Cetuximab Beta Approved in China by NMPA, Announces Simcere Zaiming

In an announcement on June 25, 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, revealed that their new anti-epidermal growth factor receptor (EGFR) antibody drug, Enlituo® (cetuximab beta injection), has received approval from the China National Medical Administration (NMPA) for marketing. This innovative drug, developed in collaboration with Mabpharm Limited, is indicated for use alongside the FOLFIRI regimen as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC)BRAF.

Colorectal cancer is a significant health concern in China, ranking as the second most common cancer according to the "Cancer Incidence and Mortality in China, 2022" report by the National Cancer Center. Each year, there are approximately 1.571 million new diagnoses and 240,000 deaths from this disease, reflecting a considerable societal burden. For those who develop metastatic colorectal cancer, chemotherapy and targeted therapies are primary treatments. Previous clinical trials have demonstrated the efficacy of EGFR-targeting antibody drugs in treating mCRC, particularly in patients without RAS/BRAF mutations.

Enlituo® is a recombinant EGFR monoclonal antibody that was developed independently in China. As a 2.4 class modified biological new drug, cetuximab beta is produced using a proprietary protein expression technique that effectively avoids glycosylation modification, a process that can lead to hypersensitivity reactions.

The approval of Enlituo® came after strong results from a phase 2/3 study and a phase 3 confirmatory clinical trial. The phase 3 study was an open-label, randomized, controlled, multicenter, prospective trial involving 505 subjects with RAS/BRAF wild-type mCRC. The clinical data indicated that the combination of cetuximab beta with the FOLFIRI regimen significantly extended progression-free survival (PFS) to 13.133 months compared to 9.567 months with FOLFIRI alone. Moreover, the study showed an improved objective response rate (ORR) of 69.1% versus 42.3%, and overall survival (OS) of 2.322 years compared to 1.900 years.

Dr. Renhong Tang, Chairman of Simcere Zaiming, highlighted the unique clinical value of Enlituo® in targeted therapy, particularly noting its potential to benefit a large patient population. He stated that the product complements Simcere Zaiming's existing therapies, and efforts are being made to accelerate its commercialization to help more cancer patients.

Dr. Hao Wang, CEO of Mabpharm, expressed enthusiasm about bridging the gap in colorectal cancer treatment with the introduction of a domestically developed EGFR-targeted drug. He noted that the collaboration with Simcere Zaiming's Marketing Team would enable the rapid realization of Enlituo®'s clinical value, providing an effective and affordable option for many cancer patients in China.

Enlituo® is notable for being the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights approved for the first-line treatment of mCRC. Its successful launch is expected to offer high-quality and affordable biological targeted treatments to Chinese cancer patients.

The drug marketing application for Enlituo® was accepted by the NMPA in March 2023. In August 2023, Simcere entered into a cooperation agreement with Mabpharm, granting them exclusive commercial rights for Enlituo® in mainland China.

Simcere Zaiming, founded in 2023, focuses on oncology and aims to address unmet clinical needs with innovative therapies. The company has launched several products in China and is determined to deliver transformative treatments globally through strategic collaborations and a robust R&D pipeline.