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礼来超10亿美元押注基因疗法,“心脏疫苗”问世还有多远?
Di Yi Cai Jing· 2025-06-18 04:53
Verve预计,这种基因编辑疗法有望在未来十年内推出,仅需一针便可用于降低心脏病患者的高胆固醇。 据介绍,Verve-102目前正在一项1b期临床试验研究中进行评估,并且已经获得了美国食品药品监督管理局(FDA)授予的快速通道资格。 Verve预计,这种基因编辑疗法有望在未来十年内推出。 市场分析人士认为,礼来通过这项收购既能获得重磅减重药以外其他前沿技术领域的资产,同时也仍然聚焦心脏代谢疾病治疗领域。礼来的GLP-1类药物替 尔泊肽今年预计将给公司带来超过300亿美元的总销售额。 "10亿美元是一笔不错的交易,如果这种基因疗法真的有效,至少在美国将拥有巨大的市场潜力。"一位生物医药投资人对第一财经记者表示。 总部位于美国波士顿的Verve公司由印度裔科学家Sekar Kathiresan创立,他专注于基因相关的心脏疾病研究。Verve正在开发的Verve-102是一种潜在首创的靶 向体内PCSK9蛋白的基因编辑药物,通过CRISPR基因编辑技术,精准修改肝脏细胞DNA的单个碱基,从而关闭导致胆固醇升高的PCSK9蛋白的合成通路。 礼来糖尿病和代谢研发副总裁露丝·吉梅诺(Ruth Gimeno)表示:"Ver ...
Merck(MRK) - 2025 FY - Earnings Call Transcript
2025-06-10 15:02
Financial Data and Key Metrics Changes - The company is anticipating over $50 billion in revenue by the early to mid-2030s, driven by a diversified set of therapeutic areas including cardiometabolic, immunology, ophthalmology, vaccines, and HIV [4][5] - The company has invested over $12 billion in manufacturing strategy from 2018 to 2024, with an additional $9 billion planned to bring more manufacturing back to the U.S. [16][18] Business Line Data and Key Metrics Changes - The company has nearly 20 new assets and product launches planned over the next few years, marking a significant period of transformation and growth [3][4] - The oral PCSK9, enlicitide, has shown promising results in Phase III studies, with ambitions to be the most potent LDL cholesterol-lowering pill [3][50] Market Data and Key Metrics Changes - The U.S. market for cholesterol management shows that 70% of individuals are not at their cholesterol goals, indicating a significant opportunity for the company's PCSK9 products [49] - The company continues to see elevated inventories in the Chinese market for Gardasil, with expectations for future growth once market conditions improve [36] Company Strategy and Development Direction - The company is focused on executing its pipeline and leveraging its R&D capabilities across both human and animal health sectors, with a strong emphasis on operational synergies [71][72] - The company is committed to addressing drug pricing issues and is engaged in constructive dialogue with the administration regarding the MFN executive order [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their vaccines, particularly klezrovimab, despite regulatory uncertainties [23][24] - The company is optimistic about its growth trajectory, with more product launches planned than ever before in a five-year window [47] Other Important Information - The company is actively pursuing business development opportunities, with a focus on identifying strategic assets that align with its scientific goals [40][41] - The company is expanding its immunology focus, particularly around the TL1A class, which is seen as a significant therapeutic target [42][43] Q&A Session Summary Question: What are the expectations regarding the political environment and MFN pricing? - Management indicated ongoing constructive dialogue with the administration and a willingness to collaborate on drug pricing solutions [7][9] Question: How is the company addressing the manufacturing shift for KEYTRUDA? - The company is bringing back KEYTRUDA manufacturing to the U.S. through a phased approach, with significant investments in infrastructure [18][19] Question: What is the outlook for Gardasil sales in the U.S.? - Management acknowledged potential headwinds from discussions around lower dosing recommendations but remains confident in the vaccine's value [26][34] Question: What is the company's strategy for business development? - Management emphasized that the recent slowdown in business development activity is due to timing rather than a change in strategy or urgency [40][41] Question: How does the company view the competitive landscape in oncology? - The company is focused on advancing its broad ADC program and is committed to moving quickly in the oncology space [62][64]
Junshi Biosciences Announces Ongericimab’s sNDA Approval in China
Globenewswire· 2025-05-27 12:00
SHANGHAI, May 27, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (the “NMPA”) has approved two supplemental new drug applications for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA (君适达® ...