Fruquintinib becomes the first homegrown oncology drug approved in China for major indication

By Ajay V. Patil

Tolerable safety profile of Chi-Med’s newly approved anti-VEGFR drug Elunate®Fruquintinib marked arrival of innovative homegrown oncology drugs in China for major indications like colorectal cancer (CRC).

National Medical Products Administration of China, approved Chi-Med’s Fruquintinib for the treatment of metastatic CRC patients, who have failed at least two prior systemic antineoplastic therapies. Fruquintinib selectively inhibits VEGFR 1, 2 and 3. Chi-Med claims ‘best in class’ safety profile and no significant off-target effects from other kinases. Phase 3 study showed improved overall survival by a median 9.3 months, compared with 6.6 months for patients with the use of placebo. Eli-Lily has an agreement concerning licence, co-development and commercialization with Chi-Med in China for Fruquintinib.

CRC is the second most common cancer in China, with around 380,000 new cases per year. In 2015, 1.5 million new CRC cases were reported globally in 2015 which are expected to increase to 1.7 million per year by 2020. Chi-Med is now eyeing competitive markets and initiated a phase 1 study in the U.S. for advanced solid tumors. Chi-Med also announced approximate US$13.6 million milestone payment from its China market launch partner Eli-Lilly.

With tolerable safety profile, Chi-Med is testing the drug for NSCLC with various combinations like AstraZeneca’s EGFR inhibitor Iressa. Chi-Med’s top executive Christian Hogg recently said, “Fruquintinib represents the first one across the finish line, but we have other drug candidates in clinical trials and there are many other companies in China with drug innovations in development”.

In this changing time of varied class of cancer therapies, Chi-Med is putting out Fruquintinib & Sulfatinib as ideal VEGFR combination partners for immunotherapy based on their promising safety profiles compared to other players. These approvals and early results have shown a growing interest for Chinese biotechnology stocks but long-term stability of these stocks is still being questioned by skeptics. However, standout performance by these homegrown drugs could quickly change the situation.

References:
1. Press Release Chi-Med –
https://globenewswire.com/news-release/2018/09/05/1565355/0/en/Chi-Med-Announces-the-Approval-of-Fruquintinib-Capsules-for-Previously-Treated-Colorectal-Cancer-in-China.html?print=1
2. Chi-Med 2018 Interim Results –
https://www.chi-med.com/ wp-content/uploads/2018/09/pre180727.pdf
3. https://www.ncbi.nlm.nih.gov/pubmed/?term=Effect+of+Fruquintinib+vs+Placebo
4. https://www.reuters.com/article/us-chi-med-cancer-china/boost-for-made-in-china-medicine-as-chi-med-wins-key-approval-idUSKCN1LL0NA
5. https://www.fiercepharma.com/pharma-asia/eli-lilly-and-chi-med-s-elunate-first-china-made-cancer-drug-to-win-a-key-nod

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