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Samsung Bioepis is embarking on the joint development of novel antibody drugs utilizing artificial intelligence with PROTEINA, an AI-driven drug development company.

Samsung Bioepis and PROTEINA announced on July 9 that they have signed a license option agreement to utilize the achievements of a national R&D project for AI-driven novel antibody drug development. This agreement is a follow-up contract related to the "development and demonstration of antibody biopharmaceuticals using AI models" project managed by the Ministry of Health and Welfare, which the two companies have been pursuing since October last year alongside a research team led by Professor Baek Min-kyung of the Department of Biological Sciences at Seoul National University. Although the total value of the contract was not disclosed by mutual agreement, it is estimated to be over approximately 41.8 billion won.

The contract is structured around a division of labor. PROTEINA will be in charge of discovering and validating candidate substances, while Samsung Bioepis will lead the preclinical research up to the investigational new drug (IND) application stage. The plan aims to discover candidate substances by 2027. Subsequently, if Samsung Bioepis exercises its license option, it will advance clinical development and commercialization, paying milestones and royalties to PROTEINA accordingly.

Both companies possess proven technical prowess in their respective fields. Samsung Bioepis has obtained marketing authorizations for a total of 11 biosimilar products from major regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and possesses R&D capabilities that have never seen a single case of IND approval rejection at the clinical trial stage. PROTEINA possesses technology that curtails the validation process, which conventionally takes several months, down to two weeks through its proprietary high-throughput antibody optimization and performance measurement platform, enabling the simultaneous analysis of over 10,000 antibody sequences every week.

This collaboration is evaluated as a case where Samsung's support for discovering promising future technologies has borne fruit. Yoon Tae-young, CEO of PROTEINA, previously received support from the Samsung Science and Technology Foundation for five years from 2014 to 2018.

Kim Kyung-ah, CEO of Samsung Bioepis, said, "Through this agreement, we are expanding our competitive edge in process optimization accumulated through biosimilar development into the field of novel antibody drug development. Based on close collaboration with our partner, we will faithfully execute the government's national project."

Yoon Tae-young, CEO of PROTEINA, stated, "I believe that solving the bottleneck in drug development by combining AI with an experimental validation platform has entered an important demonstration phase of moving beyond the research level into an actual new drug through this contract with Samsung Bioepis."

                                                                                                          Kang Hye-won