Chi-Med Receives Fast Track Designation for Cancer Drug From FDA

The cancer drug developer will begin a Phase 3 study called FRESCO-2 in the U.S., Europe, and Japan.
Anthony RussoJun 18,2020,17:20

Hutchison China MediTech Ltd. (Nasdaq: HCM) announced Thursday that it has received fast track designation for the development of its metastatic colorectal cancer drug by the U.S. Food and Drug Administration (FDA).

The company, also known as Chi-Med said in a statement today that it is commencing a Phase III study called FRESCO-2 in the U.S., Europe, and Japan. The treatment cancer drug called Fruquintinib Was granted for marketing by the China National Medical Products Administration in September 2018 after a positive Phase III study that improved overall survival.

Fruquintinib was then commercially launched by its American pharmaceutical partner Eli Lilly and Company (NYSE: LLY) in November 2018 under the brand Elunate®.

If FRESCO-2 shows positive results, along with more completed and ongoing supporting studies with metastatic colorectal cancer, Chi-Med noted that the FDA could support a New Drug Application.

According to Chi-Med, colorectal cancer claimed more than 880,000 deaths in 2018 and is the third most common cancer globally. It is projected that in 2020, 147,950 people in the U.S. will be diagnosed with colorectal cancer with deaths topping 53,200.

After the report, Chi-Med’s shares were sent nearly 2% higher from Wednesday’s close to $23.40 per American depositary share. Shares of Chi-Med are down 7% year-to-date.

With headquarters in both Hong Kong and London, Chi-Med develops cancer drugs. According to Chi-Med, it has a portfolio of eight cancer drug candidates in clinical studies around the world.  

In the full year 2019, Chi-Med's revenue fell to $205 million compared with $214 million in the prior year. It also widened its net loss to $106 million as compared to $75 million in 2018.

Chi-Med expects to start enrolling patients in FRESCO-2 during mid-2020.