Material Information- Announces on behalf of the subsidiary Handa Oncology, LLC, regarding FDA’s denial of the Citizen Petition against 505(b)(2) new drug HND-039 Omcazio
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:Not applicable
5.Cause of occurrence:Handa Oncology, LLC (hereinafter referred to as “Handa Oncology”), an indirectly held subsidiary of the Company, was informed on April 16, 2026 (U.S. time) that Exelixis, Inc. (hereinafter referred to as ‘Exelixis’), the originator of HND-039 Omcazio, had filed a Citizen Petition with the U.S. FDA (hereinafter referred to as ‘FDA’), requesting the FDA to deny Handa Oncology’s 505(b)(2) New Drug Application (NDA) for HND-039 Omcazio, among other demands. The FDA fully denied all requests in the Citizen Petition on September 3, 2026 (U.S. time).
Furthermore, HND-039 Omcazio received Final Approval from the FDA on September 3, 2026 (U.S. time).
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.):
(1)The Company will continue to actively prepare for the product launch.
(2)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.