Daewoong Pharmaceutical and Yonsei University Hearing Rehabilitation Research Center Sign Stem Cell CDMO Contract for Hearing Loss Treatment Development

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 30th that it has signed a contract for stem cell contract development and manufacturing (CDMO) to develop a hearing loss treatment drug with the Auditory Rehabilitation Research Center at Yonsei University Wonju College of Medicine.

The Yonsei University Auditory Rehabilitation Research Center is the only comprehensive auditory research institute in Korea, specializing in the diagnosis, treatment, and research of hearing loss. In preclinical studies of a hearing loss treatment drug in the form of stem cell-derived exosomes stimulated by nanoparticles, which treats damaged hair cells?the main cause of sudden hearing loss?the center confirmed positive results and plans to apply for approval of the Phase 1 clinical trial investigational new drug (IND) in 2024. Through this contract, both institutions will collaborate to establish a master cell bank (MCB) of tonsil-derived mesenchymal stem cells for the production of Phase 1 clinical trial samples.

Daewoong Pharmaceutical will be responsible for establishing the initial stages of culturing tonsil-derived mesenchymal stem cells and building the MCB for the production of Phase 1 clinical trial samples for the hearing loss treatment drug. Leveraging its experience in stem cell therapy research and development, the company will apply nanobio convergence technology to stem cells and support the industrialization and commercialization of advanced technologies such as technology establishment and standardization based on its expertise in operating pharmaceutical manufacturing facilities (GMP).

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, “Although hearing loss greatly affects daily life, it remains a field with high unmet medical needs. Daewoong Pharmaceutical will collaborate in the development of hearing loss treatments using its excellent CDMO capabilities and cell therapy technologies, contributing to the improvement of patients’ quality of life.”