Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (“CSU”) in adults and adolescents aged 12 years and above, who remain symptomatic despite histamine-1 (H1) antihistamine treatment.Following the latest FDA nod, Dupixent became the first new targeted therapy to be approved for CSU in more than a decade. The drug is now approved for seven type II inflammatory diseases in the United States.Dupixent is already approv ...

Core Insights - The U.S. FDA has approved Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment [1][4][12] - Dupixent is the first new targeted treatment for CSU in over a decade, demonstrating significant reductions in itch and hives in clinical trials [2][4] - The approval is based on data from two Phase 3 clinical trials, which showed Dupixent's efficacy as an add-on therapy to standard antihistamines [2][6] Company Overview - Regeneron Pharmaceuticals, Inc. and Sanofi are the companies behind Dupixent, which is already approved for several other conditions driven by type 2 inflammation [1][12] - Regeneron utilizes its proprietary VelocImmune technology to develop Dupixent, a fully human monoclonal antibody targeting IL-4 and IL-13 pathways [10][30] Clinical Trial Details - The Phase 3 trial program for Dupixent included three studies: Study A (n=136), Study B (n=108), and Study C (n=148), focusing on patients who were symptomatic despite antihistamine use [6][7] - Both Study A and Study C met their primary and key secondary endpoints, showing significant reductions in itch severity and urticaria activity compared to placebo [2][7] - Study B provided additional safety data but did not meet the primary endpoint for itch reduction compared to placebo [8] Patient Impact - More than 300,000 adults and adolescents in the U.S. suffer from CSU that is inadequately controlled by antihistamines, highlighting the need for effective treatment options [1][5] - The approval of Dupixent offers a new treatment avenue for CSU patients, potentially improving their quality of life [2][4] Global Regulatory Status - Dupixent is already approved for CSU in Japan, the UAE, and Brazil, with ongoing reviews in other regions, including the European Union [4][12]

Core Viewpoint - Sanofi announced preliminary data from the phase II TIDE-Asthma study for its anti-OX40L mAb, amlitelimab, which showed mixed results in treating moderate-to-severe asthma, alongside updates on other respiratory pipeline candidates [1][2][3]. Group 1: Amlitelimab Study Results - The highest dose of amlitelimab did not meet the primary endpoint of annualized exacerbation rate at week 48, while the medium dose showed nominal significance [2]. - At week 60, the medium dose demonstrated clinically meaningful reductions in asthma exacerbations, with a greater reduction observed at the high dose level [3]. - Amlitelimab also led to significant improvements in lung function and asthma control, which were secondary endpoints of the study [3]. Group 2: Other Respiratory Pipeline Developments - Sanofi is developing itepekimab in partnership with Regeneron Pharmaceuticals, currently in two phase III studies for chronic rhinosinusitis with nasal polyps [5]. - Itepekimab is also being evaluated for chronic obstructive pulmonary disease (COPD), with data expected in the second half of 2025 [6]. - Additional studies are ongoing for itepekimab in bronchiectasis and for lunsekimig in high-risk asthma and moderate-to-severe asthma, with data from these studies anticipated in 2026 [8][9]. Group 3: Market Performance - Year to date, Sanofi's shares have increased by 4.9%, contrasting with a 4.9% decline in the industry [4].

Core Insights - Sanofi has made significant advancements in its respiratory pipeline, particularly with the drug amlitelimab for asthma treatment, showing promising preliminary phase 2 results [1][2][3] Group 1: Amlitelimab in Asthma - The TIDE-Asthma phase 2 study revealed that while the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose, there were nominally significant reductions in asthma exacerbations at medium and low doses [2] - Amlitelimab demonstrated clinically meaningful improvements in lung function and asthma control, especially in a biomarker-defined patient subgroup, with a reduction of more than 70% in exacerbations at week 60 [2][3] - The treatment regimen involved administering amlitelimab every four weeks for the first 24 weeks, followed by every 12 weeks for the remaining 36 weeks, supporting a quarterly maintenance dosing schedule [3][11] Group 2: Future Clinical Studies - A phase 3 program for amlitelimab is currently being planned, with full results from the TIDE-Asthma study to be presented at an upcoming medical meeting [2][4] - Sanofi is also exploring lunsekimig in a broad population of asthma patients, with readouts from the AIRCULES phase 2 study anticipated in 2026 [5] - Itepekimab is expanding its clinical studies into chronic rhinosinusitis and COPD, with phase 3 readouts expected in H2 2025 [7][9] Group 3: Mechanism and Safety Profile - Amlitelimab operates through a unique non-depleting mechanism targeting OX40-Ligand, aiming to restore immune balance with infrequent dosing [3][10] - The safety profile of amlitelimab was consistent with previous studies, with no new safety signals identified during the 60-week treatment period [3][11]

