Taipei, Taiwan, 14 January 2019.
SynCore Biotechnology Co. (4192:TT) announces first patient in for phase III trial in SB05 pancreatic cancer (SB05PC), Hungary.
SynCore Bio has enrolled its first patient in Hungary, following on the enrolment success in Taiwan and South Korea. SB05 targets pancreatic cancer for second-line treatment in combination with gemcitabine after FOLFIRINOX first-line treatment failure. Phase III trial has received positive feedback from KOLs which, increased patient enrollment across the global sites.
Pancreatic cancer treatment is still an unmet medical need, with an expediential market of US$13 billion by 2021, according to Market Research. In Hungary, pancreatic cancer is the fourth highest cancer death with 2,078 deaths in 2018 alone. This highlights the unmet need and the demand in treatment options for patients in Hungary.
SynCoreBio’s global phase III trial has been approved in seven major countries including Taiwan, U.S., France, Hungary, South Korea, Russia and Israel. SB05PC has received approval from the EMA, the Orphan Drug Designation and Breakthrough Therapy Designation from the FDA.
| No. | Country | Status |
| 1 | USA | Phase III clinical trial ongoing |
| 2 | Taiwan | |
| 3 | France | |
| 4 | Hungary | |
| 5 | South Korea | |
| 6 | Russia | |
| 7 | Israel |
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This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of SynCore Biotechnology Co., Ltd