Human Life Code and Rohto Pharmaceutical Collaborate on Investigational Product Manufacturing for Phase III Clinical Trials
- Rohto Pharmaceutical to Undertake Contract Manufacturing of Investigational Products -
February 6, 2026
ROHTO Pharmaceutical Co., Ltd. (Headquarters: Osaka City, President and Representative Director: Hidetoshi Segi) and Human Life CORD Japan Inc. (Headquarters: Chuo-ku, Tokyo, President and Representative Director: Masamitsu Harada, hereinafter referred to as "HLC") have agreed to contract manufacturing of investigational products to be used in the Phase III clinical trial (hereinafter referred to as "this trial") of "HLC-001," a mesenchymal stromal cell derived from umbilical cord, which is being developed by HLC. Now that the clinical trial plan notification has been submitted to commence this trial, both companies are pleased to announce that they have further strengthened their stable supply system for investigational products under a strong collaborative relationship.
Background/Summary
The study is being conducted to verify the efficacy and safety of HLC-001 in patients with steroid-resistant idiopathic pneumonia syndrome (IPS), one of the non-infectious pulmonary complications (NIPCs) after hematopoietic stem cell transplantation.
Rohto Pharmaceutical has signed a contract manufacturing organization (CDMO) agreement with HLC to handle cell processing and formulation using seed cells (master cells) provided by HLC, and has been contracted to manufacture the investigational product used in the later phase of development, known as Phase III clinical trials. Following the submission of this clinical trial plan, Rohto is strengthening its manufacturing system for the investigational product for this trial and accelerating efforts to ensure a stable supply.
Through the development and manufacturing of this product, HLC and Rohto Pharmaceutical will continue to strengthen their collaboration to provide new value in this disease area where treatment options are limited, and to bring effective treatment options to patients as soon as possible.
About Human Life CORD Japan Inc.
Human Life CORD Japan Inc. manufactures and develops cell products from domestically produced and storable umbilical cords ("codes"), connecting them to hope for life for patients with intractable diseases for which there are currently no established treatments ("codes"), and beyond that, to future medical care aimed at preventing the worsening of diseases that will lead to an extension of healthy lifespans ("codes"), thereby creating a society ("human life") where everyone can realize a fulfilling life ("human life"). In 2019, the company won the Grand Prize and the Tokyo Governor's Award at the 1st Tokyo Venture Company Championship. It was selected as a company supported by the "Deep Ecosystem" operated by the Tokyo Metropolitan Government's "Startup Ecosystem Tokyo Consortium". In 2023, the company won the Minister of Health, Labour and Welfare Award at the 5th Japan Open Innovation Awards hosted by the Cabinet Office. In 2023, it was selected as a company for the "J-Startup" startup support program by the Ministry of Economy, Trade and Industry. In 2024, the company won the Grand Prize in the startup category of the "Courageous Management Award" hosted by the Tokyo Chamber of Commerce and Industry.
About ROHTO Pharmaceutical Co., Ltd.
Guided by our desire to "contribute to the well-being of people and society," we have aimed to realize medical and healthcare services that are tailored to various life stages. Regenerative medicine is a medical treatment that aims to restore bodily functions impaired by injury or illness through the power of cells, etc., and is an important business that can provide new treatment options for diseases for which no adequate treatment has been established. In addition to research and development, we are positioning our CDMO business, which supports the development and commercialization of Regenerative medicine products by leveraging our knowledge of cell processing, formulation, and quality control, as one of our growth areas.