GEROPHARM recibió un certificado de cumplimiento del estándar internacional de calidad BPF de CECMED, la autoridad reguladora nacional de Cuba. El certificado es reconocido por muchos países de América Latina, lo que facilitará el desarrollo de exportaciones en esta región.El estándar BPF o GMP (Buenas Prácticas de Fabricación, Good Manufacturing Practice) es un sistema de regulaciones y reglas relativas a la fabricación de medicamentos. El certificado confirma el cumplimiento de las buenas prácticas de fabricación de dos plantas de GEROPHARM: en Pushkin (San Petersburgo) y en Obolensk (Provincia de Moscú). CECMED ha certificado los siguientes procesos de fabricación: biosíntesis, purificación, llenado de soluciones y suspensiones, envasado, etiquetado y control de calidad de los productos. GEROPHARM recibió el certificado de cumplimiento de BPF por primera vez en 2021, y ahora se ha actualizado con éxito. El nuevo documento es válido hasta febrero de 2027.La autoridad reguladora nacional de Cuba, CECMED, tiene una amplia experiencia en el registro y auditoría de medicamentos, y el certificado de BPF de Cuba es una confirmación latinoamericana reconocida de la calidad del producto, así como una evidencia del fabricante confiable. La diabetes mellitus es una cuestión importante en América Latina. Según el Atlas de Diabetes de la FID de 2021, el número de personas con diabetes en la región es más de 32 millones, y sigue creciendo. El número proyectado de pacientes para 2045 es de 49 millones. “Los inspectores de CECMED han evaluado los procedimientos de fabricación y confirmaron el alto nivel de los estándares de BPF en la fabricación del producto y el control de calidad. El nuevo certificado incluye todas las formas de insulina humana y sus análogos producidos por la empresa, así como el primer análogo ruso de Ozempic®: Semavic®”, dice Petr Rodionov, Director General de GEROPHARM.ReferenciaCECMED es un Centro de Control Estatal de Medicamentos, Equipos y Dispositivos Médicos de Cuba.GEROPHARM es un fabricante nacional de medicamentos biotecnológicos que garantiza la seguridad farmacéutica de Rusia. La empresa se dedica a la producción de medicamentos en un ciclo completo, invierte en el desarrollo tecnológico y la creación de una infraestructura farmacéutica moderna. GEROPHARM exporta los medicamentos a 13 países del mundo: todos los países de la CEI, Mongolia, Venezuela, Marruecos.

GEROPHARM received a certificate of compliance with GMP international quality standard from CECMED, the national regulatory body of Cuba. The certificate is recognised by many countries of Latin America, which will facilitate export development in this region.GMP (Good Manufacturing Practice) standard is a system of regulations and rules regarding medicinal product manufacturing. The certificate confirms the compliance with good manufacturing practices of two GEROPHARM plants: in Pushkin (St. Petersburg) and in Obolensk (Moscow Region). CECMED has certified the following manufacturing processes: biosynthesis, purification, filling of solutions and suspensions, packaging, labelling and quality control of products. GEROPHARM received GMP compliance certificate for the first time in 2021, and it has been successfully updated. The new document is valid until February 2027.Cuba’s national regulatory body, CECMED, has extensive expertise in the registration and audit of medicinal products, and Cuba’s GMP is a recognised Latin American confirmation of product quality as well as a reliable manufacturer evidence. Diabetes mellitus is a major issue in Latin America. According to IDF Diabetes Atlas 2021, the number of people with diabetes in the region is more than 32 million, and it keeps growing. The projected number of patients by 2045 is 49 million. “CECMED inspectors have assessed the manufacturing procedures and confirmed the high level of GMP standards in the product manufacturing and quality control. The new certificate covers all forms of human insulin and its analogues produced by the company, as well as the first Russian analogue of Ozempic®: Semavic®,” Petr Rodionov, GEROPHARM Chief Executive Officer says.ReferenceCECMED is a Centre for State Control of Medicines, Equipment and Medical Devices of Cuba.GEROPHARM is a national manufacturer of biotechnological products ensuring the medicinal safety of Russia. The company is engaged in full-cycle manufacture of medicinal products, invests in technological development and creation of modern pharmaceutical infrastructure. GEROPHARM exports its products to 13 countries worldwide: all CIS countries, Mongolia, Venezuela, Morocco.

