Eli Lilly, Chi-Med’s Elunate becomes first China-made cancer drug to win a key nod

China, which has been waving through cancer therapies made by multinational pharma companies, can now count a homegrown one among its approved drugs.

China’s drug regulator, under the new name National Medical Products Administration, has approved Elunate, also known as fruquintinib, for patients with colorectal cancer who have failed at least two treatments.

Born at Hutchison China MediTech (Chi-Med) in 2007, the drug is the first domestically made medicine for a major cancer type to clear the full span of discovery, development and now commercialization completely in China. Another fully homegrown cancer drug to have won an approval is Chipscreen Biosciences’ Epidaza (chidamide), approved in China in late 2014 for peripheral T-cell lymphoma, a much smaller indication.

It is also the first approval of an innovative medicine for Chi-Med, and it will be sold in China by partner Eli Lilly through a deal signed in 2013. It's not yet clear how Lilly will price the drug. 

Chi-Med is apparently not content with the Chinese market alone. It recently initiated a phase 1 bridging study in the U.S. in the hopes of getting approvals for advanced solid tumors in a much more competitive market.

A tyrosine kinase inhibitor (TKI), Elunate works by selectively inhibiting VEGFR 1, 2 and 3 without hurting other functional kinases. In a phase 3 study in Chinese patients, it improved overall survival by a median 9.3 months, compared with 6.6 months for patients on placebo.

RELATED: Chi-Med touts fruquintinib's phase 3 safety edge in relapsed colorectal cancer

Perhaps more importantly for Chi-Med as it eyes the global market, Elunate demonstrated what the company called a “best-in-class” safety profile. In the phase 3, the rate of liver toxicity in the Elunate arm was generally lower than that of other targeted therapies, which Chi-Med CEO Christian Hogg had said would make for less treatment interruptions; about 70% of metastatic colorectal cancer patients have liver metastases or compromised liver function.

Elunate's superior tolerability “allows it to be evaluated in combination with other agents such as chemotherapies, targeted therapies and immunotherapies, thereby maximizing the number of potential patients who may benefit from this novel cancer treatment,” the company said in a statement.

Chi-Med is also testing Elunate in China as a monotherapy for non-squamous non-small cell lung cancer, with top-line phase 3 readouts expected later this year. Other experiments include pairing it with AstraZeneca’s EGFR inhibitor Iressa in NSCLC and with chemo in gastric cancer.

For now, Elunate will go up against Bayer’s Stivarga, which was also approved in China in mCRC, as well as gastrointestinal stromal tumors and liver cancer. It might also need to fight other VEGF inhibitors, such as Pfizer’s Sutent, which are approved in China, though not in mCRC.

Colorectal cancer is the fourth-most-common cancer type in China, with a total of 376,300 incidences by an official tally based on 2015 numbers. Elunate's approval also marks a rare occasion where Chinese patients will get an innovative drug before the Western markets. Until the Chinese drug regulator recently revamped its regulatory process to align with international mainstream practice, global pharma companies usually had to wait years before their drugs could enter the market.

Chinese firm Betta Pharma’s Conmana (icotinib), an EGFR-TKI sold only in China as a monotherapy in NSCLC, is a similar case. But that drug came to life first in the U.S. under Beta Pharma. Perhaps in a first for a Big Pharma, AstraZeneca is bringing its FibroGen-partnered anemia drug roxadustat to China first, before the U.S. or EU.