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恒瑞医药与默沙东就一款心血管创新药达成合作 交易金额最高19.7亿美元
Mei Ri Jing Ji Xin Wen· 2025-03-25 12:44
Core Viewpoint - HengRui Medicine has entered into a collaboration with Merck to license its oral small molecule project targeting lipoprotein(a) [Lp(a)], with a maximum transaction value of $1.97 billion [1][2] Group 1: Agreement Details - The agreement allows Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 outside Greater China [1] - HengRui will receive an upfront payment of $200 million and is eligible for up to $1.77 billion in milestone payments related to development, regulatory, and commercialization [1] - The agreement is subject to approval under U.S. regulations and is expected to take effect in the second quarter of 2025 [1] Group 2: Product Information - HRS-5346 is an investigational oral small molecule inhibitor of Lp(a), currently undergoing Phase II clinical trials in China [2] - Elevated Lp(a) levels are a common genetic lipid disorder, affecting over 1.4 billion people globally, and are an independent risk factor for atherosclerotic cardiovascular diseases [2] - Targeting Lp(a) with lipid-lowering therapies represents a significant breakthrough in the prevention and treatment of cardiovascular diseases [2] Group 3: Impact on Company - The signing of this agreement is expected to broaden the overseas market for HRS-5346 and enhance HengRui's innovative brand and international performance [2]
恒瑞医药: 恒瑞医药关于与Merck Sharp & Dohme LLC签署HRS-5346项目授权许可协议的公告
Zheng Quan Zhi Xing· 2025-03-25 11:24
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has signed a licensing agreement with Merck Sharp & Dohme LLC for the HRS-5346 project, granting MSD exclusive rights to develop, manufacture, and commercialize the oral small molecule Lp(a) inhibitor HRS-5346 outside of Greater China [1][2]. Group 1: Product Information - HRS-5346 is an investigational oral small molecule inhibitor targeting elevated lipoprotein(a) levels, which is a genetically determined condition and an independent risk factor for cardiovascular diseases, affecting approximately 1.4 billion people globally [1]. Group 2: Transaction Details - The agreement grants MSD exclusive rights to develop, produce, and commercialize HRS-5346 globally, excluding Greater China [2]. - MSD will pay Hengrui a $200 million upfront payment and is eligible for milestone payments up to $1.77 billion related to development, regulatory, and commercialization achievements [2]. - The agreement is subject to approval under the U.S. Hart-Scott-Rodino Antitrust Improvements Act and other specific closing conditions, with an expected effective date in Q2 2025 [2]. Group 3: Legal and Impact - The agreement is governed by the laws of the State of New York, USA [3]. - The signing of this agreement is expected to broaden the overseas market for HRS-5346, providing quality treatment options for global patients and enhancing the company's innovative brand and overseas performance [3]. - The company aims to strengthen international cooperation while maintaining a focus on independent research and development, facilitating rapid transformation of research outcomes and maximizing product value [3].
生物制药- 一图胜千言
2025-03-25 06:36
Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: Comprehensive analysis of the US drug market conducted by IQVIA Rx Key Market Metrics - **Total Prescription Year-over-Year (YoY) Growth**: - Latest weekly growth (week ending March 14, 2025) was +4.0%, up from +3.0% the previous week and +2.3% over the past 12 weeks [1][2] - For the week ended March 14, the total market weekly TRx YoY change was +4.0% compared to +1.2% a year ago [2] - Rolling 4-week TRx YoY was +3.1% and rolling 12-week TRx YoY was +2.3% [2] - Extended unit (EUTRx) weekly YoY growth was +2.2%, which is below the TRx YoY growth [2] Company-Specific Insights - **Bristol Myers Squibb (BMY)**: - Cobenfy, approved for schizophrenia on September 26, 2024, had approximately 1,340 scripts for the week, an increase from ~1,300 the previous week [3] - To meet 2025 consensus expectations, Cobenfy TRx needs to track at ~2-3x the volumes from recent schizophrenia launches, with an estimated requirement of ~125K TRx to reach consensus estimates of $160 million [3] - **Vertex Pharmaceuticals (VRTX)**: - Journavx, approved for acute pain on January 30, 2025, recorded ~1,150 scripts for the week, up from ~610 the previous week [4] - To achieve a sales estimate of $87 million, approximately 229K and 441K total scripts are needed for 14-day and 7-day script durations, respectively [4] Competitive Landscape - **Biosimilars**: - Updates on biosimilar launches including Amgen's Wezlana and Teva's Selarsdi, with respective launch dates of January 17, 2025, and February 21, 2025 [5] - **Seasonal Vaccines**: - RSV vaccine volumes are tracking ~65% below last year's levels, while COVID vaccine volumes are also down year-over-year [9] Notable Drug Performance - **Eli Lilly (LLY)**: - Mounjaro and Zepbound launches are being tracked, with Mounjaro showing significant growth [10] - **AbbVie**: - Humira is experiencing a decline of -41% YoY, while Rinvoq and Skyrizi are showing growth rates of 43% and 49% respectively [22][23] Additional Insights - **Market Dynamics**: - The analysis indicates that extended unit data trends were more positive than prescription trends, suggesting a shift towards longer-duration prescriptions [33] - **Sales Trends**: - The IQVIA databases differentiate between prescription and sales trends, with TRx representing total prescriptions dispensed including refills [29] This summary encapsulates the critical insights from the conference call, highlighting the current state of the biopharma industry, specific company performances, and market dynamics.
MRK LAWSUIT ALERT: The Gross Law Firm Notifies Merck & Co., Inc. Investors of a Class Action Lawsuit and Upcoming Deadline
Prnewswire· 2025-03-24 09:45
NEW YORK, March 24, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Merck & Co., Inc. (NYSE: MRK).Shareholders who purchased shares of MRK during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/merck-co-inc-loss-submission-form/?id=137692&from=4CLASS PERIOD: February 3, 2022 to Febru ...
