SBP GROUP (01177.HK): IM-101 Injection (PreS1 Recombinant Fusion Protein) Obtains NMPA Clinical Trial Approval for Chronic Hepatitis B

NewTimeSpace · 2026/07/23 17:50 · By Boyuan Chen

NewTimeSpace News: SBP Group (01177.HK) announced that Class 1 innovative drug IM-101 Injection (PreS1 recombinant fusion protein), developed by its subsidiary Chia Tai Tianqing, has secured clinical trial approval from NMPA for the treatment of chronic hepatitis B (CHB). IM-101 has the potential to break immune tolerance and rebuild HBV-specific immune responses. There are approximately 290 million chronic HBV carriers worldwide, including around 75 million cases in China.

NewTimeSpace News: On 23 July 2026, SBP Group (01177.HK) issued a voluntary announcement. IM-101 Injection (PreS1 recombinant fusion protein), a Class 1 innovative drug developed by the Group’s subsidiary Chia Tai Tianqing, has obtained clinical trial approval from the National Medical Products Administration (NMPA), indicated for chronic hepatitis B (CHB).

IM-101 is an innovative PreS1-targeted recombinant fusion protein capable of breaking immune tolerance and reconstructing hepatitis B virus (HBV)-specific immune responses. PreS1 is a vital component of the HBV large surface protein, which mediates viral attachment and entry by binding to the sodium taurocholate cotransporting polypeptide (NTCP) receptor on hepatocytes. Humoral immunity induced by IM-101 generates PreS1-specific antibodies to neutralize viral particles directly; meanwhile, it activates HBV-specific T-cell responses at the cellular immunity level to eliminate HBV-infected hepatocytes, representing a critical therapeutic strategy toward the functional cure of CHB.

CHB poses a major global public health challenge. Around 290 million people live with chronic HBV infection globally, of whom approximately 75 million are in China. Without timely and standardised antiviral treatment, CHB carries substantial risks of progression to liver cirrhosis, liver failure and hepatocellular carcinoma.

As a leading enterprise in China’s hepatology sector, the Group focuses on core areas including functional cure of hepatitis B, HBV suppression and metabolic dysfunction-associated steatohepatitis (MASH). IM-101 further expands the Group’s pipeline in active immunotherapy. The Group will continue to explore monotherapy and combination regimens of agents with distinct mechanisms to deliver diversified treatment options for broader populations of patients with liver diseases.

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