Simcere and Zaiming Announce NMPA Approval for Cetuximab Beta in China

Simcere and Zaiming Announce NMPA Approval for Cetuximab Beta in China

By, Admin 28 June 2024

Overview

Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), has announced that Enlituo® (generic name: cetuximab beta injection), an advanced anti-epidermal growth factor receptor (EGFR) antibody drug developed in collaboration with Mabpharm Limited (2181.HK), has recently been approved by the China National Medical Products Administration (NMPA) for marketing. Enlituo® is indicated for use alongside the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC).

Colorectal Cancer in China 

  • Colorectal cancer ranks as the second most common cancer in China, with 1.571 million new cases annually and 240,000 deaths, according to the National Cancer Center's 'Cancer Incidence and Mortality in China, 2022'. 
  • Enlituo® addresses a significant medical need in this population, particularly for patients without RAS/BRAF mutations.

About Enlituo

  • Enlituo® (cetuximab beta, originally CMAB009) is a recombinant EGFR monoclonal antibody developed independently in China. 
  • It falls under the 2.4 class of modified biological new drugs, made using a proprietary protein expression technique to prevent glycosylation modifications that can cause hypersensitivity reactions.

Trials Behind Approvals

  • Approval was based on robust evidence from phase 2/3 and phase 3 clinical trials. 
  • A phase 3 study involving 505 subjects with RAS/BRAF wild-type mCRC showed 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). 
  • The combination also improved 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).

Simcere Zaiming, emphasized Enlituo®'s clinical significance in targeted therapy, particularly in addressing the needs of a large patient population. Ongoing efforts are focused on accelerating its commercialization to benefit more cancer patients in China.

Mabpharm, expressed enthusiasm about Enlituo®'s role in enhancing treatment options for colorectal cancer in China, highlighting collaborative efforts to swiftly bring this innovative therapy to patients.

About Enlituo

  • Enlituo® marks a milestone as the first domestically developed EGFR monoclonal antibody drug with independent intellectual property rights approved for first-line mCRC treatment in China. 
  • Its approval is set to provide a high-quality, cost-effective treatment option for Chinese cancer patients.

NMPA Approval

In March 2023, Enlituo®'s marketing application was accepted by the NMPA, followed by a cooperation agreement between Simcere Zaiming and Mabpharm in August 2023, granting exclusive commercial rights for Enlituo® in mainland China.

Mabpharm

  • Mabpharm (stock code: 2181) focuses on monoclonal antibody development, boasting an experienced R&D team, advanced technologies, and a robust production capability. 
  • Committed to delivering high-quality and affordable biologics, Mabpharm continues to expand its portfolio through innovative R&D initiatives.

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