GEROPHARM ha registrado una nueva insulina RinGlusin® con principio activo glulisina, que tiene la misma potencia que la insulina humana habitual. Este medicamento es el primer bioanálogo ruso de Apidra® SoloStar®. En la actualidad, la empresa biotecnológica GEROPHARM produce una amplia gama de insulinas más modernas y populares en Rusia en un ciclo completo, lo que garantiza la seguridad del medicamento para los pacientes con diabetes mellitus. En julio, la empresa obtuvo el Registro Sanitario de un nuevo medicamento RinGlusin®. La insulina glulisina tiene un inicio de acción más rápido y una duración de acción más corta que la insulina humana soluble. Ahora el portafolio de GEROPHARM incluye una línea completa de los análogos de insulina de acción rápida presentados oficialmente en Rusia. El producto ha sido sometido a una serie de ensayos. Los estudios clínicos de RinGlusin® se llevaron a cabo en los principales centros de investigación de Rusia, incluidos CCE FR IPEF “CNIM de Endocrinología” del Ministerio de Salud de Rusia e IPEF “CNIM Almazov” del Ministerio de Salud de Rusia. Así como otras insulinas de GEROPHARM, RinGlusin® se producirá en Rusia en un ciclo completo: desde la sustancia hasta la forma farmacéutica terminada. La fabricación se llevará a cabo en las plantas propias de la empresa en la ciudad de San Petersburgo y la región de Moscú, que cumplen con altos estándares GMP nacionales e internacionales. El volumen de producción dependerá del nivel de demanda. “En Rusia hay millones de pacientes con diabetes mellitus, una porción significativa de ellos requiere terapia continua con la insulina. Por lo tanto, es importante que el país cuente con todos los medicamentos nacionales modernos que el sistema de salud necesita hoy en día. Esto es una garantía de compensación de alta calidad de la enfermedad”, confirma Petr Rodionov, Director General de GEROPHARM.

GEROPHARM has registered a new insulin RinGlusin® with glulisine active substance, which is equal in strength to regular human insulin. This medicinal product is the first Russian bioanalogue of Apidra® SoloStar®. Currently, GEROPHARM biotechnological company produces a wide range of modern and most popular insulins in Russia on a full-cycle basis, which ensures medicinal safety for patients with diabetes mellitus. In July, the company obtained marketing authorisation for a new medicinal product RinGlusin®. Insulin glulisine has a faster onset and a shorter duration of action than soluble human insulin. Now GEROPHARM’s portfolio includes a full line of rapid-acting insulin analogues officially presented in Russia. The product has undergone a whole range of trials. Clinical studies of RinGlusin® were conducted in leading research centres of Russia, including RF SRC FSBI “NMRC for Endocrinology” of the Ministry of Health of the Russian Federation and FSBI “Almazov National Medical Research Centre” of the Ministry of Health of the Russian Federation. Like other GEROPHARM insulins, RinGlusin® will be produced in Russia on a full-cycle basis: from the substance to the finished dosage form. The manufacturing will be performed at company’s own plants in St. Petersburg and Moscow Region, which meet high national and international GMP standards. The manufacturing volume will depend on the demand level. “In Russia there are millions of patients with diabetes mellitus, a significant portion of them require continuous insulin therapy. Therefore, it is important for the country to possess all the modern domestic medicinal products that the healthcare system needs today. This is a guarantee of high-quality compensation for the disease,” Petr Rodionov, GEROPHARM Chief Executive Officer confirms.

GEROPHARM obtained the marketing authorisation for insulin analogue biosimilars glargine and lispro from the Ministry of Health of the Republic of Uzbekistan.Thus, Uzbekistan became the third country where GEROPHARM obtained the marketing authorisation for RinLis, and the fourth one where RinGlar is registered.Plans are underway to localise insulin production at Zuma Pharma site, the Uzbek company, next year. GEROFARM will transfer the production technology for insulin biosimilars such as glargine, lispro, and biphasic lispro in pen injectors and cartridges to the partner. This agreement was signed during Saint Petersburg International Economic Forum (SPIEF).

