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Lilly and EVA Pharma Announce Regulatory Approval and Release of Locally Manufactured Insulin in Egypt

Lilly and EVA Pharma Announce Regulatory Approval and Release of Locally Manufactured Insulin in Egypt

Lilly和EVA製藥公司宣佈在埃及獲得當地生產胰島素的監管批准和發佈
禮來 ·  12/17 13:00

This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income countries annually by 2030

這一里程碑源於公司之間的合作,旨在到2030年每年爲一百萬名生活在中低收入國家的糖尿病患者提供可負擔的胰島素。

INDIANAPOLIS and CAIRO, Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa.

印第安納波利斯和開羅,2024年12月17日 /PRNewswire/ -- 埃及藥品管理局已批准EVA Pharma與禮來公司(紐交所代碼:LLY)合作生產的胰島素格拉齊注射液。該合作於2022年啓動,旨在向至少一百萬生活在低收入和中等收入國家(大部分在非洲)的1型和2型糖尿病患者提供高質量、負擔得起的胰島素的可持續供應。

This marks the first regulatory approval of EVA Pharma's insulin drug products, following Lilly and EVA Pharma's collaboration announcement in December 2022. Under this agreement, Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges.

這是EVA Pharma胰島素藥品首次獲得監管批准,此前禮來與EVA Pharma的合作公告於2022年12月發佈。在此協議下,禮來以顯著降低的價格向EVA Pharma提供其原料藥(API)以製作胰島素,並提供免費的技術轉讓,以使EVA Pharma能夠配製、灌裝和完成胰島素小瓶和卡式瓶的生產。

Less than two years after the initial announcement, EVA Pharma has completed a new biologics manufacturing facility, finalized insulin formulations and stability testing processes, engaged with the local regulatory authorities to obtain approval of the insulin glargine injection, and released the first batch of the locally manufactured insulin drug product.

在初步公告後不到兩年,EVA Pharma已完成新的生物製品製造設施,最終確定胰島素配方和穩定性測試流程,與當地監管機構接洽以獲得胰島素格拉齊注射液的批准,併發布了首批當地生產的胰島素藥品。

Additionally, EVA Pharma's human insulin injection was also submitted for local regulatory approval. Lilly and EVA Pharma continue working with the World Health Organization (WHO) to secure WHO pre-qualification for the locally manufactured human insulin injection. The WHO pre-qualification will further ensure that medicines manufactured by EVA Pharma meet the high-quality standards set by WHO.

此外,EVA Pharma的人用胰島素注射液也已提交當地監管批准。禮來和EVA Pharma繼續與世界衛生組織(WHO)合作,以確保當地生產的人用胰島素注射液獲得WHO的預認證。WHO預認證將進一步確保EVA Pharma生產的藥品符合WHO設定的高質量標準。

"For more than a century, Lilly has been at the forefront of diabetes care, offering innovative solutions that make life better for people around the world," said Ilya Yuffa, executive vice president and president of Lilly International. "Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. We will continue to work with global health systems and industry stakeholders to address systemic barriers to healthcare and expand equitable, affordable access to our medicines to transform more people's lives."

"一個多世紀以來,禮來在糖尿病護理領域處於前沿,爲全球人民提供創新解決方案,讓生活更美好,"禮來國際公司執行副總裁兼總裁伊利亞·尤法說。"我們與EVA Pharma的合作加強了我們提供可持續和可接觸藥品的承諾。我們將繼續與全球衛生系統和行業利益相關者合作,解決醫療保健中的系統性障礙,擴大大衆對我們藥品的公平、負擔得起的獲取,以改變更多人的生活。"

"Localizing essential medicines is the key to driving equitable access to healthcare," said Riad Armanious, CEO of EVA Pharma. "It takes bold collaboration, cutting-edge innovation, and tech-driven manufacturing to turn this vision into reality. Our collaboration with Lilly shows what's possible when we push boundaries together. This is just the beginning—we're on track to impact over a million lives annually across 56 countries, making a real difference for people living with diabetes."

