The China National Medical Products Administration (NMPA) has granted marketing approval for Simcere Zaiming’s Enlituo for the treatment of metastatic colorectal cancer (mCRC).

An anti-epidermal growth factor receptor antibody drug, Enlituo is developed by Simcere Zaiming along with Mabpharm.

It is intended for usage alongside the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type mCRC.

Enlituo’s production utilises a specific protein expression technique to minimise glycosylation modification, reducing the risk of hypersensitivity reactions.

The NMPA approval for Enlituo was supported by data from a Phase II/III study and a confirmatory Phase III clinical trial.

In the Phase III trial, 505 subjects with RAS/BRAF wild-type mCRC were enrolled.

According to the findings, the Enlituo plus FOLFIRI regimen improved progression-free survival (PFS) versus FOLFIRI alone.

The combination treatment resulted in an objective response rate of 69.1% versus 42.3% in the FOLFIRI treatment arm.

Overall survival following treatment with the combination regimen was 2.3 years as against 1.9 years in the FOLFIRI group.

In March last year, the NMPA accepted the marketing application for Enlituo.

In August of the same year, Simcere Zaiming signed a cooperation agreement with Mabpharm, securing exclusive commercial rights for Enlituo in mainland China.

Simcere Zaiming chair Dr Renhong Tang said: “Its [the drug's] initial indication for colorectal cancer addresses a large patient population. The product synergises well with Simcere Zaiming’s existing offerings, and efforts are underway to accelerate its commercialisation, benefiting more cancer patients.”