Pharmaceutical company SynCore Biotechnology Co Ltd (杏國新藥) yesterday said that it plans to begin a phase III clinical trial of its new pancreatic cancer drug SB05PC in China, after gaining the approval of the Chinese regulator last month.
As the company has completed a phase II trial for SB05PC in the US, the Chinese National Medical Products Administration (NMPA) approved the phase III trial, a company official surnamed Liang (梁) told the Taipei Times by telephone yesterday.
The company is still looking for hospitals with which to cooperate and finalizing the number of patients, but expects to complete the trial by the fourth quarter of 2021, Liang said.
The drug’s potential in China would be huge, as China has the most patients with pancreatic cancer in the world and the NMPA has not selected a medication to be the first-line treatment, unlike its European counterparts, Liang added.
A first-line treatment is one approved by the regulators as the best treatment. Doctors must adopt it first and cannot easily transfer to other treatments unless the first-line treatment does not work or causes serious side effects.
SynCore has applied for SB05PC to be a first-line treatment in China, Liang said.
The number of patients diagnosed with pancreatic cancer in China totaled 116,300 last year and a total of 110,400 patients died, he said citing WHO data.
Meanwhile, the company’s global phase III clinical trial in seven other nations — Taiwan, the US, France, Hungary, South Korea, Russia and Israel — is progressing smoothly, he said.
In those seven markets, the drug would be used as a second-line treatment in combination with gemcitabine for those who have exhausted commonly prescribed first-line chemotherapy treatments.
The company is to conduct interim analysis of the trial at the end of this year, Liang said.
Based on the results of the phase II trial, the company said it is confident that the phase III trial will meet its primary efficacy endpoint and improve the rates of survival of enrolled patients.
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