Hutchison China MediTech has turned an important corner, scoring positive overall survival and progression-free survival in a Phase III study of fruquintinib, its lead oncology drug, in colon cancer. The top-line success — data will come out this summer at ASCO — puts Chi-Med on a direct path with its partners at Eli Lilly to an NDA filing with Chinese regulators in a few months.
Investigators recruited 416 patients with locally advanced or metastatic colon cancer who had failed at least two chemotherapies for this study. The patients were then divvied between the drug arm and a group treated with placebo plus best standard of care.
“It’s a remarkably selective VEGFR inhibitor,” Chi-Med CEO Christian Hogg tells me. “We’ve always had confidence in shutting down that target…We have always been super confident that fruquintinib is as clean as you’re going to get.”
Chi-Med’s stock $HCM surged 11% on the news.
Hogg started out as CEO of the company when it launched 17 years ago. He was the first staffer and fruquintinib came out of its labs with the backing of billionaire Li Ka-shing. Now Chi-Med, domiciled in Hong Kong for tax reasons, listed in London and on Nasdaq (with a $1.55 billion market cap}, has 330 scientists and staff in Shanghai. And, if the data hold up, Hogg expects Chinese regulators could well come through with an accelerated approval.
“There has never been a mainstream oncology drug — I’m talking synthetic medicine, small molecules or antibodies — but never a mainstream oncology drug created in China by a Chinese company taken to a positive readout,” he tells me in a phone interview from his office in Shanghai.
And he doesn’t plan for it to be the last. While Chi-Med is setting up a bridging study in the US for fruquintinib, researchers are advancing a late-stage program for non-small cell lung cancer. Outside of China, Hogg expects to focus considerably on combination studies for his lead drug.
Chi-Med has eight drugs in 30 clinical studies around the world, says the CEO, with a follow-up program that could provide pivotal data fairly soon for savolitinib, partnered with AstraZeneca. That includes four Phase III studies now underway and 4 more getting ready to launch.
Eli Lilly has played a key role, inking an $86.5 million deal in 2013 for fruquintinib and paying 70% of the clinical trial costs. Lilly has commercialization rights in China, and has windows coming up that could allow it to grab an option on global rights.
China, says Hogg, has 30% of the world’s cancer patients and is set to become the world’s second largest pharmaceuticals market. And regulators, he says, are keen to advance new drugs into the market.
“We were in the right place at the right time,” says Hogg. “It will only get bigger and better.”
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