Nippon Shinyaku Co., Ltd.
Cite as: Japan IR Index, Nippon Shinyaku Co., Ltd. (4516), methodology GNT-BDS v1.1.1, reviewed 2026-10-20.
Findings and sources as of the review date shown. The company’s English disclosure may have changed since.
Where to start
Chosen from this company's lowest answers, easiest first. A quick fix uses material the company already has; a translation fix is usually met by translating a Japanese document (our note says whether this company has one). Questions that need a budget or a board decision are left out. Suggestions drawn from the research, separate from the scores.
O7 Named English IR contact published 3/5 Quick fix
Link a dedicated IR contact (form, address or e-mail) from the English IR section.
F1 Quarterly and full-year results summaries (tanshin) published in English 3/5 Translation
Publish the English results summary every quarter, including the qualitative section and the notes.
F2 English results summary is a full translation, not an excerpt 3/5 Translation
Translate the whole results summary rather than an excerpt.
F3 Financial statements including notes available in English 3/5 Translation
Include the notes to the financial statements in the English results.
English disclosure assessment
All 34 questions reviewed by the editor against the public documents; this is not an independent audit. 2 answers corrected after re-checks (research errors) between 20 Oct 2026 and 23 Oct 2026. These are changes to our record, not to the company’s disclosure. Changes to this record →
Compared with peers
| Peer group | Median | This company |
|---|---|---|
| Same sector (Pharmaceutical) | 75.4 | 3 of 12 |
| Same size band (¥100–500bn) | 77.1 | 13 of 50 |
Compared with the companies covered here, not the whole market. Sector is the TSE 33-sector classification; market cap is from the TSE English-disclosure survey, Aug 2026; it only sets the size band, plays no part in the score, and is refreshed once a quarter. Ties share the higher rank.
Out of 100.
Of the 34 questions reviewed, 32 scored 3 or more and 1 found no qualifying English materials within the stated review scope. Read each score with its source and scope below.
Findings by question
F1Quarterly and full-year results summaries (tanshin) published in English3/5
English 'Outline of Consolidated Financial Results' (kessan tanshin) is in the English IR library for every quarter back to 2020, and on TDnet at the same minute as the Japanese (Q1 FY2026: 6 Aug 2026 12:00 in both languages; FY2025: 15 May 2026 12:00; Q3: 9 Feb 2026; H1: 14 Nov 2025). So the periods test is a 5. But each English release is cut down: the Q1 FY2026 English is 11 pages against 20 in Japanese, and the FY2025 English 12 pages against 26. The English goes from the summary pages (sections 1-4) straight to '5. Consolidated Financial Statement' and then a product-sales table and the pipeline list. It has no counterpart to the Japanese attachment 1. 経営成績等の概況 (results review, financial position, forecast explanation) and none to the notes (going concern, segment information: Pharmaceuticals and Functional Food, with segment profit). Two tests, take the lower: the qualitative section and the segment note are cut, so 3. The Examples to follow (Miura 15 against 15, TOK, Fuji Electric) carry both. Source document →
F2English results summary is a full translation, not an excerpt3/5
We read the Q1 FY2026 tanshin of 6 Aug 2026 against the Japanese. English 11 pp (18,249 characters): summary pages, the five condensed IFRS statements (financial position, income, comprehensive income, changes in equity, cash flows), a revenue-by-product table with forecasts and the pipeline. Japanese 2027年3月期 第1四半期決算短信 20 pp: the same summary, then 1. 経営成績等の概況 (2 pp of qualitative review, financial position and the forecast explanation), 2. 要約四半期連結財務諸表及び主な注記 with (5) 注記事項: 継続企業の前提 and セグメント情報 (segment overview, measurement basis, revenue and segment profit). The FY2025 tanshin is the same pattern, 12 pp English against 26 pp Japanese. A section of the document's own substance (the qualitative review and the notes, the segment note above all) is cut, so 3. Source document →
F3Financial statements including notes available in English3/5
The English tanshin carries the full statements (balance sheet, income, comprehensive income, changes in equity, cash flows) for the latest quarter and for the year end, but no notes: no segment note, no going-concern note. The English site has no annual securities report or other English financial section with notes, and the Integrated Report 2025 has summary data only. Statements without notes, so 3. Source document →
F4Annual securities report available in English in any form0/5
Looked through the English IR Library (Financial Information, IR Meeting Resources, Integrated Report, Other Presentation), the Business/Financial Information pages and the IR site map: no annual securities report in English under any name. The Japanese library has the 有価証券報告書 for FY2025 (147 pp, June 2026).
