智通财经APP讯，诺诚健华(09969)发布公告，药品审评中心(CDE)批准启动奥布替尼治疗系统性红斑狼 疮(SLE)的III期临床试验。在IIb期临床试验坚实数据的强力支持下，III 期研究将评估每日一次75毫克给 药的方案。 本公司将继续致力于加速奥布替尼的临床开发，为自身免疫性疾病患者带来创新、可及的治疗方案。 奥布替尼(宜诺凯®)为一款处于后期临床阶段、具有潜在同类最佳优势的高中枢神经系统渗透性、选择 性、不可逆口服小分子布鲁顿酪氨酸激酶(BTK)抑制剂。在SLE领域，奥布替尼已通过IIb期试验展现出 积极成果，其临床获益与良好安全性特征获得验证。SLE的III期试验已获准启动，预计于2026年第一季 度首例患者入组(FPI)。在其他自身免疫疾病领域，其在中国针对免疫性血小板减少症(ITP)的III期注册 性试验已完成患者入组，计划于2026年上半年提交新药上市申请。本公司保留奥布替尼在大中华区及东 南亚地区针对SLE及其他自身免疫适应症的相关权益，其他国际权益已授予Zenas。 在多发性硬化症(MS)领域，原发进展型多发性硬化症(PPMS)的III期试验已在 2025年第三季度启动，继 发进展型多发 ...

Core Viewpoint - The research identifies FPR1 signaling as a potential mechanism for the progression of Multiple Sclerosis (MS), suggesting that FPR1 could serve as a new therapeutic target for MS treatment [2][3]. Group 1: Research Findings - The study published in Science highlights the development of the FPR1 small molecule antagonist T0080, which can reduce brain inflammation and neurodegeneration, thereby alleviating the progression of MS [3]. - In active MS, the presence of reactive microglia and macrophages contributes to the development of tissue-restrictive inflammation, leading to progressive tissue damage and exacerbating neurodegeneration [5]. - The research team found significant expression of FPR1 in microglia and infiltrating macrophages in MS patients, with levels of endogenous N-formyl peptides correlating dynamically with disease progression [5][6]. Group 2: Mechanism of Action - Activation of FPR1 initiates a PKC-dependent signaling cascade, leading to the release of reactive oxygen species (ROS) and inflammatory cytokines like TNF-α, which damages neuronal axons and promotes a neuroinflammatory environment [6]. - The study demonstrates that FPR1-expressing microglia secrete CCL5, facilitating the recruitment and clonal expansion of myelin-reactive CD4+ T cells, which further amplifies myelin destruction and neuroinflammation [6][8]. Group 3: Implications for Treatment - The findings suggest that targeting FPR1 with the antagonist T0080 may have therapeutic potential in slowing the progression of MS, as it has shown efficacy in various MS mouse models by mitigating autoimmune responses and inhibiting microglia-mediated axonal degeneration [6][8].

Core Insights - Roche's fenebrutinib demonstrated "unprecedented" test results for multiple sclerosis, impacting TG Therapeutics negatively [1][2] - Roche's stock increased by over 3% to $43.33, while TG Therapeutics' stock fell more than 5% to $30.53, reaching a two-month low [2] - Fenebrutinib showed significantly fewer relapses compared to teriflunomide in relapsing multiple sclerosis patients [3] - In primary progressive MS, fenebrutinib slowed disability progression comparably to Roche's Ocrevus, the only approved treatment for this condition [4] Roche's Competitive Position - Roche's fenebrutinib uses a different mechanism than TG Therapeutics' Briumvi, targeting BTK, which is involved in immune response to inflammation [7] - Roche's stock performance improved, gapping above its 50-day moving average following the news [7] TG Therapeutics' Market Performance - Briumvi's sales grew by at least double-digit percentages year-over-year, with a notable 84% increase to $152.9 million in Q3 [6] - Despite the sales growth, Briumvi still lags behind Ocrevus in overall sales [6] - TG Therapeutics maintains a strong IBD Digital Composite Rating of 97, ranking in the top 3% of stocks for performance [8]