Simcere Zaiming Announce Approval of Cetuximab Beta in China by the NMPA

NANJING, China, June 26, 2024 /PRNewswire/ -- On June 25, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), 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 (2181.HK), 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).

According to the 'Cancer Incidence and Mortality in China, 2022' by the National Cancer Center, colorectal cancer ranks as the second most common cancer in China. Annually, there are 1.571 million new cases and 240,000 deaths, imposing a substantial disease burden on the society. When colorectal cancer patients develop metastasis, the primary treatment options often include chemotherapy and targeted drugs. Previous clinical studies have demonstrated the effectiveness of EGFR-targeting antibody drugs in treating malignant tumors, particularly mCRC, in patients without RAS/BRAF mutations (wild-type).

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).

Dr. Renhong Tang, Chairman of Simcere Zaiming, emphasized Enlituo®'s unique clinical value in targeted therapy: "Its initial indication for colorectal cancer addresses a large patient population. The product synergizes well with Simcere Zaiming's existing offerings, and efforts are underway to accelerate its commercialization, benefiting more cancer patients."

Dr. Hao Wang, Chief Executive Officer of Mabpharm, expressed excitement as Enlituo® bridged the gap in colorectal cancer treatment with domestically developed EGFR-targeted drugs. "This provides clinicians and patients with updated therapeutic options. By collaborating with Simcere Zaiming's Marketing Team, we are able to rapidly realize the clinical value of Enlituo®, benefiting hundreds of thousands of patients in China with an effective and affordable biological new drug. "

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.

About Mabpharm

Mabpharm (stock code: 2181) focuses on the development of monoclonal antibodies and has an experienced R&D team, multiple core technologies, leading domestic large-scale antibody preparation system and excellent quality control system. Mabpharm strives to bring high quality and affordable innovative biologics through its efficient R&D system and low-cost pharmaceutical production capability to the market, and develops various therapeutic products by fully utilizing its extensive R&D experience.

About Simcere Zaiming

Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is devoted to crafting groundbreaking therapies aimed at fulfilling the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, and Envafolimab. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in the field of innovative cancer therapeutics.

SOURCE Simcere