Polaris Pharmaceuticals-KY Supplements Financial and Operational Impact of Voluntary Withdrawal of Pegargiminase (ADI-PEG 20) BLA Submission to U.S. FDA for Malignant Pleural Mesothelioma

1. Date of Event: 115/07/27

2. Company Name: Polaris Pharmaceuticals Group Co., Ltd.

3. Relationship with Company (please enter本公司or Subsidiary):本公司

4. Cross-shareholding Ratio: Not applicable

5. Reason for Occurrence: Supplement to Item 3 regarding impact on company's financials and operations

6. Item to be Corrected / Report Name: 3. Impact on Company's Financials and Operations

7. Information Before Correction / Amount / Content / Page:

This case represents an adjustment to the application timeline based on the company’s overall R&D and regulatory strategy. The company will proceed with the withdrawal process in accordance with relevant regulations and FDA procedures, and will continue to evaluate the feasibility of Pegargiminase (ADI-PEG 20) for other indications and future development plans. This action has no significant impact on the company’s overall operations or shareholder权益.

8. Information After Correction / Amount / Content / Page:

The financial and operational impact of the voluntary withdrawal of the Biologics License Application (BLA) for malignant pleural mesothelioma (MPM) primarily reflects a strategic shift and long-term optimization of resource allocation.

Operationally, the company is currently streamlining its internal organizational structure and comprehensively re-evaluating all key business initiatives. Throughout the BLA review process, the company has continuously supplemented data and maintained good communication with the regulatory authority (i.e., U.S. FDA). However, based on overall business strategy and long-term product commercialization planning—particularly considering core factors such as the comprehensive benefits of market exclusivity—the company has decided to voluntarily withdraw the application. Following the announcement of this material information, the company has proceeded with the BLA withdrawal in accordance with relevant regulations and procedures. It continues to review existing clinical trial data, conducting deeper analyses on treatment responses, potential patient benefits, and overall development feasibility across different patient populations. These analyses will inform the next steps for the program and assess the feasibility of developing ADI-PEG 20 for other indications.

Financially, this decision will immediately eliminate future regulatory fees and administrative expenses associated with advancing the BLA review and potential pre-launch activities. By adjusting strategy promptly, the funds saved can be reallocated, allowing the company to more flexibly concentrate financial resources on optimizing its product portfolio or other R&D projects with greater long-term commercial potential. This move not only effectively controls operating costs and improves capital efficiency but also further strengthens the company’s overall financial resilience, enabling more flexible concentration of financial resources on optimizing the existing product portfolio. It ensures R&D investments are converted into tangible asset value, continuously creating long-term benefits for patients and shareholders.

The withdrawal of the BLA is expected to save approximately USD 100,000 in future administrative and regulatory fees.

9. Response Measures: Not applicable

10. Other Matters to be Disclosed:

The estimated financial savings are provided in response to exchange requirements. The company can only estimate savings based on past experience and does not guarantee or commit to the actual future savings amount. Since the company’s core business involves clinical trials, its R&D progress is highly subject to uncertain factors such as regulatory reviews, patient recruitment rates, and clinical data outcomes. Actual financial figures may differ from the current estimates.