На полях Петербургского международного экономического форума генеральный директор Петр Родионов рассказал какие меры поддержки требуются сейчас российскому фармацевтическому бизнесу и принял участие в подписании соглашений, а директор по стратегическому маркетингу Марина Рыкова обсудила с участниками «Большой перемены» перспективы развития отечественной медицины. В стартовый день форума при поддержке Ассоциации фармацевтических производителей Евразийского экономического союза (АФПЕАЭС) состоялась сессия «Фармацевтическая промышленность в России – перезагрузка 2030: курс на независимость». Представители компаний и регуляторы обсудили краткосрочные и дальнесрочные перспективы развития фармотрасли. Петр Родионов рассказал, что ГЕРОФАРМ намерен преодолеть зависимость от поставок ключевых компонентов из недружественных стран до конца года. Он также призвал признать риск ухода зарубежных производителей как данность на уровне регуляторных решений. В числе первоочередных мер, которые потребуются в этих условиях локальному производству, он отметил инициативу «второй лишний», контроль за соблюдением норм GMP, развитие собственного производства фармсубстанций, льготное кредитование российской фармы на развитие новых инвестиционных проектов, борьбу с «озеленением» патентов, а также активное использование инструмента принудительного лицензирования в тех случаях, когда создание доступной отечественной терапии взамен дорогостоящих импортных препаратов может обеспечить всех пациентов нужными лекарствами. В пример он привел ситуацию с такими заболеваниями, как Гепатит С и муковисцидоз. Особое внимание было уделено срокам реализации этих мер и достижению ключевых показателей эффективности. «Сегодня нужно действовать быстрее и ставить более амбициозные цели. Доля стратегически значимых лекарственных средств, локализованных до полного цикла производства на территории России, должна составлять все 100% уже к 2025 году», - подчеркнул Петр Родионов. По его мнению, все эти шаги важно реализовывать в условиях постоянного контакта с пациентами, чтобы совместно искать решения их потребностей и проблем. Тогда это позволит не просто обеспечить лекарственную безопасность, но и предоставить пациентам доступ к качественной и действительно востребованной терапии. В продолжение данного тезиса на ПМЭФ было подписано соглашение между АФПЕАЭС, членом которой является ГЕРОФАРМ, и Всероссийским союзом общественных объединений пациентов. Документ предусматривает ключевые направления сотрудничества ассоциации и пациентского сообщества, чтобы способствовать расширению применения пациентоориентированного подхода на всех этапах жизненного цикла препаратов. В рамках сессии Петр Родионов также затронул вопросы развития экспорта фармацевтической продукции. Чтобы снизить долю сильно подорожавшей логистики в себестоимости препаратов, он призвал повысить субсидии для российских экспортеров. В ответ заместитель министра промышленности и торговли России Василий Осьмаков заметил, что такие предложения уже внесены на рассмотрение. Сегодня ГЕРОФАРМ продолжает выполнять взятые на себя обязательства перед зарубежными партнерами и пациентами, а также расширяет рынки присутствия. 17 июня на площадке форума ГЕРОФАРМ подписал новое соглашение с компанией ZUMA PHARMA, которое определило основные условия сотрудничества в рамках трансфера технологии производства аналоговых и человеческих инсулинов на площадку узбекской фармацевтической компании. ГЕРОФАРМ предоставит партнеру технологию производства биосимиляров – гларгин, лизпро и лизпро двухфазный – в части осуществления стадий розлива, упаковки и выпускающего контроля качества. При этом компания продолжит поставлять активные фармацевтические субстанции для производства совместного продукта, компоненты для сборки одноразовой шприц-ручки, а также многоразовые шприц-ручки. Такое сотрудничество позволит обеспечить пациентов Узбекистана качественными инсулинами, что особенно важно в условиях постоянно возрастающего числа пациентов. В свою очередь для ГЕРОФАРМ это станет возможностью получить дополнительные инвестиции в расширение портфеля препаратов и в инновации. Об инновациях и будущем медицины говорили в студии «Большой перемены» – «Точка Юниор». Вместе с директором по стратегическому маркетингу Мариной Рыковой участники всероссийского конкурса обсудили перспективы инновационных прорывов в медицине, поговорили о новых и конкурентоспособных технологиях производства и применения лекарственных препаратов, диагностических медицинских исследованиях, а также новейших методах лечения пациентов. В течение встречи были затронуты вопросы научных разработок и использования передовых медицинских технологий, в том числе в биомедицине и медицинской генетике, а также тема импортозамещения. Отдельное внимание было уделено развитию soft и hard skills, которые сегодня являются особенно востребованными у работодателей в фармацевтической отрасли.

2 ноября в рамках заседания федеральной комиссии конкурса «Экспортер года» были объявлены 13 победителей. ГЕРОФАРМ занял 1 место в номинации «высокие технологии» в категории «крупный бизнес». Всероссийская премия в области международной кооперации и экспорта «Экспортер года» присуждается организациям и индивидуальным предпринимателям, достигшим наибольших успехов в осуществлении экспорта несырьевых неэнергетических товаров, работ, услуг, а также результатов интеллектуальной деятельности. В 2020 году на участие в премии было подано более 1700 заявок, из них 85 победителей окружных этапов приняли участие в финале. Выбор номинантов основан на двух перекрестных подходах: электронное автоматическое ранжирование с использованием искусственного интеллекта, а также экспертиза членов Единой окружной конкурсной комиссии. Среди ключевых критериев: оценки экспортной деятельности и международного продвижения, а также уровень экспортной активности. Петр Родионов, генеральный директор ГЕРОФАРМ: «Для ГЕРОФАРМ развитие экспорта является одним из приоритетных направлений деятельности. Мы крайне благодарны федеральной конкурсной комиссии за столь высокую оценку успехов компании в этом направлении. Первое место премии «Экспортер года» - это подтверждение правильности взятого нами курса. По итогам 2019 года, рост объемов препаратов, поставляемых на внешние рынки, увеличился на 53%, а уже к концу 2020, по нашим прогнозам, ГЕРОФАРМ войдет в число лидеров среди российских фармацевтических компаний-экспортеров в денежном выражении. В случае с фармотраслью экспорт является одним из ключевых инструментов стимулирования развития внутреннего рынка, поскольку его развитие помогает получать дополнительную прибыль, которую можно инвестировать в расширение портфеля препаратов отечественных производителей и инновации. Однако, чтобы это направление продолжало стремительно расти, необходимо принятие четких и работающих механизмов государственной поддержки». По итогам 2019 года доля экспорта в общей выручке компании составила более 9%. На текущий момент препараты ГЕРОФАРМ доступны в 12 странах: Беларуси, Молдавии, Грузии, Армении, Азербайджане, Туркменистане, Казахстане, Узбекистане, Таджикистане, Киргизии, Монголии и Венесуэле. На зарубежных рынках представлены оригинальные препараты в области неврологии и офтальмологии – Кортексин® и Ретиналамин®, генно-инженерные инсулины человека и биосимиляры аналогов инсулина - Ринсулин® Р, Ринсулин® НПХ, Ринсулин® Микс 30/70, РинГлар®, РинЛиз®, а также многоразовые инсулиновые шприц-ручки Ринсапен® II. В начале лета 2020 года было получено регистрационное удостоверение на инсулин гларгин в Казахстане, в 2019 начато сотрудничество с Венесуэлой по обеспечению потребности страны в инсулинах (ГЕРОФАРМ – единственный поставщик этих жизненно-важных препаратов в стране) и процесс регистрации инсулинов на Кубе. Кроме того, подано досье для регистрации инсулинов в Азербайджане. Среди приоритетных регионов – Латинская Америка, Юго-Восточная Азия, Ближний Восток и Северная Африка, страны Персидского залива и Европейский Союз.

