Project CX-4945: Senhwa Biosciences Received Taiwan FDA IND Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection
Nov
Project CX-4945:Senhwa Biosciences Announces First Patient Successfully Dosed in Taiwan Phase II Study of Silmitasertib in Hospitalized Adults with COVID-19
Project CX-4945: Senhwa Biosciences Received US FDA IND Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection
Oct
Project CX-4945: Senhwa Announces IND Submission to US FDA for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection
Aug
Project CX-4945: Senhwa Announces Last Patient Last Visit in Phase I Study of Silmitasertib to treat Basal Cell Carcinoma
Apr
Project CX-4945: The company has completed an End of Phase written meeting with the US FDA on Silmitasertib in the treatment of Cholangiocarcinoma
Project CX-4945: Senwha granted IND approval from TFDA of a Phase II Study of Silmitasertib in Hospitalized Adults with COVID-19
Mar
Project CX-5461: Senhwa has signed Cooperative Research and Development Agreement with NIH-NCI to jointly develop Pindarulex in the field with unmet medical needs
Feb
Project CX-4945: Senhwa Announces Last Patient successfully dosed in in Phase I Study of Silmitasertib to treat Basal Cell Carcinoma
Project CX-4945: Senhwa Announces IND Submission to Taiwan FDA of a Phase II Study of Silmitasertib in Hospitalized Adults with COVID-19
2022
Dec
Project CX-5461: Senhwa Biosciences Announces Successful Awardee of Anticancer Pipeline, Pidnarulex, in NIH-Sponsored NExT Program
Oct
Project CX-5461: Senhwa Announces First Patient Successfully Dosed in Phase I Study of Pindnarulex in Combination with Pfizer’s Talazoparib for the Treatment of Prostate Cancer
Jun
Project CX-5461: Senhwa’s Pindnarulex in Combination Study with Pfizer’s Talazoparib for the Treatment of Prostate Cancer Granted Approval to Initiate from Australian HREC
Mar
Project CX-4945: 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
Jan
Former President and CEO Tai-Sen Soong officially retired and appointed to consultant
Project CX-4945: Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
Project CX-5461: Senhwa’s Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations.
2021
Dec
Project CX-4945: Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Medulloblastoma.
Project CX-4945: Senhwa Clinical Data Abstract for Silmitasertib in Patients with Advanced Basal Cell Carcinoma Accepted for 2022 AAD Annual Meeting.
Nov
Project CX-5461: Senhwa Biosciences Announces Abstract Accepted for Presentation at the 2022 ASCO Gastrointestinal Cancers Symposium.
Project CX-4945: Senhwa Clinical Data Abstract for Silmitasertib in Patients with Advanced Basal Cell Carcinoma Accepted for 2022 AAD Annual Meeting.
Oct
Project CX-4945: Senhwa Presents Positive Initial Data from Phase 2 Clinical Trial of Silmitasertib (CX-4945) in Moderate COVID-19 Patients At the ISIRV-WHO Conference.
Sept
Project CX-4945: Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference.
Project CX-5461: Senhwa Announces First Patient Successfully Dosed in Phase 1b Expansion Study of Pidnarulex to Treat Solid Tumors with Specific Homologous Recombination Gene Mutations.
Project CX-5461: Senhwa’s Pidnarulex to Combined With Pfizer’s Talazoparib in a Clinical Trial for the Treatment of Prostate Cancer.
Aug
Project CX-4945: Senhwa Signs Agreement with Taiwan’s CDE for COVID-19 Program Guiding Development of Silmitasertib.
Project CX-4945: Senhwa Completes Enrollment of a Phase 2 Investigator Initiated Trial of Silmitasertib as Novel Oral Drug for COVID-19.
Project CX-4945: Senhwa’s Silmitasertib Receives US FDA Fast Track Designation for the Treatment of Recurrent Sonic Hedgehog Driven Medulloblastoma.
Project CX-5461: Senhwa Biosciences Announces Dose Escalation Initiation of the Phase I Trial of Pidnarulex as a Treatment for Advanced Hematological Malignancies.
Project CX-4945: Senhwa's Silmitasertib, COVID-19 Drug Candidate, Receives Positive Interim Review from Data Monitoring Committee to Proceed.
Jun
Project CX-4945: Senhwa Announces IND Submission to India's CDSCO of a Phase II Clinical Study for Silmitasertib as a Potential COVID-19 Treatment.
Jan
Project CX-4945: Senhwa announces the first patient enrolled in an investigator Initiated trial of Silmitasertib as a treatment for patients with severe COVID-19.
2020
Dec
Project CX-4945: Senhwa announces the first patient enrolled in an investigator Initiated trial of Silmitasertib as a treatment for COVID-19.
