Core Viewpoint - Dongyangguang Pharmaceutical's HECN30227, a self-developed siRNA therapy for chronic hepatitis B, has received implied approval for clinical trials, marking a significant advancement as no siRNA drugs for hepatitis B have been approved globally [1][3]. Group 1: Clinical Trial Approval - The National Medical Products Administration's Drug Evaluation Center has granted implied permission for HECN30227 to conduct clinical trials for chronic hepatitis B [1][2]. - Chronic hepatitis B is a severe global public health issue, with approximately 75 million chronic HBV infections in China, highlighting the urgent need for new treatment options [3]. Group 2: Drug Development and Mechanism - HECN30227 is a first-class new drug developed by Dongyangguang, utilizing a small nucleic acid technology platform, targeting both cccDNA and intDNA sources of hepatitis B surface antigen (HBsAg) [3]. - Preclinical data indicate that HECN30227 has pan-genotype activity, effectively reducing HBsAg levels and maintaining efficacy against nucleoside-resistant strains, outperforming clinical competitors [3]. Group 3: Delivery System and Combination Therapy - The drug employs Dongyangguang's unique HEC-GalNova liver-targeted delivery system, ensuring precise liver delivery while significantly reducing off-target risks [3]. - The company is concurrently developing a combination therapy of "siRNA + ASO + immune modulators" to comprehensively suppress HBV and HBsAg, aiming for a functional cure for hepatitis B [3][7]. Group 4: Recognition and Future Directions - Recent preclinical research on the combination of HECN30227 and a high-selectivity hTLR8 immune agonist was recognized at the 2025 AASLD annual meeting, indicating strong international academic validation of its clinical development potential [4][7]. - Dongyangguang continues to focus on the anti-infection field, advancing functional cure strategies centered around HECN30227 and exploring its clinical application potential in broader patient populations [7].

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].