Caracas. GEROPHARM has delivered more than 850,000 packages of insulin products to Venezuela. The current commercial batch includes rapid- and medium-acting recombinant human insulins Rinsulin® R and Rinsulin® NPH in vials, as well as ultra-rapid- and long-acting insulin analogues RinLis® (insulin lispro) and RinGlar® (insulin glargine) in cartridges. This batch size is enough to cover the full demand of the country — more than 400 thousand patients with diabetes — for about two months. Since the end of 2019, GEROPHARM has delivered 2.5 million packages of insulin to Caracas. Insulin supplies to Venezuela are made under a schedule approved by the parties. GEROPHARM is supplying a somewhat larger volume of products than declared so that, in the event of an emergency, patients are not left without vital medications. Importantly, even the COVID-19 pandemic did not stop the supplies. S.M. Melik-Bagdasarov, Ambassador Extraordinary and Plenipotentiary of the Russian Federation to the Bolivarian Republic of Venezuela, the Dominican Republic and the Republic of Haiti: Interaction with Venezuela in the health sector is an important component of bilateral cooperation between our countries. The high quality of Russian pharmaceutical products, their affordability in comparison with foreign counterparts contributes to the strengthening of Russia's positions on the global pharmaceutical market. It is gratifying that GEROPHARM fulfills its obligations to deliver to Venezuela on time and without interruption, despite the difficult epidemiological situation in the world and Western anti-Venezuelan sanctions. This once again testifies to the high degree of reliability and responsibility of the Russian manufacturer and exporter. As a reminder, the company performs regular supplies under a strategic long-term cooperation agreement with the Government of Venezuela signed during the St. Petersburg International Economic Forum in 2019 by GEROPHARM CEO Pyotr Rodionov and Venezuelan Vice-President for Economic Affairs Tareck El Aissami. As of the date of the strategic cooperation agreement, international insulin manufacturers had almost completely stopped supplying essential insulin products to Venezuela — a country with no local insulin manufacturers. Implementation of the project plays a decisive role in the development of humanitarian cooperation between Russia and Venezuela, which significantly improves the country’s international image. The company estimates that the share of GEROPHARM may reach 20 % of total trade between Venezuela and Russia in 2020. Ivan Gil, Deputy Minister of Foreign Affairs of Venezuela, told TV channel Russia Today about GEROPHARM insulin supply to Caracas: https://www.youtube.com/watch?v=2Ufn50QW4F0&feature=youtu.be

