Sphere No.46 (Mar 2019)

Bright future – for Chi-Med and global cancer patients Chi-Med has established itself as the upcoming pharmaceutical firm with the first-ever single-molecule treatment discovered in China to receive an “unconditional approval” for treatment by the China Food and Drug Administration (CFDA). More will follow from Chi-Med and other firms. But Chi-Med is again leading the way by taking its drug beyond China to grow its own clinical trial infrastructure abroad. Most biotech companies developing single-molecule treatments are small (fewer than 10 scientists) and sell-out to the big players once the molecule has been proven enough for them to take over. Chi-Med is different. The company prides itself on having over 150 biochemists doing leading-edge research under the stewardship of Dr Su, himself a world-class scientist. As Mr Hogg says, “Chemistry is our edge!” Chi-Med is developing multiple drugs at the same time. The company has a national sales force in the world’s second-biggest economy and the biggest pool of patients. It has partnerships with major players, but is not being absorbed by them. Instead, it is continuing to expand its scientific, medical, sales and regulatory capabilities in order to join the ranks of world-class pharmaceutical firms. It is committed to growing and finding cures to humanity’s worst scourges and beating back the dark of illness to bring light and hope to the people of the world. << Sphere #46 2019 15 threatened by colorectal cancer. Other treatments may very well follow. Another way to expand the client base is to bring Elunate® to the rest of the world. While China is the world’s biggest market by virtue of its population and advanced economy, there are still millions of patients who could benefit from Elunate® over the next few decades. Coming to America Chi-Med has begun another journey in seeking to move through the three phases of clinical trial needed to get Elunate® to American, European and other nations’ patients. For example, in America, Hutchison MediPharma US has been established in East Hanover, New Jersey, a global centre for pharmaceutical development. A next-door neighbour is Big Pharma firm Novartis and the area is rich in a top- notch pharmaceutical research culture. The leadership team is being built, and anchored by a world-class Chief Medical Officer hired from Eli Lilly. A team of highly qualified regulatory experts is coming on board. The office will have up to 30 staff by the end of 2019 and will also guide European clinical trials. Mr Hogg aims to have this team on the ground to take over clinical trials for fruquintinib, sulfatinib and two upcoming blood cancer-fighting molecules which are in development. Starting over isn’t cheap The investment is considerable. The average cost of including one patient in a Phase 3 trial in the US is over US$100,000. Phase 3 trials are the big ones, in terms of people that need to be included in the trial to be acceptable to regulators. Phase 3 trials often have up to 1,000 patients. Do the maths and one begins to understand “Chemistry is our edge!” Christian Hogg CEO of Chi-Med why drug costs are so high. Also consider that successful drugs have to cover the cost of development of drugs that do not make it through this process, even after all the money has been spent. Further complicating the picture is the fact that clinical data from the China trials cannot be used in the US trials. The ‘standard of care’ varies in different countries, meaning that the way in which doctors treat a specific cancer varies. For example, they may use a different drug as their first line of attack, or a combination of drugs, from other countries. So fruquintinib has to be evaluated based on where it fits in the common US protocol by itself, or, more likely, as part of a blended treatment of a multi-front attack on a tumour. The bottom line is that drug companies have to start at ground zero as they go from major market to major market. But Chi-Med is up to the task and is gearing up to build the infrastructure to bring not one, but many drugs into the pipeline to many markets around the world.