Medinet Co., Ltd, a Tokyo-listed regenerative medicine and CDMO company, has signed an option licence agreement with India-based Stempeutics Research for the development and commercialisation of its Stempeucel therapy in Japan, targeting Chronic Limb Threatening Ischaemia (CLTI).

Under the agreement, Stempeutics will receive an upfront payment, followed by milestone payments, royalties, and licence fees if Medinet exercises its option to advance the therapy. Stempeucel will continue to be manufactured at Stempeutics’ cGMP facility in Bengaluru and exported to Japan for clinical trials and, upon regulatory approval, for commercial distribution.

Stempeucel is the first Made-in-India stem cell therapy to be licensed by a Japanese company and already holds a patent in Japan. The product has received marketing authorisation in India for treating critical limb ischaemia (CLI) associated with Buerger’s disease and atherosclerotic peripheral arterial disease.

CLTI is a severe form of peripheral arterial disease characterised by restricted blood flow to the limbs, often resulting in tissue loss and amputation risk. Stempeucel aims to promote revascularisation and tissue repair through its anti-inflammatory, immunomodulatory, and pro-angiogenic mechanisms.

B N Manohar, CEO of Stempeutics, described the agreement as a significant recognition of India’s innovation in advanced therapies. Kanenao Kubushiro, President of Medinet, said the collaboration would help address unmet medical needs in Japan by building upon Stempeutics’ strong scientific and clinical foundation.

Both companies have begun discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to define the regulatory pathway for local clinical trials and eventual approval.