Nov 15, 2019, FDA grants accelerated approval to BeiGene's (BGNE-0.6%) BTK inhibitor Zanubrutinib, branded as Brukinsa, for the treatment of mantle cell lymphoma, an aggressive type of non-Hodgkin lymphoma. It's the first approved drug of China in the U.S.
This is a milestone in Chinese drug history. It is a breakthrough therapy made in China, and its large data is based on Chinese patients.
In the international market, Chinese innovative drugs go into the international drug market; to China mainland, Chinese patients can get first-hand anti-cancer drugs with the international first-class standard.
These years, China market wins more and more opportunities to get innovative drugs at the same time and the same quality. In before, normally the Chinese patients buy innovative drugs from India, the US and other countries. This purchasing most are illegal, without government authority. And certainly, the qualities of the drugs are hard to be insured.
This also brings much higher costs to patients. Like Zanubrutinib, one patient needs to pay $100,000 one year for long term treatment. This time would take 3-4 years. $30,000-$40,000 drug cost is not bearable for most people, especially the patients in developing countries.
Present, there are 2 drugs launched in the market in BTK inhibitors, one is Ibrutinib from Johnson & Johnson and Abbvie, one is Acalabrutinib from AstraZeneca. Ibrutinib is approved into China market in Aug 2018, but Acalabrutinib is still not. Zanubrutinib will be the second BTK inhibitor in the China market and third in the international market. Ibrutinib is the 4th anti-cancer drug after Keytruda (pembrolizumab), Revlimid, Opdivo(nivolumab). Zanubrutinib now wins the same certificate, we can see it will be booming in the short future.