Japan · 再生医療等製品 · cell & gene therapy · iPSC · conditional approval
Every regenerative medical product approved in Japan — cell therapies, gene therapies, CAR-T, tissue-engineered and the first iPSC-derived products — with the conditional-approval clock, NHI prices and the committee pipeline. Facts only; not investment advice.
Data as of 2026-09-29 · sources: PMDA, MHLW (PDL1.0); processed by Japan Pharma Regulatory Brief · CSV · 日本語の一覧
All 8 products ever given conditional and time-limited approval, oldest first. The expiry is the last day of the limit; * = computed from the approval date and the limit (no official expiry day seen) or from a company announcement.
| Product | Company | Modality | Approved | Limit | Expiry | Outcome / status |
|---|---|---|---|---|---|---|
| HeartSheet ハートシート | Terumo Corporation | Tissue-engineered | 2015-09-18 | 5 + 3 yrs (extended) | 2023-09-17 | Lapsed / withdrawn 2024-07-25 |
| STEMIRAC Inj. ステミラック注 | Nipro Corporation | Autologous cell | 2018-12-28 | 7 yrs* | 2025-12-27* limit passed | Regular approval filed 2025-11-14; valid until MHLW decides* |
| Collategene Intramuscular Injection 4 mg コラテジェン筋注用4mg | AnGes, Inc. | Gene therapy | 2019-03-26 | 5 yrs | 2024-03-25 | Lapsed / withdrawn 2024-06-27* |
| Delytact Injection デリタクト注 | Daiichi Sankyo Company, Limited | Gene therapy | 2021-06-11 | 7 yrs | 2028-06-10* 620 days left | In force (clock running) |
| Akuugo Suspension for Intracranial Implantation アクーゴ脳内移植用注 | SanBio Company Limited | Allogeneic cell | 2024-07-31 | 7 yrs | 2031-07-30* 1,765 days left | In force (clock running) |
| Elevidys for Intravenous Infusion エレビジス点滴静注 | Chugai Pharmaceutical Co., Ltd. | Gene therapy | 2025-05-13 | 3 yrs | 2028-05-12* 591 days left | In force (clock running) |
| AMCHEPRY アムシェプリ | Sumitomo Pharma Co., Ltd. | iPSC-derived | 2026-03-06 | 7 yrs | 2033-03-05* 2,349 days left | In force (clock running) |
| RiHEART リハート | Cuorips Inc. | iPSC-derived | 2026-03-06 | 7 yrs | 2033-03-05* 2,349 days left | In force (clock running) |
| Gene therapy | 9 |
| Tissue-engineered | 8 |
| CAR-T | 5 |
| Allogeneic cell | 4 |
| Autologous cell | 2 |
| iPSC-derived | 2 |
| Full | 22 |
| Conditional & time-limited | 8 |
| Still running | 6 |
| Lapsed / withdrawn | 2 |
| 2007 | 1 |
| 2012 | 1 |
| 2015 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 7 |
Newest first; click a column to sort. Price = NHI reimbursement price when first listed, per the unit shown, with a US-dollar conversion at ¥150 = $1. 26 of 30 have a price; 4 have no price in our data (not yet listed, or older products reimbursed under a device category). Indication is our short summary; the source link has the official wording. * = unverified cell (12 of 30 products have at least one). 24 products carry an orphan designation, 6 SAKIGAKE. Highest price: Elevidys for Intravenous Infusion ¥304,972,042 per patient. Download CSV.
