UK major AstraZeneca’s (AZ, NASDAQ: AZN) blood cancer therapy Calquence (acalabrutinib) was first administered at the Hainan branch of Shanghai’s Ruijin Hospital this week. The drug is being made available ahead of official approval via the Hainan Bo’ao Lecheng medical pilot zone, offering patients early access to this innovative treatment.
Calquence: Next-Generation BTK Inhibitor
Calquence is among the world’s first next-generation Bruton’s tyrosine kinase (BTK) inhibitors. It was first approved for marketing in the US in October 2017 to treat mantle cell lymphoma. Since then, Calquence has been commercially available in 40 countries and is being assessed in multiple clinical studies targeting various B-cell hematological tumors. These include chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, and other hematological malignancies.
Regulatory and Market Status in China
Calquence is currently awaiting regulatory decisions in China, with market filings made in the country in January and December 2022. The early availability of the drug in the Hainan Bo’ao Lecheng medical pilot zone highlights AstraZeneca’s commitment to bringing innovative therapies to patients in China as quickly as possible.
Strategic Implications
The administration of Calquence in the Hainan pilot zone is a significant milestone for AstraZeneca, as it expands the drug’s reach in the Chinese market. This move not only provides patients with early access to a potentially life-changing treatment but also positions AstraZeneca to benefit from the growing demand for advanced cancer therapies in China. The ongoing clinical studies and regulatory filings are expected to further solidify Calquence’s position in the global market for blood cancer treatments.-Fineline Info & Tech
