China Drugmaker Aims for First Generic Drug Approval of Novartis’ Tasigna in China

Suzhou Therypharm Pharmaceutical’s filing for approval of its generic blood cancer drug in China has been accepted by the country’s CDE (Center for Drug Evaluation). This is a game-changer for generic versions of Novartis’ Tasigna (nilotinib); so far, the oral pill faces zero competition in the generic market. With the CDE acceptance of its filing, Therypharm takes the lead in the category and could possibly be the first company that produces nilotinib’s generic version in China.

Tap Into a Near $2 Billion Market

Nilotinib is a small-molecule tyrosine kinase inhibitor that targets the BCR-ABL protein. It is approved to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML) in adults and children who are at least 1 year old.

There is huge market demand for the drug. Novartis’s report ranks nilotinib in 4th place on net sales of their top 20 innovative medicines division product, bringing in $1.93 billion in 2020. In the first half of 2021 alone, nilotinib sales hit $1.038 billion with $523 million from Q2.

Besides nilotinib, Therypharm also worked on other generics, including for Astellas and Roche’s lung cancer drug Tarceva, AstraZeneca’s cancer drug Iressa, and cardiovascular disease drug Ticagrelor. Those were approved in China in 2021.

Therypharm’s Series C Round

In September 2020, the firm finished a Series C round with $38 million in hand. The funding was led by state-backed SND Ventures Group and investment firm CEC Capital. Other investors included GP Capital’s Su Shang Fund, Suzhou International Development Venture Capital Holding’s sub-fund, Honest Capital, and Taiho Venture Capital.

Author

Tyler Chen

"Never go to a doctor whose office plants have died."- Erma Bombeck