Fiona Yu专栏 | 默沙东(MSD)能凭K药乘风破浪，霸王再起吗？
科学研究是一场万里长征，充满了艰难险阻。新药研发的征程中结果不如预期时有发生，此时此刻，需要极大的勇气说“No Go!”美国当地时间2021年1月25日，备受尊敬的世界制药巨擘默沙东（美国默克）公司宣布，公司将停止研发SARS-CoV-2 / COVID-19候选疫苗V590和V591，并计划将其SARS-CoV-2 / COVID-19疫苗研究策略和生产能力集中在两款新冠治疗候选药物上 ，这两款药物就是MK-4482和MK-7110。此决定是基于默沙东对两款在研疫苗的1期临床研究数据进行的审查结果。在这些研究中，V590和V591通常都具有良好的耐受性，但其免疫反应不及自然感染后和其他SARS-CoV-2 / COVID-19疫苗报道的效果。默沙东继续推进两款在研药物MK-7110和MK-4482（molnupiravir）的临床研究计划，并扩大它们的生产规模；默沙东与Ridgeback Bio合作开发molnupiravir。
Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates
January 25, 2021 6:45 am EST
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. Merck continues to advance clinical programs and to scale-up manufacturing for two investigational medicines, MK-7110 and MK-4482 (molnupiravir); molnupiravir is being developed in collaboration with Ridgeback Bio.“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities.”Due to the discontinuation, the company will record a charge in the fourth quarter of 2020. The charge will be included in Merck’s generally accepted accounting principles (GAAP) results, but will not impact non-GAAP results.Merck and its collaborators plan to submit the results of the Phase 1 studies for V590 and V591 for publication in a peer-reviewed journal. In addition to advancing the development and production of MK-7110 and MK-4482, Merck will continue to conduct SARS-CoV-2/COVID-19 research. Merck will also continue to evaluate the potential of the measles-virus vector and vesicular stomatitis virus vector-based platforms and pursue broader pandemic-response capabilities. The COVID-19 pandemic underscores the need for our company and our industry to continue to invest in research to address threats to health security.About Merck’s therapeutic candidatesMK-7110 (formerly CD24Fc) is a potentially first-in-class investigational recombinant fusion protein that modulates the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Full results from this study are expected in the first quarter of 2021. In December, Merck announced a supply agreement with the U.S. government to advance the manufacturing and initial distribution of MK-7110 (link).Molnupiravir (MK-4482) is an oral novel investigational antiviral agent being developed in collaboration with Ridgeback Bio. Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. The primary completion date for the Phase 2/3 studies is May 2021. The company anticipates initial efficacy data in the first quarter of 2021, which Merck plans to share publicly if clinically meaningful.For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.View source version on businesswire.com: https://www.businesswire.com/news/home/20210125005234/en/
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