F5Segment revenue and profit disclosed in English, consistent definitions3/5
Nippon Shinyaku has two reportable segments, Pharmaceuticals and Functional Food. In English, segment revenue is given every quarter (tanshin p.8 revenue table: Pharmaceuticals ¥43,256m, Functional Food ¥5,810m in Q1 FY2026, with full-year forecasts) and in the deck's 'Segmental Review' pages, but segment profit appears nowhere in English: the tanshin drops the segment note, and the deck and the Integrated Report give consolidated operating profit only. The Japanese tanshin note gives segment profit (Q1 FY2025: 9,938 and 167). Sales without profit, so 3. Source document →
F6Multi-year financial data file (Excel or CSV) downloadable in English5/5
Business/Financial Highlights offers 'Eleven-Year Financial Data' (Excel, 17 KB) and 'Business Highlight Data' (Excel, 41 KB, updated 15 May 2026), plus a balance-sheet Excel. We fetched the eleven-year file inside the rendered page and read the sheet XML: FY2015-FY2021 (JGAAP) and FY2021-FY2025 (IFRS), so eleven years to the year ended March 2026. It has net sales by segment (Pharmaceuticals, Functional Food), cost of sales, SG&A, R&D, operating profit, net profit, depreciation, capex, operating/investing/financing cash flows, total assets, interest-bearing debt, equity, EPS, BPS, DPS, margins, ROA, ROE, PBR, PER, payout, shares and market cap. Five years and more of P&L, balance sheet totals, cash flows and per-share data, with segment sales, so 5. Comparable to the 4021 and 6143 examples. Source document →
F7Guidance disclosed in English with the basis explained5/5
The English FY2025 results deck (15 May 2026, 44 pp) gives the FY2026 forecast (revenue ¥200.0bn, OP ¥38.0bn) with the USDJPY assumption (150.0, against 152.6 and 150.8 actual) and its sensitivity (¥550m revenue, ¥410m OP per yen), revenue forecasts for the Pharmaceuticals and Functional Food segments, and product-level forecasts (Viltepso, Uptravi, Erleada, deramiocel ¥11.4bn, etc.), each with the reason. The Q1 deck (6 Aug 2026) states no change to the forecast and restates the FX sensitivity. FX and segment forecasts, with revisions addressed, so 5. Source document →
F8English financial disclosure current to the latest Japanese filing period5/5
English results for the three months to 30 June 2026 were published on 6 August 2026 at 12:00 on TDnet and the English IR library, the same period and minute as the Japanese filing. The next period (H1) is not due until November. Source document →
S1Medium-term management plan in English with numerical targets5/5
The 7th Five-Year Medium-Term Management Plan (FY2024-FY2028) is in English: an 87-page presentation (file created 27 May 2024, the date the English library lists, with the briefing Q&A summary added in June), against 79 pages in Japanese (created 30 May 2024). Targets for FY2028: revenue ¥230bn, OP ¥30bn, EPS ¥341, ROE 8%+, ROIC 9%+, segment targets (Pharmaceuticals revenue ¥203bn, Functional Food ¥27bn and OP ¥1.8bn, ROIC 9%+), overseas ratio over 50%, global revenue of three focus areas over ¥130bn, and the ¥300bn FY2030 ambition. The MTP page summarises it in English. Complete and as early as the Japanese, so 5. Source document →
S2IR presentations published in English5/5
For every quarter the English IR Meeting Resources carry the results deck (Q1 FY2026 46 pp, the same 46 pp as the Japanese; FY2025 44 pp against 44), a full English transcript with the Q&A (Q1 FY2026 25 pp, 22 questions; FY2025 27 pp; Q3 32 pp; Q2 30 pp; Q1 FY2025 21 pp) and an English webcast. The Japanese side gets deck, script version and video: item for item the same set. The R&D Meeting and Investor Meeting (March 2026) also have English decks, transcripts and webcasts. So 5, and at least as complete as the Shimadzu and Taxan examples. Source document →
S3English equity-story or investment-highlights page3/5
