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 ...

智通财经APP获悉，中信证券发布研报称，IBD作为自身免疫疾病中的"硬骨头"，拥有巨大的未满足临 床需求和广阔的市场空间。尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率(经安慰剂调整后)依 然非常有限，大多数药物的临床缓解率在10%-20%之间的水平，已获批药物的高剂量组临床缓解率通常 在15%以上。当前IBD的治疗新老产品更新迭代，对新机制新疗法的需求急迫，注射长效化+口服多点 开花。MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角。该行建议关注新靶点新机制， 密切跟踪相关临床试验的开展和进度以及重点数据的读出。 中信证券主要观点如下： MNC加速IBD领域布局，中国创新药企业在差异化赛道崭露头角 作为自身免疫疾病领域中，患者人数众多且当前一年维持期疗效仍仅有30%-50%临床缓解率的适应症， IBD吸引了众多MNC布局。老玩家通过新产品巩固领先优势;慢病头部企业通过资源倾斜快速布局;肿瘤 领域核心玩家通过BD、收购等模式进入。根据过往交易规模以及MNC对产品峰值的预期，该行预计一 项临床阶段的优质IBD资产的交易对价在20亿美金以上。 中国企业紧跟全球趋势并展现出差异化创新能力：云顶新耀引 ...

Group 1 - Sanofi has completed the acquisition of Vicebio, a clinical-stage biotechnology company focused on multi-pathogen vaccines for respiratory viral infections [1][2] - The acquisition includes Vicebio's early-stage vaccine candidate for respiratory syncytial virus and human metapneumovirus, enhancing Sanofi's vaccine design and development capabilities through Vicebio's Molecular Clamp technology [2] - Sanofi's Dupilumab, developed in collaboration with Regeneron, has received European Commission approval for treating moderate-to-severe chronic spontaneous urticaria in patients aged 12 and above, marking it as a first-line targeted treatment option [3][4] Group 2 - The approval of Dupilumab was based on positive Phase 3 study results, demonstrating symptom reduction at 24 weeks compared to placebo, with a significant addressable market of over 270,000 adults and adolescents in the EU suffering from chronic spontaneous urticaria [4] - Sanofi operates in three segments: Pharmaceuticals, Consumer Healthcare, and Vaccines, focusing on research, production, and distribution of pharmaceutical products [4]

Core Insights - Sanofi has successfully completed the acquisition of Vicebio Ltd, enhancing its capabilities in vaccine design and development, particularly for respiratory viruses [1][2] Group 1: Acquisition Details - The acquisition includes an early-stage combination vaccine candidate targeting respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) [1] - This addition allows Sanofi to diversify its vaccine pipeline by incorporating a non-mRNA vaccine option, thereby increasing choices for physicians and patients [2] Group 2: Company Overview - Sanofi is an R&D driven, AI-powered biopharma company focused on improving lives through innovative medicines and vaccines, with a commitment to addressing urgent healthcare challenges [3] - The company aims to leverage its deep understanding of the immune system to develop treatments that can benefit millions globally [3]

About LabGenius Therapeutics This collaboration combines LabGenius' AI/ML-driven antibody design capabilities with Sanofi's expertise in the development of therapeutic NANOBODY® molecules to co- optimise proteins for therapeutically valuable properties LabGenius Therapeutics is a drug discovery company pioneering the discovery of next-generation therapeutic antibodies. The company's discovery platform, EVAâ"¢, integrates several cutting-edge technologies drawn from the fields of artificial intelligence, rob ...