ESPROMED BIO, un socio estratégico de la empresa GEROPHARM en Venezuela, ha recibido la carga: 20 mil plumas-jeringas Rinsapen® II para inyección múltiple y 20 mil envases de agujas. Una parte de esta entrega es la obligación que la empresa ha asumido adicionalmente a título gratuito, reconociendo la importancia social de la cooperación con la parte venezolana con el fin de satisfacer las necesidades del país en medicamentos de insulina. GEROPHARM, al no ser un fabricante de agujas, por su propia cuenta, las compró de uno de los principales fabricantes internacionales. Como resultado, cada paciente que haya recibido una pluma de jeringa Rinsapen® II para inyección múltiple, también recibirá agujas gratuitas para la administración segura de insulina durante un largo período de tiempo. Recuerde que GEROPHARM ha sido el único proveedor de estos medicamentos en el país desde 2019. Hoy en Venezuela, están disponibles insulina humana recombinante de acción rápida e intermedia Rinsulin® R, Rinsulin® NPH y Rinsulin® Mix 30/70 en viales, así como los análogos de insulina de acción ultrarrapida y prolongada: RinLis® (insulina lispro) y RinGlar® (insulina glargina) en cartuchos. Pyotr Rodionov, Director General de GEROPHARM: “Uno de los factores fundamentales para el desarrollo de una cooperación confiable a largo plazo es, entre otras cosas, la voluntad de ayudar a los socios a resolver los problemas existentes. Y estamos contentos de haber podido suministrarles plumas-jeringas para inyección múltiple y agujas para estas sin cargo para la parte venezolana". Los suministros de insulina a Venezuela se realizan de acuerdo con el cronograma aprobado por las partes. GEROPHARM cada vez entrega un volumen ligeramente superior al fijo, de modo que en caso de circunstancias imprevistas, los pacientes no se queden sin un medicamento vital. Cabe señalar que incluso la pandemia COVID-19 no suspendió los envíos.

11 июля зафрахтованный ГЕРОФАРМ самолет доставил 840 000 упаковок инсулина в Каракас. Это – первая поставка компании, которая, помимо генно-инженерных инсулинов человека, включает аналоги инсулина и расширяет возможности терапии сахарного диабета в Венесуэле.

Сегодня, 8 мая, в 4:00 по московскому времени зафрахтованный компанией ГЕРОФАРМ Boeing 767-300 (рейс AZV2501*) вылетел из Москвы (аэропорт «Внуково») в Каракас. Компания доставит очередную партию жизненно важных препаратов инсулина в Венесуэлу и на обратном пути поможет гражданам Российской Федерации и стран СНГ вернуться на Родину.

On February 19 to 22 in Madrid, Spain, one of the key European scientific events takes place, the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), and GEROPHARM experts give presentations on clinical studies of insulin analogue biosimilars. ATTD is a well-recognised platform where renowned international experts discuss innovative solutions in diabetes mellitus treatment. The annual event is attended by speakers from USA, Israel, Slovenia, United Kingdom, Sweden, Spain, Germany, Belgium, UAE, Denmark, the Netherlands, Poland, Serbia, France, Canada, Italy, etc. GEROPHARM attends the forum for the first time. Anna Mosikyan, Medical Advisor, GEROPHARM, gave a presentation on the results of pharmacokinetics, pharmacodynamics, and safety (immunogenicity) studies of insulin glargine (RinGlar) produced by the company. The presentation abstract will be published in the specialised international journal Diabetes Technology & Therapeutics. The article will be also available on the company’s website. The information on the posters, however, is already available at the links below: Results of insulin glargine pharmacokinetics and pharmacodynamics studyResults of insulin glargine immunogenicity studyConcentration of anti-insulin antibodies in T1D patients taking different insulins

