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.
View original
content:https://www.prnewswire.com/news-releases/simcere-zaiming-announce-approval-of-cetuximab-beta-in-china-by-the-nmpa-302182678.html
SOURCE Simcere