No dedicated investment-highlights page in English. 'To Our Individual Investors' is a menu of links (president's message, about the pharmaceutical industry, DNA, highlights). 'Nippon Shinyaku's DNA' and the Integrated Report's 'Strengths of Nippon Shinyaku' (three strengths: R&D-led originality, field specialisation, integrated team capabilities) describe the company's strengths without framing or quantifying them for an investor. A company-overview page doing the job, so 3. Source document →
S4Growth drivers identified and quantified in English5/5
The English MTP names the drivers and puts numbers on them: launches of two or more growth items a year to replace Uptravi (DMD products CAP-1002, NS-089, NS-050, NS-051; Vyxeos, Jaypirca; Gazyva and Fintepla PLCM), global revenue of the three focus areas over ¥130bn in FY2028, overseas sales over 50%, at least one late-stage in-licensed item a year, and revenue of ¥300bn in FY2030. Each English tanshin and deck gives product revenue and full-year forecasts per driver (e.g. Erleada ¥14.4bn, deramiocel ¥11.4bn, Fintepla ¥6.1bn for FY2026). Named drivers with contributions attached, so 5. Source document →
S5Results-briefing transcripts or Q&A published in English4/5
Both languages publish a full transcript with Q&A for every results briefing. English and Japanese files have the same creation dates for Q1 FY2026 (17 Aug 2026), Q3 (12 Feb 2026) and Q2 (18 Nov 2025). The FY2025 transcript is later in English: Japanese created 18 May 2026, English created 22 May and listed 25 May. Every period, one of four a week behind, so 4 (ruling: English Q&A any days after the Japanese is 4). Source document →
S6Integrated or annual report available in English4/5
Integrated Report 2025 in English (44 pp, file created 16 Oct 2025) covering fiscal 2024 (April 2024 to March 2025), the same 44 pages as the Japanese 日本新薬レポート2025. The Japanese 日本新薬レポート2026 (77 pp, created 31 Jul 2026, covering fiscal 2025) has no English edition yet. Complete, one edition behind, so 4. Source document →
S7Progress against the previous plan, including misses, explained in English5/5
The English 7th MTP opens with a review of the 6th plan (pp.3-10): 'Targets of the 6th Medium-Term Management Plan' sets the FY2023 targets against results (revenue ¥150bn vs ¥148.2bn, Pharmaceuticals ¥133bn vs ¥125.1bn, Functional Food ¥17bn vs ¥23.1bn, OP ¥40bn vs ¥33.2bn, net ¥30bn vs ¥25.8bn, EPS ¥445 vs ¥383, ROE 10%+ vs 12.4%) and says plainly which were achieved (Functional Food revenue and ROE), followed by the review of what was and was not done, including the clinical delays. Targets against actuals with the misses explained, so 5, matching the Santen and Espec examples. Source document →
G1Corporate governance report available in English5/5
Corporate Governance Report in English, 'Last Update: June 30, 2026', 23 pp, linked from the English Corporate Governance page and filed on TDnet as 'Corporate Governance Report' at 17:00 on 30 Jun 2026, the same day as the Japanese (16:02). It is the filed report's structure: basic views, Code disclosures, capital structure, organisation, independent officers, remuneration, skills matrix. Current, so 5, as complete as the ADEKA and SCREEN examples. Source document →
G2Director biographies in English with tenure, expertise and independence5/5
The English notice of the 163rd AGM tabulates all 12 director candidates (the whole board: all terms expire) with tenure of office (Maekawa 21 years, Nakai 7, Wada 7, Kobayashi 5 ...), Board attendance (e.g. 100%, 14/14), outside/independent status and concurrent posts, then a full profile for each with career history, shares held and reasons for nomination. The CG Report covers the Audit & Supervisory Board members. Every director with tenure, expertise and independence, so 5, as complete as the Fujimi and Resonac examples. Source document →
G3Board skills matrix published in English5/5
The English AGM notice (p.17) has the 'Skills Matrix of Directors and Audit & Supervisory Board Members (Scheduled)' for the post-AGM board, and the English CG Report of 30 Jun 2026 (p.23) the same matrix across nine skills (corporate management, global business, finance/accounting, legal/risk, R&D, sales/marketing, HR, governance/sustainability, DX/IT) for every director and A&SB member. Current, so 5. Source document →
