Japan Archives | Page 2 of 3

Japan to Supply Human Embryonic Stem Cells (hESC) for Clinical Research

May 29, 2018 By Cade Hildreth, Founder & President Leave a Comment

Kyoto University has announced that it will start providing human embryonic stem cells (ES cells) by July 2018 to universities and companies within Japan for clinical trial applications. This is a world-first, as most countries have been hesitant to support wide-spread production and distribution of this controversial cell type.

Previously Japan limited the use of human embryonic stem cells to basic research, because the cells are produced from human embryos, making them a highly controversial cell type. In 2014, the Japanese government revised it guidelines, making possible the use human ES cells in clinical studies, as well as laboratory research. [Read more…]

Japan’s Laws Supporting Accelerated Pathways for Cell Therapies

December 30, 2017 By Cade Hildreth, Founder & President Leave a Comment

In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. While there has been much discussion about these laws, few people have a clear understanding of the implications of these regulations on a global scale.

Below, we summarize the laws, identify their importance, and most importantly, speak to how Japan has become a “gateway country” for regenerative medicines. [Read more…]

ISCT Webinar on Cell and Gene Therapy (CGT) Products in Japan

November 18, 2017 By Cade Hildreth, Founder & President Leave a Comment

Have you heard of the recent regulatory changes surrounding cell and gene therapy (CGT) products in Japan?

These changes have greatly increased the interest in taking CGT clinical programs to Japan from development through commercialization. ISCT (International Society for Cellular Therapy) and FIRM (Forum for Innovative Regenerative Medicine) have created a partnership to facilitate the entry and development of future CGT products in Japan.

Robert Preti, PhD (General Manager of Hitachi Chemical’s Regenerative Medicine Business Sector) and Kazuchika Furuishi, PhD (Deputy General Manager) are joining a leading Japanese management consultant (Colin Novick) to discuss the challenges to consider and examples of solutions for successfully taking your clinical cell or gene therapy program to Japan.

On Wednesday, December 6, the webinar will explore the attractive regulatory changes in Japan, as well as:

Increased offshore filing activity
Challenges to consider
Successful CGT programs brought to Japan

Register now for the Hitachi Chemical Advanced Therapeutics Solutions, LLC sponsored webinar and learn from experts:

http://www.celltherapysociety.org/?page=wbnr_BMI

[Read more…]

Regeneus Finalizes Terms with AGC, $5.5M Plus Future Payments of $11M

January 22, 2017 By Cade Hildreth, Founder & President Leave a Comment

Regeneus receives upfront payment of US$5.5m from AGC

Regeneus Ltd (ASX: RGS), a clinical stage regenerative medicine company, today announced it has received US$5.5m from AGC as an upfront payment for the exclusive rights to manufacture Progenza under the terms of the collaboration and licence announced on 29 December 2016.

Regeneus is expected to receive a further US$11m in specific development and approval milestone payments.

Regeneus will be entitled, through its 50 per cent interest in Regeneus Japan, to its share of upfront licence fees, milestone payments and royalties from sub licensing the development and commercialisation of Progenza for osteoarthritis and all other clinical indications in Japan. [Read more…]

ReproCELL and Steminent Partner to Commercialize Stemchymal in Japan

December 26, 2016 By Cade Hildreth, Founder & President Leave a Comment

On November 11, 2016, ReproCELL and Steminent Biotherapeutics entered into a partnership to “develop and commercialize Steminent’s allogeneic stem cell therapy product, Stemchymal, in Japan.”

ReproCELL and Steminent Partnership

In this article:

ReproCELL in Japan
Repro Therapeutics Advancement
Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal

ReproCELL in Japan

Based on the terms of the agreement between ReproCELL and Steminent:

ReproCELL will get exclusive rights for the development and commercialization of Stemchymal for treating Spinocerebellar ataxia (“SCA”) in Japan
ReproCELL will have right of first negotiation for the development and commercialization of Stemchymal for other disease indications

Japan and Regenerative Medicine

The timing of this partnership is significant because the “Act on the Safety on Regenerative Medicine” and revisions to the “Pharmaceutical and Medical device Act” took effect in Japan in 2014. There are subtle, but important differences between these two acts and how they support regenerative medicine development in Japan.

The aim of the Act on the Safety of Regenerative Medicine is to accelerate the clinical application and commercialization of regenerative products, including cell and gene therapies, as well as tissue engineered products. It covers clinical research and medical practice using processed cells and specifies the procedures required to deliver these cells to humans.

In contrast, the PMD Act introduces a regulatory framework for regenerative medicine products. It allows for conditional and time-limited marketing approval to be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety.

Time-Limited Conditional Approval

Under these new laws, once a company has demonstrated safety and basic efficiency data in humans and the cell product can be manufactured to the standards described within the Pharmaceutical and Medical Devices (PMD) Act, the cell therapy can be awarded conditional approval for up to 7 years. This allows for the commercial use of the cell product with data reporting requirements and potential for national insurance coverage.

Japan also accelerated its position as a hub for regenerative medicine research with support from Prime Minister Shinzo Abe, who identified regenerative medicine and cellular therapy as key to Japan’s strategy to drive economic growth. The Prime Minister has encouraged a growing range of collaborations between private industry and academic partners through an innovative legal framework approved last fall.

These regulatory changes have the potential to speed up the commercialization of cell therapies within Japan by allowing “time-limited conditional approval.” Assuming safety and probable efficacy have been demonstrated during early-stage clinical trials, companies are permitted to sell cell therapy products within Japan while continuing late-stage clinical trials.

Repro Therapeutics Advancement

According to REPROCELL’s recent press release, this is the first time that REPROCELL will compete within the regenerative medicine market, within Stemchymal representing its first pharmaceutical product.

If all goes as planned, ReproCELL and Steminent state that they will:

Initiate clinical trials for Stemchymal in 2017
Secure “time-limited conditional approval” in 2020
Receive marketing approval in Japan by 2023

Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal

Under the financial terms of the agreement:

ReproCELL will invest US$1M in Steminent as an allocation of new shares to a 3rd party
REPROCELL will pay development milestones which will total approximately US$4M
REPROCELL may make royalty payments during the commercialization of Stemchymal

To learn more, click here to view the full announcement issued by ReproCELL and Steminent.

In your opinion, how has Japan’s attitude towards regenerative medicine affected stem cell research? Share your thoughts in the comments section below.

Up Next: How to Find a Stem Cell Clinical Trial for Your Condition?

Editor’s Note – This post was originally published on December 26, 2016 and has been updated for quality and relevancy.