InnoPharmax Submits Phase III Trial Application for D07001 to US FDA.

■ Details : 1. Date of Occurrence : November 8, 2024 2. Company Name : InnoPharmax Co., Ltd. 3. Relationship to the Company : The Company 4. Shareholding Ratio : Not applicable 5. Description of Event : The Company has submitted an application to the U.S. Food and Drug Administration (US FDA) to conduct a Phase III (pivotal) clinical trial for its investigational orphan drug, D07001, indicated for the treatment of cholangiocarcinoma. 6. Response Measures : None. 7. Other Matters to be Specified : (1) Drug Name / Code : D07001 (2) Indication : D07001 is intended for the treatment of cholangiocarcinoma. (3) Planned Development Stages : Conduct Phase III (pivotal) clinical trial and actively pursue licensing and collaboration opportunities. (4) Current Development Status : A. An application has been submitted to initiate a Phase III clinical trial in the United States. If no comments are raised by the US FDA within the 30-day review period, the Company may proceed with the trial. B. Risks related to unsuccessful regulatory approval or non-significant clinical outcomes: Not applicable. C. Future business strategy following approval or significant clinical outcomes: Not applicable. D. Accumulated R&D expenses: Not disclosed due to ongoing international licensing strategy and to protect investor interests. (5) Next Development Stage : A. Expected timeline: Subject to the progress of the Phase III clinical trial in the United States. B. Obligations: Costs associated with conducting the clinical trial. (6) Market Overview : Cholangiocarcinoma is a malignant tumor arising from bile duct epithelial cells. Due to its often subtle symptoms, early detection is difficult, and many patients are diagnosed at an advanced stage. Currently, effective treatment options remain limited, and the overall 5-year survival rate is low. According to Transparency Market Research, global sales of gemcitabine (the active ingredient of D07001 soft capsules) were approximately USD 635 million in 2021 and are projected to reach USD 1.3 billion by 2031, representing a compound annual growth rate (CAGR) of 7.8% from 2022 to 2031. (7) Investment Risk : Drug development is time-consuming, costly, and inherently uncertain. Investors are advised to carefully evaluate and manage investment risks.

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