G4Executive remuneration structure and its performance linkage explained in English4/5
The English CG Report (pp.11-12) and Integrated Report 2025 set out the structure: fixed monthly base pay, an annual bonus and restricted-stock remuneration for executive directors, fixed pay only for outside directors. The KPI is stated: both the bonus and the number of restricted shares are calculated from consolidated operating income, adjusted by each director's performance evaluation. The amounts are given by type: directors ¥483m (fixed ¥251m, bonus ¥161m, restricted stock ¥70m), A&SB members ¥53m. But no formula, weighting or pay mix: the company says it 'does not specify the ratio of remuneration by type', and the weight of the individual evaluation against the OP formula is not given. Structure, KPI and amounts without the weights, so 4 (the Towa Corp. and Kokusai examples give the mix or the weights). Source document →
G5AGM notice in English with sufficient lead time to vote4/5
Notice of the 163rd AGM in English (17 pp), on TDnet at 08:00 on 29 May 2026, the same minute as the Japanese, for a meeting on 26 June: 28 days. It carries the Reference Documents for both proposals in full (appropriation of surplus; election of 12 directors with every candidate's profile and reasons). It explains voting by post and via the internet (evote.tr.mufg.jp, QR code login) and the platform for institutions, with the deadline (17:30 on 25 June). The 'translated from a part' caveat is disregarded per the anchors. A Japanese correction notice of 5 June has no English counterpart. Re-checked 23 Oct 2026 (G5 voting-site sweep, after the independent audit): the voting website named in the English notice, evote.tr.mufg.jp (Mitsubishi UFJ Trust and Banking), is in Japanese only, with no English option, as for ESPEC (6859) and Nitto Boseki (3110). Every proposal in English, but a Japanese-only voting route, so 4. Source document →
G6Shareholder vote results disclosed in English5/5
The English Shareholders' Meeting page carries 'Results of the Exercise of Voting Rights', an English translation of the Extraordinary Report filed 30 Jun 2026 (3 pp): votes for, against and abstaining with the approval ratio for each proposal and each of the 12 director candidates (e.g. Maekawa 543,797 for, 31,782 against, 94.41%). Also the notice of resolutions and an AGM Q&A. Counts and approval ratios per resolution, so 5, the same as the TOCALO and Nippon Sanso examples. Source document →
G7Cross-shareholdings in English with reduction schedule and rationale3/5
The English CG Report (Principle 1.4) gives the policy: the board checks each holding's rationale and economic significance and reduces holdings whose significance is immaterial, plus the voting policy. The English Integrated Report 2025 (p.38) adds a 'Status of cross-shareholdings' chart (number of stocks 48, 47, 45, 46, 45 and the balance-sheet amount) and progress (FY2024: one stock sold entirely and part of another, ¥704m, plus an additional investment in Capricor). No reduction target or schedule. Policy, numbers and progress with no target, so 3. Source document →
O1English IR section reachable within two clicks of the English homepage5/5
On the English homepage (nippon-shinyaku.co.jp/english/) 'Investor Relations' is the first item in the visible header navigation and links straight to the IR top (/english/ir/). One click, so 5. Source document →
O2English document links resolve to English documents5/5
We sampled 16 English document links across types and years (tanshin 2018, 2020, 2022, 2024, FY2021 IFRS summary; Q1 FY2025 and FY2025 transcripts; FY2025 and Q1 FY2026 decks; R&D Meeting transcript 2025; MTP; Integrated Report 2025; CG Report; AGM notice; Extraordinary Report). All are English (CJK only in a handful of chart labels). So 5. Source document →
O3English IR archive free of dead links4/5
