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About Us

2021

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