东阳光药自研乙肝小核酸新药国内获批临床

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].