Material Information- Announces on behalf of the subsidiary Handa Oncology, LLC, regarding the 505(b)(2) new formulation drug HND-039 citizen petition to the FDA examination
1.Date of occurrence of the event:2026/04/17
2.Company name:Handa Oncology, LLC
3.Relationship to the Company (please enter ”head office” or ”subsidiaries”):Subsidiaries
4.Reciprocal shareholding ratios:Not applicable
5.Cause of occurrence:The Company was informed on April 16, 2026 (U.S. time) that Handa Oncology, LLC (hereinafter referred to as “Handa Oncology”),an indirectly held subsidiary of the Company, became aware that Exelixis, Inc (hereinafter referred to as “Exelixis”), the originator of HND-039, had filed a Citizen Petition with the U.S. FDA.
6.Countermeasures:
(1)Exelixis filed a Citizen Petition with the U.S. FDA on April 9, 2026 (U.S. time), which was subsequently posted on the U.S. government website on April 14, 2026 (U.S. time). The Company was not directly notified during this process and only became aware of the matter on April 16, 2026 (U.S. time) upon notification by its U.S. legal counsel. Upon receipt of such notice, the Company promptly clarified the relevant information and
issued a material announcement.
(2)The Citizen Petition filed by Exelixis contains comments on the bioequivalence and impurity control of HND-039 without a full understanding of the specific details of HND-039’s new drug application, and recommends that the U.S. FDA not approve HND-039 under the 505(b)(2) pathway. The Company’s New Drug Application (NDA) for HND-039 was submitted following multiple communications with the U.S. FDA, including discussions on impurity control and study design, and in compliance with the bioequivalence standards established by the U.S. FDA. The Company believes that the U.S. FDA will make a reasonable decision on the HND-039 application based on scientific evidence.
(3)The Company is committed to prioritizing patient welfare and will actively cooperate with the U.S. FDA in addressing any review requirements to ensure the safety and efficacy of HND-039.
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.):
(1)The Company’s research indicates that the pharmacokinetics of the product marketed by Exelixis exhibit high variability, whereas HND-039 demonstrates a significant reduction in such variability. In addition, the Company conducted simulations to evaluate the potential clinical benefits of HND-039 based on bioequivalence. The results were presented at the Genitourinary Cancers Symposium (ASCO GU) organized by the American Society of Clinical Oncology in late February 2026 (please refer to the Company’s official website: https://handapharma.com.tw/about/history/). The simulation study suggests that the Company’s product may improve the incidence of adverse events.
(2)Based on prior U.S. FDA cases and applicable regulations, the U.S. FDA is required to respond to such petitions within 150 days. The response may include a full denial, partial approval, or full approval of the petition.
(3)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.