CSPC PHARMA (01093.HK): NDA for Envi Trastuzumab Injection Accepted by NMPA

NewTimeSpace · 2026/07/17 16:55 · By Boyuan Chen

NewTimeSpace News: CSPC Pharma (01093.HK) announced that the New Drug Application (NDA) for its self-developed Envi Trastuzumab Injection has been accepted by the NMPA. Filed as Class 1 therapeutic biological product, it is indicated for unresectable or metastatic HER2-positive adult breast cancer patients previously treated with one or more anti-HER2 agents.

NewTimeSpace News: CSPC Pharma (01093.HK) released a voluntary announcement on 17 July 2026. The New Drug Application for Envi Trastuzumab Injection developed by the Group has been accepted by the National Medical Products Administration (NMPA). Classified as a Class 1 therapeutic biological product, the candidate is indicated for adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies.

Envi Trastuzumab Injection is a HER2-targeted antibody-drug conjugate (ADC). It binds to HER2-positive tumour cells and triggers internalisation, followed by lysosomal hydrolysis to release MMAE, which suppresses tubulin polymerisation and induces tumour cell apoptosis. The NDA is principally supported by a pivotal Phase III clinical trial, whose results demonstrated that the candidate delivers statistically significant progression-free survival (PFS) improvement versus T-DM1 in second-line and later treatment settings, with favourable safety and tolerability profiles.

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CSPC PHARMA 01093.HK New Drug Application