We tested all 91 document links on the English Financial Information page in Chrome. 89 open. Two do not: the FY2025 full-year tanshin (file_id=11066, 15 May 2026) and the Q3 FY2025 tanshin (file_id=10634, 9 Feb 2026). Re-checked 20 Oct 2026: the server now sends one Content-Disposition header, but the filename in it is unquoted and contains a comma ('March 31, 2026', 'December 31, 2025'), so Chrome still reads two headers and shows an error page (ERR_RESPONSE_HEADERS_MULTIPLE_CONTENT_DISPOSITION); files without a comma in the name open. Two dead out of 91, from one server fault: scored as one dead link, as 6890 (two broken entries) was, so 4. Source document →
O4English IR pages render without blank JavaScript failures5/5
Rendered the English IR top, IR News 2026, Financial Information (with the year accordions), Annual Report, Other Presentation, Medium-Term Management Plan, Five-Year Business Highlights, Consolidated Financial Statements, Corporate Governance, Shareholders' Meeting, To Our Individual Investors, Information Disclosure Policy and the contact form. All render their content, so 5. Source document →
O5Single page listing all English IR documents by date and type4/5
IR News (year tabs 2022-2026, categories Corporate, Management & Finance, Pharmaceuticals, R&D) is one dated, typed list: tanshin, timely disclosures, licensing, regulatory and litigation news. But decks, transcripts, webcasts, the Integrated Report and AGM materials sit on type pages (Financial Information, Integrated Report, Other Presentation, Shareholders' Meeting). One dated, typed list missing some types, so 4. Source document →
O6English archive genuinely populated, not an unverifiable shell5/5
Tanshin and IR-meeting materials every quarter from FY2020 (Nov 2020) to Q1 FY2026, with transcripts and webcasts in recent years; Integrated/Annual Reports 2018-2025; R&D, ESG and MTP presentations from 2021; IR News back to 2022. Several years across types, so 5. Source document →
O7Named English IR contact published3/5
The English site's contact link (envelope icon in the header and 'Contact' in the footer) goes to the shared corporate Inquiry Form, where 'Investor Relations' is one of four inquiry types. The IR top and IR menu have no IR contact link (only IR e-mail alerts). The CG Report names Naoki Inoue, Department Manager, Public Relations & Investor Relations Department (+81-75-321-9107); the tanshin names Kenji Ban, Finance & Accounting (+81-75-321-9116). A shared form with an IR category, not a dedicated route, so 3. Source document →
R1Earnings materials published in English simultaneously with Japanese5/5
Tanshin: English and Japanese on TDnet at the same minute in every period read (Q1 FY2026 6 Aug 2026 12:00; FY2025 15 May 2026 12:00; Q3 9 Feb 2026 12:00; H1 14 Nov 2025 12:00; Q1 FY2025 7 Aug 2025). Decks: the English library lists each deck on results day (6 Aug 2026, 15 May 2026), and the English and Japanese deck files carry the same creation dates (6 Aug and 15 May). Same day, every period, so 5. Source document →
R2Median lag in days between Japanese and English statutory publication5/5
English against Japanese: Q1 FY2026 tanshin 6 Aug / 6 Aug = 0; FY2025 tanshin 15 May / 15 May = 0; AGM notice on TDnet 29 May / 29 May = 0; CG Report 30 Jun 17:00 / 30 Jun 16:02 = 0; annual securities report (Japanese filed June 2026) no English, >90. Sorted 0, 0, 0, 0, >90: median 0, so 5. Source document →
R3Timely disclosures published in English5/5
We compared kabutan's TDnet list for Oct 2025 to Oct 2026 with the English. Every timely disclosure has an English version at the same minute: four tanshin, 'Notice Regarding Executive Personnel Changes' (9 Feb 2026), both treasury-stock disposals for restricted stock compensation and their completions (Jul/Aug 2025 and 2026), the AGM notice and the CG Report; the English IR News also carries the licensing, regulatory and litigation releases. Only the 独立役員届出書 (procedural) and the 5 Jun 2026 AGM-notice correction have no English, neither of R3's kinds. So 5. Source document →
