Daewoong Pharmaceutical said Thursday that it has signed a contract development and manufacturing organization (CDMO) agreement with Yonsei University Wonju College of Medicine (YUWCM) to develop stem cell-based hearing loss therapies.

Daewoong Pharmaceutical and YUWCM’s Research Institute of Hearing Enhancement will collaborate to produce stem cell therapies for hearing loss.
Daewoong Pharmaceutical and YUWCM’s Research Institute of Hearing Enhancement will collaborate to produce stem cell therapies for hearing loss.

With this contract, the two institutions will collaborate to establish tonsil-derived mesenchymal stem cells’ Master Cell Bank (MCB) to produce specimens for phase 1 clinical trials.

YUWCM’s Research Institute of Hearing Enhancement is the only full-cycle auditory research body in Korea specializing in hearing loss diagnosis, treatment and research. Daewoong plans to apply for the approval of clinical phase 1 (IND) in 2024 after confirming the results of non-clinical research.

The research focuses on treating damaged hair cells, the leading cause of acute hearing loss, with a stem cell-derived exosome-type hearing loss therapy stimulated by nanoparticles.

Daewoong will be responsible for setting up the initial stage to produce phase 1 clinical samples of hearing loss treatments, such as culturing tonsil-derived mesenchymal stem cells and establishing the MCB.

Based on its experience in research and development of stem cell therapeutics and expertise in Good Manufacturing Practice (GMP), the company will integrate nanobiofusion technology to stem cells and support the commercialization and standardization of the developed technology.

"Despite the great impact on daily life, the unmet medical demand for hearing loss is still high," Daewoong Pharmaceutical CEO Jeon Seng-ho said, "We will cooperate in developing hearing loss treatments and contribute to improving patients' quality of life."

Seo Young-joon, head of the research institute, said, “We have focused on developing treatments for a long time and are eager to produce exosomes suitable for clinical research because there are no therapies yet.”

Daewoong Pharmaceutical entered the cell therapy-based CDMO business by obtaining approval for manufacturing advanced biomedicine in January 2021 and human cells in April 2022. It has continued expanding its business areas since signing a CDMO contract with SigBio in 2020.

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