Tokyo-based regenerative medicine company MEDINET Co., Ltd. (2370.T) has signed an Option License Agreement with Stempeutics Research Pvt. Ltd., a Manipal Group company, for the rights to develop and commercialise its flagship Stempeucel® product in Japan for the treatment of Chronic Limb Threatening Ischemia (CLTI).

The agreement marks the first instance of a Made-in-India cell therapy being licensed by a Japanese firm. Stempeucel® is already patented in Japan and has marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO) for treating Critical Limb Ischemia due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease.

Under the agreement, MEDINET will advance the development and commercialisation of Stempeucel® in line with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan regulations. The two companies have already held pre-consultation meetings with the PMDA. Stempeutics will receive an upfront payment, followed by milestone and royalty payments upon exercise of the licensing option. Manufacturing will continue at the company’s cGMP facility in Bengaluru, with products shipped to Japan for clinical trials and commercial use.

CLTI is a severe form of peripheral arterial disease characterised by reduced blood flow due to arterial blockage, leading to chronic wounds, severe pain, and a high risk of amputation. Conventional vascular procedures offer limited relief, benefiting only about 25% of patients. Stempeucel®, through its regenerative properties, aims to stimulate new blood vessel formation (angiogenesis) and restore blood flow to affected tissues.

Produced using a proprietary process of pooling bone marrow-derived mesenchymal stromal cells (MSCs) from healthy donors, Stempeucel® demonstrates enhanced immune-modulatory and anti-inflammatory properties, leading to consistent clinical outcomes. The therapy has already shown positive real-world evidence among Indian patients.

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Commenting on the partnership, Kanenao Kubushiro, President and Representative Director of MEDINET, said:

“Our focus on innovation is driven by the need to address unmet patient needs in Japan. We are delighted to partner with Stempeutics, whose Stempeucel® therapy has treated over 600 CLTI patients in India and holds a patent in Japan. Data from Indian trials will support our regulatory path with PMDA. This collaboration will help us bring this much-needed therapy to Japanese patients soon.”

B.N. Manohar, CEO of Stempeutics, described the deal as a “historic milestone” for Indian regenerative medicine:

“This agreement validates our scientific and clinical leadership in allogeneic, pooled MSC technology. Stempeucel® represents a game-changing therapeutic solution for millions suffering from this devastating condition.”

Kunihiko Suzuki, Executive Fellow at MEDINET and ISCT Regional Vice President Elect (Asia), added:

“This partnership exemplifies responsible global collaboration in stem cell therapy. Together, we aim to make off-the-shelf stem cell therapy accessible for CLTI, paving the way for stem cells to become a standard of care in modern medicine.”

Dr Pawan Kumar Gupta, President of Medical & Regulatory Affairs at Stempeutics and ISCT Asia Regional Vice President, highlighted the patient impact:

“CLTI patients face imminent risks of amputation and death. Stempeucel® offers new hope—an effective, safe treatment that can dramatically improve quality of life.”

This collaboration underscores the growing global confidence in India’s biotech innovation and paves the way for advanced, accessible regenerative therapies to reach patients worldwide.

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