The project is based on the strengthening of Richter Gedeon Nyrt’s R & D activity in two areas in the gynecological and biotechnology fields, based on the knowledge base of the Partners, and increasing the Company’s competitiveness. To this end, the project aims to implement short-term and longer-term interdependent tasks. Our goals include the development of two products, a biosimilar protein product and a herbal-based gynecological product family. These products are based on both the knowledge of biotechnology and the medical and clinical knowledge of the Faculty of Pharmaceutical Sciences accumulated in Richter. After successful pre-clinical development, we plan to conduct clinical trials in a series of tasks. The realisation of the projects together serves the balanced development and expansion of Richter’s gynecological portfolio. Recently, Richter has built its own marketing network for the distribution of its gynecological products, which will enable the products resulting from the project to enter the market quickly and effectively. Continuous infrastructure developments are necessary to maintain the competitiveness of biotechnology activity. To this end, we develop our analytical and quality assurance capacities. These new capabilities contribute to the efficient implementation of the project’s product development work in line with the requirements of the pharmaceutical authorities and the market. In order to maintain our competitiveness in the long term — to create high value-added products — it is essential to maintain our R & D activities in a high quality and to carry out excellent research. As part of the project, we plan to develop R & D technologies together with the working groups of the SZTE and MTA SZBK, the knowledge from which the biotechnologically produced protein medicines significantly contribute to understanding the mechanism of action of our biotechnological protein medicines and the development of adverse reactions. Microlipidomic “mapping” of cell membranes of therapeutic target cells and the transfer of therapeutic proteins through the cell membrane and knowledge of the fate within the cell opens new directions of development. In addition to originator research, among the innovative generic (generic plus) developments, we plan to develop nanotechnologies that lead to the development of innovative therapeutic methods using innovative formulations of medicinal products, including protein medicines. One of the most critical points in drug research is the definition of a pharmacological target. The processing and re-evaluation of clinical/pharmacological/biopharmaceutical knowledge and data related to known medicines on the basis of new aspects will pave the way for a better understanding of the mechanisms leading to adverse reactions. The ‘data driven research’ used in the project relates to the definition of therapeutic indications for innovative generic developments. The expected market demand has been assessed in the case of two products that can be placed on the market within a few years, which are the independent output of the developments, which we intend to exploit through commercial distribution: 1. biotechnological biosimilar protein preparation 2. herbal based gynecological tool 1.: The international market for biotechnological medicinal products, which accounts for 12 % of total pharmaceuticals, is growing by 12-15 % per year. In recent years, the practice of curing chronic diseases is increasingly based on such drugs. The study “The Global Biosimilars Market, 2015-2025”, which analyses the topic, calculates that the global biosimilar market could reach $32 billion by 2025. The use of these products increases from year to year (~50 % of new drug developments are in this segment). There are currently around 200 biosimilars on the US and European markets. The annual average of the Hungarian drug register is ~300 billion HUF, of which the proportion of biological agents is ~5. ~20 % of the funding is increasing year on year for these products. The expected market size can be estimated from the share of new pharmaceutical products in the corporate portfolio (~5 %). On the domestic market, this suggests an annual market of HUF 1.5-2 billion, internationally 13-15 billion HUF. The primary target markets for the medicinal products created are: EU, China, Japan, Russia and the USA. 2.The protection of the vaginal mucosa, the reduction of menopause symptoms at home, represents a multi-million layer of long-term use of products for women of childbearing potential and menopause; the frequency of vaginal infections creates a lasting demand for our products. Their treatment with the currently available products is not fully solved, taking into account the consumer’s needs — we target a broad consumer layer, regardless of geographical area, on the natural basis