The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic treatments. The phosphatidylin-ositol-3-kinase (PI3K) inhibitor had previously obtained priority review status in April 2021, under the conditional approval pathway.
Global Market for PI3K Inhibitors
Other PI3K inhibitors available in the global market include Gilead’s Zydelig (idelalisib), Verastem’s Copiktra (duvelisib), Novartis’ Piqray (alpelisib; BYL719), and TG Therapeutics’ umbralisib. In China, Yingli/Hengrui’s linperlisib, another PI3Kδ inhibitor, has already received market approval. Additionally, Innovent/Incyte’s parsaclisib is awaiting an approval decision, while BeiGene, Chia Tai Tianqing, and Sanhome are developing innovative PI3K inhibitors.
Ongoing Regulatory Review for Copanlisib in China
Bayer’s copanlisib was filed in China in July 2021 as a second-line treatment for inert non-Hodgkin’s lymphoma (NHL), with regulatory review currently underway. This latest approval for follicular lymphoma further expands the potential patient population that may benefit from copanlisib’s therapeutic effects.-Fineline Info & Tech
