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Tonghua Dongbao: First Patient Dosed in Phase III Clinical Trial of Semaglutide Injection (THDB0225 Injection)
Date：2024-08-01
Author：東寶
Views：54
In May 2024, 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 (indication: Type 2 Diabetes Mellitus (T2DM), current name: THDB0225 injection), 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. Tonghua Dongbao has initiated Phase III clinical trials in China, successfully dosing the first patient recently. This marks another solid step for the company in the research and development in the GLP-1 field.
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.
Given the immense clinical and commercial potential of GLP-1 products in diabetes and weight management, the Company has adopted a two-pronged strategy of "Internal R&D and External Cooperation" to build a multi-tiered and diversified GLP-1 product lineup of liraglutide, semaglutide, and oral small-molecule GLP-1 and dual GLP-1/GIP receptor agonists. These products target both diabetes and weight loss indications, while applications in other therapeutic areas are being explored. The GLP-1 portfolio will effectively synergize with the Company's existing diabetes therapies, further sharpening the Company's core competitive advantage in the treatment of diabetes, endocrine and metabolic disorders.
About THDB0225 Injection
THDB0225 injection (formerly known as 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).
About Clinical Study on THDB0225 Injection
Following NMPA approval of THDB0225 injection (formerly ZT001 injection) for clinical trials, Beijing QL Biopharmaceutical Co., Ltd. (QL Biopharm) has completed a Phase I study comparing the pharmacokinetics of THDB0225 injection versus Ozempic? injection 0.25 mg after a single dose in healthy male Chinese subjects. The results demonstrate bioequivalence between THDB0225 injection and the comparator Ozempic?, with no unexpected safety risks or clinically significant changes or trends related to the investigational product.
Upon signing an agreement with QL Biopharm, Tonghua Dongbao launched a Phase III trial to compare the efficacy and safety of subcutaneous THDB0225 injection versus Ozempic? in type 2 diabetes patients with inadequate glycemic control on metformin therapy. The primary objective of this multi-center, randomized, open-label, parallel-controlled study is to evaluate the efficacy of subcutaneous THDB0225 injection and Ozempic? in type 2 diabetes patients with inadequate glycemic control after metformin treatment. Secondary objectives include evaluating the safety, population pharmacokinetics (PopPK), and immunogenicity of THDB0225 compared to Ozempic?.
