Chimigen Biomedical (Chengdu) Co., Ltd. (Chimigen) recently announced that the Investigational New Drug (IND) application for SN2001, a therapeutic vaccine for chronic hepatitis B, has been approved by the US FDA. Phase I clinical trials officially commenced on July 1 in Australia. This therapeutic vaccine addresses critical gaps in current chronic hepatitis B treatments, particularly challenges such as viral rebound after treatment cessation and patient intolerance. SN2001 holds promise as a leading functional cure vaccine for hepatitis B, offering a novel therapeutic approach with significant clinical potential.

About SN2001

Built upon Chimigen’s proprietary SynNeogen® platform, SN2001 combines AI-driven antigen identification with engineered Fc delivery to enhance therapeutic efficacy. Leveraging AI, the vaccine precisely targets HBV-specific T cell epitopes and incorporates engineered heterologous Fc regions along with glycoengineering to develop a universal therapeutic vaccine. Through Fc receptor (FcR)-mediated dendritic cell targeting, SN2001 robustly activates antigen presentation pathways, reshaping the immune system to achieve a functional cure for chronic hepatitis B. Preclinical studies have demonstrated its favorable safety profile and strong immune activation capabilities.

Genevoyager Supports Chimigen in Securing FDA Approval for SN2001

Leveraging its cutting-edge baculovirus insect cell CDMO technology platform, Genevoyager played a pivotal role in securing FDA approval for the IND application of Chimigen’s SN2001 therapeutic vaccine. This milestone accelerates the seamless transition from innovation to production, bringing SN2001 closer to clinical success. We anticipate that this breakthrough will offer new hope and improved treatment options for patients battling chronic hepatitis B.

About Chimigen

Chimigen is a biotechnology company focused on developing innovative immunotherapies targeting oncology and viral infections. Leveraging its proprietary SynNeogen® platform, Chimigen aims to redefine the paradigm of immune treatment. The company is advancing multiple therapeutic vaccine programs, including immunotherapies for solid tumors such as primary liver cancer, metastatic castration-resistant prostate cancer (mCRPC), and pancreatic cancer. These efforts aim to address the global challenges of low overall response rates and limited survival benefits in current cancer immunotherapies. Guided by a commitment to innovation, breakthrough, and scientific rigor, Chimigen strives to deliver better and more effective treatment options for patients worldwide.

About Genevoyager

Genevoyager provides one-stop CRO/CDMO services for viral vectors, proteins, and vaccines. With a proprietary technology platform for large-scale AAV production and cGMP-grade facilities, Genevoyager is dedicated to advancing healthcare by supporting our partners to develop safe, effective, affordable, and accessible protein-based products, therapeutic vaccines, and gene therapies to address unmet medical needs.

In the field of therapeutic vaccines, the insect cell expression system offers unique advantages over mammalian cell systems: it more effectively activates T-cell immune responses, enhances vaccine immunogenicity, enables efficient and correct protein folding to ensure product activity, and ensures high safety with minimal side effects during manufacturing. Genevoyager’s proprietary One-Bac 4.0 baculovirus-insect cell system incorporates multiple world-leading patented technologies, delivering significant advantages in therapeutic vaccine production:

● High Yield and Efficiency

Enables high-level protein expression, significantly reducing large-scale production costs for subunit vaccines, enzymes, and other biologics.

● Superior Stability and Consistency

The baculovirus seed exhibits exceptional stability, maintaining consistently high yields during large-scale manufacturing. Genevoyager’s Sf9 cell banks are free from rhabdovirus contamination, ensuring product reliability and quality.

● Rapid Scalability

Backed by a robust technology platform, an expert team, and GMP-compliant facilities meeting China, US, and EU standards, the system supports efficient scale-up for complex protein therapeutics, underpinned by stringent quality control and proven IND experience.