Core Viewpoint - Shimai Pharmaceutical has submitted an application to the Hong Kong Stock Exchange for its main board listing, with Huatai International acting as the sole sponsor [1] Industry Summary - The T-cell engaging (TCE) therapy market is projected to grow significantly, from $3 billion in 2024 to $121.1 billion by 2035, representing a compound annual growth rate (CAGR) of 40.0% [1] Company Summary - As of November 5, 2025, Shimai Pharmaceutical has four self-developed clinical-stage candidate drugs, including DNV3 targeting LAG3, SMET12 for intravenous use targeting EGFR×CD3, CMD011 targeting GPC3×CD3, and the next-generation cloaked TCE CMDE005 [1] - The company is also developing two preclinical next-generation multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [1] - Shimai Pharmaceutical emphasizes that its TCE therapies feature selective activation, zero immune cell toxicity, precise tumor recognition, and prevention of tumor recurrence, aiming to become a cornerstone therapy in future tumor immunotherapy [1]

Investment Rating - The report maintains a "Buy" recommendation for the industry [3] Core Insights - The report highlights the urgent need for innovative therapies in the treatment of systemic lupus erythematosus (SLE), a condition with a significant patient burden and no current curative treatment options [7][19][21] - B cell-targeted therapies, particularly myeloid cell engagers (MCE), are emerging as promising solutions for SLE, with the potential to achieve deep and lasting depletion of pathogenic B cells [9][10][19] - The report emphasizes the clinical progress of companies like Yiming Oncology, Sanofi, Dren Bio, and LTZ Therapeutics, which are leading in the development of MCE therapies [10][19] Summary by Sections B Cell Autoimmune Diseases - Autoimmune diseases are characterized by the immune system mistakenly attacking the body's own tissues, with a wide variety of B cell autoimmune diseases affecting millions globally, including rheumatoid arthritis (39.8 million), systemic lupus erythematosus (7.8 million), and multiple sclerosis (2.8 million) [13][14] SLE: Patient Population and Disease Burden - SLE is a complex autoimmune disease affecting multiple systems and organs, with a significant prevalence in women aged 20-40, leading to severe health impacts and a strong desire for effective treatments [17][18] SLE Treatment: Unmet Clinical Needs - Current treatments for SLE are inadequate, with a low long-term remission rate and high recurrence risk, highlighting the need for innovative therapies that can provide sustained relief and potentially cure the disease [19][20][21] T Cell-Based Therapies: CAR-T and TCE - CAR-T and T cell engagers (TCE) are being explored for their ability to target and deplete pathogenic B cells, with CAR-T showing promising long-term efficacy in SLE patients [24][37] - However, CAR-T therapies are expensive and complex, while TCEs offer a more standardized and potentially safer alternative, though they may not achieve the same depth of B cell depletion [41][43] Myeloid Cell Engagers (MCE) - MCE therapies represent a novel approach by utilizing myeloid cells to target and eliminate pathogenic B cells, with initial clinical data suggesting promising safety and efficacy profiles [9][10][46] - Companies like Yiming Oncology are at the forefront of this innovation, with upcoming clinical data expected to provide further insights into the effectiveness of MCE therapies for SLE [10][19]