Welcome to our dedicated page for YD Bio SEC filings (Ticker: YDESW), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
YD Bio Limited’s SEC filings document foreign private issuer reports on material events, agreements, governance and regulatory-service activity. Form 6-K disclosures cover YD Bio USA’s strategic alliance agreement for FDA liaison and submission-support work, including IND, NDA and BLA-related projects, as well as capital-structure and clinical or regulatory disclosures.
The filings also record board committee appointments, audit committee composition, Nasdaq Listing Rule 5605 compliance, changes in certifying accountant and related audit disclosures, including going-concern language reported in prior audit reports. These records frame the company’s public disclosure around operating subsidiaries, governance controls, accounting oversight and regulatory-service partnerships.
YD Bio Limited announced that its U.S. subsidiary, YD Bio USA, has entered a Master Strategic Alliance Agreement with YC Biotech to build a Taiwan-U.S. “Dual-Core” regulatory platform. YD Bio USA becomes YC Biotech’s exclusive U.S. Agent and formal liaison to the FDA for its Asian CRO clients.
The partnership covers a wide range of FDA interactions, including IND, NDA, BLA, IDE, 510(k), De Novo, and PMA submissions, as well as inspection readiness and ongoing regulatory strategy. YC Biotech will lead project acquisition and technical execution, while YD Bio USA handles U.S. regulatory interface and strategy.
The company describes this as a shift from single-project advisory work toward a scalable platform designed to onboard more Asian CRO partners, potentially expand to EMA-related work, and deepen a U.S. clinical network. Management notes that its pipeline already includes projects that have completed INTERACT, pre-IND, and IND meetings.
YD Bio Ltd files an amended Schedule 13G showing beneficial ownership stakes. The filing reports that Ethan Shen beneficially owns 54,345,011 ordinary shares (77.06%) and YD Biopharma Holding Limited beneficially owns 43,120,858 ordinary shares (61.15%). The filing states these percentages are calculated from a total of 70,521,359 ordinary shares as of November 17, 2025, per the issuer's Rule 424(b)(3) prospectus. The cover-page rows break ownership into sole and shared voting and dispositive powers, with Mr. Shen holding 11,224,153 sole voting and dispositive shares and 43,120,858 shared voting and dispositive shares through the Cayman Islands entity.
YD Bio Limited has entered into a binding letter of intent to acquire Safe Save Medical Cell Sciences & Technology Co., Ltd. (“SSMC”), a Taiwan-based dendritic cell immunotherapy platform. The deal is structured through a new offshore holding entity, Safe Save Cell (KY) Holdings Limited, which will hold 100% of SSMC’s equity.
The total consideration is expected to be NT$839,832,000 (approximately US$26.87 million), paid in a mix of cash and newly issued YD Bio ordinary shares. Large SSMC shareholders, including the founder and affiliates, will receive YD Bio shares via share swap, while other shareholders may choose cash or shares. New shares will be locked up for six months for general shareholders and one year for specific shareholders.
Closing is subject to due diligence, SSMC’s restructuring, and no material adverse change, with due diligence targeted by March 20, 2026 and closing expected within 30 days thereafter. After completion, YD Bio expects to own all of SSMC’s shares, business, and assets, strengthening its position in advanced immunocell and cancer therapies.
YD Bio Limited reports governance changes and a listing status update. On January 16, 2026, the Board appointed Dr. Chang as Chairman of the Compensation Committee and as a member of the Audit Committee and the Nominating and Corporate Governance Committee. On the same date, Dr. Lu was appointed Chairman of the Nominating and Corporate Governance Committee and as a member of the Audit Committee and Compensation Committee.
The company states that Dr. Chang and Dr. Lu have no material related-party interests, arrangements, or family relationships requiring disclosure under specified SEC regulations. On January 20, 2026, YD Bio notified Nasdaq that it has regained compliance with Audit Committee requirements under Nasdaq Listing Rule 5605 and is no longer in a cure period under Listing Rule 5605(c)(4)(B).
YD Bio Limited reports a change in its independent auditor. On September 16, 2025, the company ended its engagement with CBIZ CPAs P.C. as its independent registered public accounting firm, with the decision approved by both the audit committee and the board of directors.
CBIZ CPAs’ reports on YD Bio’s consolidated financial statements since inception on February 6, 2024 contained no adverse or disclaimed opinions and were not qualified, although they included an explanatory paragraph raising substantial doubt about the company’s ability to continue as a going concern. The company states there were no disagreements with CBIZ CPAs on accounting, disclosure, or audit matters, and none of the specified reportable events under Item 16F of Form 20-F occurred.
Effective September 17, 2025, YD Bio engaged ARK Pro CPA & Co as its new independent registered public accounting firm for the fiscal year ending December 31, 2025, with no prior consultations on accounting or audit opinions reported.