In the near future, short- and intermediate-acting human biosynthetic insulins Rinsulin® R and Rinsulin® NPH in vials will be available for patients throughout the country. It is worth noting that the indicated volume is enough to meet the full demand for insulin for more than 166,000 patients with diabetes mellitus over a period of a month. The supply has been implemented under the Long-Term Cooperation Agreement between GEROPHARM and ESPROMED BIO, as signed on the margins of the St. Petersburg International Economic Forum 2019 by the CEO of GEROPHARM and Tareck El Aissami, the Venezuelan Vice President for Economic Affairs. Shipments will be performed every month. Looking ahead, in the next few months, the list of supplied products will be extended to include human biosynthetic insulin Rinsulin® Mix* in vials and analog insulins RinLis® (Lispro) and RinGlar® (Glargine) in cartridges. The project implementation will be an important step in the development of the humanitarian cooperation between Russia and Venezuela, and make a meaningful contribution to the international image of the country. Under the contract, GEROPHARM will supply over 5 million product packages to Venezuela in 2019–2020 that will provide over 400,000 diabetic Venezuelans with the life-saving medicine. The Company estimates that GEROPHARM’s share in the total trade between Venezuela and Russia can reach 20 % as early as 2020. It should be noted that, at the time the strategic cooperation agreement was concluded, Venezuela had a limited number of the medicine, which was insufficient for the continuous provision of the population. At the same time, there are no local insulin manufacturers. P. P. Rodionov, CEO of GEROPHARM, “Implementing the project to satisfy the Venezuelan demand for insulin products is a very serious step for us and an opportunity to help solving a pressing social problem. By the middle of 2020, we will satisfy 100 % demand for insulins in the country. This is of critical importance since lives of diabetic patients depend on daily injections. Besides, the development of insulin exports is now a strategic objective for the Company. During the last year, we made significant advances in this regard in Cuba, Kazakhstan and Belarus. GEROPHARM is expecting to conclude a number of other agreements with foreign partners in the near future. The regions of priority for the Company are the countries of Latin America, South-East Asia, Middle East and Northern Africa, Persian Gulf and the European Union.” D. V. Manturov, the Minister of Industry and Trade of the Russian Federation, “Currently, we satisfy the demand for insulins of the Russian healthcare system, as well as develop exports. The advanced technologies for development and manufacture, quality and affordability of the products ensure the high competitiveness of the Russian insulins in international markets. The commencement of insulin deliveries is a major contribution to the development of the strategic bilateral cooperation between Russia and Venezuela, as well as an important step in expanding our non-resource and non-energy exports.” V. I. Skvortsova, the Minister of Health of the Russian Federation, “The demand for domestic medicines, including insulins, in international markets is a key indicator of the successful work of the Ministry of Health of the Russian Federation on improving the state regulation for medicine circulation. It can be said that today there is a market authorization system in Russia, which complies with the latest international requirements and makes it possible to guarantee the safety and efficacy of the Russian-manufactured drug products, as well as enables domestic companies to expand the geography of their location.” *** * The product is currently undergoing the registration procedure. GEROPHARM is a Russian biotechnology company, the leader in the development and manufacture of insulins. Since late 2016, the Company has been ranking first in the sales volumes among the manufacturers of human biosynthetic insulins (HBIs). Currently, the Company covers about 30 % of the Russian demand for HBIs. All the insulin manufacturing stages, including the molecule biosynthesis, are carried out at the Company’s own manufacturing facilities within the Russian Federation. In 2018, the Company held an opening ceremony for a new factory in St. Petersburg with the participation of the President of the Russian Federation. Launching of new manufacturing capacities of GEROPHARM in November 2018 created conditions for the development of insulin exports to far-abroad countries. The advanced technologies of development and manufacture, high quality of the products, and independence from foreign deliveries provide the basis for the high competitiveness of the Russian insulins in international markets. The Company’s endocrinology portfolio includes two human biosynthetic insulins (HBIs) Rinsulin® R and Rinsulin® NPH, as well as rapid-, intermediate- and long-acting insulin analogs RinLis®, RinLis® Mix 25 and RinGlar®, respectively. Another 7 products (analogues of insulins and HBIs) are being developed, 1 of them is expected to be registered soon. ESPROMED BIO C. A. is a public company developing and manufacturing biological medicinal products. The company is managed by the Ministry of the People’s Power for Health of the Bolivarian Republic of Venezuela. The company manufactures vaccines, monoclonal antibodies, erythropoietins, interferons and other biologicals. The manufacturing capacity of the Venezuelan factory is 120 million doses of biologicals per year. Apart from that, the company has three independent laboratories equipped with the latest technology, which can produce 50 million doses of diphtheria toxoid, the same amount of pertussis vaccines, and 60 million doses of tetanus toxoid per year. In 2016, the biotechnology factory ranked among the major ones in Latin America expanded its capacities through the consolidation with a factory of non-sterile solid oral dosage forms. This allows for the provision of the Venezuelan population with patented pharmaceutical products.

На профессиональном медицинском портале для врачей опубликована обзорная статья, посвященная инсулинотерапии сахарного диабета. Отдельное внимание в статье уделено эффективности и безопасности применения отечественных инсулинов - Ринсулина Р и Ринсулина НПХ. Авторы статьи - проф. А.М. Мкртумян и Л.В. Егшатян. В статье приводятся статистические данные по динамике роста заболеваемости сахарным диабетом в последние годы, которые свидетельствуют о прогрессирующем росте заболеваемости сахарным диабетом как в мире, так и в РФ. Согласно рекомендациям ВОЗ, для стабильного обеспечения пациентов инсулином в странах с населением более 50 млн. человек должно быть создано собственное производство данных препаратов. В статье приводятся результаты клинических исследований, доказавших безопасность и терапевтическую эквивалентность Ринсулина и импортных человеческих генно-инженерных инсулинов. Отдельно отмечается, что ГК «ГЕРОФАРМ» является единственным в России производителем высококачественного генно-инженерного инсулина человека (от субстанции до готовых лекарственных форм). Полная версия статьи опубликована на Медицинском портале для врачей: http://umedp.ru/articles/_insulinoterapiya_sakharnogo_diabeta_effektivnost_i_bezopasnost_otechestvennykh_insulinov_rinsulina_.html 

