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 ...
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 Announces First Patient Successfully Dosed in Phase I Study of Pindnarulex in Combination with Pfizer's Talazoparib for the Treatment of Prostate Cancer
TAIPEI and SAN DIEGO, Oct. 31, 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 their first patient has been successfully dosed, in a phase I c...
Senhwa's Pindnarulex in Combination Study with Pfizer's Talazoparib for the Treatment of Prostate Cancer Granted Approval to Initiate from Australian HREC
TAIPEI and SAN DIEGO, June 6, 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 that it has received written approval from the Human Research Ethics Committ...
At the 2022 AAD Annual Meeting, Senhwa Presents Positive Initial Data from Clinical Trial of Silmitasertib Used to Treat Patients with Advanced Basal Cell Carcinoma
* Early results showed 2 laBCC (locally advanced Basal Cell Carcinoma) subjects out of 10 experienced a Partial Response (30% decrease in tumor size) at week #24. * The first biopsy analysis in the laBCC subject showed a more than 90% decrease of GLI-1 expression at week #8 (GLl-1 is involved...
Senhwa's Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
TAIPEI and SAN DIEGO, Jan. 20, 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 that the US Food and Drug Administration (FDA) has granted Orphan Drug Des...
Senhwa's Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Medulloblastoma
TAIPEI and SAN DIEGO, Dec. 17, 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 the US Food and Drug Administration (FDA) has granted Orphan Drug Des...
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 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 Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference
* Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful. * No SAE related to Silmitasertib was reported. * Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against eme...
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...
Senhwa's Silmitasertib Receives US FDA Fast Track Designation for the Treatment of Recurrent Sonic Hedgehog Driven Medulloblastoma
TAIPEI and SAN DIEGO, Aug. 18, 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 the US Food and Drug Administration (FDA) has granted Fast Tr...
Senhwa Signs Agreement with Taiwan's CDE for COVID-19 Program Guiding Development of Silmitasertib
TAIPEI and SAN DIEGO, Aug. 13, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and coronaviruses, today announced that its novel oral drug, Silmitasertib, has been included inTaiwan's Center...
Senhwa Biosciences Silmitasertib filed IND of Basal Cell Carcinoma approved by FDA
TAIPEI, and SAN DIEGO, Nov. 1, 2018 /PRNewswire/ -- Senhwa Biosciences Inc. (TPEx: 6492) announced today that FDA has approved its IND application for basal cell carcinoma (BCC). To accelerate the development of this new drug, Senhwa followed the latest draft guidance released by FDA for clinica...
