TAIPEI and SAN DIEGO, Sept. 16, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492, "Senhwa") today announced its official entry into the fast-growing global immuno-oncology market. The Company's novel investigational drug Pidnarulex (CX-5461) will be evaluated in combination with the approved PD-1 inhibitor Cemiplimab (Libtayo®), provided by Sanofi and Regeneron Pharmaceuticals, in a Phase 1/2 clinical trial for patients with microsatellite-stable colorectal cancer (MSS CRC) who are refractory to immune checkpoint inhibitors.

This strategic collaboration marks the third clinical trial under Senhwa's NCI-sponsored five-year cancer research program with the U.S. National Cancer Institute (NCI). An Investigational New Drug (IND) application has been submitted to the U.S. FDA. The partnership underscores the unique mechanism of action of CX-5461 and the strong interest from leading global pharmaceutical companies in its potential to enhance the immunotherapy efficacy.

Dr. Pin-Yen Huang, Chief Medical Officer of Senhwa, stated:
"This is more than a clinical trial—it is a transformative opportunity to redefine the future of cancer therapy. The compelling synergy between CX-5461 and PD-1 inhibitors holds the promise of bringing renewed hope to countless patients, while also showcasing Taiwan's spirit of innovation on the global stage."

Breaking Through Solid Tumor Immunotherapy Barriers

While immune checkpoint inhibitors have revolutionized cancer care, their response rates in solid tumors — other than melanoma — remain low at approximately 20–30%. The CX-5461 plus Cemiplimab combination aims to significantly improves these response rates, broaden the reach of PD-1 inhibitors, and potentially overcome treatment bottleneck in MSS CRC and other low-immunogenicity tumors.

Rising Momentum for Cross-Border Partnerships in Asia

According to recent data, cross-border licensing and M&A transactions in Asia's pharmaceutical sector surged to US$66 billion in just the first seven months of 2025, already surpassing the total value for the entire previous year. Several blockbuster deals exceeding US$1 billion demonstrate how global pharma leaders are rapidly pivoting strategic investments toward Asia.

Amid this trend, Senhwa stands at the intersection of differentiated innovation, strong collaborations with the NCI, and partnerships with global pharmaceutical companies. As immunotherapy and precision medicine markets continue their robust expansion, Senhwa is well-positioned to become a pivotal partner for multinationals while emerging as a key innovator in Asia's biotech landscape — creating a dual opportunity for growth and value for its stakeholders.

Unmet Need in MSS CRC and Young-Onset Colorectal Cancer

In metastatic CRC approximately 95% of metastatic colorectal cancer cases are MSS, for which effective immunotherapy options remain limited. Alarmingly, incidence among younger patients continues to rise, highlighting the urgent need for innovative approaches. Many patients either fail to respond or develop resistance to existing immunotherapies; and high treatment costs plus a lack of reliable biomarkers posing additional clinical challenges.

Through its innovative combination and precise design, this trial seeks to breakthrough current limitations, offering patients new hope by extending survival and improving quality of life.

Global Market Potential and Outlook for CX-5461

According to Coherent Market Insights, the global cancer immunotherapy market is projected to surpass US$150 billion by 2025, with sustained double-digit growth expected to push the market beyond US$300 billion by 2035. Combination therapies, in particular, have emerged as a central focus for industry R&D and investment.

As a first-in-class small molecule with a novel mechanism, preclinical data has shown CX-5461to have the ability to reprogram the tumor microenvironment, increase tumor mutational burden, and induce neoantigen presentation. Preclinical data also suggests the drug to enhance dendritic and cytotoxic T-cell infiltration while reducing immunosuppressive macrophages, thereby boosting sensitivity and efficacy of immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 therapies.

Crucially, CX-5461 has not shown marked bone‑marrow suppression at evaluated doses, in contrast to levels commonly seen with conventional chemotherapy. This advantage not only preserves cytotoxic immune cells but also creates a tumor microenvironment more favorable to immunotherapy and even cell-based therapies.

Looking Ahead

Senhwa will continue to advance global collaborations with pharmaceutical companies and academic institutions, leveraging the strong support of the NCI-NExT program to accelerate CX-5461 toward licensing and commercialization. Through this, Senhwa is committed to pioneering a new era of cancer care, strengthening its long-term competitive position, and driving sustainable growth.

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SOURCE Senhwa Biosciences, Inc.