China's NMPA Accepts NDAs for Lung and Liver Cancer Therapies
核心洞察
Hansoh Pharmaceutical (搜索)'s Aumolertinib (搜索) NDA was accepted for first-line treatment of NSCLC with EGFR (搜索) mutations, marking its fifth indication.
Akeso (搜索)'s Penpulimab sNDA was accepted for first-line treatment of advanced hepatocellular carcinoma (搜索), based on positive Phase III trial results.
The Penpulimab combination therapy showed significant improvements in PFS and OS compared to sorafenib in HCC patients.
The National Medical Products Administration (NMPA) of China has accepted New Drug Applications (NDAs) for two cancer therapies, signaling potential advancements in the treatment of non-small cell lung cancer (搜索) (NSCLC) and hepatocellular carcinoma (搜索) (HCC). These regulatory milestones highlight the ongoing efforts to address significant unmet needs in cancer treatment within China.
Aumolertinib for First-Line NSCLC
Hansoh Pharmaceutical (搜索) Group Company Limited announced that the NMPA has accepted the fifth NDA for its innovative drug, Aumolertinib (搜索) Mesilate Tablets (Ameile). This application seeks approval for Aumolertinib in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR (搜索)) exon 19 deletions or exon 21 (L858R) mutations.
Aumolertinib (搜索) is the first innovative third-generation EGFR (搜索)-TKI drug wholly developed in China. It was previously approved for NSCLC patients with T790M mutation who progressed on or after EGFR-TKI therapy and as a first-line treatment for NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.
Penpulimab Combination Therapy for HCC
Akeso (搜索), Inc. announced that the NMPA has accepted its supplemental new drug application (sNDA) for Penpulimab, a differentiated PD-1 (搜索) monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (搜索) (HCC). This marks Penpulimab’s fifth indication, following approvals for various NSCLC and Hodgkin lymphoma treatments.
The sNDA is supported by the ALTN-AK105-III-02 study, a Phase III clinical trial that demonstrated positive outcomes in both progression-free survival (PFS) and overall survival (OS). According to Akeso (搜索), the Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001). The regimen also reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013).
The combination of Penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. Akeso (搜索) believes this makes the combination a promising first-line treatment option for advanced HCC.