Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release.
Background on Parsaclisib and Collaboration with Incyte
Parsaclisib, a next-generation PI3Kδ inhibitor, was in-licensed by Innovent from Incyte Corporation as part of a December 2018 deal that also included two other small-molecule cancer drugs. Innovent had been pursuing approval for parsaclisib as a treatment for recurrent or refractory follicular lymphoma (FL) in the third-line setting. The approval filing was initially accepted for review by the National Medical Products Administration (NMPA) in January of this year.
Reasons for Withdrawal and Development Halt
Innovent’s decision to end the development of parsaclisib at the approval filing stage is attributed to a change in Incyte’s overseas development strategy for the molecule. This strategy would necessitate increased investment from Innovent to conduct a separate confirmatory Phase III study and extend the study timeline. Considering the overall research and development strategy and product value management, Innovent proactively withdrew the market filing to focus resources on more critical pipeline candidates.
Market Landscape for PI3K Inhibitors
Globally, multiple PI3K inhibitors have been approved, including Gilead’s idelalisib, Bayer’s copanlisib, Verastem’s duvelisib, Novartis’s alpelisib, and TG Therapeutics’ umbralisib. In China, Yingli/Hengrui’s linperlisib has been approved for marketing, while BeiGene, Chia Tai Tianqing, and Sanhome Pharma are developing similar products. Incyte announced in May this year that it was ending Phase III development of parsaclisib.
Conclusion
Innovent Biologics’ withdrawal of the market approval filing for parsaclisib and the halt of its development reflect a strategic realignment in response to changes in the development landscape and the need to prioritize resources on other pipeline candidates. This move underscores the dynamic nature of drug development and the constant evaluation of investment strategies in the pharmaceutical industry.-Fineline Info & Tech
