小干扰RNA(siRNA)
Search documents
具备“同类最优”潜力 东阳光药乙肝siRNA疗法获批临床
Zheng Quan Shi Bao Wang· 2025-10-30 03:02
Core Insights - The approval of HECN30227, a novel siRNA therapy developed by Dongyangguang Pharmaceutical, marks a significant advancement in the treatment of chronic hepatitis B (CHB) and highlights China's progress in the small nucleic acid drug development field [1][3]. Group 1: Treatment Landscape - Chronic hepatitis B is a major global health issue, with approximately 254 million chronic HBV carriers worldwide, including around 87 million in China, representing one-third of the global total [2]. - Current mainstream treatments, including nucleos(t)ide analogs (NAs) and interferon, have significant limitations such as difficulty in achieving functional cure, side effects, and challenges in long-term adherence [2]. - The medical community is exploring new treatment avenues, including immune/gene therapy and small nucleic acid drugs, with siRNA showing promising potential in early studies [2]. Group 2: HECN30227 Development - HECN30227 is the first siRNA drug developed by Dongyangguang Pharmaceutical, designed to eliminate HBsAg from both cccDNA and intDNA sources, demonstrating broad genotype activity and efficacy against drug-resistant strains [3]. - The drug is part of a combination therapy strategy that includes siRNA, ASO, and immune modulators, aiming for comprehensive suppression of HBV and immune reconstruction [3]. - HECN30227 has been recognized for its clinical development potential, receiving a "Poster of Distinction" at the 2025 AASLD annual meeting, indicating high international academic recognition [4]. Group 3: Market Potential - The small nucleic acid drug market is projected to exceed 10 billion yuan by 2030 in China, driven by a large patient population and urgent clinical needs [5]. - Dongyangguang Pharmaceutical has established a comprehensive R&D platform for small nucleic acid drugs, positioning itself among the top tier in the domestic market [5]. - The company has over 10 small nucleic acid pipelines across various therapeutic areas and plans to advance multiple candidates into clinical stages annually [5]. Group 4: Strategic Vision - Dongyangguang Pharmaceutical aims to lead the innovation wave in small nucleic acid drugs through a multi-faceted approach involving technology, pipeline development, and industrialization [6]. - The company has successfully challenged patents in the U.S. and is committed to addressing unmet clinical needs, exemplified by its recent approval of a generic for multiple sclerosis [6]. - Recent reports have recommended Dongyangguang Pharmaceutical as a strong investment opportunity, reflecting confidence in its innovative and international development strategy [6].