HanchorBio Announces Receipt of U.S. FDA Type C Meeting Minutes Supporting HCB101 Development Path in Second-Line Gastric/GEJ Cancer

1. Date of Event: 115/06/30

2. Company Name: HanchorBio Inc. (Chinese translation: Hanchor Biotechnology Co., Ltd., Cayman Islands)

3. Relationship to Company (please enter '本公司' or 'subsidiary'):本公司 (the Company)

4. Cross-shareholding Ratio: Not applicable

5. Reason for Occurrence: The Company today received the official minutes from a Type C meeting with the U.S. Food and Drug Administration (U.S. FDA) regarding the follow-up development strategy for HCB101 after its Phase I clinical trial.

The meeting minutes outline the future development direction of HCB101 in second-line gastric/gastroesophageal junction (GEJ) cancer and serve as a basis for future communication with the FDA.

According to the FDA meeting minutes, the FDA raised no objections to the Company’s shift in near-term development focus from declaring the recommended Phase II dose (RP2D) for monotherapy to a pre-planned, systematic evaluation of dosing and scheduling for combination therapy administered once every two weeks (Q2W).

The minutes also indicate that continued exploration of HCB101 in combination with ramucirumab and paclitaxel is scientifically justified.

Furthermore, in this treatment context, advancing to a future registrational Phase III clinical trial with overall survival (OS) as the primary endpoint is considered an appropriate development path.

6. Response Measures: The Company will incorporate the content of the FDA meeting minutes into the future clinical development plan for HCB101, including optimization of trial protocols for dose/schedule exploration, dose optimization in the Phase 2b lead-in stage, confirmation of safety profile, and the statistical framework for the future pivotal Phase II/III clinical study required for clinical trial applications.

7. Other Matters to be Disclosed (If the entity involved in the event or resolution is a publicly listed company or above, this material information also meets the criteria under Article 7, Paragraph 9 of the Enforcement Rules of the Securities and Exchange Act, regarding matters that significantly affect shareholders’ rights or securities prices):

(1) New drug development involves long timelines, high investment costs, and highly uncertain clinical trial outcomes. Investors are advised to make cautious judgments and invest prudently.

(2) This announcement describes the progress of the Company’s new drug development and has no significant immediate impact on the Company’s financial condition or business operations.