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Tonghua Dongbao Introduces GLP-1 Semaglutide Injection
Date：2024-05-08
Author：東寶
Views：2
Recently, Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as "Tonghua Dongbao" or "the Company") signed the Commercialization Licensing and Marketing Authorization Holder (MAH) Agreement ("the Agreement") with Beijing Quality Peptide Biopharmaceutical Technology Co., Ltd. ("QL Biopharm") for the GLP-1 Semaglutide injections.
Under the terms of the Agreement, the Company will obtain exclusive commercial rights to QL Biopharm's clinical investigational drug in the Chinese Mainland, namely ZT001 Semaglutide Injection (indicated for controlling blood sugar in adult patients with Type 2 diabetes), hereafter referred to as "the Collaborative Product." Additionally, the Company will also have rights to joint overseas market development with QL Biopharm. The Collaborative Product has completed the Phase I clinical trial for Type 2 diabetes in the Chinese Mainland and has entered Phase III clinical studies.
In recent years, GLP-1 products have demonstrated significant clinical and commercial value in the treatment of diabetes and in weight loss. Tonghua Dongbao has strategically developed a series of GLP-1 products. Among these, the Company's first GLP-1 product, Liraglutide injection, was successfully approved and launched in 2023. Additionally, two first-in-class GLP-1 novel drugs, namely the oral small-molecule GLP-1 receptor agonist (THDBH110 capsules) and the dual GLP-1/GIP receptor agonist (THDBH120 injection), completed the enrollment of the first participant in the Phase I clinical trial for diabetes indications. Furthermore, the clinical trial application for the weight loss indication of the dual GLP-1/GIP receptor agonist (THDBH120 injection) has been approved.
While remaining steadfast in-house R&D, the Company is also actively seeking external high-quality projects and collaboration opportunities. The in-licensing and introduction of Semaglutide injection will effectively synergize with the Company's existing diabetes therapies, accelerating the development of a multi-tiered and diversified GLP-1 product lineup. This strategy will further sharpen the Company's core competitiveness in the treatment of diabetes, endocrine and metabolic disorders.
In terms of market strategy, the Company has acquired exclusive commercial rights to the Collaborative Product in the Chinese mainland. Additionally, the Company will jointly develop overseas markets for the Collaborative Product with QL Biopharm. This represents a significant step in the Company's global strategy, adding important products to its global portfolio and further extending its reach into broader global markets.
Mr. Li Jiahong, Chairperson of Tonghua Dongbao, commented, "QL Biopharm is home to an outstanding R&D team and boasts multiple internationally leading technology platforms. We are delighted to announce our cooperation, through which we will introduce the licensed Collaborative Product – Semaglutide injection. This will significantly enhance and expand our GLP-1 product portfolio. Moreover, this partnership will further our internationalization strategy by enriching our product lineup. Leveraging our extensive experience in clinical R&D and our strong advantage in commercializing endocrine and metabolic disorder treatments, we are committed to delivering this product to global patients as swiftly as possible."
Mr. Zhang Xujia, Chairperson of QL Biopharm, remarked, "Tonghua Dongbao is a renowned Chinese biopharmaceutical company, specializing in drug R&D, production, and sales. The company is committed to providing comprehensive treatment solutions for diabetes and endocrine disorders. We are confident that through this collaboration, we can more rapidly introduce Semaglutide—a cutting-edge international therapy—to a wider range of domestic diabetes patients. QL Biopharm is also enthusiastic about partnering with Tonghua Dongbao to penetrate overseas markets and to collaborate in the development of other novel drugs."
About ZT001
ZT001 injection is a formulation of Semaglutide, a long-acting GLP-1 (Glucagon-like Peptide-1) analog. GLP-1 medications work by mimicking the effects of natural GLP-1 in human body, effectively lowering blood glucose levels, promoting weight loss, and showing potential therapeutic benefits in various chronic diseases.
The inventor of Semaglutide injection is the Denmark-based Novo Nordisk. The company's diabetes product, branded as Ozempic, was approved by the U.S. FDA in 2017. In China, it was approved by the National Medical Products Administration (NMPA) in 2021 under the trade name 諾和泰 (Nuo He Tai).
In recent years, the sales of Semaglutide injection have grown rapidly both in China and globally. According to regular reports from Novo Nordisk, in 2023, the global sales of Ozempic amounted to DKK 95.718 billion (approximately RMB 100.851 billion), representing a 66% increase year on year. In the Chinese market (including the Chinese mainland, Hong Kong, and Taiwan), sales reached DKK 4.821 billion (approximately RMB 5.08 billion), marking a 137% increase compared to the previous year.
About QL Biopharm
QL Biopharm specializes in producing recombinant protein drugs using Escherichia coli, and is dedicated to developing novel biopharmaceuticals to treat chronic metabolic diseases such as diabetes, obesity, and non-alcoholic steatohepatitis (NASH). The company aims to improve the quality of life for people worldwide. Currently, the company's development pipeline includes 10 investigational novel recombinant protein drugs and biosimilars.
The core members of the QL Biopharm's R&D team are highly experienced professionals in biopharmaceuticals, drawn from world-renowned pharmaceutical firms like Novo Nordisk. QL Biopharm boasts comprehensive proprietary technology platforms that cover the entire recombinant protein production process. Its pioneering technology platforms include the QLLong for long-acting therapies, QLOral for oral peptides, QLFold for efficient refolding of inclusion body proteins, and QLFusion for fusion protein technologies, each setting international benchmarks in their respective fields.
About Tonghua Dongbao
Tonghua Dongbao Pharmaceutical Co., Ltd. (abbreviated name: Tonghua Donghao; stock code: 600867.SH) is a leading pharmaceutical company in China, specializing in drug R&D, production, and sales. While maintaining its focus on diabetes treatment with the most extensive R&D pipeline in the industry, the Company is also expanding into other areas of endocrinology, such as gout/hyperuricemia and weight loss with its first-in-class drugs. Its current product lineup includes human insulin, insulin glargine, insulin aspart, liraglutide injection, Zhennaoning Capsules, and diabetes-related medical devices. The company's R&D pipeline features ultra-fast-acting insulin, insulin co-formulation, dual GLP-1/GIP receptor agonist, small-molecule GLP-1 receptor agonist, URAT1 inhibitor, and XO/URAT1 dual inhibitor.
