Japan's approved regenerative medical products: the list

Thirty approvals, and the English index shows only some

Start with the sources, because the obvious one is incomplete. PMDA's English index of review reports covers 25 products with their month of approval, and PMDA says it chose them "in consideration of relevant factors including the novelty and priority".

The full record sits in PMDA's Japanese yearly lists of approved new regenerative medical products, one table per fiscal year. The tables split products into processed cells and tissues on one side and gene therapy on the other. They also mark orphan products and products designated under SAKIGAKE.

Five approvals from 2026 are missing from the English index. Ishin Pharma's Allostem Sheet and Novartis's intrathecal ZOLGENSMA were approved on April 3. In May came FUJIFILM Toyama Chemical's Seibiscus, autologous synovial stem cells for meniscus injury, and Ferring Pharma's Edstiladrin, a gene therapy instilled into the bladder for bladder cancer. Oncolys BioPharma's oncolytic virus Telomelysin followed on June 8, 2026. We found no further approvals up to mid-October 2026.

Two entries predate the category itself. JACE was approved in October 2007 as a medical device, as PMDA notes, and JACC in July 2012. Japan created the regenerative medical product category in 2014.

Our count includes new approvals only. It leaves out partial changes that added indications, and it counts intrathecal ZOLGENSMA separately because it holds its own approval.

Build your precedent list from PMDA's Japanese yearly tables and company announcements, because the English index leaves out every 2026 approval after March.

Cell and tissue products: sixteen approvals, mostly Japanese

Cell and tissue products other than CAR-T account for 16 of the 30 approvals. Only three of them came from developers abroad.

Japan Tissue Engineering (J-TEC) holds five, all made from the patient's own cells: JACE (cultured epidermis, 2007), JACC (cartilage, 2012), Nepic (corneal epithelium, March 2020), Ocural (oral mucosal epithelium, June 2021) and JACEMIN (epidermis containing melanocytes, March 2023). JCR Pharmaceuticals' Temcell, bone marrow mesenchymal stem cells from donors for graft-versus-host disease, was approved in September 2015. Sakracy, a sheet of the patient's oral mucosal cells grown on human amniotic membrane, followed in January 2022.

The three from abroad took different paths. Aurion Biotech, based in Seattle, licensed cultured corneal endothelial cell technology from Kyoto Prefectural University of Medicine in 2020. It contracted manufacturing to S-RACMO, a Japanese joint venture of Sumitomo Chemical and Sumitomo Pharma, in April 2021. Its Japanese subsidiary won approval for Vyznova on March 17, 2023.

Takeda's Alofisel, adipose-derived stem cells from donors, was approved in September 2021 on a Japanese study in 22 patients plus the ADMIRE-CD trial run in Europe and Israel. Allostem Sheet, a donor adipose stem cell sheet for severe epidermolysis bullosa, came from Anterogen in Korea. Anterogen says it supplied the preclinical and CMC data and its partner Ishin Pharma the clinical data.

Five of the sixteen took conditional approval, all held by Japanese companies: Terumo's HeartSheet, Nipro's Stemirac, SanBio's Akuugo, Sumitomo Pharma's AMCHEPRY and Cuorips's RiHEART. Seibiscus, approved in May 2026, went the ordinary route.

If you bring a cell or tissue product from outside Japan, study Vyznova, Alofisel and Allostem Sheet first: all three took ordinary approval, and each put a company in Japan in charge of the filing.

CAR-T and gene therapies: mostly from abroad, mostly ordinary approval

Here the pattern reverses. Eleven of the fourteen CAR-T and gene therapy approvals went to products from developers outside Japan, and ten of those eleven were ordinary approvals.

All five CAR-T products came from abroad, and none used the conditional route. Novartis's Kymriah was approved on March 26, 2019. YESCARTA followed in January 2021 under Daiichi Sankyo, which held the Japanese rights from Kite. Daiichi Sankyo added a Japanese Phase 2 study of 16 patients to Kite's global ZUMA-1 trial. Bristol Myers Squibb's Breyanzi (March 2021) and Abecma (January 2022) came next. Carvykti, filed by Janssen Pharmaceutical K.K. and announced by its partner Legend Biotech, was approved in September 2022.

The in vivo gene therapies follow the same line. Novartis Pharma K.K. announced ZOLGENSMA's approval on March 19, 2020, Luxturna followed in June 2023, and the intrathecal ZOLGENSMA in April 2026. Krystal Biotech says its topical gene therapy Vyjuvek won approval on July 24, 2025. Ferring's Edstiladrin was approved in May 2026.

The exception is Elevidys. Chugai won conditional and time-limited approval for it on May 13, 2025, with a time limit of three years, not the maximum of seven.