「本地化基本藥物是推動公平醫療獲取的關鍵,」EVA藥品的首席執行官Riad Armanious表示。「這需要大膽的合作、尖端的創新和技術驅動的製造,將這一願景變爲現實。我們與萊莉的合作展示了當我們共同突破界限時,有可能實現的目標。這僅僅是開始——我們正致力於每年在56個國家影響超過一百萬人,爲那些生活在糖尿病中的人們帶來真正的改變。」

This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.

這項合作是萊莉30x30計劃的一部分,旨在到2030年每年改善3000萬人在資源有限地區的優質醫療服務獲取。

Most recently, Lilly and EVA Pharma expanded their collaboration, announcing that Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases across 56 low- to middle-income countries in Africa.

最近,萊莉和EVA藥品擴展了合作,宣佈萊莉將授權某些巴瑞替尼的製造技術,以使EVA藥品能夠在56箇中低收入國家制造和供應各種免疫系統疾病的治療。

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. I-LLY

關於禮來
萊莉是一家將科學轉化爲治療的藥品公司,旨在改善全球人們的生活。我們已經在改變生活的發現方面開創了近150年的先鋒歷程,如今我們的藥品幫助全球數千萬的人。利用生物技術、化學和基因醫學的力量,我們的科學家們正在緊急推進新發現,以解決一些全球最重要的健康挑戰:重新定義糖尿病護理;治療肥胖及其最具破壞性的長期影響;推進對阿爾茨海默病的鬥爭;爲一些最具削弱性的免疫系統疾病提供解決方案;以及將最難治療的癌症轉變爲可管理的疾病。朝着更健康的世界邁出的每一步,我們的動力只有一個:讓更多的人的生活變得更好。這包括開展反映我們世界多樣性的創新臨床試驗,並努力確保我們的藥物可及且負擔得起。如欲了解更多信息,請訪問Lilly.com和Lilly.com/news,或在Facebook、Instagram和LinkedIn上關注我們。I-LLY

About EVA Pharma
EVA Pharma is dedicated to improving access to affordable, high-quality medicines around the world, focusing on three core pillars: innovation, development and sustainable access. The company leverages cutting-edge technology at two research centers bringing first-of-its-kind capabilities to the Middle East and Africa including mRNA research and development from AI prediction to biological products.

關於EVA製藥
EVA製藥致力於改善全球人們獲得負擔得起的高質量藥物的機會,專注於三個核心支柱:創新、開發和可持續獲取。該公司在兩個研究中心利用前沿科技,爲中東和非洲帶來首創的能力,包括從人工智能預測到生物產品的mRNA研究和開發。

With a 5,000-strong team of professionals, EVA Pharma produces more than one million healthcare products a day at four state-of-the-art manufacturing facilities, which are internationally recognized for innovation, and have been approved by multiple regulatory agencies.

EVA製藥擁有5000多名專業團隊,每天在四個先進的製造設施中生產超過一百萬種醫療產品,這些設施因其創新而享有國際聲譽,並獲得多個監管機構的批准。

Guided by a relentless drive to ensure sustainable access to pressing yet unmet disease areas, the company's product portfolio focuses on twelve therapeutic areas: Anti-infectives, metabolic health, bone, neuroscience, oncology, respiratory, gynecology, urology and andrology, pediatrics, ophthalmology, gastrointestinal tract, family medicine to meet both local and international demand.

在不斷推動可持續獲取迫切而未滿足的疾病領域的指導下,公司產品組合關注十二個治療領域:抗感染、代謝健康、骨骼、神經科學、腫瘤學、呼吸、婦科、泌尿科和男科、兒科、眼科醫療、胃腸道、家庭醫學,以滿足本地和國際需求。

EVA Pharma is one of the fastest-growing healthcare companies in the Middle East and Africa, with an extensive pan-African presence, while operating in more than 70 countries worldwide. For more information, please visit:  &  or follow us on Facebook, LinkedIn & Instagram.

EVA Pharma 是中東和非洲增長最快的醫療保健公司之一,擁有廣泛的泛非洲業務,同時在全球70多個國家開展業務。欲了解更多信息,請訪問: &  或關注我們的Facebook、LinkedIn 和Instagram。

SOURCE  Eli Lilly and Company

來源  禮來公司

譯文內容由第三人軟體翻譯。


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