Hutchison China MediTech has taken another step forward in a major rite of passage for this groundbreaking Chinese biotech. The company arrived at ASCO with positive data on their lead drug fruquintinib in colon cancer. And now it will pursue a speedy approval in China as its partner Eli Lilly gets ready to roll out a new marketing effort.
The data all lined up in the company’s favor, with an overall survival rate of 9.3 months compared to 6.57 months in the placebo arm. The median progression-free survival rate hit 3.71 months compared to 1.84 months for the control group. While not a radical improvement, the data line up as approvable — unless some nasty surprise erupts.
Investigators also touted evidence of a better safety profile than some of the targeted therapies in use.
US studies for this drug will kick off this year as Chi-Med $HCM looks for a quick OK in China.
Chi-Med CEO Christian Hogg told me a few months ago that this is the first time a Chinese biotech has discovered, developed and prepped a drug for the Chinese market. And don’t look for it to be the last, either.
Biotech execs in China have been telling me that the country has been overhauling its FDA over the past year. The bureaucracy has been notoriously slow in the past granting INDs and the central government is behind a push to accelerate the way the bureaucracy handles all aspects of in-country work.
The government’s support for the biotech industry includes backing the construction of new facilities as it encourages a new wave of drug developers to develop new drugs for the massive Asian market as well as the rest of the world.
That trend was on full view in Chicago on Monday, when the low-profile Nanjing Legend made the marquee list of developers to report new data at ASCO, offering some jaw-dropping data on its new BCMA CAR-T.
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