| Product | Company | Modality | Approved | Approval type | Indication (short) | Reimbursement price (at listing) | NHI listing | Source |
|---|---|---|---|---|---|---|---|---|
| Telomelysin Injection* テロメライシン注 orphan SAKIGAKE | Oncolys BioPharma Inc.* | Gene therapy | 2026-06-08 | Full | Oesophageal cancer (with radiotherapy)* | ¥3,102,489 ~$21k · per 2 mL vial | 2026-08-13 | source |
| Adstiladrin for Intravesical Use エドスチラドリン膀胱内注入液 orphan | Ferring Pharmaceuticals Co., Ltd. | Gene therapy | 2026-05-08 | Full | High-risk non-muscle-invasive bladder cancer after BCG | ¥2,327,036.9 ~$16k · per 20 mL vial | 2026-07-15 | source |
| Savyscus Injection セイビスカス注 | Fujifilm Toyama Chemical Co., Ltd. | Autologous cell | 2026-05-08 | Full | Meniscal injury | not NHI-listed | source | |
| Allostem Sheet アロステムシート orphan | Ishin Pharma Co., Ltd. | Tissue-engineered | 2026-04-03 | Full | Epidermolysis bullosa (erosions/ulcers) | ¥182,096 ~$1,214 · per 5 cm × 5 cm sheet | 2026-07-15 | source |
| ZOLGENSMA Suspension for Intrathecal Injection ゾルゲンスマ髄注 orphan | Novartis Pharma K.K. | Gene therapy | 2026-04-03 | Full | Spinal muscular atrophy, age 2+ (intrathecal) | ¥167,077,222 ~$1.1M · per patient | 2026-05-20 | source |
| AMCHEPRY アムシェプリ orphan SAKIGAKE | Sumitomo Pharma Co., Ltd. | iPSC-derived | 2026-03-06 | Conditional & time-limited 7 yrs | Parkinson's disease (motor symptoms) | ¥55,306,737 ~$369k · per set of 18 vials | 2026-05-20 | source |
| RiHEART リハート orphan | Cuorips Inc. | iPSC-derived | 2026-03-06 | Conditional & time-limited 7 yrs | Severe heart failure due to ischaemic cardiomyopathy | ¥53,200,000 ~$355k · per patient (one treatment) device rule | 2026-09-01 | source |
| Vyjuvek Gel バイジュベックゲル orphan | Krystal Biotech, Inc. | Gene therapy | 2025-07-24 | Full | Dystrophic epidermolysis bullosa | ¥2,955,232.7 ~$20k · per set of 2 vials | 2025-10-22 | source |
| Elevidys for Intravenous Infusion エレビジス点滴静注 orphan | Chugai Pharmaceutical Co., Ltd. | Gene therapy | 2025-05-13 | Conditional & time-limited 3 yrs | Duchenne muscular dystrophy | ¥304,972,042 ~$2.0M · per patient | 2026-02-20 | source |
| Akuugo Suspension for Intracranial Implantation アクーゴ脳内移植用注 orphan SAKIGAKE | SanBio Company Limited | Allogeneic cell | 2024-07-31 | Conditional & time-limited 7 yrs | Chronic motor paralysis after traumatic brain injury | ¥72,716,528 ~$485k · per dose | 2026-05-20 | source |
| Luxturna Injection ルクスターナ注 orphan | Novartis Pharma K.K. | Gene therapy | 2023-06-26 | Full | Inherited retinal dystrophy (biallelic RPE65) | ¥49,600,226 ~$331k · per 0.5 mL vial | 2023-08-30 | source |
| JACEMIN ジャスミン | Japan Tissue Engineering Co., Ltd. | Tissue-engineered | 2023-03-17 | Full | Vitiligo | ¥4,460,000 ~$30k · per collection/culture kit (+ ¥154,000 per sheet) device rule | 2024-10-01 | source |
| Vyznova ビズノバ orphan | Aurion Biotech Japan, LLC. | Allogeneic cell | 2023-03-17 | Full | Bullous keratopathy | ¥9,464,500 ~$63k · per product device rule | 2024-09-01 | source |
| Carvykti Suspension for Intravenous Infusion カービクティ点滴静注 orphan | Janssen Pharmaceutical K.K. | CAR-T | 2022-09-26 | Full | Multiple myeloma (relapsed/refractory) | not NHI-listed | source | |
| Abecma Intravenous Infusion アベクマ点滴静注 orphan | Bristol-Myers Squibb K.K. | CAR-T | 2022-01-20 | Full | Multiple myeloma (relapsed/refractory) | ¥32,647,761 ~$218k · per patient | 2022-04-20 | source |
| Sakracy サクラシー orphan | Hirosaki Lifescience Innovation, Inc. | Tissue-engineered | 2022-01-20 | Full | Limbal stem cell deficiency with adhesions | ¥7,940,000 ~$53k · per sheet package (+ tissue transport set ¥5,470,000) device rule | 2022-09-01* | source |
