Group 1 - The global market for Multiple Sclerosis (MS) products is approximately $20 billion, with a significant focus on Relapsing Multiple Sclerosis (RMS) treatments [1][2] - The existing approved products primarily target RMS, while there is a notable unmet clinical need in the Progressive Multiple Sclerosis (PMS) area, with only one product, Ocrelizumab, approved for Primary Progressive Multiple Sclerosis (PPMS) [2][3] - The patient base for MS is substantial, with projections indicating that the number of MS patients globally will reach 3.71 million by 2030 [1] Group 2 - BTK inhibitors are expected to address the treatment gap in PMS, with their ability to penetrate the blood-brain barrier and modulate key immune cells [3] - Sanofi's Tolebrutinib and Roche's Fenebrutinib are anticipated to release Phase III clinical trial data in the second half of 2025, which could enhance the value of BTK inhibitors in PMS [3][4] - Tolebrutinib has received priority review from the FDA for the treatment of non-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS), with a PDUFA date set for September 28, 2025 [4]

Investment Rating - The investment rating for the biotechnology industry is "Positive" (maintained) [1] Core Insights - The global stock of multiple sclerosis (MS) patients is significant, with the market size exceeding $20 billion, primarily focused on relapsing forms of MS (RMS) [6][9] - BTK inhibitors are expected to fill the treatment gap in primary progressive MS (PPMS) and non-relapsing secondary progressive MS (nrSPMS) [7][9] - The anticipated release of clinical data for BTK inhibitors in the second half of 2025 is expected to enhance the attractiveness of the sector [9] Summary by Sections 1. Multiple Sclerosis Overview - MS is an immune-mediated inflammatory demyelinating disease of the central nervous system, characterized by "spatial" and "temporal" multiplicity [5][27] - The global and Chinese stock of MS patients is projected to reach 3.71 million and 60,000 respectively by 2030, with a CAGR of approximately 2.7% and 2.1% from 2025 to 2030 [19][22] 2. Market Size and Product Landscape - The global MS market is approximately $20 billion, with a focus on RMS treatments [6][40] - Existing products include monoclonal antibodies and oral therapies, with CD20 monoclonal antibodies expected to account for over 60% of sales by 2024 [6][46] 3. BTK Inhibitors and Clinical Development - BTK inhibitors are positioned to address unmet needs in the treatment of PPMS and nrSPMS, with several candidates in late-stage clinical trials [7][51] - Tolebrutinib and Fenebrutinib are expected to release pivotal clinical data in the second half of 2025, which could significantly impact their market potential [8][51] 4. Investment Recommendations - The ongoing clinical developments and the large patient base present significant investment opportunities in companies like 诺诚健华, 翰森制药, 云顶新耀, 恒瑞医药, and 百济神州-U [9]