Material Information- Correction to Handa Pharmaceuticals, Inc., and on behalf of the subsidiary, regarding the 505(b)(2) new formulation drug HND-039 patent infringement lawsuit
1.Parties to the legal matter:
Plaintiff：Exelixis, Inc
Defendant：Handa Pharmaceuticals, Inc., Handa Pharma, Inc. and Handa Oncology, LLC
2.Name of the court or punishing agency of the legal matter:United States District Court for DELAWARE
3.Reference/Case number of relevant documents of the legal matter:NO. 1:26-cv-00813-UNA
4.Date of occurrence of the event:2026/07/15
5.Details of occurrence (including the matter under dispute):The 505(b)(2) new drug formulation HND-039, developed by Handa Oncology, LLC, was submitted to the US FDA for a New Drug Application (NDA) on September 29, 2025, and was accepted on November 18, 2025. The PDUFA target action date is July 29, 2026 (U.S. time).
On July 7, 2026, Handa Pharmaceuticals, Inc., the subsidiary Handa Pharma, Inc. and Handa Oncology, LLC received a patent infringement notice from Exelixis, Inc. This is a standard patent infringement lawsuit and does not trigger the 30-month stay under the Hatch-Waxman Act. Accordingly, the FDA’s target action date remains unchanged.
6.Handling procedure:Such kind of patent disputes are not uncommon among companies developing 505(b)(2) new formulation drugs and a part of the industry norm, the Company has already engaged attorneys to respond to the legal dispute. The Company will actively defend the rights of HND-039 and resolve the legal dispute as soon as possible consistent with US law and practice.
7.Impact on the Company’s finance and business and projected amount: Attorneys will handle subsequent matters according to legal procedures. As of now, there is no material impact on the Company’s operations or financial condition.
8.Countermeasures and improvement status:The Company will continue to cooperate with the US FDA’s review process and carry out related procedures for the patent litigation.
9.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 2 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) Such patent litigation is a routine procedure in the US drug approval process and is common in the development of 505(b)(2) new formulation drugs. The Company will continue to execute its previously planned product launch and business development strategies as scheduled.
(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.
(3)The Company received the written complaint on July 15, 2026, and accordingly updated the relevant case number.