Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) announced in a stock exchange statement that the National Medical Products Administration (NMPA) has declined to issue a market approval for plinabulin, a potential first-in-class GEF-H1-targeted small-molecule drug in-licensed from US-based BeyondSpring Inc. (NASDAQ: BYSI). Hengrui was seeking approval for the drug’s use in treating chemotherapy-induced neutropenia (CIN) in patients with non-myeloid malignancies, combined with PEGylated recombinant human granulocyte stimulating factor.
Mechanism and Development History
Plinabulin is a differentiated immune and stem cell modulator that activates the GEF-H1 protein to enhance the ability of dendritic cells to activate T-cells. The drug is designed to prevent chemotherapy-induced bone marrow neutrophil damage and prevent CIN at an early stage. Originally developed by US-based Nereus Pharmaceuticals as a treatment for non-small cell lung cancer (NSCLC), BeyondSpring acquired and repurposed the asset in 2012.
Partnership and Regulatory Challenges
Hengrui entered into a partnership with BeyondSpring’s Dalian-based subsidiary in August 2021, taking co-development and exclusive commercialization rights to the drug in Greater China, alongside an equity investment in the firm. BeyondSpring made a first filing for plinabulin with the US FDA but received a complete response letter (CRL) in December 2021 due to the single Phase III study’s failure to demonstrate CIN benefit. Hengrui has not conducted any study for the drug at this stage and has not revealed any follow-up development plans.
Financial Commitments
Hengrui has paid BeyondSpring RMB 200 million (USD 29 million) upfront under the license deal terms, while the RMB 100 million (USD 14.5 million) equity investment has yet to be transferred.-Fineline Info & Tech
