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Telix Pharma’s (ASX:TLX) got the Chinese market locked in its sights with a maiden application for Illuccix, a prostate cancer imaging agent, now lodged with (and accepted by) the National Medical Products Application (NMPA). Worth noting is this is just an acceptance of the application and not an approval of the drug for use; shares jumped around +4% in morning Tuesday trades.
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Working alongside Hong Kong-listed Grand Pharmaceuticals Group (GPG), the application was fired across with recent Phase 3 study data, pulled from a trial that wound up with positive results in December last year.
That study, Telix reminded on Tuesday, satisfied its original target outcomes with successful detections of tumours recorded in 94.8% of patients; some 67% of this cohort had treatment plans changed to better address tumours as a result of the study.
“Submitting this New Drug Application for TLX591-Px, the first for any of our products in China, is a major milestone for Telix and our partner Grand Pharma,” TLX CEO of Precision Medicine Kevin Richardson said.
That’s well and good, but there might be reason for Telix shareholders to stay cautious, which at least one HotCopper user pointed out on Tuesday.
To date, short-selling pressure on Telix Pharmaceuticals remains fairly popular, with some 11% of Telix shares on issue currently shorted today.
That’s come on the back of recent trouble for Telix. It seemed to have trouble with the FDA last year as two different applications were more or less knocked back by the U.S. drug regulator; perhaps more pressing is the Securities and Exchange Commission took Telix to court over claims the company had made to market.
TLX last traded at $11.75/sh.
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