■ Details :
1. Date of Occurrence : February 5, 2025
2. Company Name : InnoPharmax Inc.
3. Relationship to Company : The Company
4. Shareholding Ratio : Not applicable
5. Event Description :
The Company’s investigational new drug, D07001 Softgel Capsules, has been approved by the Taiwan Food and Drug Administration (TFDA) to be used in combination with Xeloda or TS-1 for a Phase II/III clinical trial in patients with advanced biliary tract cancer who have failed first-line chemotherapy with gemcitabine and platinum-based regimens.
The first stage of the trial began enrolling subjects on September 29, 2022. Patients received combination therapy with either Xeloda or TS-1. Enrollment has now been successfully completed with the inclusion of the final subject.
A total of 18 subjects were enrolled in this stage. The results of this trial will provide supporting data for a global Phase III clinical trial planned for 2025.
(1) Study Title :
Open-Label, Multicenter, Phase II/III Study of Combination Therapy of D07001 Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer After Gemcitabine and Cisplatin-Based Treatment Failure
For more details, please refer to ClinicalTrials.gov:
https://clinicaltrials.gov/ct2/show/NCT05065957
(2) Study Objective :
To evaluate the efficacy and safety of D07001 Softgel Capsules in combination with Xeloda or TS-1 in patients with advanced biliary tract cancer who have failed first-line gemcitabine and platinum-based chemotherapy.
(3) Number of Subjects :
18 subjects enrolled in the first stage.
(4) Trial Locations :
Five clinical trial centers in Taiwan.
6. Actions Taken :
None.
7. Other Information :
(1) Drug Name/Code : D07001 Softgel Capsules
(2) Indication : Cancer treatment
(3) Planned Development Stages :
Phase II/III clinical trials in biliary tract cancer and New Drug Application (NDA) review.
(4) Current Development Status :
- No application submission, approval, rejection, interim analysis results, or other significant events affecting development at this stage.
(5) Next Development Stage :
- Expected completion timeline will be disclosed in accordance with regulatory requirements and clinical progress.
- No specific obligations at this stage.
(6) Market Overview :
According to Transparency Market Research, global sales of gemcitabine (the active component of D07001 Softgel Capsules) were approximately USD 635 million in 2021 and are projected to reach USD 1.3 billion by 2031, with a compound annual growth rate (CAGR) of 7.8% from 2022 to 2031.
(7) Investment Risk Statement :
New drug development involves long timelines, high costs, and inherent uncertainties. Success is not guaranteed. Investors are advised to carefully assess risks and exercise prudent judgment.