The First International Pharmaceutical Conference “Import substitution 2015” took place in the House of the Moscow Region Government in Krasnogorsk on June 10. The event was held with the cooperation and support of the Government of the Moscow Region and the Ministry of Industry and Trade of the Russian Federation. Andrey Vorobyov, Governor of the Moscow region, was the chairman of the conference. The conference was dedicated to the region’s pharmclusters development prospects and gathered managers of the leading Russian pharmaceutical companies, representatives of distributors and pharmacy chains, physicians of Moscow region hospitals as well as representatives of the federal and regional ministries and departments. At the conference state support measures necessary for development of the industry in the current economical environment were discussed. The participants also analysed an import substitution strategy and ways to improve the availability and affordability of medical products. As part of interactive discussion “New Russian pharmaceutical industry. Response to modern healthcare challenges” practical suggestions of manufacturers, aimed at raising awareness of medical community, were submitted. Dmitry Burovik, Director of GEROPHARM-Bio (a part of GEROPHARM, Group of Companies) made a report “Development of pharmaceutical substances manufacturing in the region. Challenges, achievements and prospects”. In this report he drew attention to the need of development of production with maximum local content, i.e. industrial production of substances. Only full circle production including the production of pharmaceutical substances can ensure real import substitution and improve drug safety of the country. Natalia Novichkova, Quality Director of GEROPHARM, made a report on a quality assurance system implemented at the comany’s factory. She told about this system during the round table “Assurance of quality, efficiency and safety of drugs is the common goal of regulatory authorities and manufacturers” which was held at the same time. Natalia Novichkova presented practical cases and told about the development of validation system at the factory. The representatives of the Ministry of Industry and Trade, the Ministry for Economic Development, the Ministry of Health and the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation told about the opportunities for the development of the pharmaceutical industry in Russia. The representatives of the Ministry of Investments and Innovations of the Moscow region shared the experience of pharmclusters development on the example of regional initiatives. As the result of the First International Pharmaceutical Conference “Import substitution 2015”, the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation and the Government of the Moscow region concluded an agreement on the formation of a unified system of non-clinical and clinical trial based on the exiting federal laboratory infrastructure and the clinical site of the Moscow region in the interests of pharmaceuticals manufacturers for the Central Federal District. An exhibition was held as a part of the conference. The leading Russian companies provided participants an opportunity to learn more about their product portfolio and the most recent developments. GEROPHARM, Group of Companies, allowed the participants not only to see company’s drug products and unique 3D model of the GEOPHARM-Bio factory, but also to take a virtual tour on the company’s modern production line and check out high level and quality of manufactured products. An interactive table located at the company’s exhibition stand made it possible to take the virtual tour on the production line and see stages of production of modern and hi-tech GEROPHARM products. Reference: Today the Moscow region is one of the biggest constituent entities of the Russian Federation in terms of concentration of pharmaceutical factories. 26 pharmaceutical factories are located in the region. They produce innovative products, as well as branded and non-branded generic products, veterinary drugs. Overall revenue of the companies exceeds 40 million roubles per year, and four of these companies (Akrikhin, Valenta Pharm, KRKA-Rus and Sotex) belong to Top 15 pharmaceutical companies of Russia in terms of revenue (according to SPARK analytic system and Deloitte analysis for 2014). There are three pharmclusters in the Moscow region: Pushchinsky (in Serpukhovsky District), Severny (both Krasnogorsk and Khimkinsky District) and Shchelkovsko-Noginsky. “In the previous year the Government of the Moscow region managed to implement a number of initiatives contributing the development of pharmaceutical industry and promoting health care in the region”, said Aleksandr Ganov, Minister of Investments and Innovations of the Moscow region. He added: “In order to move forward, it is important to receive feedback from representatives of the pharmaceutical industry and physicians. Currently, we actively work together with the state federal authorities on the pilot projects”. http://360tv.ru/news/zavod-v-serpuhovskom-rajone-postavljaet-insulin-v-77-subektov-rossii-25223

