ARCT-810 Overview - Arcturus is a commercial mRNA medicines company with a pipeline of multiple therapeutic candidates in advanced clinical trial development[7] - ARCT-810 aims to restore OTC enzyme function, potentially preventing neurological damage and the need for liver transplantation in Ornithine Transcarbamylase (OTC) Deficiency patients[9] - ARCT-810 has received Orphan Drug Designation (FDA), Orphan Medicinal Product Designation (EMA), Fast Track Designation (FDA), and Rare Pediatric Disease Designation (FDA)[14, 15, 16, 17] Clinical Trial Results - European Phase 2 study (N = 8; 6 ARCT-810 / 2 placebo) is completed, and the U S Phase 2 study (N = 3 completed to date) is ongoing[20] - Combined analysis of both Phase 2 studies showed mean glutamine levels decreased significantly (N = 8, p-value = 0 0055)[25] - In the Phase 2 Open-label U S Study, mean glutamine levels decreased significantly (N = 3, p-value = 0 004), with all subjects achieving normal levels after three administrations[28] - Interim Phase 2 data from the U S Open Label Study (N = 3) showed a mean RUF (relative ureagenesis function) increase of +14 7% from baseline to 28 days post-fifth dose, from 29 0% (SD 9 1%) to 43 7% (SD 21 7%), which is statistically significant (p-value = 0 026)[31] Safety and Tolerability - ARCT-810 was generally safe and well-tolerated in Phase 2 studies at all tested dose levels, comprising 40 participants to date, including 20 OTC deficient participants[34, 35] KOL Insights - Glutamine rises earlier than ammonia in OTC deficiency and has lower variability, making it a reliable indicator of urea cycle stress[47] - 15N-Ureagenesis assay directly reflects cycle function, providing a clear readout of therapeutic efficacy[47]

21世纪经济报道记者 韩利明 上海报道 从传统小分子到小分子靶向药物，再逐步拓展至大分子、细胞疗法与mRNA疗法，生物医药领域的每一 次研发突破都在为临床诊疗拓宽路径。其中，mRNA技术在新冠疫情期间通过疫苗研发迅速完成商业化 验证，Moderna、BioNTech和CureVac借此成长为全球mRNA巨头。然而，随着疫情影响消退，mRNA行 业也步入转型关键期。 在技术应用层面，麦高证券研报指出，mRNA肿瘤疫苗有望成为一种适用于泛癌种、具备高可及性、能 够实现现货化与个性化兼具的新型肿瘤免疫疗法。通过广泛的联合应用，以辅助疗法作为切入点，该疫 苗有望逐步释放出数百亿美金的市场潜力。 在企业战略布局上，特别是进入2025年，行业巨头动作频频。其中，BioNTech通过战略收购布局 ADC、PD(L)1/VEGF双抗等热门肿瘤管线之余，更是在今年 6月斥资12.5亿美元收购CureVac，强化其在 研mRNA癌症免疫疗法的全链条能力。而全力押注mRNA技术的Moderna，也呈现出喜忧参半的发展态 势。 与此同时，大洋彼岸的中国正处于创新药物爆发期，mRNA赛道呈现出冰火两重天的格局。既有明星药 企黯然退场， ...

Summary of Arcturus Therapeutics KOL Presentation on ARCT-810 Phase II Interim Data for OTC Deficiency Company Overview - **Company**: Arcturus Therapeutics - **Headquarters**: San Diego - **Focus**: mRNA medicines, specifically targeting rare liver diseases like ornithine transcarbamylase (OTC) deficiency [5][6] Industry Context - **Industry**: Biotechnology, specifically in the development of mRNA therapeutics for rare diseases - **Condition**: OTC deficiency is the most common urea cycle disorder with significant unmet medical needs [6][7] Key Points from the Presentation 1. **ARCT-810 Overview**: - ARCT-810 is an mRNA therapeutic designed to replace dysfunctional OTC enzymes, improving urea cycle activity, detoxifying ammonia, and potentially eliminating the need for liver transplants [6][7][8] - It utilizes Arcturus' proprietary lunar delivery platform for effective delivery to hepatocytes [7] 2. **Regulatory Designations**: - ARCT-810 has received multiple designations: orphan drug designation, orphan medicinal product designation, fast track designation, and rare pediatric disease designation [8] 3. **Phase II Study Design**: - Two Phase II studies were conducted: one in the US and one in Europe, focusing on safety, tolerability, and biomarker assessments [11][12] - The US study enrolled patients with more severe disease, while the European study included patients with stable disease [12] 4. **Biomarker Results**: - **Plasma Glutamine**: - In the European study, mean glutamine levels decreased from high to normal during treatment and began to rise again after four weeks post-treatment [13][14] - In the US study, glutamine levels normalized after three doses and remained normal for approximately twenty days [14] - **Ureagenesis Function**: - The new N15 assay showed significant increases in relative ureagenesis function (RUF) post-treatment, with a mean increase of 14.7% [16][17] - Two subjects achieved RUF levels above 50%, indicating clinically meaningful improvements [17] - **Ammonia Levels**: - Ammonia levels remained stable and within normal ranges after treatment, supporting the favorable glutamine and ureagenesis data [18] 5. **Safety Profile**: - The safety database included 40 participants, indicating that ARCT-810 was generally safe and well-tolerated [19] - No serious infusion-related reactions were reported, and adverse events were manageable [19][20] 6. **Next Steps**: - Arcturus plans to complete the ongoing Phase II US study and engage with regulatory agencies for a multi-biomarker driven pivotal trial [68][69] Additional Insights - **Clinical Implications**: - The KOLs emphasized the importance of normalizing diet and reducing the need for ammonia scavengers as key success metrics for OTC therapies [78][80] - mRNA therapies are viewed as a potential alternative to liver transplants, especially for severe cases [100][101] - **Comparison with Other Therapies**: - ARCT-810 is positioned as a more effective solution compared to existing ammonia scavengers, which do not restore urea cycle function [87][88] Conclusion - The interim data for ARCT-810 demonstrates promising results in reducing glutamine levels and improving urea cycle function, with a favorable safety profile. The company is poised to advance its clinical development and regulatory strategy to address the significant unmet needs in OTC deficiency treatment [67][68]