Company Overview - Sanofi (SNY) is currently positioned as an intriguing investment choice within the Large Cap Pharmaceuticals sector due to solid earnings estimate revisions and favorable industry ranking [1][3]. - The company has experienced positive earnings estimate revisions over the past month, indicating increased analyst optimism regarding its short and long-term prospects [3]. Industry Analysis - The Large Cap Pharmaceuticals industry holds a Zacks Industry Rank of 71 out of more than 250 industries, suggesting a strong position relative to other sectors [2]. - The overall positive trends in the industry may benefit individual securities, including Sanofi, as a rising tide can lift all boats within the sector [2]. Earnings Estimates - Current quarter earnings estimates for Sanofi have increased from $0.87 per share to $0.89 per share, while current year estimates have risen from $4.21 per share to $4.34 per share [4]. - Sanofi currently holds a Zacks Rank of 3 (Hold), which is considered a favorable signal for potential investors [4]. Investment Consideration - Given the strong industry performance and solid estimate revisions, Sanofi is recommended as a compelling option for investors looking for opportunities in a robust industry segment [5].

Core Viewpoint - Sanofi's investigational BTK inhibitor, rilzabrutinib, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), addressing significant unmet medical needs in these rare diseases [1][2]. Company Developments - Rilzabrutinib is currently undergoing mid-stage studies for both wAIHA and IgG4-RD, with no approved therapies available for these conditions [1]. - Data from a phase IIb study for wAIHA indicated clinically meaningful outcomes in response rates and disease markers [5]. - A phase IIa study for IgG4-RD patients showed a reduction in disease flare and other disease markers after 52 weeks of treatment, with further details to be announced at an upcoming medical conference [6]. Regulatory Status - A regulatory application for rilzabrutinib to treat immune thrombocytopenia (ITP) is under review in the United States, with a decision expected on August 29, 2025. The drug has received both fast-track and orphan drug designations for ITP [8]. - Rilzabrutinib is also under review in the European Union and China for ITP treatment [9]. Market Performance - Year-to-date, Sanofi's shares have increased by 11.9%, outperforming the industry average rise of 0.8% [3].

Core Insights - The U.S. FDA granted orphan drug designation to Sanofi SA's rilzabrutinib for two rare diseases: warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD) [1] - Rilzabrutinib is under regulatory review in the US, EU, and China for immune thrombocytopenia (ITP) [2] - The FDA's target action date for the regulatory decision on ITP is August 29, and rilzabrutinib has also received orphan drug designation for ITP in the US, EU, and Japan [3] Clinical Study Results - Phase 2b study results for wAIHA presented at ASH 2024 indicated that rilzabrutinib treatment led to clinically meaningful outcomes in response rate and disease markers [3] - In a phase 2a study for IgG4-RD, rilzabrutinib treatment over 52 weeks resulted in reduced disease flare and other disease markers, along with glucocorticoid sparing [4] - The safety profile of rilzabrutinib in both studies was consistent with previous studies [4] Recent Developments - The FDA recently approved Sanofi's Qfitlia (fitusiran), the first antithrombin-lowering therapy for hemophilia A or B, based on data from the ATLAS phase 3 studies [5] - Sanofi's stock increased by 3.54% to $55.86 during the premarket session following these developments [6]