| Alofisel Injection アロフィセル注 orphan | Takeda Pharmaceutical Company Limited | Allogeneic cell | 2021-09-27 | Full | Complex perianal fistula in Crohn's disease | ¥5,620,004 ~$37k · per set of 4 vials | 2021-11-25 | source |
| Delytact Injection デリタクト注 orphan SAKIGAKE | Daiichi Sankyo Company, Limited | Gene therapy | 2021-06-11 | Conditional & time-limited 7 yrs | Malignant glioma | ¥1,431,918 ~$9,546 · per 1 mL vial | 2021-08-12 | source |
| Ocural オキュラル orphan | Japan Tissue Engineering Co., Ltd. | Tissue-engineered | 2021-06-11 | Full | Limbal stem cell deficiency | ¥5,470,000 ~$36k · per cultured epithelium package (+ tissue transport set ¥4,280,000) device rule | 2021-12-01* | source |
| Breyanzi Suspension for Intravenous Infusion ブレヤンジ静注 orphan | Bristol-Myers Squibb K.K. | CAR-T | 2021-03-22 | Full | Large B-cell and follicular lymphoma (relapsed/refractory) | ¥34,113,655 ~$227k · per patient | 2021-05-19 | source |
| YESCARTA Intravenous Drip Infusion イエスカルタ点滴静注 orphan | Daiichi Sankyo Company, Limited | CAR-T | 2021-01-22 | Full | Large B-cell lymphoma (relapsed/refractory) | ¥34,113,655 ~$227k · per patient | 2021-04-21 | source |
| Nepic ネピック orphan | Japan Tissue Engineering Co., Ltd. | Tissue-engineered | 2020-03-19 | Full | Limbal stem cell deficiency | ¥5,470,000 ~$36k · per cultured epithelium package (+ tissue transport set ¥4,280,000) device rule | 2020-06-01* | source |
| ZOLGENSMA Intravenous Infusion ゾルゲンスマ点滴静注 orphan SAKIGAKE | Novartis Pharma K.K. | Gene therapy | 2020-03-19 | Full | Spinal muscular atrophy (IV) | ¥167,077,222 ~$1.1M · per patient | 2020-05-20 | source |
| Collategene Intramuscular Injection 4 mg コラテジェン筋注用4mg | AnGes, Inc. | Gene therapy | 2019-03-26 | Conditional & time-limited 5 yrs | Ulcers in chronic arterial occlusion | ¥600,360 ~$4,002 · per 4 mg vial no longer reimbursed | 2019-09-04 | source |
| Kymriah Suspension for Intravenous Infusion キムリア点滴静注 orphan | Novartis Pharma K.K. | CAR-T | 2019-03-26 | Full | B-ALL and DLBCL (CD19+, relapsed/refractory) | ¥33,493,407 ~$223k · per patient | 2019-05-22 | source |
| STEMIRAC Inj. ステミラック注 SAKIGAKE | Nipro Corporation | Autologous cell | 2018-12-28 | Conditional & time-limited 7 yrs* | Spinal cord injury (neurological symptoms) | ¥14,957,755 ~$100k · per dose (one course) | 2019-02-26 | source |
| HeartSheet ハートシート | Terumo Corporation | Tissue-engineered | 2015-09-18 | Conditional & time-limited 5 + 3 yrs (extended) | Severe heart failure due to ischaemic heart disease | ¥6,360,000 ~$42k · per A kit (+ B kit ¥1,680,000) device rule no longer reimbursed | source | |
| TEMCELL HS Inj. テムセルHS注 orphan | JCR Pharmaceuticals Co., Ltd. | Allogeneic cell | 2015-09-18 | Full | Acute GVHD after stem cell transplant | ¥868,680 ~$5,791 · per 10.8 mL bag | 2015-11-26 | source |
| JACC ジャック | Japan Tissue Engineering Co., Ltd. | Tissue-engineered | 2012-07-27 | Full | Traumatic cartilage defects / osteochondritis dissecans (knee) | no price in our data | source | |
| JACE* ジェイス orphan | Japan Tissue Engineering Co., Ltd. | Tissue-engineered | 2007-10-29* | Full | Severe extensive burns; giant congenital melanocytic nevus; epidermolysis bullosa* | no price in our data | source |
Committee on Regenerative Medicine Products and Biological Technology (PAFSC) (薬事審議会 再生医療等製品・生物由来技術部会). 20 meetings since 2023-05-26 in our data; the last 6 are shown. Next meeting: not yet announced. MHLW usually posts the notice about a week ahead; product reviews are closed sessions (checked 2026-09-29).
