Partnership & Licensing
RepliCel is a company focused on conducting innovative research leading to the development of high-value products for large-market opportunities. Our clinical strengths are in addressing hair, skin and tendon conditions. Our technology strengths are in cell therapy and medical devices.
We work with numerous collaborators to deliver on our research, clinical, manufacturing, regulatory, finance, development, engineering programs. We use partners to take our products to market.
RepliCel is purpose-built to partner with other companies for late-stage product development and commercialization. We look for licensing partners to complement our strengths. Our partners have proven commercial capabilities in our clinical markets (aesthetics and orthopedics).
All four RepliCel products currently in development are fully licensed to partners in Greater China (China, Hongkong, Macau, and Taiwan). Our RCH-01 asset is licensed across all of Asia. We still hold all the commercial rights to our products in the rest of the world outside of Asia.
In 2021, MainPointe and RepliCel signed a strategic partnership agreement in which MainPointe invested $2,700,000in RepliCel, committed to managing and funding the FDA approval of the RepliCel RCI-01 Dermal Injector Product Portfolio, and was granted a limited-term, exclusive distributorship of the RCI-02 products in the United States.
- Product: RCI-02 dermal injector and consumables
- Territory: United States
- Field: All uses
- Terms: Over-the-market investment in RepliCel plus paying costs of FDA approval
- Status: MainPointe is working with RepliCel and its service providers to produce all the data needed to complete an application to the FDA seeking permission to launch the product line in the U.S. market.
Shiseido Company, Limited
Shiseido and RepliCel are co-developing the RCH-01 technology and will conduct human clinical trials in each of their territories with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair.
In 2013, RepliCel and Shiseido entered into a co-development and licensing agreement in which Shiseido was granted an exclusive license in Asia to RCH-01 and certain rights to related injected technologies in exchange for a ~$4,0000,000 upfront licensing fee and a commitment to pay all the costs related to clinical trials, regulatory clearances/approvals, manufacturing, clinical studies, sales, marketing, and distribution in their Territory and up to $31,000,0000 in post-commercial milestone payments plus sales royalties.
- Product: RCH-01 and related injection technologies
- Territory: Asia including Japan, Greater China, South Korea, etc.
- Field: Treating male and female androgenetic alopecia
- Terms: Upfront licensing fee, co-development of the Product in the Territory, milestone payments,
and sales royalties
- Status: Shiseido has funded and manufactured product for a randomized placebo-controlled, double-blinded, dose-finding clinical study of one-time RCH-01 injections in men and women at Tokyo Medical University Hospital and Toho University Ohasi Medical Center in Japan. A second study in Japan has now been launched funded, and using the product manufactured, by Shiseido. This study is evaluating a series of injections over several weeks. RepliCel has also recently completed the first stage of a research study at the University of British Columbia which delivered promising data which will potentially underpin improved manufacturing, product profiles, and clinical outcomes. Outside of Asia, RepliCel is also planning a phase 2 clinical study of RCH-01 testing even lower doses of RCH-01 than already tested, in a series of injections using RepliCel's proprietary RCI-02 dermal injector.
YOFOTO (China) Health Industry Co. Ltd
YOFOTO and RepliCel are co-developing several technologies and will conduct human clinical trials in each of their territories with the goal of commercializing safe and effective treatments for aging/sun-damaged skin and tendon degeneration.
In late 2017, RepliCel and YOFOTO entered into a co-development and licensing agreement in which YOFOTO was granted an exclusive license in Greater China to RCS-01, RCT-01 and certain rights to RCI-02 in an investment, co-development, and licensing deal in exchange for an investment in RepliCel of ~$8,000,000 (priced at a 20% premium to market price), a commitment to pay all the costs (minimum ~$11,000,000) related to clinical trials, regulatory clearances/approvals, manufacturing, clinical studies, sales, marketing, and distribution in their Territory, and ~$4,500,000 in milestone payments plus sales royalties.
- Product: RCS-01, RCT-01, and certain rights to RCI-02
- Territory: Greater China (China, Hongkong, Taiwan, Macau)
- Field: Sun-damaged/aging skin and Tendinopathy/Tendinosis
- Terms: Upfront investment and licensing fee, co-development of the Product in the Territory,
milestone payments, and sales
- YOFOTO has completed building, equipping, staffing, and validating a cell therapy manufacturing facility. It has entered into a collaboration with local hospitals and is currently validating its manufacturing of RCT-01 and RCS-01. YOFOTO is currently preparing its submission to the Chinese regulatory agency seeking permission to launch phase 2 clinical studies of both RCT-01 for tendon regeneration and RCS-01 for skin rejuvenation in China. YOFOTO is also laying plans for the commercial launch of the RCI-02 dermal injector products in Hong Kong upon registration of the US or European marketing approval there.
For an update on the collaboration click here.
RepliCel is currently in active discussions with potential partners in Japan to co-develop and commercialize the tendon, skin, and injector technologies. We expect one or more of these to be announced in 2021.
To explore potential collaboration or licensing opportunities, submit your query to firstname.lastname@example.org or call (604) 248.8730.