On June 25, 2024, Simcere Zaiming announced that Enlituo®? (generic name: cetuximab beta injection), a new generation anti-epidermal growth factor receptor (EGFR) antibody drug developed in collaboration with Mabpharm Limited, has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo®?

is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). Enlituo® (cetuximab beta, originally known as CMAB009) is a recombinant EGFR monoclonal antibody developed independently in China. Classified as a 2.4 class modified biological new drug, cetuximab beta is prepared using a proprietary protein expression technique, effectively avoiding glycosylation modification that may lead to hypersensitivity.

Enlituo® received approval based on robust evidence from a phase 2/3 study and a phase 3 confirmatory clinical trial. In an open-label, randomized, controlled, multicenter, prospective phase 3 study, 505 subjects with RAS/BRAF wild-type mCRC were treated and analyzed. Clinical data revealed that combining cetuximab beta with FOLFIRI significantly extended progression-free survival (PFS) compared to FOLFIRI alone (13.133 months vs.

9.567 months, P = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs. 42.3%, P < 0.001) and overall survival (OS) (2.322 years vs.

1.900 years, P = 0.024). Enlituo represents the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights that are approved for the first-line treatment of mCRC. The successful launch of Enlituo® will provide high quality and affordable biological targeted remedy for Chinese cancer patients.

In March 2023, the drug marketing application of Enlituo® was accepted by the NMPA. On August 18, 2023, the Group entered into a cooperation agreement with Mabpharm, pursuant to which the Group obtained the exclusive commercial rights in respect of Enlituo® in Chinese mainland.