Medinet Exercising Option to Develop Stempeucel in Japan
TOKYO, Jul 02 (Pulse News Wire) – Medinet CO.,LTD. (2370.T) exercised its option right to develop and commercialize MDNT-03, a mesenchymal stem cell product targeting chronic limb ischemia, in Japan based on a licensing agreement signed with STEMPEUTICS RESEARCH PVT LTD in India.
The decision was made during a board meeting held on July 02, 2026. Since signing the contract in October 27, 2025, MEDINET has collaborated with PMDA to evaluate MDNT-03's quality, non-clinical, and clinical aspects. This evaluation confirmed the feasibility of conducting trials and obtaining approval for MDNT-03 in Japan. As a result, the company decided to exercise its exclusive development and commercialization rights for MDNT-03. Under the agreement, MEDINET will make milestone payments to STEMPEUTICS RESEARCH PVT LTD upon achieving development milestones and royalty payments based on sales once MDNT-03 receives regulatory approval in Japan. MDNT-03, known as Stempeucel®, is manufactured through a patented process using cells derived from multiple healthy adult donors.
In India, Stempeucel has demonstrated high efficacy in treating severe lower limb ischemia, earning conditional marketing authorization in 2017 and full approval in 2020. It also holds approvals for peripheral arterial disease-related ischemic conditions and osteoarthritis. Clinical data shows that Stempeucel has maintained consistent safety and effectiveness since its initial approval, with over 800 patients treated successfully. Chronic limb-threatening ischemia, the target condition for MDNT-03, is a serious late-stage complication of peripheral artery disease characterized by severe arterial blockages leading to pain, ulcers, and tissue necrosis. With aging populations and increasing diabetes cases, there is growing demand for effective treatments, making early practicalization of new therapies highly anticipated. MEDINET plans to submit a trial application by September 2026 and initiate patient enrollment in early 2027.
The company expects minimal impact on its fiscal year ending September 2026 but will promptly disclose any significant developments.