SinoMab BioScience Limited announced that on 14 November 2023, an Investigational New Drug application (IND), for Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's Disease (AD) for Suciraslimab has been filed with and accepted by the Center for Drug Evaluation (theCDE) of the National Medical Products Administration of China (the 'NMPA'). The Company plans to initiate the Phase I clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of early phase symptomatic AD, including MCI or Mild Dementia Due to AD.

Suciraslimab is the Company's self-developed product and is a first-in-class anti-CD22 monoclonal antibody for the treatment of rheumatoid arthritis (RA''), and potentially other diseases such as systemic lupus erythematosus (SLE), non-Hodgkin's lymphoma (NHL), Sjogren's syndrome (SS) as well as Alzheimer's Disease (AD). It adopts a novel mechanism of action, which differentiates itself from the current treatments available in the market. Currently, there are relatively high worsening rates existing between mild cognitive impairment and mild dementia, as well as mild dementia and moderate to severe dementia due to Alzheimer's Disease, thus, the key therapeutic strategy for the disease is to delay the disease progression, and prevent the situation of mild dementia from turning into moderate to severe dementia.

Suciraslimab are also developed in accordance with this strategy in Alzheimer's Disease. Suciraslimab, upon binding to CD22, promotes the clearance of b-amyloid and simultaneously suppresses neuroinflammation, offering a therapeutic advantage over other approved products which clear b-amyloid at the expense of neuroinflammation. With this unique mechanism of action, Suciraslimab could potentially reduce the risk of serious adverse reactions commonly associated with anti-b-amyloid treatments such as amyloid-related imaging abnormalities-Edema (ARIA-E) and Amyloid-related imaging anomalies-hemorrhage (ARIA-H).

A biologics license application for Suciraslimab in the treatment of RA was accepted by the NMPA in September 2023 and is currently under technical review. A Phase III extension study on RA is also ongoing in China.