■ Details :
 

1. Date of Occurrence : December 10, 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’s investigational orphan drug D07001, indicated for the treatment of cholangiocarcinoma, has been cleared to proceed with a Phase III (pivotal) clinical trial.

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. The Company submitted an IND application to the U.S. Food and Drug Administration on November 8, 2024 (U.S. time) for a new formulation of D07001 to conduct a Phase III clinical trial in cholangiocarcinoma and received an automatic acknowledgment of receipt on the same day.

B. According to U.S. regulations (21 CFR 312.40(b)(1) and (2)), if no clinical hold is issued by the US FDA within 30 days of submission, the trial may proceed. As of December 9, 2024 (U.S. time), the Company has not received any clinical hold notification. Therefore, the Company is permitted to proceed with the Phase III clinical trial.

C. The Phase III trial is designed as an open-label, randomized, controlled, multi-regional, multi-center study. Approximately 195 patients will be enrolled across the United States, Europe, and Asia. Eligible patients include those with cholangiocarcinoma who have failed first-line gemcitabine plus platinum therapy and FOLFOX treatment, or are unsuitable for FOLFOX.

(5) Next Development Stage :
A. Expected timeline: Subject to the progress of the Phase III clinical trial.
B. Obligations: Costs associated with conducting the clinical trial.

(6) Market Overview :
Cholangiocarcinoma is a malignant tumor originating from bile duct epithelial cells. Due to its often subtle symptoms, early diagnosis is challenging, and most patients are diagnosed at an advanced stage. 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.