SID & GP MINPROMTORG OF RUSSIA Corporate Communication Center IV ALL-RUSSIA GMP CONFERENCE ASPECTS OF PPP ACCORDING TO THE PROGRAM OF MODERNIZATION FOR REGIONAL BLOOD TRANSFUSION STATIONS UNDER SPIC

SPIC At present, domestic plasma preparations are not produced in an amount sufficient to meet the needs of Russian patients. There is no Russian production of certain types of plasma preparations. At the same time, recombinant preparations cannot completely replace plasma products. .RU СПИК In order to develop Russian manufacturing competencies, on September 25, 2018, a special investment contract No. 25 was signed between the Russian Federation, Octapharma-Pharmimex LLC, a joint venture of the Swiss Octapharma and Pharmimex JSC, Scopinfarm LLC and Pharmimex JSC itself. Production of the following 10 plasma preparations will be mastered under the SPIC: coagulation factors VIII and IX, VIII + von Willebrand factor coagulation factors II, VII, IX and X in combination [Prothrombin complex] human immunoglobulin anti-Rhesus Rho [D]) human immunoglobulin normal for subcutaneous (extravascular administration) human immunoglobulin normal 5% and 10% human albumin General partner: Strategic partners: Official partners: Regional partners:

MODERNIZATION OF BLOOD TRANSFUSION STATIONS The main problems of domestic production of high-quality and competitive (including on the world market) plasma drugs: the lack of modern technologies and the necessary legislative framework for the preparation of plasma for fractionation (substance), as well as limited access to a sufficient amount of plasma produced in full compliance with GMP. .RU ГЧП Within the framework of the concluded SPIK, Pharmimex JSC has to create 10 plasma centers by 2025, including using public-private partnership mechanisms with the constituent entities of the Russian Federation and the Federal State Budget Health Institution Blood Center of the FMBA of Russia. PHARMIMEX Group Carries out the creation and furnishing of a plasma center Carries out technical operation Transfers production technology Carries out quality audits Provides for consumables Acquires plasma for fractionation Constituent entity Accepts a plasma center and hands over its stations for operation Fulfills other obligations under PPP Blood transfusion station Carries out procurement of human plasma for fractionation in accordance with GMP Transmits plasma for Pharmimex fractionation General partner: Strategic partners: Official partners: Regional partners:

BENEFITS FOR PARTICIPANTS PHARMIMEX Group Constituent entity Obtaining high-quality substance for the functioning of the pharmaceutical production of domestic drugs from human blood plasma Stable long-term relations with the manufacturer (SEC) with the participation of a Constituent entity of the Russian Federation Investments in the construction of a regional plasma center Furnishing the SEC with modern equipment; Savings of the budget funds of the constituent entity for the re-equipment and maintenance of the stations at the expense of a private investor Creation of new jobs at the SEC Payment of taxes to the local budget Modern technology transfer as per GMP standards Development of a new improved donor program in the region, optimization of the use of donor resources Acquisition of new competencies by SEC employees Stable long-term investor relations. General partner: Strategic partners: Official partners: Regional partners:

FURTHER MARKET DEVELOPMENT This direction development will allow to: Fully meet the needs of Russian patients in plasma preparations; Organize the supply of high-quality and competitive plasma preparations for export; In the future - master the production of new drugs from blood plasma. However, further development of the legislative framework is necessary, including for the following purposes: Involvement of private investors in the process of procuring blood and its components for industrial use (creating private plasma centers) while maintaining state control over the circulation of this raw material within the Russian Federation; Harmonization of legislation on blood donation and its components with legislation on the circulation of drugs in terms of the procurement of raw materials as a pharmaceutical substance, eliminating gaps and contradictions; Involvement of private investors in the development of donor programs. General partner: Strategic partners: Official partners: Regional partners:

THANK YOU FOR YOUR ATTENTION! General partner: Strategic partners: Official partners: Regional partners: