TAIPEI and SAN DIEGO, Aug. 11, 2021 -- 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 in Taiwan’s Center for Drug Evaluation: “CDE can Help: COVID-19 Regulatory Consultation Program". Senhwa and Taiwan’s CDE have entered an agreement to facilitate the development of Silmitasertib for treating COVID-19 in Taiwan.
Taiwan’s CDE is an instrumental partner of the Taiwan Food and Drug Administration (TFDA), assisting in drafting regulations and guidance, while also maintaining professional connections with other regulatory agencies in major countries. In response to the urgent public health need, the “CDE can Help” program was launched to provide scientific consultation and guidance on the regulations at each stage of development for COVID-19 treatments. Taiwan’s CDE holds regular weekly meetings with selected program participants, performing reviews and providing feedback, to accelerate the progress of potential COVID-19 therapeutics. The program was paramount in the first domestic COVID-19 vaccine being granted Emergency Use Authorization (EUA) on July 19th, 2021.
“Under the guidance of Taiwan’s CDE, Senhwa plans to launch a COVID-19 clinical trial in Taiwan to further examine the safety and human efficacy of Silmitasertib in treating COVID-19. With this collaboration Senhwa’s drug, Silmitasertib, will have a greater opportunity to obtain EUA from TFDA,” said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
Silmitasertib is already provided under compassionate use for patients with severe COVID-19 in Taiwan (treatment was initiated in June 2021). Currently two Phase 2 Investigator Initiated Trails (IIT) are enrolling moderate and severe COVID-19 patients, respectively, in the United States.