Levi & Korsinsky Notifies Shareholders of Merck & Co., Inc. (MRK) of a Class Action Lawsuit and an Upcoming Deadline
GlobeNewswire News Room· 2025-03-21 17:37
NEW YORK, March 21, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Merck & Co., Inc. ("Merck" or the "Company") (NYSE: MRK) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Merck investors who were adversely affected by alleged securities fraud between February 3, 2022 and February 3, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/merck-co-inc-lawsuit-submissio ...
Levi & Korsinsky Notifies Merck & Co., Inc. Investors of a Class Action Lawsuit and Upcoming Deadline - MRK
Prnewswire· 2025-03-21 09:45
Core Viewpoint - A class action securities lawsuit has been filed against Merck & Co., Inc. due to alleged securities fraud affecting investors between February 3, 2022, and February 3, 2025 [1] Group 1: Lawsuit Details - The lawsuit aims to recover losses for Merck investors who were impacted by the company's misleading statements regarding expected revenue of $11 billion from Gardasil sales by 2030 [2] - Merck's optimistic forecasts were based on anticipated consumer activation and education efforts to drive demand for Gardasil, particularly in China [2] - On February 4, 2025, Merck announced it would not meet the $11 billion sales target for Gardasil by 2030, citing a need to halt shipments to China due to over-inflated inventories and lower-than-expected demand [2] - Following this announcement, Merck's stock price dropped from $99.79 to $90.74, a decline of over 9% in one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until April 14, 2025, to request appointment as lead plaintiff in the lawsuit [3] - Participation in the lawsuit does not require serving as a lead plaintiff, and there are no costs or obligations for class members [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]
The Gross Law Firm Reminds Merck Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of April 14, 2025 – MRK
GlobeNewswire News Room· 2025-03-20 17:01
Shareholders who purchased shares of MRK during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Merck & Co., Inc. (NYSE: MRK). CONTACT US HERE: https://securitiesclasslaw.com/securities/merck-co-inc-loss-submission-form/?id=137119&from=3 CLASS PERIOD: February 3, 2022 ...
Shareholders of Merck & Co., Inc. Should Contact The Gross Law Firm Before April 14, 2025 to Discuss Your Rights - MRK
Prnewswire· 2025-03-20 09:04
Group 1 - The Gross Law Firm has issued a notice to shareholders of Merck & Co., Inc. regarding a class action lawsuit related to misleading statements about Gardasil's expected revenue [1] - The class period for the lawsuit is from February 3, 2022, to February 3, 2025, during which Merck projected $11 billion in sales from Gardasil by 2030 [1] - On February 4, 2025, Merck announced it would not achieve the projected sales due to ceasing shipments to China, leading to a stock price decline of over 9% in one day [1] Group 2 - Shareholders are encouraged to register for the class action by April 14, 2025, to potentially become lead plaintiffs and receive updates on the case [2] - The Gross Law Firm aims to protect investors' rights and seeks recovery for losses incurred due to misleading statements that inflated Merck's stock price [3]
Merck Loses Almost $52B in 6 Months: How to Play MRK Stock
ZACKS· 2025-03-19 15:15
Core Viewpoint - Merck's stock has faced significant declines due to various challenges, including competitive pressures and reliance on its blockbuster drug Keytruda, which is set to lose exclusivity in 2028 [1][10][23]. Group 1: Stock Performance and Market Value - Merck's stock has declined 19.2% in the past six months, resulting in a loss of nearly $52 billion in market value [1]. - The stock has underperformed compared to the industry and the S&P 500, with a 23.5% decline over the past year [15][22]. - Merck's shares currently trade at a price/earnings ratio of 10.30, which is lower than the industry average of 16.85 and its 5-year mean of 13.18 [17]. Group 2: Key Products and Revenue Drivers - Keytruda is Merck's most significant product, accounting for approximately 50% of the company's pharmaceutical sales and driving steady revenue growth [3][4]. - The company is exploring innovative strategies to enhance Keytruda's long-term growth, including combinations with other therapies and a subcutaneous formulation [5][6]. - Gardasil, Merck's second-largest product, has seen a 3% decline in sales in 2024, primarily due to weak performance in China [13]. Group 3: Pipeline and Strategic Moves - Merck's pipeline has nearly tripled over the past three years, with several new vaccines and drugs expected to launch in the next five years [8]. - The company has made strategic acquisitions, including Eyebiotech Limited and Harpoon Therapeutics, to bolster its pipeline [7]. - Promising candidates in the late-stage pipeline include MK-0616 for hypercholesterolemia and a respiratory syncytial virus vaccine under FDA review [9]. Group 4: Future Outlook and Guidance - Merck's guidance for 2025 indicates expected revenues between $64.1 billion and $65.6 billion, reflecting a year-over-year growth of 2% to 4% [23]. - Analysts have lowered earnings estimates for 2025 from $9.44 to $9.01 per share, indicating a bearish outlook [19][23]. - Concerns about the company's ability to grow its non-oncology business ahead of Keytruda's patent expiration in 2028 are rising [11][12].
Class Action Filed Against Merck & Co., Inc. (MRK) - April 14, 2025 Deadline to Join – Contact Levi & Korsinsky
GlobeNewswire News Room· 2025-03-18 17:21
NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Merck & Co., Inc. ("Merck" or the "Company") (NYSE: MRK) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Merck investors who were adversely affected by alleged securities fraud between February 3, 2022 and February 3, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/merck-co-inc-lawsuit-submissio ...