growth of 66%. Among this, sales in the China market (including mainland China, Hong Kong, and Taiwan) reached 4.821 billion Danish kroner (approximately RMB 5.08 billion), representing year-on-year growth of 137%.
About Zhitai Bio:
Zhitai Bio focuses on producing recombinant protein drugs using E. coli, dedicated to developing innovative biologics for the treatment of chronic metabolic diseases (such as diabetes, obesity, non-alcoholic steatohepatitis, etc.) and improving people's quality of life. Currently, Zhitai Bio's pipeline includes 10 research-stage recombinant protein innovative drugs and biosimilar candidates.
Zhitai Bio's core R&D team members come from Novo Nordisk and other internationally renowned pharmaceutical companies, having accumulated extensive experience in biopharmaceuticals. Zhitai Bio's proprietary intellectual property technology platforms cover the complete recombinant protein production process. Its independently innovated key technology platforms — including the QLLong long-acting technology platform, QLOral oral peptide technology platform, QLFold efficient inclusion body protein refolding technology platform, and QLFusion fusion protein technology platform — all meet internationally leading standards.
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