Cell therapy in Asia has been gathering momentum over the past several years. Japan accelerated its position as a hub for regenerative medicine research, largely driven by support from Prime Minister Shinzo Abe, who identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth.
China, South Korea, and other Asian nations have also taken measures to support cell therapy development within their borders.
Growing Market Potential for Cell Therapy in Asia
Regenerative medicine, and specifically stem cell therapies, hold great promise to effectively treat a broad range of conditions including difficult and costly-to-treat chronic conditions.
While North America, led by the U.S., is the largest market for stem cell therapies, cell therapy in Asia is becoming the fastest growing market.
The drivers for rapid growth of cell therapy in Asia include:
- Mounting government and private investment
- Establishment of accelerated approval pathways
- An aging population with increasing healthcare needs
While large pharmaceutical companies will serve the Asian market, biotechs from outside of Asia that focus on developing innovative cell therapies may play a pivotal role by bringing their technologies to these growing markets.
They will likely do this through various forms of partnering and joint ventures with local companies.
Strategic Partnerships and Joint Ventures in Asia
We have seen partnering activities in Japan for cell therapy companies, including Pluristem, Mesoblast and Athersys, and a range of others. Israel-based Pluristem Therapeutics, a late-stage biotech and a leader in clinical development and manufacturing of stem cell therapies, has two products, PLX-PAD and PLX-R18, that are in or are entering into late stage trials.
Pharma companies and VCs in Japan, South Korea and China have taken notice. Pluristem announced that it has signed a term sheet for a joint venture in Japan with Sosei CVC, the venture capital arm of Japanese biopharma company Sosei Group.
Pluristem had already been very active in Japan, receiving agreement from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its PLX-PAD cells to be developed under an accelerated regulatory pathway for regenerative medicine.
In South Korea, Pluristem has a strategic partnership with CHA Bio. CHA is to perform and fund multiple clinical trials in South Korea with PLX cells and a JV is to be established upon commercialization; CHA is already recruiting for an ongoing Phase 2 trial in intermittent claudication. China’s Innovative Medical Management, a healthcare focused VC fund, is looking to invest $30 million in Pluristem, based on a binding terms sheet signed by the parties in November 2016.
Pluristem is an interesting case study for how to partner and align with Asian partners for purposes of optimizing global market potential.
Japanese Players Are Aligning Themselves with their MSC Biotech of Choice
This is extremely true, as MSC biotechs that have partnered with Japanese companies include:
- Mesoblast with JCR Pharmaceuticals Co. Ltd. – December 3, 2015
- Pluristem with Sosei CVC – December 20, 2016
- Athersys with Healios – January 8, 2016
- TiGenix with Takeda – July 5, 2016
- Cynata Therapeutics with FUJIFILM Corporation – September 5 2016
- Steminent with ReproCELL – November 22, 2016
- Regeneus with AGC Asahi Glass – December 29, 2016
Most of these deals were recently inked, with six of the seven occurring during the 2016 calendar year and the seventh signed in December of 2015.
This was greatly facilitated by the Japanese government passing the “Act on the Safety on Regenerative Medicine” and making revisions to the “Pharmaceutical and Medical device Act” in late 2014, which was a major boost for cell therapy in Asia.
Details of the Japanese Deal-Making with MSC Biotechs
Specifics of agreements between major Japanese companies and mesenchymal stem cell (MSC) biotechs are detailed below.
On December 3, 2015, Mesoblast entered into an agreement with its licensee in Japan, JCR Pharmaceuticals Co. Ltd., to launch its mesenchymal stem cell (MSC) product for the treatment of acute graft versus host disease ( acute GVHD) in children and adults in Japan.
On December 20, 2016, Pluristem signed a term sheet for a joint venture in Japan with Sosei CVC, the venture capital arm of Japanese biopharma company Sosei Group. Pluristem also has a strategic partnership with CHA Bio in South Korea, and China’s Innovative Medical Management is looking to invest $30M in Pluristem, based on a binding terms sheet signed by the parties in November 2016.
On January 8, 2016, Athersys entered into a partnership with Healios, a Japanese fund that has previously partnered with Japanese pharma and academic institutions to develop cell therapies. The partnership was formed to develop Athersys’ product to treat ischemic stroke and other potential indications using accelerated regulatory pathways for regenerative medicine.
On July 5, 2016, TiGenix NC entered into a partnership with Takeda Pharmaceutical Company for an “exclusive ex-U.S. license, development and commercialization agreement for Cx601, a suspension of allogeneic adipose-derived stem cells (eASC) injected intra-lesionally for the treatment of complex perianal fistulas in patients with Crohn’s disease.” This is a lucrative deal, because TiGenix received an upfront cash payment of €25M and could qualify for additional regulatory and sales milestone payments up to €355M.
Takeda executed its option to opt into the Canada and Japanese markets very recently as “add-ons” to the original deal that they signed back in July.
On September 5, 2016, Cynata Therapeutics executed a term sheet with FUJIFILM Corporation of Japan for the “development and commercialization of certain Cynata technology, including Cynata’s lead induced pluripotent stem cell (iPSC) derived therapeutic mesenchymal stem cell (MSC) product, CYP-001.” FUJIFILM is one of the world’s leading companies investing in the development of regenerative medicine therapies, making this a major deal for the Australian start-up, Cynata Therapeutics.
On November 11, 2016, Steminent Biotherapeutics entered into a partnership with ReproCELL to “develop and commercialize Steminent’s allogeneic stem cell therapy product, Stemchymal, in Japan.” Based on the terms of the agreement, ReproCELL will get exclusive rights for the development and commercialization of Stemchymal for treating Spinocerebellar ataxia (“SCA”) in Japan and have right of first negotiation for the use of Stemchymal in other disease indications.
On December 29, 2016, Regeneus entered into a partnership with AGC Asahi Glass (AGC), a major Japanese manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals, for “exclusive manufacture of Progenza stem cell technology for Japanese market.” According to Regeneus, the Progenza product is generated from expanded MSCs extracted from the adipose tissue and includes secretions from MSCs that enhance the viability and functionality of the cells during the freezing/thawing process.
Regeneus will form a 50/50 joint-venture (JV) with AGC as part of their deal, and this JV will be in charge of finding a pharmaceutical company to provide the commercialisation of the Progenza product in Japan.
Asia is Becoming the Fastest Growing Market for Cell Therapies
Clearly, cell therapy in Asia is a rapidly growing market. The trend toward strategic cooperation with Asian-based companies is clear, with Japan leading the way.
Looking to bring the most advanced regenerative medicines to their populations, Asian pharma companies are often looking outside their borders for technology.
Know of other companies that should be added to this list? Share them in the comments below.