Project CX-4945: Senhwa Biosciences’s positive topline cholangiocarcinoma data abstract accepted by 2021 ASCO Gastrointestinal Cancers Symposium.
Project CX-5461: Senhwa Biosciences receives US FDA and Health Canada ‘Study May Proceed’ Letters respectively to Treat BRCA2+ or PALB2+ solid tumors with CX-5461.
Nov
Project CX-5461: Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations
Project CX-4945: Banner Health and Center for Advanced Research & Education, Georgia received Study May Proceed Letter from US FDA to initiate Phase II clinical trial respectively
Oct
Project CX-4945: Positive topline results from global phase II trial interim analysis evaluating combination of Silmitasertib plus Gemcitabine/Cisplatin compared to Gemcitabine/Cisplatin in the frontline treatment of patients with cholangiocarcinoma. The trial met its primary endpoint in PFS (P<0.05) and was stopped early for superior efficacy
Sept
Project CX-4945: First EIND COVID-19 patient recovered and discharged from hospital in 5 days after treatment with Silmitasertib (CX-4945)
Aug
Project CX-4945: Singed LOI with Banner Health and Center for Advanced Research Education, Georgia respectively to explore therapeutic potential in COVID-19
Project CX-4945: Granted approval by US FDA to treat first severe COVID-19 patient under emergency IND (EIND)
Jul
Project CX-4945: Granted Rare Pediatric Disease Designation (RPD) in Brain tumor-Medulloblastoma by US FDA
Project CX-5461: Named as a PCF-Pfizer Global Challenge Award recipient and will be used in combination with Pfizer’s PARPi to treat prostate cancer.
Jun
Increased capital of NT$325 thousand by the employees' exercise of stock options. The paid-in capital increased to NT$745,311 thousand after the capital increase.
Project CX-4945: New study highlights Silmitasertib (CX-4945) as potential treatment for COVID-19 and published in《Cell》
Apr
Project CX-4945: to actively solve the COVID-19 pandemic, the National Institute of Allergy and Infectious Diseases (NIAID) from the U.S. National Institutes of Health (NIH) has formed a partnership agreement with Senhwa for a series of clinical trials for Silmitasertib (CX-4945) on treating COVID-19.
Feb
Project CX-5461: nominated by Pfizer and The Prostate Cancer Foundation, and may receive a fully-funded trial and medicinal sponsorship from Pfizer, as well as the combined use of Pfizer's complimentary PARP inhibitor during human clinical trial for prostate cancer treatment.
2019
Dec
Project CX-5461: clinical partner Canadian Cancer Trials Group (CCTG) published the Phase I trial results of the Company's breast cancer new drug CX-5461 at the San Antonio Breast Cancer Symposium (SABCS) in 2019.
Increased capital of NT$230 thousand by the employees' exercise of stock options. The paid-in capital increased to NT$744,986 thousand after the capital increase.
Sept
Project CX-5461: announcement was received on September 1, 2019 (US time) during the breast cancer trial in Canada that the first patient was enrolled as a part of widening the test subject group.
Jul
Project CX-4945: human subject Phase I/II clinical trial was launched in the United States for treating pediatric brain tumor, medulloblastoma (MB), and the first patient was successfully enrolled.
Apr
Project CX-4945: The clinical trial in humans using CX-4945 for the treatment of Basal Cell Carcinoma (BCC), a kind of skin cancer, was launched and has successfully enrolled the first patient.
Project CX-5461: phase I dose escalation was completed for breast cancer clinical trial in Canada and primary evaluation indicator was achieved.
Mar
Project SHP01-2-B: Due to the backward development of Chaperone, it is still impossible to complete the development of candidate medication and enter the GLP toxicology experiment, resulting in a delay in being qualified for "Investigational New Drug." In order to maintain shareholders interest and the development potential of the Company's intangible assets, the Board of Directors decided to terminate the license agreement with Chaperone Therapeutics, Inc.
Jan
Project CX-4945: The clinical trial for the new indication, namely medulloblastoma, a kind of child brain tumor, was approved by the US Food and Drug Administration (FDA) in January 2019. The Phase I /II trial will enroll patients at PBTC's participating member children's hospitals and medical research centers across the United States, including Lucile Packard Children's Hospital Stanford, the nation's ranked No. 1 cancer center: Memorial Sloan-Kettering Cancer Center, St. Jude Children's Research Hospital, and the Cincinnati Children's Hospital Medical Center.
2018
Dec
Increased capital of NT$590 thousand by the employees' exercise of stock options. The paid-in capital increased to NT$744,756 thousand after the capital increase.
