Senhwa Biosciences Highlights AI-Validated Oncology Platform and Strategic Clinical Collaborations Targeting Next-Generation Immuno-Oncology products at Its 2025 Annual Investor Conference
TAIPEI and SAN DIEGO, Dec. 23, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage companies focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today outlined continued progress across its AI-enabled drug developm...
Senhwa Biosciences CX-5461 Secures NCI Support to Advance into MYC-Driven Lymphoma, Driving Cross-Cancer and Global Licensing Value
TAIPEI and SAN DIEGO, Sept. 5, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase1b/2 clin...
US NCI Sponsors Senhwa Biosciences' Second Program-IND Submitted for Clinical Trial Targeting MYC-Aberrant Lymphoma
TAIPEI and SAN DIEGO, Aug. 7, 2025 /PRNewswire/ -- 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 ...
Senhwa Biosciences announces first patient dosed in NCI-sponsored pilot study of Pidnarulex (CX-5461) pharmacodynamics in patients with advanced solid tumors
TAIPEI and SAN DIEGO, July 15, 2025 /PRNewswire/ -- 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 its new drug Pidnarulex (CX-5461) has been selected by the U...
Senhwa Biosciences Highlights Breakthroughs in Dual First-in-Class Drug Programs at Annual Shareholders' Meeting Today
TAIPEI and SAN DIEGO, June 25, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, held its 2025 Annual Shareholders' Meeting today, chaired by Chairman Mr.Benny T. Hu. The company delivered updates on its ongoing drug development programs, outl...
Senhwa Biosciences Announces Positive Clinical Data from Phase 1/Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma
Basal Cell Carcinoma CSR Highlights * CX-4945 Monotherapy: Progression-free survival (PFS) exceeded 21 months in two patients. * Optimal Treatment Response: Three patients achieved partial response (PR), while ten patients had stable disease (SD). * Tolerability & Disease Control Rate: Sho...
Senhwa Biosciences Announces the Appointment of Dr. Yiu-Lian Fong, the Former Global Head of Janssen Diagnostic Innovation and R&D at Johnson & Johnson as the New Corporate Director
TAIPEI and SAN DIEGO, Nov. 1, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced the appointment of Dr.Yiu-Lian Fong to the board of directors for Din...
US FDA issues Study May Proceed letter for the Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors, Sponsored by the US National Cancer Institute
TAIPEI and SAN DIEGO, Oct. 14, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that FDA issues Study May Proceed letter for its developing drug Pid...
Senhwa Biosciences Announces IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI
TAIPEI and SAN DIEGO, Sept. 17, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), , a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that an Investigational New Drug (IND) application for Pidnarulex ...
US FDA Grants RPD Designation to Senhwa Biosciences Silmitasertib for Pediatric Neuroblastoma
TAIPEI and SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- 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 its new drug Silmitasertib (CX-4945) was granted a rare pe...
Senhwa Biosciences Presents Clinical Data Abstract on Pidnarulex at 2024 ESMO Congress
* The study involved end-stage oncology patients with no other suitable treatment options. * In this Phase Ib study, Pidnarulex (CX-5461) demonstrated acceptable clinical tolerability and showed preliminary signs of efficacy, even in patients who had previously failed treatment with PARP inhi...
Senhwa Biosciences receives US FDA Study May Proceed letter for the Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
TAIPEI and SAN DIEGO, Aug. 6, 2024 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug A...
Senhwa Biosciences Clinical Data Abstract of Pidnarulex Accepted for Presentation at 2024 ESMO Congress
TAIPEI and SAN DIEGO, July 12, 2024 /PRNewswire/ -- Senhwa Biosciences' new drug Pidnarulex (CX-5461) has demonstrated efficacy in treating various solid tumors with BRCA2 or PALB2 gene defects. The abstract of this clinical trial has been selected for presentation at the 2024 European Society fo...
Senhwa's Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations
TAIPEI and SAN DIEGO, Jan. 25, 2022 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that the US Food and Drug Administration (FDA) has granted Fast Track...
Senhwa Clinical Data Abstract for Silmitasertib in Patients with Advanced Basal Cell Carcinoma Accepted for 2022 AAD Annual Meeting
TAIPEI and SAN DIEGO, Dec. 16, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that an abstract highlighting preliminary clinical data for their lead drug...
Senhwa Biosciences Announces Abstract Accepted for Presentation at the 2022 ASCO Gastrointestinal Cancers Symposium
TAIPEI and SAN DIEGO, Nov. 15, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that an abstract highlighting clinical design for their lead drug candidate...
Senhwa Presents Positive Initial Data from Phase 2 Clinical Trial of Silmitasertib (CX-4945) in Moderate COVID-19 Patients At the ISIRV-WHO Conference
* Statistically significant 133% faster time to COVID-19 clinical symptoms recovery versus standard of care (SOC)/best supportive care. * Statistically significant 114% faster time to reach EQ-5D-5L Q6 ≥ 90% versus SOC/best supportive care. * Statistically significant 57% faster time to norm...
Senhwa Announces First Patient Successfully Dosed in Phase 1b Expansion Study of Pidnarulex to Treat Solid Tumors with Specific Homologous Recombination Gene Mutations
TAIPEI and SAN DIEGO, Sept. 10, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced t hat their first patient has been successfully dosed, in a Phase1b c...
Senhwa's Silmitasertib, COVID-19 Drug Candidate, Receives Positive Interim Review from Data Monitoring Committee to Proceed
TAIPEI and SAN DIEGO, Aug. 31, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that its oral new drug, Silmitasertib, had received a positive feedbac...
Senhwa Biosciences Announces Dose Escalation Initiation of the Phase I Trial of Pidnarulex as a Treatment for Advanced Hematological Malignancies
TAIPEI and SAN DIEGO, Aug. 25, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the initiation of Dose Escalation within the Phase I Investigator Init...
