Senhwa Biosciences’ Pidnarulex joins forces with global PD-1 leaders to advance next-gen immunotherapy

This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program

Senhwa Biosciences announced its official entry into the rapidly expanding 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 represents the third clinical trial under Senhwa’s five-year NCI-sponsored 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, reflecting the strong interest from leading global pharmaceutical companies in the unique mechanism of action of CX-5461 and its potential to enhance immunotherapy efficacy.

“This is more than a clinical trial—it is a transformative opportunity to redefine the future of cancer therapy,” said Dr. Pin-Yen Huang, Chief Medical Officer of Senhwa. “The compelling synergy between CX-5461 and PD-1 inhibitors promises renewed hope for countless patients, while highlighting Taiwan’s innovation on the global stage.”

Immune checkpoint inhibitors have revolutionized cancer treatment, yet their response rates in solid tumors—beyond melanoma—remain low, at approximately 20–30 percent. The CX-5461 and Cemiplimab combination aims to significantly improve these response rates, extend the reach of PD-1 inhibitors, and address treatment challenges in MSS CRC and other low-immunogenicity tumors.

Recent data shows cross-border licensing and M&A transactions in Asia’s pharmaceutical sector surged to US$66 billion in the first seven months of 2025, surpassing the total value for all of 2024. Several blockbuster deals exceeding US$1 billion illustrate how global pharmaceutical leaders are increasingly investing in Asia.

Approximately 95 percent of metastatic colorectal cancer cases are MSS, for which effective immunotherapy options remain limited. The incidence of colorectal cancer among younger patients is rising, highlighting the urgent need for innovative treatments. Many patients fail to respond or develop resistance to existing immunotherapies, while high treatment costs and the lack of reliable biomarkers pose additional challenges.
Through its innovative combination therapy, this trial aims to overcome current limitations, offering new hope by extending survival and improving quality of life for patients.
The global cancer immunotherapy market is projected to surpass US$150 billion by 2025, with continued double-digit growth expected to exceed US$300 billion by 2035. Combination therapies are a central focus for industry R&D and investment.