Copyright thehindubusinessline
In a first of sorts in stem cell therapy, India’s Stempeutics has inked an “option licence agreement” with Japan’s Medinet, a listed company focussed on regenerative medicine – to take the former’s product used in treating chronic limb threatening ischemia (CLTI), to Japan. Japan is a tough regulatory market, BN Manohar, Stempeutics Chief Executive Officer told businessline, and the product will undergo a pivotal study in Japan - undertaken by Medinet, with Stempeutics providing the required regulatory information, he added. Stempeutics will have to meet certain regulatory milestones, he said, as the product would be made in India and sent to Japan. Medinet then has the option to exercise exclusive rights to develop and commercialise the product, Stempeucel, in Japan. Stempeutics India is a group company of Manipal Education & Medical Group, and drugmaker Cipla holds 34 per cent stake in the company, and markets the product in India. Pharmaceutical industry insiders point out that Japan is a developed market and has stringent regulatory standards. Manohar said, the agreement comes after about two-and-a-half years of discussion, a year of due diligence and multiple visits to the manufacturing facility. While the deal size has not been disclosed, the CEO said, it involved an upfront payment, milestone payments and royalty, if the product does eventually hit the market about four years on. Innovation focus Kanenao Kubushiro-san, Medinet President and Representative Director of the Board, said, their innovation focus was guided by the intent to address unmet patient needs in Japan. “We are happy to partner with Stempeutics since its product Stempeucel has already been approved in India and treated more than 600 CLTI patients. Also, the product has been patented in Japan. Data from Indian clinical trials will be useful for getting pivotal study approval in Japan. CLTI is a serious and painful condition that impacts patients in Japan, and we are happy that we will be able to introduce this therapy in the country in the near future.” CLTI is a progressive form of peripheral arterial disease caused by severe blockage in the arteries that further reduces blood flow to the lower limbs, the company explained. This could lead to sores and wounds in the legs and feet with a high risk of limb amputation, it added. With current contemporary vascular techniques, only about 25 per cent of patients can be managed with satisfactory clinical outcomes, the company said. Stempeucel enhances the body’s limited capability to restore blood flow in the ischemic tissue, it added. “Stempeucel is produced by pooling bone marrow-derived MSC’s (Mesenchymal Stromal Cells) of healthy individuals through a proprietary, patented process,” the company said, adding that research showed “pooling balances out variations observed with individual donor cells, resulting in a product with strong immune-modulatory properties, broader cytokine / growth factors array, longer lifespan and consistent clinical outcomes.” Published on October 27, 2025
