Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company specializing in innovative treatments for oncology, rare disease, and infectious diseases, announced its participation in its annual institutional investor conference today (12/26) at the invitation of Cathay Securities to offer investors insight into the company’s activities and prospects. Executive Vice President and CFO Sarah Chang, together with Chief Medical Officer Jason Huang, M.D., delivered presentations and addressed inquiries from investors.
As immunotherapy applications expand swiftly in fields such as cancer, inflammation, and autoimmune disorders, the market for immunotherapy medications is expected to surpass $1.58 trillion by 2036, featuring a compound annual growth rate of 15.2% from 2024 to 2036. Consequently, the advancement of Senhwa's new drug Pidnarulex (CX-5461) through the National Cancer Institute's (NCI) five-year-funded NExT initiative is garnering considerable interest, bolstered by financing, regulatory insights, and expertise. Within the NCI NExT program, Pidnarulex (CX-5461) is set to be utilized as a single-agent therapy in late-stage solid tumor clinical trials and will investigate different biomarkers to support the expansion of indications. At the same time, the NCI is organizing multiple combination clinical trials for Pidnarulex (CX-5461), involving therapies such as immunotherapy and antibody-drug conjugates (ADCs), which are key trends actively being explored by leading pharmaceutical companies in cancer care.
Another new drug under development, Silmitasertib (CX-4945), acts as a human kinase CK2 inhibitor, influencing several oncogenic pathways. Its innovative mechanism holds significant therapeutic promise for multiple rare diseases, having already obtained orphan drug status for cholangiocarcinoma, bile duct carcinoma, medulloblastoma, and neuroblastoma. It has additionally received rare pediatric disease designations for neuroblastoma and medulloblastoma. Given that orphan drugs benefit from regulatory privilege in nations like the U.S., Europe, and Japan—such as tax incentives, a 7 to 10-year market exclusivity duration, and R&D funding—along with the recent trend of major pharmaceutical corporations acquiring rare disease drug development companies to penetrate the orphan drug market, Senhwa aims to concentrate its development strategy for Silmitasertib (CX-4945) in the orphan drug sector to accelerate its path to market.
In recent years, Senhwa has focused on clinically validating two groundbreaking drugs within their markets, dedicated to evaluating their effectiveness and development prospects while actively pursuing licensing and international partnership initiatives to boost visibility and competitiveness worldwide. In R&D, the company is dedicated not only to enhancing its pipeline by investigating and approaching late-stage new drugs but is also proactively pursuing novel therapies with growth potential. The company has formed strong alliances with multiple international health agencies and specialists, such as the National Cancer Institute (NCI), the U.S. Beat Childhood Cancer Research Consortium (BCCRC), and leading cancer centers in both the U.S. and Canada. These collaborations not only increase the company's presence in the worldwide market but are also anticipated to promote various advancements in licensing and co-development initiatives. To support substantial growth, Senhwa diligently seeks out experts from international pharmaceutical firms, utilizing the team's expertise and experiences to advance new treatments that address patient needs, with the objective of creating notable commercial value and ensuring sustainable development.