| Date | Meeting | Agenda (English: our template translation) | Source |
|---|---|---|---|
| 2026-06-29 | 令和8年度第3回 |
| MHLW |
| 2026-05-21 | 令和8年度第2回 |
| MHLW |
| 2026-04-20 | 令和8年度第1回 |
| MHLW |
| 2026-03-09 | 令和7年度第8回 |
| MHLW |
| 2026-02-19 | 令和7年度第7回 |
| MHLW |
| 2025-12-22 | 令和7年度第6回 |
| MHLW |
Outcomes come from the minutes (published months later) or from the approval/designation that followed.
Products not yet approved in Japan, ordered by how far along they are: on the committee agenda, filed (company announcement), pivotal / late-stage data with a filing planned, then SAKIGAKE and orphan designations. 28 candidates in total (Filed (company) 8, Pivotal data, filing planned 2, Phase 3 1, Phase 1/2-2 (filing planned) 2, SAKIGAKE-designated 7, Orphan-designated 8). A designation is not a filing, and nothing here predicts an approval date. * = English text is our AI translation or the entry is not yet checked against an official source.
| Product | Company | Indication | Stage | Note |
|---|---|---|---|---|
| brexucabtagene autoleucel (Tecartus) ブレキスカブタゲン オートルユーセル（テカルタス） | Gilead Sciences K.K. | Relapsed or refractory mantle cell lymphoma and B-cell acute lymphoblastic leukemia | Filed (company) Orphan 2026-01-16 | Filed 2026-08-21 (ZUMA-2, ZUMA-3, Japanese JKART-1); orphan-designated, so priority review (target ~9 months). |
| lunsotogene parvec (DB-OTO) lunsotogene parvec（DB-OTO） | Regeneron Japan KK | Hearing loss due to biallelic OTOF mutations* | Filed (company) Orphan 2026-03-06 | Filed 2026-07-29 (CHORD trial); orphan-designated 2026-03; FDA approved April 2026. |
| pariglasgene brecaparvovec (DTX401) パリグラスジーン ブレカパルボベク（DTX401） | Ultragenyx Japan K.K. | Glycogen storage disease type Ia | Filed (company) Orphan 2024-11-26 | Filed 2026-06-30; orphan-designated (Nov 2024), so priority review. |
| Stemchymal Stemchymal（ステムカイマル） | ReproCELL Inc. (manufacturer: Steminent Biotherapeutics) | Slowing progression of ataxia in spinocerebellar ataxia types 3 and 6* | Filed (company) Orphan 2018-12-21 | Filed 2026-06-24; orphan (Dec 2018) priority review, target 9 months from acceptance (company). |
| Breyanzi (CLL/SLL, partial change) ブレヤンジ静注（慢性リンパ性白血病／小リンパ球性リンパ腫） | Bristol-Myers Squibb K.K. | Relapsed or refractory CLL/SLL* | Filed (company) | Partial change (new indication) filed 2026-05-29; not yet on a council agenda. |
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Used under the Public Data License 1.0 (compatible with CC BY 4.0) — processed, translated and analysed by Japan Pharma Regulatory Brief (unofficial). See the MHLW terms of use. This page is not made by, affiliated with or endorsed by MHLW or PMDA. The Japanese originals prevail.
出典：独立行政法人医薬品医療機器総合機構「新再生医療等製品の承認品目一覧」、厚生労働省 中央社会保険医療協議会 総会の資料、薬事審議会 再生医療等製品・生物由来技術部会の資料を加工して Japan Pharma Regulatory Brief が作成
Last built: (council data 2026-09-29).