Group 1 - The presentation features Graham Parry from Citigroup introducing Sanofi and its CEO, Paul Hudson, at an investment community event in Miami [1] - Investors are particularly interested in Sanofi's plans regarding the Dupixent loss of exclusivity (LOE) expected in 2031 and the company's outlook post-LOE [2]

Summary of Olema Pharmaceuticals FY Conference Call Company Overview - **Company**: Olema Pharmaceuticals (NasdaqGS:OLMA) - **Focus**: Oncology, specifically breast cancer - **Lead Asset**: Palazestrant, a selective estrogen receptor degrader (SERD) in two phase 3 trials: OPERA-01 and OPERA-02 [2][30] Key Trials and Developments - **OPERA-01**: - Focuses on second- and third-line treatment for ER-positive HER2-negative breast cancer - Expected data readout in the second half of 2026 - Control arm includes Exemestane or Fulvestrant [2][32] - **OPERA-02**: - First-line trial combining palazestrant with ribociclib (Kisqali) - Currently enrolling patients [2][30] - **KAT6 Inhibitor (OP-3136)**: - Phase 1/2 program exploring monotherapy and combination therapies with fulvestrant and palazestrant [3] Industry Context - Recent advancements in the SERD space, particularly from Roche's lidERA trial, have renewed investor confidence in estrogen receptor targeting agents [4][5] - The SERD landscape has seen mixed results, with many agents failing to demonstrate efficacy in wild-type estrogen receptors [12][16] Competitive Landscape - **EMERALD Trial**: - First oral SERD (Orsurdu) showed efficacy only in ESR1 mutant patients [7][9] - **Roche Trials**: - **acelERA** and **evERA** trials showed varying results, with giredestrant demonstrating activity in mutant but not wild-type settings [11][14] - Upcoming **persevERA** trial results are anticipated to influence perceptions of OPERA-02's potential success [39] Market Potential - The potential market for palazestrant in the wild-type endocrine-resistant population is estimated at $5 billion in the U.S. [36] - The differentiation of palazestrant as a complete antagonist may provide a unique advantage over other SERDs [15][36] Formulation and Administration - Both OPERA-01 and OPERA-02 trials utilize a tablet formulation of palazestrant, with a consistent dose of 90 mg [46] - Previous phase 1/2 data included both tablet and capsule formulations, with overlapping bioavailability [48] Future Outlook - Anticipated data from the KAT6 study and ongoing trials in 2026 [50] - Continued focus on understanding the efficacy and tolerability of palazestrant in various patient populations [52]

Financial Data and Key Metrics Changes - Company revenue increased from EUR 33 billion to approximately EUR 45 billion since 2019, reflecting significant growth [2] - The workforce reduced from 118,000 in 2019 to around 72,000, indicating a strategic shift towards modernization [2] - Manufacturing sites decreased from over 70 to 38, showcasing efforts to streamline operations [2] - In Q3, the company reported an 8.8% growth in top-line revenue, 9.7% growth in BOI, and 12.4% growth in EPS, with a 10.2% growth excluding buybacks [17][18] Business Line Data and Key Metrics Changes - DUPIXENT experienced a 26% growth in Q3, demonstrating strong commercial capabilities despite competitive threats [3] - The company is focusing on advancing its pipeline, with several drugs in various stages of development, including tolebrutinib and amlitelimab [4][5] Market Data and Key Metrics Changes - The U.S. market is projected to face loss of exclusivity (LOE) for DUPIXENT in 2031, while Europe is expected to follow in 2033 [3] - The company anticipates significant growth opportunities in specialty care, which is becoming a larger part of its portfolio [17] Company Strategy and Development Direction - The company aims to transform into an R&D-led pharmaceutical entity, having exited the consumer health sector [2] - There is a commitment to enhancing the internal pipeline, with a recognition that the current number of preclinical and phase I programs is insufficient compared to peers [5] - The acquisition of Blueprint is seen as a strategic move to support top-line growth through the DUPIXENT LOE period [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to commercialize new drugs effectively, despite challenges in R&D [3][4] - There is a cautious outlook for 2027, primarily due to the anticipated loss of R&D offsets from Regeneron [15] - The company is focused on maintaining efficiency while investing in R&D, with a goal to deliver attractive financials alongside growth [17][18] Other Important Information - The company is actively pruning its R&D portfolio to focus on high-value indications, which is expected to enhance overall efficiency [43] - Management highlighted the importance of understanding patient populations and treatment paradigms in immunology to drive future success [59][70] Q&A Session Summary Question: How is the company planning to navigate the LOE in 2031? - The company has a robust pipeline and several patents that will support its strategy post-LOE, with plans to launch new medicines [3] Question: What is the mix between internal pipeline and M&A? - The company acknowledges a need for additional high-quality programs and is actively looking for opportunities to enhance its pipeline [5] Question: How does the company view margin progression? - Management indicated that while there are challenges, the transition to a specialty care-led portfolio is expected to improve efficiency and margins [17] Question: What are the expectations for DUPIXENT's growth? - Management remains optimistic about DUPIXENT's growth trajectory, projecting it to reach EUR 22 billion by 2030 [71] Question: How does the company plan to address the competitive landscape in immunology? - The company believes that multiple treatment options will benefit the market, and it is focused on ensuring its products meet the needs of patients effectively [157][166]

