Material Information- Announces on Behalf Handa Oncology, LLC, regarding the 505 (b)(2) new formulation drug HND-039 OMCAZIO receives U.S. FDA Final Approval (FA)
1.Date of occurrence of the event: 2026/09/04
2.Company name: Handa Oncology, LLC
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):Subsidiaries
4.Reciprocal shareholding ratios: Handa Oncology, LLC is a 100% indirectly owned subsidiary of the Company.
5.Cause of occurrence: On September 03, 2026 (U.S. time) , Handa Oncology, LLC received notification from the U.S. Food and Drug Administration (”FDA”) that its NDA for HND-039 OMCAZIO capsules(11.5 mg, 23 mg and 34.5 mg) has been granted Final Approval.
6.Countermeasures: This announcement is made in compliance with applicable disclosure requirements.
7.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
I. Relevant Information Regarding the Development Program
(I) Name or Code Name of the Drug Under Development: HND-039 Omcazio capsules(11.5 mg, 23 mg and 34.5 mg).
(II) Indication: A 505(b)(2) new drug for the treatment of cancer.
(III) All Development Stages Planned: All development stages have been completed.
(IV) Current Development Status:
1. Application Submitted / Approval Obtained / Approval Not Obtained: HND-039 OMCAZIO has received Final Approval from FDA.
2. Risks Faced by the Company and Countermeasures if Approval from the Competent Authority Has Not Been Obtained: Not applicable.
3. Future Business Direction After Approval from the Competent Authority Has Been Obtained: The Company will actively proceed with the relevant preparations for the product launch.
4. Cumulative R&D Expenses Incurred: As the relevant information involves marketing strategies, in order to protect investors’ interests, the Company will not disclose such information at this time.
(V) Next Development Stage to Be Conducted:
1. Expected Completion Date: Not applicable
2. Expected Obligations to Be Assumed: None
(VI) Market Status: According to information disclosed in the original patent holder’s annual report for fiscal year 2025, sales of the reference listed drug in the U.S. market amounted to approximately US$2.113 billion in 2025.
II. Drug development involves long timelines, high costs, and requires regulatory review. The approval timeline is uncertain and success is not guaranteed, which may pose investment risks. Investors should exercise caution and make prudent judgments.