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资讯 Double Breakthroughs in Two Days
Hybio Pharmaceutical Accelerates Full Line of Multi-dosage Forms of Triple Agonist
Frontier Target Portfolio
Following yesterday’s clinical trial authorization of HY3003 Injection by the U.S. FDA, Hybio Pharmaceutical (Stock Code: 300199) announces another positive update: its clinical trial application for HY3003 Tablets has been accepted by the National Medical Products Administration (NMPA), and this oral formulation of GLP-1R/GIPR/GCGR triple receptor agonist has officially entered the clinical development phase.
Covering Diverse Metabolic Indications
HY3003 Tablets are a core innovative asset of the Company in the metabolic disease sector. Classified as a Class 1 chemical drug for registration purposes, it is an innovative medicine with a completely novel mechanism of action. As an oral formulation of GLP-1R/GIPR/GCGR triple receptor agonist, its intended indications span multiple metabolic disease areas with robust clinical demand, including weight management, type 2 diabetes mellitus and metabolic associated steatohepatitis (MASH).
Unlike the single-formulation development path adopted by most drugs targeting the same receptors in the industry, the HY3003 program has implemented a parallel development strategy for multiple formulations since its inception, to cover diverse administration scenarios and patient needs.
The acceptance of the clinical trial application for the oral tablets marks that HY3003’s full formulation portfolio of "long-acting injection + daily oral administration" has fully entered the clinical development phase. When the product matrix is launched in the future, it will cater to patient groups with different medication habits and at various treatment stages, creating a prominent differentiated competitive advantage.
一
Anchoring at the Forefront of Technology
As a cutting-edge direction in global metabolic drug R&D, triple receptor agonists synergistically regulate glucose metabolism, energy expenditure and lipolysis. They outperform single-target and dual-target agents in glucose lowering, weight loss and liver metabolism improvement, making them a fiercely contested R&D focus for pharmaceutical companies worldwide.
二
Preclinical Efficacy Validation
HY3003 Tablets have demonstrated a clear dose-dependent weight loss effect in both diet-induced obesity (DIO) mouse and rat models. Its druggability and efficacy potential have been fully verified, laying a solid preclinical research foundation for the steady progress of subsequent clinical trials.
三
Dual-track Advancement at Home and Abroad
Within two days, the clinical trial authorization of HY3003 Injection by the U.S. FDA and the acceptance of the oral tablets’ clinical trial application by the NMPA mark a solid implementation outcome of the Company’s R&D strategy of "international layout + full-formulation development".
The breakthrough in overseas filing confirms that the quality system and compliance level of the Company’s innovative drug R&D have been aligned with international standards, paving the way for subsequent global multi-center clinical development and overseas market expansion. The clinical advancement of oral peptide formulations embodies the results of the Company’s years of in-depth development in oral peptide delivery technology. It will further improve the Company’s product pipeline in metabolic disease treatment and continuously strengthen its core competitiveness in the oral peptide innovative drug sector.
关于翰宇药业
深圳翰宇药业股份有限公司（股票代码：300199）是深耕多肽创新领域二十余年的国家高新技术企业，专注于创新多肽药物的研发、生产与全球化销售。公司搭建了覆盖全球主流代谢靶点的完整管线，涵盖GLP-1单靶点、多靶点创新药及多款全球重磅多肽品种，已形成从原料药到制剂、从研发到商业化、从中国市场到全球市场的全产业链布局。包括但不限于GLP-1R/GIPR/GCGR三重受体激动剂原创新药、瑞他鲁肽、替尔泊肽、司美格鲁肽、利拉鲁肽等。
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