China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC).
Commercialization and Market Presence
Penpulimab, a differentiated PD-1 therapy, is commercialized through a joint venture (JV) between Akeso and Chia Tai Tianqing, established in December 2021 with equal shares. This approval expands the drug’s market presence, following previous marketing approvals in China for relapsed/refractory classic Hodgkin lymphoma (cHL), first-line locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC), and third-line recurrent/metastatic NPC.
Pending Regulatory Decisions
The drug is also awaiting regulatory decisions in China for use in combination with anlotinib for first-line advanced hepatocellular carcinoma (HCC).-Fineline Info & Tech
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