Komori
Kohjin Bio (177A) · RiskMaterialised

Non-Compliance with Pharmaceutical and Regenerative Medicine Regulations

First written in FY2024. 2 of 4 entries say "Materialised", first in 2026-06-03. Latest entry: FY2026.

4entries
3years
1from disclosures
Share on X
How it moved
ProgressHeldSoftenedWorseFirst statedFY2024 – FY20252024: 120242025: 120252026: 22026
Same theme, other companies
Risk of Administrative Sanctions for Violations of Laws, Permits and RegulationsA theme 43 companies write about · 43 as a headwind · 0 as a tailwind

Kohjin Bio moved to the "Worse" side of this theme in 2026, 3 years after the typical company in this theme (2023).

The whole theme swung hardest in 2026: 4 of 13 companies on the "Worse" side.

3 other companies' latest entry also says "Materialised".

Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Showing 14 of the 43 companies compared. The sentences above are computed from all 43.
Full recordFilings, disclosures and news, newest first
  1. FY2026MaterialisedAnnual report

    「In January 2026, the Company received administrative action (the “Administrative Action”) for violating the compliance requirements for manufacturers of specified cell-processed products and other products stipulated in the Enforcement Regulations of the Act on Ensuring the Safety of Regenerative Medicine, etc.」

    Regarding the risk of non-compliance with pharmaceutical and regenerative-medicine regulations, administrative action for violating compliance requirements has actually occurred.
  2. 2026-06-03MaterialisedGeneral Meetings of Shareholders

    「2025年８月、当社が製造を行った特定細胞加工物等（以下「本製品」といいます。）について、本製品との関係が疑われる死亡事例（以下「本事例」といいます。）が発生したことを受けて、当社は再生医療等の安全性の確保等に関する法律（以下「法」といいます。）に基づく行政処分を受けました。」

    医薬品・再生医療関連規制への不適合リスクについて、2025年8月および2026年1月の行政処分と、是正措置・再発防止策の実施を事業報告で記載している。
  3. FY2025RestatedAnnual report

    「In conducting its business, the Group is subject to various legal regulations, including the Act on Ensuring the Safety of Regenerative Medicine, etc., the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and other relevant laws and regulations applicable to some products.」

    The risk of non-compliance with pharmaceutical and regenerative-medicine regulations remains ongoing.
  4. FY2024First statedAnnual report

    「In conducting its business, the Group is subject to various legal regulations, including the Act on Ensuring the Safety of Regenerative Medicine, etc., the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, and other relevant laws and regulations applicable to some products.」

    It identifies maintaining licenses and approvals, legal compliance, and review by the Risk and Compliance Committee as measures.
Moved together

None of this company's other threads moved the same way in the same document twice or more.

When this could move next
No upcoming earnings preview for Kohjin Bio yet. It last moved in the General Meetings of Shareholders of 2026-06-03: "Materialised".
News
No news is linked to this thread yet. When an article touches it, it will appear here by date.
Non-Compliance with Pharmaceutical and Regenerative Medicine Regulations | Kohjin Bio Co.,Ltd. (177A) | Komori