Kelun-Biotech’s Product Cetuximab N01 Injection Approved For Marketing By NMPA Of China

---Feb. 7, 2025, Chengdu, China---

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“the Company”) announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody (“mAb”) Cetuximab N01 Injection (达泰莱®, formerly A140) used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of rat sarcoma virus (RAS) wild-type metastatic colorectal cancer (mCRC) with 500mg/m2 every other week (Q2W), or starting dose of 400 mg/m2 and maintenance dose of 250 mg/m2 weekly (Q1W).

The authorization of 达泰莱® is based on a randomized, double-blinded, controlled, multi-center phase III clinical study. This is the first domestic large scale phase III clinical study to conduct a head-to-head comparison with Cetuximab Solution for Injection (Erbitux®) in first-line treatment of RAS wild-type mCRC patients (688 patients enrolled). As demonstrated by this trial, compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy, the Cetuximab N01 combination chemotherapy was clinically equivalent in objective response rate (ORR) (Cetuximab N01 vs. Cetuximab Solution for Injection (Erbitux®): 71.0% vs. 77.5%; ORR ratio is 0.93 [95% CI: 0.87, 0.99]), and Cetuximab N01 did not demonstrate any clinically meaningful or statistically significant differences in duration of response (DoR) or progress-free survival (PFS) compared with Cetuximab Solution for Injection (Erbitux®) (median PFS: 10.9 months vs 10.8 months, HR: 1.03 [95% CI: 0.83, 1.28]; median DoR: 10.2 months vs. 9.5 months). As for safety, this phase III large scale head-to-head clinical study has sufficiently proven that the Cetuximab N01 combination chemotherapy is comparable in safety, tolerance and immunogenicity compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy[1].

According to Analysis of the China’s Malignant Tumor Prevalence in 2022 published by the National Cancer Center of China, 517,100 CRC cases and 240,000 deaths occurred in China, which are 10.7% and 9.3% of the total malignant tumor population, respectively. The incidence rate and death rate are 36.63/100,000 and 17.00/100,000, respectively, which indicates an upward trend overall.

Chemotherapy (FOLFOX or FOLFIRI) in combination with anti-EGFR mAb targeted therapy is one of the standard of care for mCRC. According to published analysis[2], EGFR mAb based therapy regimen is the priority for first-line treatment in patients with RAS wild-type mCRC. Cetuximab N01 Injection will provide significantly increased accessibility for the treatment of advanced CRC upon its approval.

Dr. Micheal Ge, CEO of Kelun-Biotech said, “We are pleased that our third self-developed product, Cetuximab N01 Injection, has been successfully approved for domestic marketing after sacituzumab tirumotecan (sac-TMT) and tagitanlimab (formerly KL-A167). As a non-ADC asset, this is the result of our exploration of targeted therapies in the field of oncology. Cetuximab N01 Injection is of great clinical significance in providing more accessible drug options for colorectal cancer patients with treatment needs.”

ABOUT KELUN-BIOTECH
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.

References:
[1] Label of Cetuximab N01 Injection; clinical study report of KL140-III-02-CTP.
[2] Chih-Chien Wu, et al. Journal of Clinical Medicine 2021 Nov; 10(21): 5166.