R4English disclosure free of machine-translation accuracy disclaimers5/5
Rendered the English homepage, IR top, Terms of Use ('About the use of this website') and the contact form, and read the documents: no machine- or AI-translation notice and no translation pop-up anywhere. The documents carry only the human-translation 'original shall prevail' line (R5's). So 5. Source document →
R5English version stated as authoritative, not subordinate to Japanese2/5
'This document has been translated from the Japanese original for reference purposes only ... the original shall prevail' is on the tanshin, the CG Report, the AGM notice and (in substance) the decks and MTP. The Integrated Report 2025 and the earnings-call transcripts carry no such statement. Disclaimed on some documents, so 2. Source document →
Open a question for the reasoning and the document its score was read from. A zero means no qualifying English materials were located within the stated review scope as of 2026-10-20. Compare this question across companies →
Capital-policy review
Each action is read against the company’s own filings on four checks: was the promise specific, can the steps be traced, were the economics explained, and did it report back against the target. This records the status of selected actions, not an assessment of the company as a whole. How this is scored →
7th Five-Year Medium-Term Management Plan (FY2024-FY2028)
Strategy or target reset · In progress · Plan announced 27 May 2024
Nippon Shinyaku set FY2028 targets to grow through the Uptravi patent cliff. FY2025 operating profit already exceeds the FY2028 target, but the plan has not been restated; the FY2028 outcome is not due.
Timeline and sources (2 steps)
- 27 May 2024Plan announced FY2028 targets of ¥230bn revenue, ¥30bn operating profit, EPS ¥341, ROE of 8% or more and ROIC of 9% or more, with a ¥300bn revenue ambition for FY2030; the deck opens with a target-versus-result review of the 6th plan. 7th Five-Year Medium-Term Management Plan (FY2024-FY2028) presentation
- 15 May 2026Second plan year reported FY2025 revenue ¥170.8bn and operating profit ¥35.5bn; FY2026 forecast ¥200.0bn revenue and ¥38.0bn operating profit at ¥150 per US dollar. FY2025 Financial Results presentation
What management said it would do
The 7th plan targets FY2028 revenue of ¥230bn, operating profit of ¥30bn, EPS of ¥341, ROE of 8% or more and ROIC of 9% or more.
From the company’s own disclosure · 7th Five-Year Medium-Term Management Plan (FY2024-FY2028) presentation
What it actually did, and when
FY2025 operating profit of ¥35.5bn is already above the FY2028 target; the plan has not been restated in the reviewed sources.
Partly disclosed — a gap remains · FY2025 Financial Results presentation
What it disclosed about the economics
Capital efficiency is framed through ROE and ROIC floors; the reviewed sources give no quantified allocation of cash.
Partly disclosed — a gap remains · 7th Five-Year Medium-Term Management Plan (FY2024-FY2028) presentation
What has happened since
The FY2028 result is not due.
Partly disclosed — a gap remains · 7th Five-Year Medium-Term Management Plan (FY2024-FY2028) presentation
The question this leaves open
Investor question: is the FY2028 target still the expected path, and how will surplus cash be used? IR preparation: publish an annual plan-versus-actual table and an allocation envelope.
Our analysis, not a company statement
Exclusive licence of the RGX-121 and RGX-111 gene therapies from REGENXBIO (U.S. commercial, Asia development and commercial rights, January 2025)
Acquisition · In progress · Licence agreed 14 January 2025
Nippon Shinyaku licensed U.S. commercialization rights and Asian development and commercialization rights to two gene therapies. The English release gives no upfront payment, milestones or royalties. RGX-121 received a Complete Response Letter in February 2026, an agreed path to resubmission in June, and a new clinical hold in August 2026.
