■ Details :
 

1. Date of Occurrence : April 10, 2025

2. Company Name : InnoPharmax Inc.

3. Relationship to Company : The Company

4. Shareholding Ratio : Not applicable

5. Cause of Occurrence :
The Company’s investigational drug, D07001 softgel capsules, has been approved by the Taiwan Food and Drug Administration (TFDA) for a Phase II/III clinical trial in combination with Xeloda or TS-1. The study targets patients with advanced biliary tract cancer who have failed first-line chemotherapy with gemcitabine and platinum-based regimens.

Stage 1 of the trial began patient enrollment on September 29, 2022. A total of 18 subjects were enrolled and treated with D07001 in combination with either Xeloda or TS-1. Patient enrollment and treatment have been completed, and the Safety Review Committee (SRC) has completed its evaluation and confirmed the completion of the safety assessment for this stage.

Data indicate that D07001 softgel capsules, at the maximum tolerated dose (MTD), can be safely combined with Xeloda or TS-1, supporting dose selection for subsequent studies.

Following completion of Stage 1, the study will proceed to a pivotal global Phase III clinical trial using the highest dose to evaluate the efficacy of D07001 softgel capsules.

(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 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 Stage 1

(4) Study Locations :
Five clinical trial sites in Taiwan

6. Countermeasures : None

7. Other Disclosures :

(1) Drug Name/Code : D07001 Softgel Capsules
(2) Indication : Cancer treatment
(3) Planned Development Stages : Phase II/III clinical trials for biliary tract cancer and New Drug Application (NDA) submission
(4) Current Development Status :
A. Application/approval status or clinical results: Not applicable
B. Risks and mitigation if not approved or if results are not statistically significant: Not applicable
C. Future development direction if approved or successful: Not applicable
D. Accumulated R&D expenses: Not disclosed due to ongoing international licensing negotiations

(5) Next Development Stage :
A. Expected completion timeline: To be disclosed in accordance with regulatory requirements and clinical progress
B. Obligations: Not applicable

(6) Market Overview :
According to Transparency Market Research, global sales of gemcitabine (active component of D07001) 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) Risk Statement :
New drug development is time-consuming, costly, and not guaranteed to succeed. Investors are advised to exercise prudent judgment.