Senhwa Biosciences and BeOne Medicines Announces a Clinical Supply Agreement to Address the Challenge of Cold Tumors

TAIPEI and SAN DIEGO, Dec. 10, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company developing first-in-class therapies for difficult-to-treat cancers, today announced a clinical supply agreement with BeOne Medicines, a global oncology company. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwa's lead compound Pidnarulex (CX-5461) in combination with BeOne's tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

This agreement represents a significant milestone for Senhwa as CX-5461 enters the immuno-oncology field, and it also underscores the company's commitment to advancing strategic combination therapies that break through the limitations of immunotherapy —bringing new hope to cancer patients worldwide.

Senhwa Biosciences: Driving a New Era in Immuno-Oncology

"This agreement represents a major step forward for Senhwa as we expand into the heart of immuno-oncology," said Benny T. Hu, Chairman of Senhwa Biosciences. "By leveraging the unique mechanism of action of CX-5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing treatment options, while increasing international recognition and building long-term strategic value for the company," added by Chairman Hu.

Under the terms of the agreement, BeOne Medicines will provide tislelizumab for the combination study, while Senhwa will supply CX-5461 and lead clinical and regulatory operations. The study will enroll patients at multiple sites in the United States and Taiwan, assessing safety, tolerability, and preliminary efficacy of the CX-5461 plus tislelizumab combination.

By modulating the tumor microenvironment, CX-5461 breaks through the barriers of immunotherapy, opening new possibilities for cancer treatment

Discovered and developed by Senhwa, CX-5461 is the world's first G-quadruplex stabilizer with significant clinical data—a novel therapeutic class designed to selectively disrupt genomic stability in tumor cells through replication stress induction.

Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumor microenvironment, enhancing immune recognition and response.

By converting immunologically "cold" tumors into "hot" ones, CX-5461 may sensitize previously resistant tumors to checkpoint blockade and broaden the clinical utility of immunotherapy.

The "cold-to-hot" tumor concept represents one of the most promising frontiers in cancer immunology. CX-5461's differentiated mechanism positions Senhwa to play a leading role in improving the efficacy of the immune checkpoint inhibitors approved by FDA with only 20-30% response rates.

Global Immunotherapy Market: Expanding Horizons

According to Precedence Research, the global cancer immunotherapy market is expected to grow from USD 136.4 billion in 2025 to USD 338.4 billion by 2034, representing a compound annual growth rate (CAGR) of 10.65%. Similarly, Grand View Research projects that the broader immunotherapy market will exceed USD 486 billion by 2030.

As major pharmaceutical companies approach a looming patent cliff—most notably with the immune checkpoint inhibitor blockbuster KEYTRUDA®, which is expected to lose its exclusivity in 2028—the industry is ramping up efforts to secure next-generation immuno-oncology assets through strategic partnerships, mergers, and acquisitions.

With its differentiated pipeline, established collaboration with the U.S. National Cancer Institute (NCI), and now entering the supply agreement with BeOne Medicines, Senhwa Biosciences is uniquely positioned at the intersection of scientific innovation and global capital markets. The company aims to play a pivotal role in the next wave of expansion and innovation in precision medicine and immuno-oncology by partnering with global pharmaceutical companies and to drive sustainable growth and long-term value creation for its stakeholders.

About Senhwa Biosciences, Inc.

Senhwa Biosciences, Inc. (TPEx: 6492) is a Taiwan-based clinical-stage biopharmaceutical company focused on developing novel therapeutics in oncology and rare diseases. The company's lead asset, CX-5461 (Pidnarulex), is a first-in-class G-quadruplex stabilizer currently in clinical development across North America and Asia. Senhwa is committed to translating scientific innovation into transformative therapies that improve treatment outcomes for the patients worldwide.

Website: www.senhwabio.com

SOURCE Senhwa Biosciences, Inc.