Timeline and sources (4 steps)
- 14 January 2025Licence agreed Exclusive U.S. commercialization and Asian development and commercialization rights to RGX-121 (MPS II) and RGX-111 (MPS I); effective on HSR clearance; NS Pharma to market in the U.S. No financial terms are given. Nippon Shinyaku and REGENXBIO Enter into an Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis Diseases in the U.S. and Asia (English published the same day as the Japanese; Japanese version 2025-01-14)
- 10 February 2026Complete Response Letter The FDA issued a Complete Response Letter on the RGX-121 BLA. RGX-121: REGENXBIO received Complete Response Letter from the U.S. FDA for Biologics License Application for mucopolysaccharidosis type II (English published the same day as the Japanese; Japanese version 2026-02-10)
- 23 June 2026Resubmission path agreed REGENXBIO and the FDA aligned on an accelerated-approval resubmission after a Type A meeting expected in July. REGENXBIO Announces Alignment with FDA on Path Forward for RGX-121 BLA Resubmission for Accelerated Approval (English published the same day as the Japanese; Japanese version 2026-06-23)
- 25 August 2026Clinical hold The FDA placed a clinical hold on RGX-121; the path forward awaits FDA feedback. Regulatory Update on RGX-121 for MPS II (English published the same day as the Japanese; Japanese version 2026-08-25)
What management said it would do
Nippon Shinyaku licensed exclusive U.S. commercialization and Asian development and commercialization rights to RGX-121 and RGX-111 from REGENXBIO in January 2025.
From the company’s own disclosure · Nippon Shinyaku and REGENXBIO Enter into an Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis Diseases in the U.S. and Asia (English published the same day as the Japanese; Japanese version 2025-01-14)
What it actually did, and when
RGX-121 received a Complete Response Letter in February 2026, an agreed resubmission path in June and a clinical hold in August 2026; the licence's effectiveness and payments are not reported.
Partly disclosed — a gap remains · RGX-121: REGENXBIO received Complete Response Letter from the U.S. FDA for Biologics License Application for mucopolysaccharidosis type II (English published the same day as the Japanese; Japanese version 2026-02-10) · REGENXBIO Announces Alignment with FDA on Path Forward for RGX-121 BLA Resubmission for Accelerated Approval (English published the same day as the Japanese; Japanese version 2026-06-23) · Regulatory Update on RGX-121 for MPS II (English published the same day as the Japanese; Japanese version 2026-08-25)
What it disclosed about the economics
No upfront payment, milestones or royalties are disclosed in the English releases.
Partly disclosed — a gap remains · Nippon Shinyaku and REGENXBIO Enter into an Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis Diseases in the U.S. and Asia (English published the same day as the Japanese; Japanese version 2025-01-14)
What has happened since
There is no approval yet to report against.
Partly disclosed — a gap remains · Regulatory Update on RGX-121 for MPS II (English published the same day as the Japanese; Japanese version 2026-08-25)
The question this leaves open
Investor question: what has the licence cost so far and what is still owed? IR preparation: disclose payments, the carrying value and the impairment assessment.
Our analysis, not a company statement
U.S. commercialization rights to Tadekinig alfa from AB2 BIO (option agreed January 2025, exercised July 2026)
Acquisition · In progress · Option agreed 27 January 2025
Nippon Shinyaku took an option on U.S. commercialization of Tadekinig alfa, an IL-18 binding protein for two rare autoinflammatory diseases, and exercised it in July 2026. Neither release gives financial terms; NS Pharma is to sell the product after U.S. approval.
