Sunshine Pharma's self-developed hepatitis B small nucleic acid new drug has been approved for clinical use in China

According to information from the Drug Evaluation Center of the National Medical Products Administration, Dongyang Sunshine Pharma (06887) has received implied permission for clinical trials of its self-developed siRNA therapy—HECN30227, which has been approved to conduct clinical trials for chronic hepatitis B (hereinafter referred to as hepatitis B) indications. Currently, there are no approved siRNA drugs for hepatitis B globally. Figure 1: HECN30227 approved to conduct clinical trials for chronic hepatitis B indications Chronic hepatitis B is a serious global public health issue, with a large patient base in China, approximately 75 million chronic hepatitis B virus (HBV) infections[1], resulting in a heavy disease burden. Existing nucleos(t) ide analogs and interferon treatment regimens can suppress HBV replication and improve liver tissue pathology, but achieving functional cure is difficult, and there are limitations such as significant side effects or the need for long-term medication. In this context, there is an urgent need to develop new treatment options. HECN30227 is a first-class new drug independently developed by Dongyang Sunshine Pharma with global intellectual property rights. It is also the company's first siRNA drug developed based on a small nucleic acid technology platform, capable of simultaneously eliminating hepatitis B surface antigen (HBsAg) derived from cccDNA and intDNA. Preclinical data indicate that HECN30227 has pan-genotype activity, can efficiently reduce HBsAg levels, and maintains outstanding efficacy against nucleoside-resistant strains, with in vivo and in vitro efficacy superior to clinical competitors. The drug utilizes Dongyang Sunshine Pharma's uniquely designed HEC-GalNova (N-acetylgalactosamine) liver-targeted delivery system, achieving precise and efficient liver delivery while significantly reducing off-target risks. Based on a profound understanding of the HBV clearance mechanism, the company is simultaneously developing a "siRNA + ASO + immune modulator" triple therapy, which comprehensively suppresses HBV and HBsAg through multi-target synergistic action and opens a new era of "functional cure" for hepatitis B through immune reconstruction, bringing new hope to patients. Recently, important research results on the combination of HECN30227 and the company's self-developed highly selective hTLR8 immune agonist in preclinical studies were selected as "Poster of Distinction" for the 2025 American Association for the Study of Liver Diseases (AASLD) annual meeting. This title is only awarded to results ranked in the top 10% of scores, marking the high recognition of the clinical development potential of the HECN30227 combination by international authoritative academic institutions. Figure 2: HECN30227 and highly selective hTLR8 immune agonist preclinical combination research results selected as AASLD "Poster of Distinction" SUNSHINE PHARMA continues to focus on the field of anti-infection, relying on its independently developed small nucleic acid technology and delivery platform, continuously advancing the functional cure strategy centered on HECN30227. In the future, the company will continue to deepen the "multi-target combination" research and development path, actively exploring the clinical application potential of this therapy in a broader patient population, and is committed to providing accessible and curable innovative treatment solutions for hepatitis B patients in China and globally. References: [1] Deng You, Meng Tongtong, You Hong, et al. Latest epidemiology and prevention and treatment progress of hepatitis B in China. Chinese Journal of Hepatology, 2025, 33(02):115-120