Tragrisso, a drug developed by AstraZeneca plc (ADR) (NYSE:AZN), has been granted approval in China. The treatment is designed to assist patients who are suffering from cancer and who have particular genetic mutations that are commonly found in the world’s most populous country. China’s approval of Tagrisso not only boosts the prospects of AstraZeneca in a lucrative drug segment but also gives the British pharmaceutical giant a head start in a key market.
The drug whose dosage is one pill a day is presently utilized as a second-line treatment meaning that patients have to first try Tarceva, developed by Roche and Iressa, also by AstraZeneca. A clinical trial that is slated for this year could, however, assist Tagrisso in getting approval for first-line use.
Ambitious sales target that were set three years ago by AstraZeneca projected that Tagrisso would achieve blockbuster status and contribute to the pharmaceutical firm approximately $3 billion a year by 2022. Then, it was viewed by many analysts as an unrealistic sales target but the consensus right now is that it is highly achievable. This is because of a launch that has been successful so far and also due to the fact that products from competitors have failed. In 2016, sales of Tagrisso reached $423 million.
For AstraZeneca, China could easily emerge as the largest market for Tagrisso since between 30% and 40% of the patients in China who suffer from non-small cell lung cancer have mutated tumors that respond well to the drug. This is a higher efficacy rate than in Europe and North America. Additionally, cases of lung cancer are rising in China due to the adoption of unhealthy lifestyles as incomes rise, high smoking rates and air pollution. In 2015, over 700,000 cases of lung cancer were reported in China.
In a priority review pathway recently introduced by the Food and Drug Administration of China, Tagrisso is among the first to benefit. Other than speeding up drug approvals, the regulator is also considering easing clinical trial requirements for pharmaceutical firms.
In Mondays early trading hours shares of AstraZeneca were ranging between $31.10 and $31.38.