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. (Head office: Osaka City; President and Representative Director: Hidetoshi Seki) and Human Life Cord Co., Ltd. (Head office: Chuo-ku, Tokyo; President and Representative Director: Masamitsu Harada; hereinafter "HLC") are currently contracted to manufacture the investigational product to be used in a Phase III clinical trial (hereinafter "this trial") of umbilical cord-derived mesenchymal stromal cells "HLC-001," which HLC is developing. Following the submission of the clinical trial plan to commence this trial, the two companies are pleased to announce that, through their strong collaboration, they have further strengthened their system for the stable supply of investigational products.
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 Code Co., Ltd.
Human Life Code, Inc.'s vision is to create a society where everyone can live a fulfilling life ("human life") by manufacturing and developing domestically produced, stockpilable umbilical cord ("cord") cell products, bringing hope to patients with incurable diseases for which no established treatments are currently available ("cord"). This will ultimately lead to future medical treatments aimed at preventing the progression of illness and extending healthy lifespans ("cord"). In 2019, the company won the Grand Prize and Tokyo Governor's Award at the 1st Tokyo Venture Business Championship. It was selected as a support company for the "Deep Ecosystem" run by the Tokyo Metropolitan Government's Startup Ecosystem Tokyo Consortium. In 2023, it won the Minister of Health, Labor and Welfare Award at the 5th Japan Open Innovation Awards sponsored by the Cabinet Office. It was selected as a company for the Ministry of Economy, Trade and Industry's startup support program "J-Startup" in 2023. It also won the Grand Prize in the Startup Category at the 2024 "Courageous Management Awards" sponsored 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.