Introduced GLP-1 product Simeglutide Injection

May 10, 2024  Source: drugdu 45

"/Recently, Tong Hua Dong Bao Pharmaceutical Company Limited ("Tong Hua Dong Bao" or the "Company") signed a Commercialization License and MAH Cooperation Agreement ("Commercialization License and MAH Cooperation Agreement") on the GLP-1 product simelglutide injection ("Simelglutide Injection") with Beijing Quality Peptide Bio-pharmaceutical Technology Co. (hereinafter referred to as "QPBio") entered into the Commercialization License and MAH Cooperation Agreement (hereinafter referred to as the "Agreement") in relation to the GLP-1 product, Simeglutide Injection.

Pursuant to the Agreement, the Company will obtain the exclusive commercialization rights and interests in Mainland China for ZT001 Simeglutide Injection (indication: blood glucose control in adults with type 2 diabetes mellitus) (the "Collaboration Product"), which is a clinical product under development by Plasmapeptide Biologics, as well as the right to co-develop the overseas market. The Cooperative Product has completed the Phase I clinical trial for the indication of type 2 diabetes mellitus in Mainland China and has initiated the Phase III clinical trial.

In recent years, GLP-1 products have demonstrated great clinical and commercial value in diabetes treatment and weight loss, etc. Tong Hua Dong Bao has strategically laid out a series of GLP-1 products, of which the Company's first GLP-1 product, liraglutide injection, has been successfully approved for marketing in 2023; two GLP-1 class I innovative drugs, oral small molecule GLP-1 receptor agonist (THDBH110 capsules) and GLP-1/GIP dual-target receptor agonist (THDBH120 for injection), have both completed the enrollment of the first subject in the Phase I clinical trial for the diabetes indication, of which the declared clinical trial for the weight loss indication of GLP-1/GIP dual-target receptor agonist (THDBH120 for injection) has also been approved.

On the basis of adhering to independent research and development, the company is also actively seeking external high-quality projects and cooperation opportunities. The authorization to introduce simethicone injection will form effective synergy with the company's existing diabetes treatment products, accelerating the construction of a multi-level, diversified GLP-1 product echelon, and further consolidating and strengthening the company's core competitiveness in the field of diabetes and endocrine metabolism.

In terms of market, in addition to obtaining the exclusive commercialization rights of the cooperative products in mainland China, the Company will also cooperate with QPB to develop overseas markets. This is another important step for the company to implement the strategy of products going overseas, adding important product reserves for internationalization and further opening up a broader overseas market space.

Mr. Li Jiahong, Chairman of Tong Hua Dong Bao, said, "Quality Peptide Bio has an excellent R&D team and a number of technology platforms of international leading standards. We are very pleased to enter into this cooperation with QPT. The authorization to introduce the cooperative product Simeglutide Injection will further enrich and accelerate the company's product layout in the field of GLP-1, and provide corresponding product reserves for the company to accelerate its internationalization strategy. The company will rely on its years of accumulated clinical development and commercialization advantages in the field of endocrine metabolism to bring this product to the global patients as soon as possible. "

Mr. Zhang Xujia, Chairman of Plasmapeptide Bio, said, "Tong Hua Dong Bao is a famous biological drug manufacturer integrating drug research and development, production and sales in China, and is committed to holistic solutions in the field of diabetes and endocrine treatment. We believe that through this cooperation, we can deliver the international leading variety of simethicone to more domestic diabetic patients more quickly. Quality Peptide is also very much looking forward to working together with Tong Hua Dong Bao to jointly develop overseas markets and cooperate in other innovative drug products."

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