On March 9, 2026, SicaGene announced that its proprietary Class I innovative drug candidate, SG12 Injection (“SG12”) for the treatment of chronic hepatitis B (CHB), has received Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA).

The approved Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of single and multiple subcutaneous doses of SG12 in healthy adult participants and nucleos(t)ide analogue-treated HBeAg-negative chronic hepatitis B patients.

Chronic hepatitis B represents a major global public health challenge. Existing therapies often require long-term or even lifelong treatment, with a low proportion of patients achieving functional cure, (i.e., sustained virological response after treatment discontinuation). Antisense oligonucleotide (ASO) therapies, which precisely target and degrade disease-associated mRNA, have emerged as a promising new therapeutic approach for achieving functional cure in hepatitis B.

Its mechanism of action lies in the design of ASO drugs complementary to key hepatitis B virus (HBV) mRNA sequences, thereby suppressing viral protein expression, such as hepatitis B surface antigen (HBsAg). Reduction or clearance of HBsAg is widely regarded as a critical step in restoring patients' own immune response and achieving functional cure in chronic hepatitis B.

Dr. Wang Haisheng, CEO of SicaGene, stated that the IND approval of SG12 Injection represents a significant milestone in the company’s development. “This approval not only validates the capabilities of our proprietary R&D platform, but also marks an important step toward our mission of delivering transformative therapies for patients,” said Dr. Wang. “From target discovery to molecular design, our team has adhered to the highest scientific standards throughout the development process. We are greatly encouraged by this milestone and will continue to advance the clinical development of SG12 with scientific rigor to further evaluate its potential in achieving functional cure for chronic hepatitis B and addressing this significant unmet medical need.”

Dr. Huang Yue, Chief Translational Science Officer of SicaGene, noted that SG12 was developed based on the company’s deep understanding of HBV biology and ASO technology platforms. “Preclinical findings have strengthened our confidence in the differentiated mechanism and therapeutic potential of SG12,” said Dr. Huang. “The IND approval enables us to formally evaluate the safety and efficacy of SG12 in human clinical studies. Our translational science team will closely follow the clinical development process to transform scientific insights into tangible clinical benefits, with the goal of bringing this innovative therapy to the hundreds of millions of chronic hepatitis B patients worldwide as soon as possible.”