Group 1 - Ayvens has received notification from the Autorité de Contrôle Prudentiel et de Resolution (ACPR) regarding the implementation of Minimum Requirement for Own Funds and Eligible Liabilities (MREL) requirements effective from 31 December 2026, with a total MREL requirement of 19.95% of the Ayvens Group's Risk-Weighted Assets (RWA) and 5.91% of the leverage ratio exposure [1][2] - As a non-resolution entity within the Societe Generale resolution group, Ayvens plans to increase its eligible liabilities by raising intragroup Senior Non-Preferred debt to meet the MREL requirement on a consolidated basis [2] - Ayvens is a leading global player in sustainable mobility, providing full-service leasing, flexible subscription services, fleet management, and multi-mobility solutions to various clients including large international corporates and SMEs [3][4] Group 2 - The company employs over 14,000 staff across 41 countries and manages a fleet of 3.2 million vehicles, including the world's largest multi-brand electric vehicle fleet, positioning itself to lead in the transition to net zero and digital transformation in the mobility sector [4] - Ayvens is listed on Compartment A of Euronext Paris with the ISIN FR0013258662 and Ticker AYV, and is majority-owned by Societe Generale Group [4]

每经记者｜许立波 每经编辑｜董兴生 6月30日，云顶新耀（HK01952，股价62.2港元，市值203亿港元）股价上涨8.74%，近7个交易日累计上涨28.6%。 在近日举行的mRNA创新技术平台研发日活动上，云顶新耀展示了mRNA（信使核糖核酸）技术平台和自身免疫疾病领域的三款产品，分别是通用型现货肿 瘤治疗性疫苗EVM14、个性化肿瘤治疗性疫苗EVM16，以及自体生成CAR-T（嵌合抗原受体T细胞免疫疗法）项目。 "我们已与全球Top 20药企广泛建立接洽，BD（商务拓展）策略聚焦通过国际伙伴资源推动创新药全球布局。"云顶新耀首席执行官罗永庆表示，公司在BD 方面"有选择权"，能够等待一个好的时间点以追求最大的回报。 据云顶新耀透露，EVM14全球多中心I期临床试验（EVM14 C101）即将启动，预计于2025年第三季度完成首例患者入组。云顶新耀嘉善工厂已于今年6月9 日顺利放行首批GMP临床试验样品，预计将于8月中旬运抵美国各临床研究中心。 mRNA平台已成国际药企关注焦点 云顶新耀曾是mRNA新冠疫苗大军中的一员。2021年9月，云顶新耀与Providence签订许可协议，引进了mRNA新冠疫苗，但 ...

Moderna on Monday said its experimental mRNA-based flu vaccine produced a stronger immune response than a currently available shot in a late-stage trial, clearing a path forward for the product and the company's separate combination flu and Covid jab.Moderna in May voluntarily withdrew an application seeking approval of its combination shot targeting Covid-19 and influenza, saying it had plans to resubmit it with efficacy data from the phase three trial on its standalone flu vaccine. That decision came afte ...

宠物医药：突破从 0 到 1，何以从 1 至 1020260629 摘要 中国宠物药品市场增长迅速，年复合增长率达 22%，需求具有刚性，贯 穿宠物生命周期。宠物老龄化加速，七岁以上老年犬占比显著提升，推 动老年病用药需求增加，养宠意识提升也增强了消费意愿。 宠物临床用药面临供给瓶颈，尤其老年病用药紧缺，长期依赖进口。行 业探索人药转化，发布《宠物临床急需使用的人用药品目录》以缓解供 需矛盾，并加速研发创新，突破慢性疾病、肿瘤等特效药研发。 国产企业在核心疫苗领域取得进展，如猫三联疫苗。瑞普生物推出国内 首个获批上市的猫三联疫苗瑞苗舒，截至 2025 年 6 月，共有 11 款国 产猫三联疫苗上市，逐步打破外资垄断。 宠物疫苗市场空间广阔，国产替代加速。国内强制免疫狂犬疫苗市场份 额约为 30-40 亿元，猫三联和犬联两种核心疫苗分别约 20 亿元左右规 模。国产企业逐步突破，形成技术集权效应。 国产猫三联疫苗在毒株匹配性和价格方面具有优势。国产疫苗毒株更适 合国内猫咪，且价格通常比进口疫苗低 20%左右，推动国产替代。 Q&A 当前我国宠物药品市场的主要特征是什么？ 我国宠物药品市场的主要特征包括需求爆发和 ...

