Hutchison China MediTech Ltd., or Chi-Med, became the first Chinese company to get approval for a China-discovered, China-developed drug for a major cancer type.
Chi-Med's cancer treatment fruquintinib was approved Sept. 5 by the National Medical Products Administration of China to treat colon cancer patients whose disease has spread to other parts of the body and for whom at least two treatments have failed.
The treatment, which will be marketed in China under the brand name Elunate, is an oral inhibitor that targets vascular endothelial growth factor receptors, or VEGFR, which feed the tumors' growth to up to 10 centimeters in diameter, Chi-Med CEO Christian Hogg said.
Although this type of inhibitor has been developed before, Chi-Med's version is unique in that it is "designed to only hit VEGFR 1, 2 and 3 and nothing else," according to Hogg. "Basically, it's the cleanest VEGFR inhibitor seen to date," he added.
Elunate's approval is based on the results of a phase 3 trial, which showed that fruquintinib improved the survival of colorectal cancer patients.
The fruquintinib capsules are also in phase 3 clinical trials for the treatment of lung cancer, with results expected in the fourth quarter. An additional indication area of gastric cancer is in phase 3 clinical trials, with an interim analysis planned for early 2019.
Hong Kong-based Chi-Med has set its sights on developing fruquintinib for U.S. approval as well. In December 2017, the company initiated a phase 1 clinical trial for the treatment of advanced solid tumors in U.S. patients; the study has an estimated completion date of December 2019.
The approval of Elunate is a "major step" for Chi-Med's development and regulatory capabilities, Panmure Gordon analyst David Cox said in a Sept. 5 research note. Cox wrote that it is a "huge milestone" and will validate Chi-Med's innovative capabilities. According to the note, Chi-Med's stock was up 4.4% on the London Stock Exchange on the day of the approval.
Hogg said that while Chi-Med has built a "strong share register" in Europe and the U.S., having completed its listing on the Nasdaq in 2016, the company is still better known in Asia and among Asian investors. Nevertheless, events like the Elunate approval help establish a reputation.
Chi-Med's landmark approval also has implications for the broader biotech industry in China, which has continued to gain steam.
"The signal it sends is that world-class drug research is happening in China," Hogg said. "Finally, after a decade, the fruits of labor are showing in an approved therapy."
Chinese biotech only recently began its foray into discovery and development, having previously focused on bringing international pharma companies' drugs to Chinese markets. According to Hogg, there was a lacking biotech ecosystem 18 years ago.
"You need to run clinical trials in China; to discover drugs, you need infrastructure around you," he said. "It didn't really exist."
Now, there are approximately 50 clinical trial sites able to sustain a global clinical trial capacity, though this is still a "very small number" considering China's size and high volume of cancer patients.
"The unmet medical need in China is so vast," Hogg said. "30% of cancer patients in the world are in China."
Hogg said he expects continued stiff competition in the field but also sees it as a positive because the influx of resources will allow Chinese biotech to further build the capability to develop innovative treatments.
The CEO added that he believes it is inevitable that China's pharmaceuticals industry, particularly in oncology, will eventually surpass the U.S.
Chi-Med, which has partnerships with Eli Lilly and Co. and AstraZeneca PLC, as well as a 50/50 joint venture with Nestle Health Sciences, is primarily focused on targeting cancer.