Timeline and sources (2 steps)
- 27 January 2025Option agreed Option for U.S. commercialization rights; AB2 BIO had completed Phase III and was preparing a BLA. No financial terms. Nippon Shinyaku and AB2 BIO enter into an Option Agreement for Commercialization of Tadekinig alfa for the treatment of NLRC4 mutation and XIAP deficiency in the U.S. (English published the same day as the Japanese; Japanese version 2025-01-27)
- 30 July 2026Option exercised Exclusive U.S. commercialization rights obtained for NLRC4- and XIAP-mutation IL-18 driven hyperinflammatory syndrome. No financial terms. Nippon Shinyaku Exercises Option Rights for Commercialization of AB2 Bio's Tadekinig alfa in the U.S. (English published the same day as the Japanese; Japanese version 2026-07-30)
What management said it would do
Nippon Shinyaku agreed an option on U.S. commercialization rights to Tadekinig alfa in January 2025 and exercised it in July 2026.
From the company’s own disclosure · Nippon Shinyaku and AB2 BIO enter into an Option Agreement for Commercialization of Tadekinig alfa for the treatment of NLRC4 mutation and XIAP deficiency in the U.S. (English published the same day as the Japanese; Japanese version 2025-01-27) · Nippon Shinyaku Exercises Option Rights for Commercialization of AB2 Bio's Tadekinig alfa in the U.S. (English published the same day as the Japanese; Japanese version 2026-07-30)
What it actually did, and when
Both steps were announced the same day in English and Japanese.
From the company’s own disclosure · Nippon Shinyaku and AB2 BIO enter into an Option Agreement for Commercialization of Tadekinig alfa for the treatment of NLRC4 mutation and XIAP deficiency in the U.S. (English published the same day as the Japanese; Japanese version 2025-01-27) · Nippon Shinyaku Exercises Option Rights for Commercialization of AB2 Bio's Tadekinig alfa in the U.S. (English published the same day as the Japanese; Japanese version 2026-07-30)
What it disclosed about the economics
No option fee, exercise payment or milestones are disclosed.
Partly disclosed — a gap remains · Nippon Shinyaku Exercises Option Rights for Commercialization of AB2 Bio's Tadekinig alfa in the U.S. (English published the same day as the Japanese; Japanese version 2026-07-30)
What has happened since
U.S. approval and launch are still ahead.
Partly disclosed — a gap remains · Nippon Shinyaku Exercises Option Rights for Commercialization of AB2 Bio's Tadekinig alfa in the U.S. (English published the same day as the Japanese; Japanese version 2026-07-30)
The question this leaves open
Investor question: how much have the 2025 in-licensing deals committed in total? IR preparation: give a combined figure for upfront and milestone payments, even if individual terms are confidential.
Our analysis, not a company statement
Balance sheet and capital-policy indicators
A source-backed first-pass capital-efficiency, balance-sheet and governance reading, separate from the accountability score.
Cash use and returns
FY2025 operating profit was ¥35.5bn; the FY2026 forecast is ¥38.0bn on revenue of ¥200.0bn, with deramiocel and licensing revenue as the main growth.
Capital structure
Cash was ¥76.6bn and the equity ratio 84.2% at March 2026.
Governance of capital decisions
The plan sets ROE of 8% or more and ROIC of 9% or more for FY2028 while FY2025 ROE was 11.0%.
Preliminary and not scored: a selected-source reading, reviewed 20 October 2026. Surplus cash, leases, maturities, project returns, cost of capital, committed spend and peer comparability are not fully assessed; none enters the accountability score. Figures are the company’s own reported numbers; a large cash balance is not called excess without a defensible operating reserve and investment plan. Every company with a balance-sheet reading →
Changes to this record
- Research error 23 October 2026 · G5: 5 → 4. Every proposal is in the English notice, but the voting website shareholders use (Mitsubishi UFJ Trust and Banking) is in Japanese only.
- Research error 20 October 2026 · O3: 3 → 4. Two English results files still fail in Chrome, both from one server fault. Scored as one dead link, consistent with other companies.
Every change is labelled as a research error, new evidence supplied, improved disclosure or a rule change, with its date and the previous score. Change log →
Scores assess how English information is published, not the quality of the business or its investment value. To report an error or a document we missed, see how to contact us.