Mochida Pharmaceutical Co., Ltd. (Head Office: Shinjuku-ku, Tokyo, Japan; President: Naoyuki Mochida, hereinafter “Mochida”) and Human Life CORD Japan Inc. (Head Office: Chuo-ku, Tokyo, Japan; President and CEO : Masamitsu Harata, hereinafter “Human Life CORD”) have entered into a joint commercialization agreement (the “Agreement”) on March 27, 2023 to develop and market regenerative medicine product, “HLC-001” (the “Product”) for intractable diseases, including non-infectious pulmonary complications (“NIPCs”) after hematopoietic stem cell transplantation in Japan.
The Product is a cell therapy products using mesenchymal stromal cells obtained from the umbilical cord, which is the tissue connecting the placenta and the fetus. The foundation of the Product was built by the research of Dr. Tokiko Nagamura, Associate Professor of the Cord Blood/Cord Bank/Somatic Stem Cell Research Area at the Institute of Medical Science, the University of Tokyo (IMSUT CORD). Human Life CORD is currently engaged in several R&D programs for treatment of intractable diseases using Product including Phase II clinical trial for treatment of NIPCs after hematopoietic stem cell transplantation.
Under the Agreement, Human Life CORD grants Mochida the exclusive right to develop and commercialize the Product in Japan for diseases agreed by both companies, including NIPCs after hematopoietic stem cell transplantation. Mochida will pay to Human Life CORD an upfront payment for the conclusion of this agreement, a milestone in accordance with the progress of development and commercialization, and a royalty in accordance with the sales. In NIPCs after hematopoietic stem cell transplantation business collaboration of the Product, Human Life CORD is primarily responsible for the clinical trial, pharmaceutical application, and manufacturing, while Mochida is primarily responsible for distribution, sales and the collection of post-market safety information.
Junichi Sakaki, Member of the Board and Senior Executive Managing Officer of Mochida, stated the following:
“We believe that the Product derived from the umbilical cord could be one of the new treatment options for intractable diseases. Mochida has materialized our existing long-term vision and developed the “Vision for 2031” that the Group aims to realize in 2031. Toward 2031, one of our focus areas is regenerative medicine products. With the Product, we will expand our lineup of regenerative medicine products and aim to contribute to unmet medical and health needs.”
Masamitsu Harata, President and CEO of Human Life CORD, stated the following:
“As a business model for a profitable startup company, we have placed a virtual pharma model at the core of our management strategy since our founding, and have thus far built a framework for our supply chain. This joint commercialization agreement will be the culmination of our partnering strategy. We expect that the partnership with Mochida, which focuses on regenerative medicine products and has a wealth of development experience in the areas of rare diseases will contribute to maximizing the value of HLC-001 and, in turn, dramatically enhance the corporate value of both companies.”
The two companies will build a close cooperative framework through this agreement, aiming to create novel and effective treatment options using the Product for patients as soon as possible.
■Non-infectious pulmonary complications after hematopoietic stem-cell transplantation
Non-infectious pulmonary complications (NIPCs) after hematopoietic stem-cell transplantation are disorders caused by factors other than infection after transplantation. The most common NIPCs are idiopathic pneumonia syndrome (IPS), bronchiolitis obliterans (BO), and crypto-genic organizing pneumonia (COP). Among them, steroid refractory IPS often develops in the early post-transplant period, and the lethality rate is high, as there are still no effective therapeutic options at present, and the development of new therapies is highly desired.
■About Mochida Pharmaceutical Co., Ltd. (https://www.mochida.co.jp/english/)
Mochida Pharmaceutical Co., Ltd. has been committed to research and development of innovative pharmaceutical products since its establishment in 1913 thereby providing distinctive medicines to the medical field. Currently, the core pharmaceutical business focuses resources on the targeted areas of cardiovascular medicine, obstetrics and gynecology, psychiatry and gastroenterology, while also providing medicine for intractable disease as well as generics including biosimilars, to meet medical needs.
■About Human Life CORD Japan Inc. (https://humanlifecord.com/en/)
Human Life CORD Japan Inc. manufactures and develops cellular products from domestic and stockable umbilical cords which are connected to the living desire of patients with rare diseases without any established treatment at present, and then leads to future medical treatment aimed at preventing the serious illness that leads to the extension of their healthy life span. The vision is to create a world where growing older is more enjoyable. In 2019 “First Tokyo Venture Corporate Championship Conference” Best Award & Tokyo Metropolitan Governor’s Award. Selected as a supplier of the “Deep Ecosystem” operated by the Tokyo Metropolitan Government “Start-up Ecosystem Tokyo Consortium”. In 2023, the Ministry of Health, Labor and Welfare was awarded the 5th Japan Open Innovation Award, sponsored by the Cabinet Office.
< For further information, contact >
Mochida: Public Relations, Corporate Planning Department (TEL. +81(0)3-3225-6303)
Human Life CORD: Hayashi, Public Relations (TEL.+81(0)80-4671-0405)