InnoPharmax BendaReady Approved as New Bendamustine Formulation in Taiwan.

■ Details :
 

1. Date of Occurrence : January 2, 2026

2. Company Name : InnoPharmax Inc.

3. Relationship to the Company (please specify parent company or subsidiary) : The Company

4. Reciprocal Shareholding Ratio : Not applicable

5. Cause of Occurrence :
The Company’s BendaReady Injection has been approved by the Ministry of Health and Welfare (MOHW) of Taiwan and has obtained the first marketing authorization for a new formulation of Bendamustine. The approval number is “MOHW Drug Manufacturing No. 062092.” The Company will proceed with preparations for product launch.

6. Countermeasures : None.

7. Other Matters to be Stated :
(1) The Company’s self-developed new formulation drug, BendaReady Injection, has been approved for marketing by the Taiwan Food and Drug Administration (TFDA). The approved indications include:
A. Chronic lymphocytic leukemia (CLL), Binet stage B and C
B. Indolent non-Hodgkin lymphoma (NHL) that has progressed during or within six months following treatment with rituximab, as monotherapy in patients who have received at least one prior chemotherapy
C. Bendamustine in combination with rituximab for previously untreated CD20-positive, stage III/IV indolent non-Hodgkin lymphoma; and for patients with previously untreated stage III/IV mantle cell lymphoma (MCL) who are not candidates for autologous stem cell transplantation

This represents the first solution-form Bendamustine HCl new formulation drug approved in Taiwan.

(2) According to the Bendamustine Market report (October 2025) by Market Research Future, the global Bendamustine market was estimated at USD 2.066 billion in 2024. It is projected to grow from USD 2.179 billion in 2025 to USD 3.715 billion by 2035, with a compound annual growth rate (CAGR) of 5.48%. North America remains the largest market, while the Asia-Pacific region is expected to be the fastest-growing, driven by expanded healthcare coverage and increasing cancer awareness.

(3) As the Company operates in the biotechnology industry, investors are advised to refer to publicly disclosed financial and revenue information on the Market Observation Post System and to exercise prudent judgment in investment decisions.


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