This India-made stem-cell treatment drug will be sold in Japan
What's the story
Manipal Group-backed Stempeutics Research has signed a licensing agreement with Tokyo-listed Medinet. The deal will see the introduction of Stempeucel, a stem cell therapy developed by Stempeutics, into the Japanese market. The treatment is designed for Chronic Limb Threatening Ischemia (CLTI), a severe peripheral artery disease. This is the first time an Indian company has licensed its cell therapy product to a Japanese firm.
Agreement
Details of the agreement
As per the deal, Medinet will develop and commercialize Stempeucel in Japan, subject to regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA). Stempeutics will be paid an upfront fee, with additional milestone payments and royalties if Medinet opts to license the product. The drug will be made at Stempeutics's cGMP facility in Bengaluru and sent to Japan for clinical trials and later for commercialization.
Therapy details
What is Stempeucel?
Stempeucel is a stem cell therapy made from the pooled mesenchymal stromal cells (MSCs) of healthy donors. The proprietary pooling process improves the consistency, immune-modulatory strength, and clinical efficacy, key differentiators in the global cell therapy space. CLTI is a critical form of peripheral arterial disease that often results in limb amputation. Current vascular treatments only work in about 25% of cases, but Stempeucel hopes to improve the outcomes by restoring blood flow through anti-inflammatory and angiogenic mechanisms.
Expansion strategy
Stempeutics's journey so far
Founded in 2006, Stempeutics has developed a strong portfolio of cell-based and acellular therapies. The company has marketing partnerships with Cipla and Alkem in India, and has licensed its technology to several international markets. "Signing a licensing agreement with a Japanese regenerative medicine company is an important milestone for Stempeutics," said BN Manohar, CEO of Stempeutics. He added that the deal highlights their global leadership in allogeneic, pooled MSC technology.
Patient benefit
Statements from Medinet and Stempeutics officials
"Stempeucel has already treated over 600 CLTI patients in India and is a patented product in Japan," said Kanenao Kubushiro, President of Medinet. "We believe this therapy can make a real difference for Japanese patients suffering from this painful and serious condition." Dr. Pawan Kumar Gupta, President of Medical & Regulatory Affairs at Stempeutics, emphasized that "Stempeucel offers hope for a new, effective treatment and a better quality of life."