SynCore Biotechnology Co (杏國新藥) has begun the race to introduce SB05PC, its new pancreatic cancer drug, to the Chinese market as a first-line treatment.
The company has begun enrolling patients in a global phase III clinical trial, that is to take place in seven countries, including the US.
The drug would be used as a second-line treatment in combination with gemcitabine for those who have exhausted other commonly prescribed first-line chemotherapy treatments such as FOLFIRINOX.
SB05PC would be competing against PharmaEngine Inc’s (智擎) onivyde, which has been approved and covered by the National Health Insurance (NHI) program since August.
“Gaining marketing approval from the US Food and Drug Administration would greatly improve SynCore’s odds of succeeding in the Chinese market, where the availability of first-line options is lacking, in particular FOLFIRINOX,” SynCore general manager Su Muh-hwan (蘇慕寰) said.
The company would be required conduct a separate clinical trial if it wants to introduce SB05PC as a first-line treatment and tap into the immense Chinese market for pancreatic treatments, which has yet to be dominated by an established product, Su said.
The company has enrolled its second patient in Taiwan for the phase III global trial and should be able to enroll the required 218 patients before the end of next year, Su said.
“Once site visits are completed in the the US and China, the pace of patient enrollments should pick up dramatically,” Su said, adding that health authorities in France, Hungary, South Korea and Russia have approved SB05PC’s phase III global trial.
The company has also applied for FOLFIRINOX to be covered by the NHI, Su said.
“Based on the results of the phase II trial, we are confident that phase III will meet its primary efficacy endpoint and produce a 40 percent improvement in terms of overall survival among enrolled patients,” said Hsieh Ruey-kuen (謝瑞坤), a physician and a director at the Taiwan Cooperative Oncology Group who worked with SynCore in designing SB05PC’s clinical trial parameters.
Phase III is basically the same study as phase II, only with more patients enrolled to meet regulatory requirements, Hsieh said, adding that SB05PC’s toxicity profile is relatively lower compared with other second-line drugs.
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