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
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.
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.
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.
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.
"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."
"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."
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.
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.
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
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.
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.
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.
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.
SOURCE Eli Lilly and Company
這一里程碑源於兩家公司的合作,即到2030年,每年向低收入至中等收入國家的100萬糖尿病患者擴大獲得負擔得起的胰島素的機會
印第安納波利斯和開羅,2024年12月17日 /PRNewswire/ — 埃及藥物管理局批准了EVA Pharma與禮來公司(紐約證券交易所代碼:LLY)合作生產的甘精胰島素注射劑。該合作於2022年啓動,旨在向低收入至中等收入國家(LMIC)(其中大多數在非洲)的每年至少一百萬1型和2型糖尿病患者提供可持續的高質量、負擔得起的人用胰島素和模擬胰島素。
這標誌着繼禮來公司和EVA Pharma於2022年12月宣佈合作之後,EVA Pharma的胰島素藥物產品首次獲得監管部門的批准。根據該協議,禮來一直以大幅降低的價格向EVA Pharma供應胰島素活性藥物成分(API),並提供無償技術轉讓,使EVA Pharma能夠配製、填充和完成胰島素瓶和藥筒。
在首次宣佈後不到兩年,EVA Pharma已經完成了新的生物製劑製造工廠,完成了胰島素配方和穩定性測試流程,與當地監管機構進行了合作,以獲得甘精胰島素注射劑的批准,併發布了第一批本地生產的胰島素藥物產品。
此外,EVA Pharma的人用胰島素注射液也已提交當地監管機構批准。禮來公司和EVA Pharma繼續與世界衛生組織(WHO)合作,確保世衛組織對當地製造的人用胰島素注射劑進行資格預審。世衛組織資格預審將進一步確保EVA Pharma生產的藥品符合世衛組織制定的高質量標準。
禮來國際執行副總裁兼總裁伊利亞·尤法說:「一個多世紀以來,禮來一直處於糖尿病護理的最前沿,提供創新的解決方案,改善世界各地人們的生活。」「我們與EVA Pharma的合作進一步推動了我們對在全球範圍內提供可持續和可獲得藥物的承諾。我們將繼續與全球衛生系統和行業利益相關者合作,解決醫療保健的系統性障礙,擴大公平、負擔得起的藥物獲取渠道,從而改變更多人的生活。」
EVA Pharma首席執行官里亞德·阿馬尼烏斯表示:「基本藥物本地化是推動公平獲得醫療保健的關鍵。」「要將這一願景變爲現實,需要大膽的合作、尖端的創新和技術驅動的製造。我們與禮來公司的合作表明了我們共同突破界限的可能性。這僅僅是開始——我們有望每年影響56個國家的100多萬人的生活,爲糖尿病患者帶來真正的改變。」
這項合作是禮來30x30計劃的一部分,該計劃旨在到2030年每年改善生活在資源有限環境中的3000萬人獲得優質醫療保健的機會。
最近,禮來公司和EVA Pharma擴大了合作,宣佈禮來公司將許可某些巴里替尼的生產專有技術,使EVA Pharma能夠在非洲的56個低收入至中等收入國家生產和供應各種免疫疾病的治療藥物。
關於禮來
禮來是一家將科學轉化爲療法的製藥公司,旨在改善世界各地人們的生活。近150年來,我們一直在開創改變生活的發現,如今,我們的藥物爲全球數千萬人提供了幫助。利用生物技術、化學和基因醫學的力量,我們的科學家正在緊急推進新發現,以解決世界上一些最重要的健康挑戰:重新定義糖尿病護理;治療肥胖並減少其最具破壞性的長期影響;推進對抗阿爾茨海默氏病的鬥爭;爲一些最令人衰弱的免疫系統疾病提供解決方案;以及將最難治療的癌症轉化爲可控的疾病。每邁向一個更健康的世界,我們的動機都是一件事:讓數百萬人生活更美好。這包括提供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易於獲得且負擔得起。要了解更多信息,請訪問 Lilly.com 和 Lilly.com/News,或在臉書、Instagram 和 LinkedIn 上關注我們。我哈哈哈
關於 EVA 製藥
EVA Pharma致力於改善全球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、發展和可持續獲取。該公司利用兩個研究中心的尖端技術,爲中東和非洲帶來了首創的能力,包括從人工智能預測到生物製品的mRNA研發。
EVA Pharma擁有5,000多人的專業團隊,在四個最先進的製造設施中每天生產超過一百萬種醫療保健產品,這些工廠因創新而獲得國際認可,並已獲得多個監管機構的批准。
在不懈努力確保持續進入緊迫但尚未解決的疾病領域的指導下,該公司的產品組合側重於十二個治療領域:抗感染藥物、代謝健康、骨骼、神經科學、腫瘤學、呼吸學、婦科、泌尿科和男科、兒科、眼科、胃腸道、家庭醫學,以滿足本地和國際需求。
EVA Pharma是中東和非洲增長最快的醫療保健公司之一,在泛非地區擁有廣泛的業務,業務遍及全球70多個國家。欲了解更多信息,請訪問:或在臉書、領英和Instagram上關注我們。
來源 Eli Lilly and Company