33. Brukinsa

Brukinsa
(BeiGene)

Active ingredient: zanubrutinib
Disease: mantle cell lymphoma
Peak sales estimate: $2.2 billion (2025)
Approved: Nov. 14, 2019
Company: BeiGene

The scoop: Brukinsa marked the first cancer drug discovered in China to get an FDA green light. The approval, largely based on tumor shrinkage results from a phase 2 trial in 86 Chinese patients, “provides validation” for using primarily China data to support U.S. drug approvals, SVB Leerink analyst Andrew Berens, M.D., said. The new BTK inhibitor, which is also BeiGene’s first commercial drug in the U.S., is now going after AbbVie and Johnson & Johnson’s blockbuster Imbruvica and AstraZeneca’s Calquence in previously treated patients with mantle cell lymphoma, while eyeing to expand into other indications of the two Big Pharma rivals, including the key chronic lymphocytic leukemia (CLL) market. Determined to show that Brukinsa is better than market leader Imbruvica in terms of both efficacy and safety, BeiGene is already running head-to-head studies in Waldenström macroglobulinemia and CLL. It has priced Brukinsa on par with Imbruvica tablets but below Calquence. In a November note, Berens’ team figured Brukinsa could collect $220 million in 2021 and grow to $2.20 billion in 2025. — Angus Liu

33. Brukinsa

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