SUNSHINE PHARMA (06887) domestically approved for clinical trials of in-house developed Hepatitis B nucleic acid new drug.

The National Medical Products Administration Drug Evaluation Center public information shows that SUNSHINE PHARMA (06887) has obtained an implied license for clinical trials for HECN30227, a siRNA therapy developed independently, and has been approved to conduct clinical trials for the indication of chronic hepatitis B (hereinafter referred to as hepatitis B). Currently, there are no approved siRNA drugs for hepatitis B worldwide. Chronic hepatitis B is a serious global public health issue, with a large number of patients in China, with approximately 75 million cases of chronic hepatitis B virus (HBV) infection. The disease burden is heavy. Existing nucleos(t)ide analogs and interferon treatment regimens can inhibit HBV replication, improve liver histopathology, but are difficult to achieve functional cure, and have limitations such as large side effects or long-term medication. In this situation, it is urgently needed to develop new treatment strategies. HECN30227 is a type 1 new drug independently developed by SUNSHINE PHARMA with global intellectual property rights. It is also the company's first siRNA drug developed based on the small nucleic acid technology platform, which can simultaneously eliminate hepatitis B surface antigen (HBsAg) originating from cccDNA and intDNA. Preclinical data show that HECN30227 has pan-genotypic activity, can efficiently reduce HBsAg levels, and also maintains significant efficacy against nucleos(t)ide-resistant strains, with in vivo and in vitro efficacy superior to clinical competitors. The drug uses SUNSHINE PHARMA's unique HEC-GalNova (N-acetyl galactosamine) liver-targeted delivery system, which achieves precise and efficient liver delivery while significantly reducing off-target risks. Based on a deep understanding of the HBV clearance mechanism, the company is simultaneously developing a "siRNA+ASO+immunomodulator" triple therapy, which comprehensively inhibits HBV and HBsAg through multi-target synergistic effects, and opens a new era of hepatitis B "functional cure" through immune rebuilding, bringing New Hope Liu River to patients. Recently, the significant research results of preclinical combination therapy of HECN30227 with the company's self-developed highly selective hTLR8 immunostimulant were selected as "Poster of Distinction" at the American Association for the Study of Liver Diseases (AASLD) annual meeting in 2025. This title is only awarded to the top 10% of results, indicating the high recognition of the international authoritative academic institution for the potential of clinical development of HECN30227 combination therapy. SUNSHINE PHARMA continues to focus on the field of anti-infection, continuously advancing the functional cure strategy centered on HECN30227 based on the independently constructed small nucleic acid technology and delivery platform. In the future, the company will continue to deepen the development path of "multi-target combination," actively explore the clinical application potential of this therapy in a wider range of patient populations, and strive to provide innovative treatment solutions that are accessible and curative for hepatitis B patients in China and globally. Reference: [1] Deng Y, Meng T, You H, et al. The latest epidemiology and prevention and treatment progress of hepatitis B in China. Chinese Journal of Hepatology, 2025, 33(02): 115-120.