Nov
Project CX-4945: The clinical trial for the new indication, namely basal cell carcinoma (BCC), a kind of skin cancer, was approved by the US Food and Drug Administration (FDA)
May
PBTC and Senhwa sign cooperation agreement to develop CX-4945 for pediatric brain tumor treatment
Apr
Registered Capital changed to NTD$744,166,200
Jan
Registered Capital changed to NTD$743,926,200
2017
Oct
Registered Capital changed to NTD$743,456,200
Apr
Senhwa raised NT$1.4 billion ($45.5 million) through the sale of 8.5 million shares at NT$162 in an IPO
Senhwa completed IPO and began trading on the TPEx mainboard on 24th
Mar
Senhwa held pre-TPEx-listing performance presentation on 17th
Feb
US subsidiary promoted John Soong M.D., FCAP as Chief Medical Officer
The research of CX-5461 is a DNA G-quadruplex stabilizer with selective lethality in BRCA1/2 deficient tumours was accepted and published in Nature Communications on 17th
Jan
Taipei Exchange board of directors approved listing application on the Exchange's Main Board
2016
Dec
US subsidiary appointed Dr. Lucas S. Chang as General Counsel
CX-4945 Phase I clinical trial results accepted for presentation at the 2017 ASCO Gastrointestinal Cancers Symposium
CX-4945 granted Orphan Drug Designation by the US FDA in Cholangiocarcinoma
Nov
Senhwa filed a new patent application covering the use of CX-5461 in combination with PARP inhibitors, PI3K and immunotherapeutic agents.
CX-5461 shows a synergistic effect in prostate cancer cells when combined with targeted drug, and this data was published by Senhwa’s partner in Australia.
Oct
Senhwa filed an application with the Taiwan Stock Exchange to seek a primary listing on the main board.
Mar
Senhwa enters into Clinical Trial Agreement with Canadian Cancer Trials Group (CCTG) for CX-5461 Phase I/II Study.
Health Canada approves Clinical Trial Application for Phase I/II Clinical Trial of CX-5461 in Solid Tumors and Breast Cancers.
2015
Dec
Senhwa’s clinical partner Peter MacCallum Cancer Centre (PMCC) published the study of CX-5461 combined with other drugs in treatment of Haematologic Malignancies in Clinical Cancer Research.
Oct
CX-4945: Senhwa receives Taiwan FDA approval to begin Phase I/II trial for Cholangiocarcinoma.
Sept
Senhwa and Chaperone Therapeutics, Inc. enter into an exclusive license agreement focused on the development of CK2 inhibitor for the treatment of neurodegenerative diseases.
CX-5461 granted 2015 Canada SU2C-CBCF Dream Team Drug and funded for a total of CAD$ 9 Million over 4 years.
Jan
CX-4945: Senhwa receives Korean MFDS approval to begin Phase I/II trial for Cholangiocarcinoma.
2014
Dec
Senhwa debuts on Taiwan's emerging stock market and begins trading under the ticker"6492.TT" on 4 Dec. 2014
An investigational new drug (IND) application was submitted to Korean Ministry of Food and Drug Safety (MFDS) for treatment of human Cholangiocarcinoma with CX-4945
Oct
Senhwa completed its initial public offering of stock.
Sept
Senhwa won the silver prize of 2014 Taiwan Healthcare and Agricultural Biotech Industries Innovation and Excellence Awards.
Aug
Senhwa completed its NTD$ 27.6 million fundraising.
Apr
Senhwa qualified to regulations and investment incentives according to “Act For The Development Of Biotech And New Pharmaceuticals Industry” by Biotechnology and Pharmaceutical Industries Promotion Office, MOEA, Taiwan
Senhwa’s clinical partner Peter MacCallum Cancer Centre (PMCC) was invited and presented the results of CX-5461 in animal study at AACR Annual Meeting 2014.
Mar
Senhwa and Development Center for Biotechnology (DCB) signed a Collaboration Agreement
Feb
CX-4945: The US FDA approves a phase I/II trial that used in Cholangiocarcinoma
2013
Nov
Funded by New Taipei City Government grant
Senhwa completed its NTD$ 198 million fundraising.
Sept
Senhwa completed its NTD$ 25 million fundraising
Apr
Senhwa signed an Asset Purchase and Sale Agreement with the American biotechnology company.
Senhwa’s US subsidiary is foundedin April, 2013.
CX-5461: A phase I clinical trial in hematologic malignancies is initiated with Peter MacCallum Cancer Center (PMCC) in Australia.
2012
Nov
Senhwa Biosciences, Inc. begins operation on Nov. 16, 2012.Senhwa had raised NTD$ 339 million in its first round of funding