近日，港股创新药企云顶新耀(1952.HK)举办"2025云顶新耀mRNA创新技术平台研发日"成为生物医药 行业的焦点。此次研发日系统集中展示了云顶新耀自主研发的AI+mRNA技术平台的最新进展，以及基 于该平台开发的肿瘤及自身免疫疾病领域核心管线，标志着"双轮驱动"战略的进一步深化与升级。 在业内看来，通过"双轮驱动"战略，以引进的大单品构建现金流基石，以自研mRNA平台开拓长期价值 空间，云顶新耀正重塑中国创新药在全球产业链中的定位。 AI赋能+全产业链整合，构筑全球竞争壁垒 最新的研究成果表明，mRNA疫苗具有诱导免疫记忆的潜力，有望有效预防肿瘤的复发与转移；自体生 成CAR-T，在人源化小鼠肿瘤模型中可快速、深度清除肿瘤细胞，为治愈肿瘤及难治性自身免疫疾病带 来了全新可能。 从原理来看，mRNA技术集合了软件式平台、通用型生产平台的优势，具备覆盖从肿瘤到自免、代谢性 疾病、传染病、罕见病等多种难治性疾病的药物开发能力。作为基因技术，mRNA技术可将药物开发 从"分子筛选"转变为"信息设计"，实现了"信息即药物"，可利用人体自身生成药物，使人体成为为自身 生产药物的"智能工厂。" 在mRNA疗法即将催化 ...

金融工程 | 动态跟踪 报告发布日期 2025 年 06 月 28 日 杨怡玲 yangyiling@orientsec.com.cn 执业证书编号：S0860523040002 研究结论 风格表现监控 本周市场正收益风格集中在 Beta 风格上，负收益风格表现在 Value 风格上。一年动 量是中证全指成分股中，本周表现最好的因子。 因子表现监控 公募基金指数增强产品表现跟踪 投资建议 风险提示 量化模型失效风险、 市场极端环境冲击。 有关分析师的申明，见本报告最后部分。其他重要信息披露见分析师申明之后部分，或请与您的投资代表联系。并请阅读本证券研究报告最后一页的免责申明。 | 捕捉趋势的力量：基金动量刻画新范式： | 2025-06-12 | | --- | --- | | ——FOF 研究系列 | | | Neural ODE：时序动力系统重构下深度学 | 2025-05-27 | | 习因子挖掘模型：——因子选股系列之一 | | | 一六 | | | 广发中证全指电力公用事业 ETF 投资价值 | 2025-05-20 | | 分析：——FOF 系列研究之七十五 | | | DFQ-diversify ...

Core Insights - Seagate Technology (NASDAQ: STX) has experienced a remarkable 60% year-to-date increase, significantly outperforming the S&P 500's 4% rise, driven by structural improvements and strong market dynamics, particularly in advanced technologies like HAMR [2] - The company has seen a resurgence in the data-storage market, largely due to heightened demand from generative AI applications [2] Financial Performance - Seagate's revenue fell sharply from $11.66 billion in FY2022 to $6.55 billion in FY2024, marking a 44% decline due to weak demand in consumer PCs, Covid-related disruptions, component shortages, and inflationary pressures [3] - However, in the first nine months of FY2025, revenue surged 42% year-over-year to $6.7 billion, driven by strong demand from data-center and cloud customers [3] Market Positioning - Despite the rise of SSDs, HDDs remain essential for large-scale storage due to their cost-effectiveness, leading Seagate to focus on enterprise-grade, high-capacity HDDs while reducing lower-capacity consumer drives [4] - The company has opted to procure NAND from partners like Kioxia, allowing it to concentrate on cost-effective bulk storage solutions [4] Valuation Metrics - Seagate's price-to-sales (P/S) ratio has increased from 1.2x in FY2022 to 3.2x currently, indicating a substantial rise in valuation multiples [5] - The P/S multiple has risen 176% from 1.16x in FY2022 to 2.30x in FY2024, and currently stands at around 3.20x [6] Growth Drivers - The demand for AI-driven storage solutions and the adoption of HAMR technology are significantly boosting high-capacity nearline HDD sales [11] - Seagate reported strong Q3 results with adjusted earnings of $1.90 per share and quarterly revenue of $2.16 billion, reflecting a 31% year-over-year increase [11] - A $5 billion share repurchase initiative has been introduced, indicating confidence in enhancing earnings per share [11] - Operating margins have expanded to 20% in the first three quarters of FY2025, compared to only 3% during the same period last year [11]