Key Highlights of SpringWorks Therapeutics - OGSIVEO (nirogacestat) is the first and only FDA-approved therapy for desmoid tumors[15] - GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for both adults and children with NF1-PN[15] - SpringWorks Therapeutics expects profitability in the first half of 2026[10] - SpringWorks Therapeutics had $461.9 million in cash, cash equivalents, and marketable securities[132] OGSIVEO (Nirogacestat) for Desmoid Tumors - OGSIVEO generated $61.5 million in net revenue in Q4 2024 and $172.0 million in FY 2024[15] - Between October 2023 and October 2024, approximately 11,000 patients with desmoid tumor ICD-10 claims were identified[15] - Objective response rate (ORR) increased from 34.3% with up to 1 year of treatment to 45.7% with up to 4 years of treatment[48] GOMEKLI (Mirdametinib) for NF1-PN - GOMEKLI is approved for the treatment of adult and pediatric patients 2 years of age and older with NF1-PN[10] - The U S market includes approximately 30,000 adult and 10,000 pediatric patients with NF1-PN[15] - In clinical trials, GOMEKLI showed a confirmed overall response rate of 41% in adults (n=58) and 52% in pediatrics (n=56)[67]

Group 1 - Romoss Technology's fast-charging power bank 3C certifications have been largely revoked, with the status showing "suspended" [1] - Romoss power banks are no longer available on its official Douyin flagship store, with only charging plugs and cables remaining [1] - Anker Innovations announced a voluntary recall of certain batches of basic power banks due to quality issues with a common battery cell [3] Group 2 - iQIYI and Shanghai Film Technology Factory have established the "Yingqi AI Laboratory" to enhance the quality and efficiency of classic film digital restoration [2] - The laboratory will utilize advanced AI algorithms for audio and visual restoration of old films [2] Group 3 - Cathay Pacific Group has reached 100 global passenger destinations, with May passenger volume hitting a ten-year high, increasing by 36.1% year-on-year [6] - The airline's available seat kilometers increased by 31.2%, with a load factor of 84.7%, the highest since 2015 for the same month [6] Group 4 - Long Cable Technology plans to raise no more than 460 million yuan through a private placement to expand high and ultra-high voltage cable accessory production capacity [8] - Zhifei Biological has received approval for clinical trials of its adsorbed tetanus vaccine from the National Medical Products Administration [9] Group 5 - Tencent Cloud Development has launched "AI Builder," allowing users to generate complete applications from a simple sentence description [10] - The platform supports full project generation and code export for professional developers [10] Group 6 - The European Medicines Agency has given a positive opinion on Springworks' drug Ogsiveo for treating progressive fibromatosis in adults [11] - The Financial Supervisory Administration has issued guidelines to prevent conflicts of interest in market risk management staff compensation [12] Group 7 - The National Medical Products Administration is set to introduce new measures to support the innovation and development of high-end medical devices [13]

Core Viewpoint - SpringWorks Therapeutics has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its MEK inhibitor, mirdametinib, aimed at treating a rare genetic disorder [1][2]. Company Developments - The CHMP has recommended conditional marketing authorization for mirdametinib to treat symptomatic, inoperable plexiform neurofibromas in patients aged two years and older with neurofibromatosis type 1 [2]. - If approved, mirdametinib will be the first therapy authorized for treating NF1-PN in the European Union [3]. - The FDA approved mirdametinib under the brand name Gomekli in February 2025, generating sales of $4.9 million in the U.S. during Q1 2025 [3]. Financial Performance - Year-to-date, SpringWorks shares have increased by 28.6%, contrasting with a 5.5% decline in the industry [5]. - Merck KGaA announced plans to acquire SpringWorks for $47 per share, totaling approximately $3.9 billion, with the transaction expected to close in the second half of 2025 [6]. Product Pipeline - Ogsiveo, an oral gamma-secretase inhibitor, was approved in the U.S. for treating desmoid tumors in November 2023 and generated $172 million in sales in 2024, with $44.1 million in Q1 2025 [7][8]. - Ongoing label expansion studies for Ogsiveo are targeting various cancer indications, with the EMA's opinion on its MAA expected in Q2 2025 [8]. Market Position - The acquisition by Merck KGaA is anticipated to enhance SpringWorks' ability to reach global markets and support patients with rare tumors [9].

证券研究报告 | 行业周报 2025 年 05 月 06 日 医药 本周医药板块上涨 0.49%，百济神州 BCL-2 抑制剂申报上市 | 股票 | 股票 | 投资 | EPS（元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 93.95 | 67.11 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 13.13 | 11.22 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | -43.54 | -723.88 | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.53 | 22.68 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 3 ...

每经记者 甄素静 每经编辑 张益铭 丨2025年4月29日 星期二丨 NO.1 药明康德一季度净利润同比增长89.06% 4月28日，药明康德公告称，2025年第一季度实现营业收入96.55亿元，同比增长20.96%；归属于上市公 司股东的净利润36.72亿元，同比增长89.06%。 点评：药明康德2025年一季度营收、净利双增，展现强劲增长势头，凸显其在医药研发服务领域强大竞 争力与行业领先地位。 NO.2 派格生物通过港交所聆讯即将上市，8轮融资估值40亿 派格生物近日通过聆讯，拟在香港主板上市，独家保荐人为中金。公司是自主研究及开发慢性疾病创新 疗法的生物技术公司。2024年收入0.07亿元，净亏损2.83亿元。 点评：派格生物通过港交所聆讯，即将登陆港股。其专注慢性疾病创新疗法，虽目前亏损，但核心产品 潜力大，8轮融资获40亿估值，上市后有望借资本加速发展。 NO.3 德国默克将以39亿美元收购SpringWorks 4月28日，德国默克宣布，将收购SpringWorks，交易代价约为39亿美元的股权价值，或根据 SpringWorks截至2024年12月31日的现金余额计算的34亿美元企业价值。 点 ...

Core Viewpoint - Merck has agreed to acquire SpringWorks Therapeutics for $3.9 billion in equity value to enhance its oncology drug business [1][2] Group 1: Acquisition Details - The acquisition price is set at $47 per share, translating to an equity value of approximately $3.9 billion and an enterprise value of about $3.4 billion (30 million euros) after accounting for SpringWorks' cash [1] - The transaction will be funded through available cash and new debt, and is expected to increase Merck's adjusted earnings per share by 2027 [1] Group 2: Strategic Implications - This acquisition marks one of Merck's largest pharmaceutical deals in recent years, reinforcing its ongoing efforts to build a cancer treatment portfolio [2] - Analysts suggest that this deal could accelerate Merck's growth, especially as sales of its cancer drug Bavencio slow down and its multiple sclerosis treatment Mavenclad faces patent expiration [2]

Core Viewpoint - SpringWorks Therapeutics, Inc. anticipates a favorable opinion from the CHMP of the EMA regarding the marketing authorization application for nirogacestat in Q2 2025, aimed at treating adults with desmoid tumors [1] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with FDA-approved products including OGSIVEO (nirogacestat) for desmoid tumors and GOMEKLI™ (mirdametinib) for neurofibromatosis type 1 associated plexiform neurofibromas [2]