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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
OSCA Signs Domestic L/O Contract
07
2024.11
On July 7, Kangstem Biotech signed a licensing agreement with YooYoung Pharmaceutical, a domestic pharmaceutical company specializing in musculoskeletal treatments, for its stem cell-based fusion drug, OSCA.
On July 7, Kangstem Biotech signed a licensing agreement with YooYoung Pharmaceutical, a domestic pharmaceutical company specializing in musculoskeletal treatments, for its stem cell-based fusion drug, OSCA. The drug is being developed as a DMOAD(disease-modifying osteoarthritis drug) aimed at treating osteoarthritis.
Under the terms of the agreement, Kangstem Biotech will receive a minimum of KRW 14 billion, which includes an upfront non-refundable payment of KRW 2 billion and short-term milestone payments totaling KRW 6 billion. Additionally, Kangstem Biotech will receive further payments if the drug achieves conditional approval during the clinical trial process.
YooYoung Pharmaceutical will take full responsibility for the cost and development of OSCA’s Phase 2b and 3 clinical trials in Korea, as well as handling exclusive domestic sales and distribution.
This arrangement will allow Kangstem Biotech to significantly reduce its R&D expenses while will supply OSCA as a clinical drug, which will lead to the sale of stem cell therapies. Furthermore, Kangstem Biotech will be in charge of manufacturing and supply for domestic sales and will receive sales royalties from the market, ensuring a long-term revenue stream.
OSCA aims to treat osteoarthritis at its root by administering an intra-articular injection into the knee joint cavity without surgery. With an estimated 600 million people worldwide suffering from osteoarthritis, demand for treatments is growing rapidly, particularly as the global population ages. Currently available treatments only pain relief, and no DMOAD exists on the market. However OSCA has already shown positive results in Phase 1 clinical trials, demonstrating not only pain reduction but also structural improvements, such as cartilage regeneration. Given these promising results, OSCA is expected to become a global blockbuster by addressing the significant unmet needs of osteoarthritis patients.
Jong-chun Na, CEO of Kangstem Biotech, commented, “This technology transfer is significant as it marks the first R&D-driven technology transfer of our stem cell therapy, and it is the world's first transfer for a stem cell-based fusion drug.” He added, ”It is also significant because it was conducted at the early stage of development, Phase I, and the efficacy and potential of OSCA as a treatment for osteoarthritis were recognized early. In particular, this deal is likely to serve as a signal and lead to additional big deals such as global technology exports in the future.”
Ju-pyeong Yoo, CEO of YooYoung Pharmaceutical, stated, “We are moving forward with this technology transfer because OSCA has demonstrated its potential as a fundamental treatment for osteoarthritis by confirming the link between pain, function, and activity improvement and structural improvement from the early clinical stage,” He continued, “We believe OSCA has a distinct competitive advantage over currently marketed therapies and other drug candidates in development, thanks to its ability to reduce the physical and cost burden on patients by offering a single injection into the knee joint cavity, without the need for surgery or procedures like knee incision.”
Founded in 1975, YooYoung Pharmaceutical is a mid-sized company with extensive experience in the clinical development and commercialization of osteoarthritis drugs in Korea. and has great potential with steady growth.
A representative from Kangstem Biotech added, “YooYoung Pharmaceutical has a proven track record of successfully developing new drugs through technology transfers from both domestic and international partners. As a result, we expect them to strengthen their domestic market share with OSCA, while also sending a strong signal to potential overseas partners during future licensing negotiations.”
Meanwhile, Kangstem Biotech plans to obtain the full results of the Phase 1 clinical trial of OSCA in November and will present the Phase 1 data, including MRI images showing structural improvements such as cartilage regeneration, at various international conferences.
https://www.yakup.com/news/index.html?mode=view&cat=12&nid=301795