Core Insights - Sanofi's tolebrutinib did not meet its primary endpoint in the PERSEUS phase 3 study for primary progressive multiple sclerosis (PPMS), leading the company to decide against pursuing regulatory registration for this indication [1][8][10] Company Updates - Sanofi expressed disappointment over the study results but emphasized the importance of these findings in enhancing the understanding of multiple sclerosis biology [2] - The safety profile of tolebrutinib was consistent with previous studies, with drug-induced liver injury (DILI) identified as a risk, necessitating strict liver monitoring [2][4] - Tolebrutinib was provisionally approved in the UAE for non-relapsing secondary progressive multiple sclerosis and is under regulatory review in the EU and other regions [3] Financial Considerations - Sanofi will conduct an impairment test on the intangible asset value of tolebrutinib, with results expected in January 2026, but this will not impact the business net income or financial guidance for 2025 [4] Industry Context - Multiple sclerosis (MS) is characterized by progressive disability, with PPMS representing about 10% of the overall MS patient population [1][5] - There is a significant unmet need in addressing disability accumulation in MS, particularly for secondary progressive multiple sclerosis [6]

Core Insights - Sanofi's regulatory submission for tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS) is expected to face delays, with further guidance from the FDA anticipated by the end of Q1 2026 [1][2] - The company has submitted an expanded access protocol for tolebrutinib, demonstrating its commitment to providing access to this investigational therapy for eligible patients [2] - Tolebrutinib is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor designed to target neuroinflammation, a key factor in disability progression in multiple sclerosis [5][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative treatments, particularly in neurology and immunoscience [7] - The company is committed to addressing significant unmet needs in multiple sclerosis and other neuro-inflammatory and neuro-degenerative conditions [6][7] - Sanofi's neurology pipeline includes several projects in phase 3 studies across various diseases, indicating a robust commitment to advancing treatment options [6]

北京市贸促会党组书记、北京国际商会会长章建伟指出，举办"京品出海"系列活动的核心是为企业搭建 精准高效的对接平台，切实助力企业开拓海外市场。专委会将紧密围绕企业实际需求，成为连接政府与 市场、国内与国际的重要桥梁。 据介绍，目前副中心已被纳入全市医药健康产业"多点"优势布局，漷县镇集聚区已吸引包括4家上市企 业在内的众多创新主体落户，预计今年产值达60亿元，明年目标突破百亿元。 新京报讯(记者陈琳)近日，由北京市贸促会、北京国际商会主办的"京品出海"医药健康行业专场分享会 举办。会上，北京国际商会医药健康专业委员会正式揭牌成立，标志着北京在推动医药健康产业国际化 方面迈出关键一步。活动吸引了来自全球多地的专业机构代表及150余家国内外企业参会。 在当前全球科技革命与产业变革加速的背景下，医药健康产业已成为创新最活跃的赛道之一。推动"京 品"医药健康产品与服务开拓国际市场，是企业提升竞争力的必然选择。新成立的医药健康专业委员会 由北京医药行业协会倡议发起，联合默沙东、赛诺菲、阿斯利康、强生等25家国内外知名企业共同组 成，旨在聚焦行业国际化发展的共性需求，提供政策解读、市场对接、合规指导等全链条服务。 ...

The National Medical Products Administration (NMPA) in China has approved Sanofi SA’s (NASDAQ:SNY) two medicines for rare hematologic diseases: Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura. • Sanofi stock is showing upward movement. Why is SNY stock advancing?With Qfitlia and Cablivi, Sanofi reaches its fourth and fifth approvals in China this year, following Tzield for stage 2 type 1 diabetes and Sarclisa for two indications in relapsed and ...

血友病是我国首批被纳入罕见病目录的疾病之一，目前国内登记患者数约4万例。患者因先天缺乏特定 凝血因子，面临自发性或创伤后过度出血的风险，如不能很好控制，最终可导致关节损伤、变形乃至残 疾，甚至威胁生命。规范的规律替代治疗是控制出血的关键，2025年版《血友病治疗中国指南》将非因 子治疗定义为规律替代治疗（预防治疗）之一，但规范意味着患者每周需要进行2—3次预防性足剂量凝 血因子注射，每年100多次静脉注射，沉重的"针头负担"让不少患者望而却步。而对于伴抑制物的血友 病患者，为实现同样的凝血效果，注射量显著高于抑制物阴性患者。 ATLASⅢ期临床研究全球牵头研究者之一、南方医科大学南方医院血液科主任医师孙竞教授表示，首 个降低抗凝血酶创新疗法的获批，标志着中国血友病治疗真正迈入了非因子治疗的新时代。该药物通过 靶向降低抗凝血酶，重建凝血平衡，实现了对伴或不伴抑制物的12岁及以上重型血友病A/B患者的全覆 盖。其一年最少6针皮下注射，极大提高了给药便捷性和治疗依从性，彻底告别了传统因子治疗需要频 繁静脉注射的痛苦。它不仅填补了抑制物阳性患者无药可防的治疗空白，也为所有血友病患者提供了一 种更高效、更可持续的治疗新 ...

Core Insights - Two treatments for bleeding disorders, Qfitlia and Cablivi, have received approval in China [1] Group 1 - Qfitlia is indicated for chronic bleeding disorders [1] - Cablivi is indicated for acute bleeding disorders [1]

Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases Qfitlia, the first antithrombin-lowering therapy for hemophilia, can offer consistent protection with as few as six injections a yearCablivi, the first Nanobody medicine, targets acquired/immune-mediated thrombotic thrombocytopenic purpura — a rare, life-threatening blood clotting disorder Paris, December 11, 2025. The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rar ...

Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases Qfitlia, the first antithrombin-lowering therapy for hemophilia, can offer consistent protection with as few as six injections a yearCablivi, the first Nanobody medicine, targets acquired/immune-mediated thrombotic thrombocytopenic purpura — a rare, life-threatening blood clotting disorder Paris, December 11, 2025. The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rar ...

Sanofi (NASDAQ:SNY) is one of the best pharma stocks to invest in. Sanofi (NASDAQ:SNY) was downgraded to Neutral from Overweight by JPMorgan on December 8, with the firm also bringing the price target down to EUR 95 from EUR 105. Is Sanofi (SNY)the Best Gene-Editing Stock to Buy? The firm told investors that it is adjusting its ratings in the European pharma group to take into account its 2026 outlook. It anticipates pipeline readouts to drive sector performance, albeit if a considerable amount of the co ...

Sanofi (NASDAQ:SNY) is among the cheap healthcare stocks to buy heading into 2026. As of December 7, Sanofi (NASDAQ:SNY) has a ‘Buy’ or equivalent rating from the majority of the analysts covering the stock. With a one-year median price target of $61, the stock has an upside potential of 23.16%. According to TheFly, BofA reduced the price target on Sanofi (NASDAQ:SNY) to EUR 102 from EUR 115 on December 1, while keeping a ‘Buy’ rating on the stock. Tempus AI (NASDAQ:TEM) Acquires Ambry Genetics in $600M ...