The official ceremony marking the opening of the cutting-edge high-tech complex “GEROPHARM-Bio”, JSC, was held on October 2, 2013; it is the first Russian full-cycle plant manufacturing genetically engineered human insulin: from the substance synthesis to the finished dosage form. The ceremony was held within the Company’s production complex premises located at Obolensk (the Moscow Region, the Serpukhov District). The GEROPHARM-Bio plant is a large investment project which was implemented as part of the Federal Strategy PHARMA-2020. The project was completed in a relatively short period of time. The construction works began in 2011. The project investments amounted to RUB 1.5 billion. The plant has a total area of 2.5 ha. The area of its production premises is approx. of 10,000 sq.m. The plant will allow to adjust the existing production of genetically engineered human insulin, to launch a fully automated line manufacturing the drug in cartridges and vials, as well as to set up production of new advanced products for the treatment of socially significant diseases, including diabetes. The expected production volume will be 25 mln vials and 5 mln cartridges per year. Most of the tasks in the plant are performed by automated manufacturing systems. The production is organized in accordance with GMP standards. The commissioning of the “GEROPHARM-Bio”, JSC plant is included in the 2013-2018 Activity Plan of the Ministry of Industry and Trade of the Russian Federation. The plant is a unique one not only in the Moscow Region, but also in Russia, as it creates the conditions for the drug safety; it is the first plant which locates all the stages of socially significant drug production within the country and ensures its independence from foreign suppliers of raw materials. The official ceremony was opened by the Governor of the Moscow Region A.Yu. Vorobiev. The following guests have participated in a symbolic commissioning of the plant: Assistant to the Minister of Health of the Russian Federation Ye.A. Maksimkina, Director of the Department of Chemical Engineering and Bioengineering Technology at the Ministry of Industry and Trade of the Russian Federation S.A. Tsyb, Head of the Social Control and Trade Administration of the Federal Antimonopoly Service of the Russian Federation T.V. Nizhegorodtsev, Executive Director of the Association of Innovative Regions of Russia, Chairman of the Supervisory Board of the Fund for Assistance to Small Innovative Enterprises in Science and Technology I.M. Bortnik. Ye.A. Maksimkina in her speech emphasized the importance of the plant in providing the population with drugs to achieve full quality of life. S.A. Tsyb presented the speech on behalf of the Minister of Industry and Trade of the Russian Federation which emphasized the important role of the plant in the development of the pharmaceutical industry and improving the country’s drug safety. T.V. Nizhegorodtsev noted in his speech that the new plant is “a visible evidence of fair competition”, and that the competition in the drug market is very complicated. “Our aim is to ensure easy marketing of the company’s products throughout the country, as well as to gain benefits from the competition for the health care system,” he said. “The benefits from the competition are price reduction, release of additional funds in the budget which could be used for improvement of the quality of people’s lives.” Congratulations were also made by the honoured guests at the event. Director of the Diabetes Institute, Deputy Research Director of the Federal State-Funded Institution “Endocrinology Research Center” of the Ministry of Health of the Russian Federation M.V. Shestakova said that the GEROPHARM-Bio plant is the first full-cycle plant, i.e. the plant which produces its own substance. She also noted that the country faces an enormous need for insulin: official data shows that there are 3.7 million people with diabetes in Russia, but it is 3 times smaller than the actual figures. Marina Vladimirovna ended her speech by wishing the company further progress in the field of insulin analogues development. The Head of the Serpukhov District A.V. Shestun also emphasized the particular importance of the opening unique high-tech production facilities in the region, as well as in terms of creating new work places. Deputy Chairman of the State Duma Committee on Culture, People’s Artist of the USSR I.D. Kobzon and Director of the Elena Obraztsova Music Charity Foundation N.M. Ignatenko were the honoured guests at the ceremony. General Director of the Group of Companies “GEROPHARM” P.P. Rodionov expressed his gratitude to all the guests for their congratulations and said: “We are facing an ambitious challenge, and we will achieve the objectives that have been set. The opening of the plant is just the beginning. Next year we will start supplying our products as part of disposable insulin pens. Along with that, we are working to develop the most modern insulins, and we will soon begin registration of new insulins in Russia, the insulins that patients need.” After the opening ceremony all guests attended the organized tours of the GEROPHARM-Bio plant. In addition to visiting the production premises the guests were given a unique opportunity to see the exhibition of works of the famous Russian photographer Valery Plotnikov. Photo project “Diabetes in Persons” was initiated by “GEROPHARM” in order to attract public attention to the problem of diabetes. The project involved the people for whom diabetes had become a routine lifestyle forever, but it had not taken their zest for life. Reference: “GEROPHARM-Bio” JSC (formerly “National Biotechnologies” JSC) belongs to the Group of Companies “GEROPHARM”. In 1998, the company was initially established to meet the state’s ambitious objective which consisted in setting up a pilot production technology for genetically engineered human insulin as part of the program “Diabetes”. A key aspect is the company’s strategic independence from foreign suppliers. Establishment of new production not only implies providing modern drugs to the population, but also creating new work places. The plant will employ up to 260 highly qualified experts. The project was implemented under the auspices of several major financial institutions: Sberbank of Russia, a long standing partner of the Group of Companies “GEROPHARM”, the European Bank for Reconstruction and Development, as well as VTB Leasing. “GEROPHARM-Bio” is currently producing short-acting insulin drugs under the trade mark Rinsulin R (solution) and intermediate insulin drugs under the trade mark Rinsulin NPH (suspension), which are manufactured by its own technology. Proteome Factory AG Berlin, Prolytic GmbH Frankfurt am Main, Labor L+S AG, three independent certified European laboratories, appreciated the quality of the genetically engineered insulin substance produced by “GEROPHARM-Bio” and declared it compatible with the U.S.and British Pharmacopoeias. Today, the product has registration in Ukraine and Kyrgyzstan, and is currently under registration in Kazakhstan and Vietnam. The company expects to be audited for compliance with GMP standards by the end of this year; this will expand greatly the Rinsulins’ export routes. Russian insulins provoke general public interest abroad: this fact is confirmed by the participation of the Group of Companies “GEROPHARM” in the following major international pharmaceutical exhibitions and congresses: CPhI South East Asia (Jakarta, Indonesia), BIO International Convention (Chicago, USA). The agreements on further cooperation with a number of companies from the South-East Asia region, Latin America and North Africa were signed as a result of these events.