The three Japanese gene therapy products split by route. AnGes's Collategene, a plasmid, and Daiichi Sankyo's oncolytic virus Delytact took conditional approval. Oncolys BioPharma's Telomelysin, another oncolytic virus, won ordinary approval in June 2026 on a Phase 2 study at 17 sites in Japan.

If your CAR-T or gene therapy was developed abroad, plan for ordinary approval through a holder in Japan, because that is how ten of the eleven foreign approvals in this group came in.

What the eight conditional approvals turned into

Three have reached a decision, and one was positive. That makes conditional status a weak precedent to rely on.

Terumo's HeartSheet, approved in September 2015, was refused full approval when the Pharmaceutical Affairs Council agreed with its expert committee on July 24, 2024, and Terumo ended sales. AnGes withdrew its full approval application for Collategene in June 2024, and PMDA now notes that the marketing authorization has expired. On October 15, 2026, the expert committee endorsed full approval for Nipro's Stemirac, approved in December 2018, the first product to make the conversion. The Minister's formal approval follows the committee's endorsement.

Five are still inside their time limits. Delytact was approved in June 2021 with seven years. SanBio's Akuugo, approved in July 2024, could not ship until a partial change proved commercial product matched the trial product; SanBio announced that approval on December 9, 2025 and launched in May 2026. Elevidys carries a three-year limit. AMCHEPRY and RiHEART received seven-year limits on March 6, 2026.

The guide to conditional and time-limited approval explains the legal frame, the re-application and the manufacturing conditions in detail.

Treat every conditional approval on your precedent list as unfinished business, because for products approved since 2021 nobody yet knows whether they will stay on the market.

Who held the approval, and where the product was made

Every product on the list reached patients through a marketing authorization holder in Japan. For a foreign developer, that means a subsidiary or a licensee.

Subsidiaries carry the multinationals' products: Novartis Pharma K.K. for ZOLGENSMA and Luxturna, Bristol Myers Squibb K.K. for Breyanzi and Abecma, Janssen Pharmaceutical K.K. for Carvykti, and Aurion Biotech Japan for Vyznova. Licensees carry the rest. Daiichi Sankyo held YESCARTA under a 2017 agreement with Kite, Chugai holds Elevidys in Japan, and Ishin Pharma holds Allostem Sheet for Anterogen.

These arrangements move. In December 2022, Kite and Daiichi Sankyo announced that the YESCARTA marketing authorization would transfer to Gilead Sciences K.K. in 2023. The same release said Japanese authorities had approved Kite's plant in El Segundo, California, to manufacture YESCARTA for Japan, with supply expected to start in early 2023. The MAH guide explains how a holder is licensed and how an approval moves between holders.

For a CDMO the list shows two models. A plant abroad can supply Japan, as Kite's El Segundo plant was approved to do. Such a site needs the Accreditation of Foreign Manufacturers and PMDA's inspection against the GCTP Ministerial Ordinance, Japan's GMP for regenerative medical products. Or the developer can contract a site in Japan, as Aurion did with S-RACMO two years before approval. A product built on a viral vector also meets the Cartagena Act.

Approval is not launch. Vyznova was approved in March 2023 and listed for reimbursement on September 1, 2024. Akuugo waited from July 2024 to May 2026. Plan supply volumes against the expected reimbursement listing, not the approval date.

Agree with your Japanese holder, before the filing is drafted, which manufacturing sites the application will name and who will prepare their accreditation and GCTP inspection.

Steps before you choose a route for Japan

Work through these with your regulatory lead and the Japanese partner you are considering.

1. Pull PMDA's Japanese yearly lists of approved new regenerative medical products for every fiscal year since 2015, and add 2026 approvals from company announcements.
2. Mark the three or four products closest to yours by modality, cell source (autologous or donor) and indication, and note each one's route, holder and approval month.
3. For each conditional approval among them, write down the expiry of the time limit and whether the holder has re-applied, using the conditional approval guide.
4. Read the review reports of your closest precedents, in English where PMDA has translated them, for the Japanese data PMDA accepted and the approval conditions it set.
5. Decide who will hold the approval in Japan, a subsidiary or a licensee, and put the choice of manufacturing sites into that agreement.
6. Confirm the Accreditation of Foreign Manufacturers and the GCTP inspection plan for every site named, and the Cartagena Act procedure if the product contains a vector.
7. Ask the holder for the expected reimbursement listing date and plan launch volumes from that date, not from approval.

If the product will be used at clinics without a marketing approval, a different law applies: see the guide to the Act on the Safety of Regenerative Medicine. For the terms you will meet in Japanese approval documents, see the side box and the glossary.