Core Insights - The FDA has granted orphan drug designation to rilzabrutinib for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), which currently have no approved treatments [1][2] - Rilzabrutinib is also under regulatory review for immune thrombocytopenia (ITP) in the US, EU, and China, with a target action date for FDA decision set for August 29, 2025 [2][8] Rilzabrutinib Overview - Rilzabrutinib is an investigational, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, showing potential as a first- and best-in-class treatment for several immune-mediated diseases [5] - The drug utilizes Sanofi's TAILORED COVALENCY® technology to selectively inhibit BTK, potentially minimizing off-target side effects [5] Clinical Data - A phase 2b study on wAIHA indicated that rilzabrutinib treatment resulted in clinically meaningful outcomes regarding response rates and disease markers [3] - In a phase 2a study for IgG4-RD, rilzabrutinib treatment over 52 weeks led to a reduction in disease flare and other disease markers, along with glucocorticoid sparing [4] Disease Background - wAIHA affects 1 to 3 individuals per 100,000 in the US annually and is characterized by the premature destruction of red blood cells, leading to severe fatigue and other symptoms [6] - IgG4-RD affects approximately 8 out of 100,000 adult patients in the US each year and is a chronic condition that can cause organ damage and dysfunction [7]

为本土创新医药企业提供跨越式发展平台。 来源 | 凯辉基金 今日，由凯辉基金和赛诺菲在上海共同设立的赛诺菲凯辉医药创新基金正式成立。作为 双方深化合作、助力上海生物医药产业高质量发展的重要举措，该基金管理规模约为20 亿元人民币，将专注于投资中国已进入临床阶段的创新药管线和相关产业机会，帮助本 土企业打通从研发到商业化的关键路径，加速创新药的本土市场准入。 凯辉基金创始人及董事长蔡明泼 表示："赛诺菲凯辉医药创新基金的设立标志着我们在 推动中国医药创新达到国际领先水平方面迈出的重要一步。我们始终相信，中国的医药 创新拥有巨大的潜力，而我们的使命是为本土企业提供跨越式发展的平台。与赛诺菲多 年来的互信合作，让我们能够充分整合双方在技术、市场与资本层面的优势，为本土企 业提供加速实现高水平创新能力的关键支持。我们期待通过这一基金，推动各界创新力 量的协同，推动创新药品市场的多元化与持续发展。" 赛诺菲执行副总裁夏立维（Oli vi e r Charme il） 表示："作为全球最具创新活力的医疗 健康市场之一，中国持续优化的营商环境和高水平对外开放政策，为跨国药企与本土伙 伴的深度协同提供了战略机遇。我们坚信，在 ...

Core Insights - Regeneron Pharmaceuticals and Sanofi received marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in Japan, marking the first new treatment approach for COPD in over a decade in the country [1][3] - The approval is based on the pivotal BOREAS Phase 3 trial, which demonstrated that Dupixent significantly reduced exacerbations and improved lung function in adults with uncontrolled COPD and elevated blood eosinophils [2][3] - Dupixent is already approved for multiple indications in Japan, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and chronic spontaneous urticaria [3] COPD Overview - COPD is a chronic respiratory disease that leads to progressive lung function decline and is the fourth leading cause of death globally [4] - Symptoms include persistent cough, excessive mucus production, and shortness of breath, which can significantly impair daily activities and lead to mental health issues [4] - Approximately half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy, with those having elevated eosinophils at a higher risk for exacerbations and hospitalizations [4] Dupixent's Mechanism and Development - Dupixent is a first-in-class biologic that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, targeting a specific population with type 2 inflammation [6][9] - The Dupixent development program has been extensive, involving over 60 clinical trials with more than 10,000 patients across various chronic diseases driven by type 2 inflammation [11][12] - Dupixent is administered as a subcutaneous injection, available in a 300 mg dose, and is intended for bi-weekly use [8][9] Clinical Research and Future Directions - Regeneron and Sanofi are also investigating itepekimab, another biologic targeting interleukin-33 (IL-33), in two ongoing Phase 3 trials for COPD [7][12] - The companies aim to transform the treatment paradigm for COPD by exploring the role of different types of inflammation in disease progression [5][6]