InnoPharmax Submits Phase II Trial Application for D07001 (GemOral) to TFDA.

■ Details :


1.Date of Occurrence : January 5, 2026

2.Company Name : InnoPharmax Inc.

3.Relationship to the Company : The Company

4.Shareholding Ratio : Not applicable

5.Description of Event :
The Company has submitted a new Phase II clinical trial application for its self-developed D07001 soft capsule to the Taiwan Food and Drug Administration (TFDA).

(1) Name/Code of the Investigational Drug : D07001 Soft Capsule
(2) Indication: Cancer treatment

(3) Planned Development Stages :
A Phase II clinical trial (Protocol No.: Inno-GO-08) has been submitted to TFDA for review. The study adopts a basket trial design to evaluate indications in advanced non-small cell lung cancer (NSCLC) and pancreatic cancer. Approximately 48 patients are expected to be enrolled (about 24 patients per indication).

(4) Current Development Status :

(i) The Company has submitted the Phase II clinical trial application (Protocol No.: Inno-GO-08) to TFDA for review (Indications: advanced NSCLC / pancreatic cancer).
(ii) Risk factors and mitigation measures: Not applicable.
(iii) Future business direction upon approval or significant results: Not applicable.
(iv) Accumulated R&D expenses: Not disclosed to protect the Company’s and investors’ interests in future international licensing negotiations.

(5) Next Development Phase :

(6) Market Overview :
The global pancreatic cancer market is experiencing strong growth. According to Precedence Research, the market size is estimated at approximately USD 3.25 billion in 2025 and is projected to reach USD 10.25 billion by 2034. Chemotherapy remains the cornerstone of pancreatic cancer treatment, with regimens such as FOLFIRINOX and gemcitabine-based combinations widely used.

Non-small cell lung cancer (NSCLC) represents the largest segment of lung cancer (approximately 85%), making it a key therapeutic market. According to GlobalData, the NSCLC market size across the seven major markets was USD 24.1 billion in 2022 and is expected to reach USD 56.5 billion by 2032, with a compound annual growth rate (CAGR) of 8.9%.

(7) Risk Statement :
New drug development requires long timelines and substantial investment, and success is not guaranteed. Investors should carefully assess and exercise caution.

  • A Taiwan Phase 2a clinical trial combining D07001 with capecitabine or TS-1 for advanced biliary tract cancer is in the process of study closure (Protocol No.: Inno-GO-05).
  • A global Phase III clinical trial combining D07001 with capecitabine for advanced biliary tract cancer is ongoing (Protocol No.: Inno-GO-07).
  • Estimated Completion Timeline : Subject to regulatory review timelines and clinical trial execution progress.
  • Obligations : Not applicable.

6. Response Measures : None.

7. Other Information :
This application is currently under regulatory review. Future progress may be affected by TFDA’s review outcome, clinical trial execution, and patient recruitment. The Company will make further announcements in accordance with regulations if there are any material developments.


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