Chi-Med has achieved a major milestone for itself and China’s fast-developing pharma market, announcing today the launch of cancer treatment Elunate (fruquintinib) in the country.
The company (also known as Hutchison China MediTech) gained approval from the National Medical Products Administration of China (NMPA) in September for Elunate, which it says has best-in-class status in the VEGF-inhibitor class.
The drug represents a significant step forward for China: it is the first drug to be discovered and developed for a mainstream oncology indication to be unconditionally approved, and now launched, in the country.
Chi-Med is partnering with Eli-Lilly to commercialise the drug across China, where the two companies see a huge opportunity.
The VEGF-inhibitor class is already well-established outside China – in fact Roche’s Avastin is now available as a biosimilar in Europe – but it has never been approved in China, where there is just one other VEGF drug currently available, Bayer’s Stivarga.
However, the high cost and limited availability of Bayer’s drug means Chi-Med can tap into an enormous market in China: there are around 380,000 new cases of colorectal cancer in China every year, making it the country’s second most common cancer type behind lung cancer.
Chi-Med’s Simon To
“This launch is a major milestone for Chi-Med,” said Simon To, Chairman of Chi-Med. “We are very proud to have brought fruquintinib from its initial discovery through to its first sale, and now look forward to seeing patients in China benefit from this important new therapy.” He added, “this achievement reinforces Chi-Med’s position as a fast emerging biotech company, and illustrates China’s capability to emerge as an important global force in oncology innovation”.
Elunate is approved for treatment of patients with metastatic colorectal cancer (CRC) previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received or are unsuitable for VEGF therapy and/or EGFR therapy (Ras wild type).
The company has ambitions beyond its home market, and wants to launch fruquintinib in the US market. However as commentators have pointed out, Chi-Med faces a much higher bar in more developed markets, especially as its pivotal trials in China compare the drug with placebo – a trial design which doesn’t reflect the more advanced nature of western markets.
Also in its late stage pipeline is savolitinib, which the company says is a potentially first in class selective c-met inhibitor, and is currently in combination trials with AstraZeneca’s Tagrisso in Met+ non-small cell lung cancer.
The company is aiming for three drug approvals in the next three years, and has more than 20 programmes in phase 1 and phase 2 development.
Chi-Med has a pivotal phase 3 trial of fruquintinib as a second line combination with paclitaxel in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma due in the first half of 2019.
It received a knock back in November when fruquintinib failed as a third line treatment against non-small cell lung cancer.
This year has seen China’s regulator approve a record number of new foreign-developed treatments, including MSD’s Keytruda for melanoma and BMS’ Opdivo in NSCLC, the biggest oncology market.
This means China is rapidly catching up with the most developed markets, meaning ‘me-too’ compounds – even those developed in the country – will gain less traction.
However companies like Chi-Med can rely on the sheer scale of China’s market to deliver significant revenues and provide a platform for further expansion and R&D investment.
Chi-Med is among a wave of companies looking to enter the immuno-oncology market behind the frontrunners, and has launched a trial of fruquintinib with genolimzumab (GB226), a PD-1 inhibitor being developed by another China-based firm, Genor Biopharma.