Financial Data and Key Metrics Changes - Company revenue increased from EUR 33 billion to approximately EUR 45 billion since the CEO's appointment, reflecting significant growth [2] - The workforce reduced from 118,000 in 2019 to around 72,000, indicating a focus on efficiency [2] - Manufacturing sites decreased from over 70 to 38, showcasing a modernization effort [2] - In Q3, the company reported an 8.8% growth in revenue, 9.7% growth in BOI, and 12.4% growth in EPS, with a 10.2% growth excluding buybacks [17][18] Business Line Data and Key Metrics Changes - Dupixent experienced a 26% growth in Q3, demonstrating strong commercial capabilities despite competitive threats [3] - The company is focusing on advancing its R&D pipeline, with several drugs in various stages of development, including Tolebrutinib and Amlitelimab [4][5] Market Data and Key Metrics Changes - The U.S. market is projected to face loss of exclusivity (LOE) in 2031, while Europe is expected to follow in 2033 [3] - The company anticipates significant growth opportunities in specialty care, which is becoming a larger part of its portfolio [17] Company Strategy and Development Direction - The company aims to transition into an R&D-led pharmaceutical entity, having exited the consumer health sector [2] - There is a commitment to enhancing the internal pipeline, with a recognition that the current preclinical and early-stage programs are insufficient compared to peers [5] - The acquisition of Blueprint is seen as a strategic move to support top-line growth through the LOE of Dupixent [4][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to commercialize new drugs effectively, despite challenges in R&D [3][4] - There is a cautious outlook for 2027, primarily due to the anticipated loss of R&D offsets from Regeneron [15][17] - The company is focused on maintaining a leveraged P&L while ensuring efficient operations and continued investment in R&D [19][21] Other Important Information - The company is actively pruning its R&D portfolio to focus on high-value indications, which is expected to enhance overall efficiency [43] - Management highlighted the importance of understanding patient demographics and treatment paradigms in immunology to drive future success [69][70] Q&A Session Summary Question: How does the company plan to navigate the LOE in 2031? - The company has a strategy to launch new medicines and has several patents and ideas in development to mitigate the impact of LOE [3] Question: What is the balance between internal pipeline and M&A? - The company acknowledges a shortfall in high-quality preclinical programs and is looking to enhance its pipeline through both internal development and potential acquisitions [5] Question: How does the company view margin progression? - Management indicated that while there are challenges, they expect to maintain efficiency and drive growth in margins through strategic investments and operational improvements [15][17] Question: What is the outlook for Dupixent amidst new competitors? - Management believes Dupixent will continue to grow due to low current biologic penetration in the market, indicating strong future demand [71] Question: What are the expectations for Tolebrutinib's approval? - The company is optimistic about Tolebrutinib's potential market size and is focused on ensuring a perfect REMS for its launch [92][96]