- London-listed drugmaker Hutchinson China MediTech has won the first unconditional approval from Chinese regulators of a cancer medicine both discovered and developed in China, marking a milestone for the country's emerging biotech sector.
- Better known as Chi-Med, the company on Wednesday said its drug, a VEGF inhibitor called fruquintinib, is now cleared to treat metastatic colorectal cancer in patients who have failed two other systemic therapies.
- Fruquintinib's approval is a tangible sign of the progress made by a new crop of Chinese biotech companies that aim to invent novel therapies and shift away from the country's historical role as a manufacturer of raw pharmaceutical ingredients.
Chi-Med began work on what would become fruquintinib in 2007, pushing the compound into clinical testing four years later. That decade-plus of drug development has now paid off, with an approval that puts the drugmaker at the forefront of China's biotech scene.
Clinical progress from biotechs like Chi-Med, coupled with sweeping regulatory reforms and the recent opening of Hong Kong's stock exchange to pre-revenue biotech companies, has fueled a surge of interest in Chinese drug development.
Historically, China's contribution to drug supply chains has been the active pharmaceutical ingredients that make up foreign-made medicines. Chi-Med and its Chinese biotech peers, on the other hand, hope to take their place alongside U.S. and European companies in developing new drugs.
It's clear why drugmakers are interested in introducing more branded drugs in China. The country is the second-largest market for drugs globally, trailing only the U.S. in overall size.
Fruquintinib's approval was backed up by a Phase 3 study, published in JAMA earlier this year, that showed the drug improved median overall survival versus placebo by nearly three months in 416 colorectal cancer patients whose tumors had grown after prior treatment with two chemotherapies.
The National Medical Products Administration of China approved fruquintinib roughly a year after granting the drug priority review status.
"What that illustrates is that Chinese companies now are conducting science and developing drugs in a way that meets the height of global standards," said Brad Loncar, head of Loncar Investments, in an interview with BioPharma Dive. "I think that this is a sign of things to come."
That optimism is tempered, however, by continued concerns over production quality among Chinese manufacturers. A recent vaccine scandal and global recalls of a heart drug made by a Chinese drugmaker indicate that, even as biotech companies push forward, the broader industry still lags in meeting global standards.
Under a 2013 collaboration deal with Chi-Med, Eli Lilly will launch fruquintinib in China under the brand name Elunate.
Studies of the drug in gastric and lung cancer are ongoing and, in December of last year, Chi-Med initiated a Phase 1 trial in the U.S.
Beyond fruquintinib, Chi-Med hopes to win approval of two other cancer drugs within the next three years.
Other Chinese biotechs are making strides in drug development as well. Beigene recently filed for Chinese approval of its anti-PD-1 cancer immunotherapy tislelizumab and Jiangsu Hengrui Medicine won a conditional approval for its breast cancer drug pyrotinib.
At the same time, Chinese regulators have ramped up the pace of approvals of foreign-made drugs, particularly in cancer. Just in the past few months, Merck & Co., Bristol-Myers Squibb, Roche and AstraZeneca have all secured OKs for key drugs, including the immuno-oncology stars Opdivo (nivolumab) and Keytruda (pembrolizumab).