【上海迪赛诺获得许可制造默沙东新冠口服药molnupiravir，森萱医药为其主要供应商】27 家仿制药制造商与 MPP 签署协议，生产低成本版本的 COVID-19 抗病毒药物 molnupiravir，供应 105 个中低收入国家 $森萱医药(BJ830946)$ $精华制药(SZ002349)$ $复星医药(SH600196)$
2022 年 1 月 20 日
日内瓦——药品专利池 (MPP) 今天宣布，它已与 27 家仿制药制造公司签署协议，生产口服 COVID-19 抗病毒药物 molnupiravir，并供应 105 个中低收入国家 (LMIC) 。许可协议是 MPP 和默沙东 (Merck & Co., Inc., Kenilworth, NJ, USA) 于 2021 年 10 月签署的自愿许可协议的结果，以促进默努匹韦（molnupiravir）在全球范围内获得可负担的价格，默沙东正在开发该协议与 Ridgeback Biotherapeutics 合作。
非排他性分许可允许仿制药制造商生产莫努匹拉韦的原材料和/或成品药本身。获得分许可的公司成功地证明了他们有能力满足 MPP 对生产能力、法规遵从性以及满足质量保证药品国际标准的要求。 5家公司将重点生产原料药，13家公司将同时生产原料药和成品药，9家公司将生产成品药。这些公司遍布 11 个国家，孟加拉国、中国、埃及/约旦、印度、印度尼西亚、肯尼亚、巴基斯坦、南非、韩国和越南。
虽然 MSD 与 MPP 谈判了一项协议以确立条款和条件，但仿制药生产商的分许可请求仅由 MPP 审查并提交给 MSD。 MSD、Ridgeback Biotherapeutics 和发明该药物的埃默里大学都不会从 MPP 分许可持有人的莫努匹拉韦销售中获得特许权使用费，而 COVID-19 仍被世界卫生组织 (WHO) 列为国际关注的突发公共卫生事件。
“大量新的和现有的合作伙伴迅速采取行动，通过 MPP 获得了 molnupiravir 的分许可，我们对此感到鼓舞，” MPP 执行董事 Charles Gore 说。 “这是确保全球获得急需的 COVID-19 治疗的关键一步，我们相信，随着制造商与监管机构密切合作，预期的治疗将很快在 LMIC 中获得。”
“从一开始，加速广泛、负担得起的 molnupiravir 保障供应一直是 MSD 的优先事项，这导致我们与 MPP 合作签署许可协议，以扩大对质量有保证的 molnupiravir 仿制药版本的保障供应，但需获得当地监管机构的授权，”Paul 说Schaper，默沙东全球公共政策执行董事。 “我们很高兴看到这一愿景变为现实，MPP 选定的仿制药制造授权许可制造商具有很强的地域多样性。”
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英文原文：
27 generic manufacturers sign agreements with MPP to produce low-cost versions of COVID-19 antiviral medication molnupiravir for supply in 105 low- and-middle-income countries
20 January 2022
Geneva – The Medicines Patent Pool (MPP) announced today that it has signed agreements with 27 generic manufacturing companies for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- and-middle-income countries (LMICs). The sublicence agreements are the result of the voluntary licensing agreement signed by MPP and MSD, a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, in October 2021 to facilitate affordable global access for molnupiravir, that MSD is developing in partnership with Ridgeback Biotherapeutics.
The non-exclusive sublicences allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself. The companies that were offered the sublicence successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug. The companies span 11 countries, Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.
While MSD negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicences from generic producers were reviewed solely by MPP and presented to MSD. Neither MSD, Ridgeback Biotherapeutics nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).
“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicence for molnupiravir through MPP,” said Charles Gore, MPP Executive Director. “This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in LMICs.”
“Accelerating broad, affordable access to molnupiravir has been a priority for MSD from the start, which led us to partner with MPP on a licensing agreement to expand access to quality-assured generic versions of molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director, Global Public Policy, MSD. “We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”