CSPC Pharmaceutical’s Trastuzumab Envedotin NDA Accepted by China’s NMPA

Bulletin Express07-17

Hong Kong-listed CSPC Pharmaceutical Group announced that the National Medical Products Administration (NMPA) has formally accepted the new drug application (NDA) for Trastuzumab Envedotin Injection, classified as a Class 1 therapeutic biological product.

The antibody-drug conjugate targets HER2-positive tumour cells in adults with unresectable or metastatic breast cancer who have received at least one prior anti-HER2 regimen. Mode-of-action data show the molecule binds to HER2 receptors, is internalised, and releases MMAE to block tubulin polymerisation, inducing tumour-cell apoptosis.

Regulatory submission is supported by a pivotal Phase III trial comparing Trastuzumab Envedotin with T-DM1 in patients previously treated with trastuzumab and taxane. Headline results indicated a statistically significant and clinically meaningful improvement in progression-free survival, alongside superior performance across secondary endpoints and subgroup analyses. The investigational therapy also demonstrated favourable safety and tolerability profiles.

Management expects the product’s efficacy and safety profile to translate into strong clinical value for a broader population of HER2-positive breast-cancer patients, pending final regulatory approval.

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