Sino Biopharmaceutical Limited Gains Clinical Trial Approval for Innovative Hepatitis B Drug IM-101
Key Highlights
- IM-101, a first-in-class PreS1 recombinant fusion protein, receives clinical trial approval from China’s NMPA for chronic hepatitis B (CHB).
- IM-101 introduces a novel immunotherapy approach, aiming for a functional cure of CHB, which remains a major global health challenge.
- The drug is developed by Chia Tai Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharmaceutical Limited.
- This approval further strengthens the Group’s pipeline in active immunotherapy, adding to several other late-stage innovations in liver disease.
Detailed Report
Sino Biopharmaceutical Limited (Stock code: 1177) announced a significant milestone with the approval by China’s National Medical Products Administration (NMPA) to initiate clinical trials for IM-101, a “PreS1 recombinant fusion protein” injection, for the treatment of chronic hepatitis B (CHB).
About IM-101 and Its Mechanism
- IM-101 is a recombinant fusion protein that targets the PreS1 domain, a key component of the hepatitis B virus (HBV) surface protein.
- It is designed to overcome immune tolerance and restore HBV-specific immune responses, potentially offering a functional cure for chronic hepatitis B.
- The drug works by blocking the binding of HBV to sodium taurocholate co-transporting polypeptide (NTCP) receptors on hepatocytes, thereby preventing the virus from entering liver cells.
- IM-101 induces multiple immune effects:
- Humoral immunity: PreS1-specific antibodies neutralise viral particles, block NTCP receptor binding, and reduce reinfection and replenishment of the viral reservoir.
- Cellular immunity: Activates HBV-specific T-cell responses, promoting clearance of infected cells by both cytolytic and non-cytolytic mechanisms.
- IM-101 is thus positioned as a promising strategy to achieve a functional cure, going beyond the limitations of current therapies.
Market Potential and Disease Burden
- CHB is a major global health concern, affecting approximately 290 million people worldwide, with around 75 million cases in China alone.
- Without effective treatment, CHB carries high risks of progression to cirrhosis, liver failure, or hepatocellular carcinoma.
Current Treatment Landscape and Unmet Needs
- Current treatments rely mainly on nucleos(t)ide analogues (NAs) and interferons.
- NAs:
- Effectively suppress HBV DNA replication but achieve only 0-3% clearance of HBsAg (hepatitis B surface antigen).
- High relapse rates after stopping therapy, requiring long-term or lifelong use for most patients.
- Interferons:
- Offer direct antiviral and immunomodulatory effects, but with variable response rates and only 3-7% HBsAg seroclearance as monotherapy.
- Functional cure is defined as sustained suppression of HBsAg and HBV DNA after a finite therapy course—a major unmet need in the field.
Strategic Pipeline and Competitive Position
- Sino Biopharmaceutical is a leading player in China’s liver disease market, with a robust pipeline:
- Lanifibranor (pan-PPAR agonist): In global Phase III clinical trial for metabolic dysfunction-associated steatohepatitis (MASH).
- TQA3605 (HBV core protein allosteric modulator): Approved for Phase III development in China.
- TQ-A3334 (TLR-7 agonist) and Kylo-0603 (THR- agonist): Both in Phase II clinical trials.
- Strategic collaboration with GSK: Accelerating the launch of Bepirovirsen in China, with priority review status. This drug could become the first-in-class innovative therapy approved for the functional cure of CHB globally.
- The approval to initiate clinical trials for IM-101 further enriches Sino Biopharm’s active immunotherapy pipeline, reinforcing its leadership and innovation in the liver disease segment.
- The Group plans to explore both monotherapy and combination regimens, leveraging diverse mechanisms of action to broaden therapeutic options for liver disease patients.
Implications for Investors and Shareholders
- This announcement is highly significant and potentially price sensitive:
- IM-101 represents a major pipeline advance, addressing a huge unmet medical need in CHB and potentially capturing a large market both in China and globally.
- Progress in innovative immunotherapies like IM-101 and Bepirovirsen, coupled with late-stage assets for MASH and HBV, could materially impact Sino Biopharmaceutical’s growth prospects and future earnings.
- Shareholders should note the accelerating pace of clinical development and strategic partnerships, which may drive re-rating of the company’s valuation.
Board and Leadership
The Board, led by Chairwoman Theresa Y Y Tse, comprises five executive directors and six independent non-executive directors, emphasizing strong governance and strategic oversight.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or consult with professional advisors before making investment decisions. Past performance is not indicative of future results. All information is based on company announcements as of July 23, 2026, and is subject to change.
