TAIPEI and SAN DIEGO, Aug. 7, 2025 -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that US National Cancer Institute (NCI) sponsors Senhwa's second program IND has been submitted to US FDA for clinical trial targeting MYC-aberrant lymphoma. Following the initiation of the first trial using CX-5461 as a monotherapy in advanced solid tumors, the IND-submission of the second trial marks a milestone in the development of CX-5461.

With sponsorship from the NCI, this program significantly reduces Senhwa's clinical development expenditures, easing its R&D financial demands while enhancing the overall project value and commercialization potential—a major positive for the company's future growth.

A Globally Innovative G4-Targeting Mechanism Against Hard-to-Treat MYC-Driven Lymphomas – 30% of Cancers Involve MYC Mutation

MYC is a critical oncogene, with approximately 28% of cancer patients exhibiting gene amplification or mutation, including in lung, breast, liver cancers, and lymphomas. The MYC protein drives cell proliferation, angiogenesis, and apoptosis suppression, playing a key role in multiple malignancies. CX-5461, developed by Senhwa, precisely stabilizes the G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways.

Preclinical research has demonstrated that CX-5461 exhibits strong inhibitory effects against MYC-overexpressing tumors, highlighting its potential as a next-generation targeted cancer therapy—especially promising for difficult-to-treat lymphomas.

With NCI Sponsorship Significantly Reduces R&D Costs

The clinical trial program is fully led and partially funded by the NCI, covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources. According to Senhwa's internal estimates, this sponsorship could reduce Senhwa's clinical development expenditures, easing its R&D financial costs, enhancing development efficiency and accelerating commercialization progress.

Substantial Market Potential for B-cell Lymphomas – Global Annual Sales Expected to Surpass USD 10 Billion

According to BioSpace market data, global sales of B-cell lymphoma therapies reached USD 4.9 billion in 2024 and are projected to grow to USD 8.9 billion by 2035, with a steady compound annual growth rate (CAGR) of 5.79%. There is particularly strong demand for novel targeted therapies for relapsed and refractory lymphoma patients, revealing a significant market gap.

With its unique mechanism and precision medicine potential, Senhwa's CX-5461 is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval, offering substantial commercial value.

CX-5461: The World's First and Most Advanced G4-Quadruplex Stabilizer for Cancer Treatment

CX-5461 is the world's first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. It specifically modulates the expression of key oncogenes like MYC, thereby inhibiting cancer cell proliferation and survival. The upcoming NCI-sponsored will evaluate CX-5461 dose optimization and treatment efficacy in Patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options, aiming to address critical unmet medical needs with a potentially breakthrough therapeutic solution.