Material Information- Announces on Behalf Handa Oncology, LLC, regarding the 505 (b)(2) new formulation drug HND-039 OMCAZIO receives U.S. FDA Tentative Approval (TA)
1.Date of occurrence of the event: 2026/07/30
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:
Handa Oncology, LLC, a subsidiary of the Company, is developing a 505(b)(2) new formulation drug HND-039 OMCAZIO, for the treatment of cancer.
As previously announced, on November 18, 2025 (U.S. time), the U.S. Food and Drug Administration (”FDA”) notified Handa Oncology, LLC that its NDA for HND-039 OMCAZIO had been accepted for substantive review, with a target action date of July 29, 2026 (U.S. time).
On July 29, 2026 (U.S. time) , Handa Oncology, LLC received notification from the FDA that its NDA for HND-039 OMCAZIO has been granted Tentative Approval (”TA”).
Under the U.S. Federal Food, Drug, and Cosmetic Act, when the FDA completes its review of an NDA before the expiration of the applicable patent or regulatory exclusivity period, and the application otherwise satisfies all requirements for approval, the FDA may grant Tentative Approval. A Tentative Approval indicates that the FDA has concluded that the NDA meets the applicable standards for quality, safety, and efficacy. However, the product may not be commercially marketed in the United States until the applicable patent and exclusivity period has expired and all remaining regulatory requirements have been satisfied, at which time the FDA may grant Final Approval (”FA”).
The FDA granted Tentative Approval for HND-039 OMCAZIO because the compound patent covering the reference listed drug remains in effect.
The applicable patent is scheduled to expire on August 14, 2026 (U.S. time). The Company will continue to pursue Final Approval while advancing commercial launch preparations. Upon receipt of Final Approval, the Company expects to commercialize HND-039 OMCAZIO in the United States.
6.Countermeasures:This announcement is made in compliance with applicable disclosure requirements. The Company will continue to pursue Final Approval (”FA”) for HND-039 OMCAZIO in accordance with the FDA’s regulatory process, the expiration of the applicable patent and regulatory exclusivity period, and all applicable U.S. laws and regulations.
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
(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 Tentative Approval (”TA”) from the U.S. Food and Drug Administration (”FDA”); however, Final Approval (”FA”) has not yet been obtained.
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: HND-039 OMCAZIO has received FDA Tentative Approval.
Upon expiration of the applicable patent in the United States on August 14, 2026 (U.S. time) and removal of the relevant restrictions, the Company will complete the remaining procedures required to obtain FDA Final Approval and subsequently launch HND-039 OMCAZIO in the U.S. market. The Company will formulate subsequent commercialization plans based on the FDA’s regulatory process, the anticipated timeline for Final Approval, and market conditions.
4. Cumulative R&D Expenses Incurred: As the relevant information involves future international licensing negotiations, and in order to avoid affecting potential licensing terms and 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:
The Company will promptly initiate the process for applying for FDA Final Approval. Based on industry experience, the FDA review process is expected to be completed within 1 quarter; however, the actual review timeline remains subject to the FDA’s review progress. The Company will make further announcements upon obtaining Final Approval.
2. Expected Obligations to Be Assumed:
Based on the current plan, no significant additional obligations are expected in connection with the procedures required to obtain Final Approval.
(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.