The first of its kind in China! Kelun-Biotech's Cetuximab Solution for Infusion Accepted for market registration application by the National Medical Products Administration.

On September 11, 2023, Kelun-Biotech announced that the major product A140 solution for infusion (Cetuximab Solution for Infusion, trade name: Datalai?) was recently accepted for marketing application by the Center for Drug Evaluation of the National Medical Products Administration (acceptance number: CXSS2300075).   A140 solution for infusion is the first cetuximab solution for infusion that filed an application for marketing in China. It is intended for the treatment of metastatic colorectal cancer with wild-type RAS genes: used in combination with FOLFOX or FOLFIRI regimens for first-line treatment; and in combination with irinotecan for patients who have failed treatment containing irinotecan. At the same time, it is also intended for the treatment of head and neck squamous cell carcinoma (HNSCC): used in combination with platinum and fluorouracil chemotherapy for first-line treatment of recurrent and/or metastatic diseases; and in combination with radiotherapy for the treatment of locally advanced diseases.   This product is a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody (mAb), which inhibits the growth and survival of tumor cells expressing EGFR. The A140 solution for infusion is firstly developed in China to be filed for production in accordance with the “Guidelines for Design of Clinical Trials of Injectable Cetuximab Biosimilar (for Trial Implementation)” using the original cetuximab as a reference drug. The reference drug ctuximab (trade name: Erbitux?) was approved for import into China in 2007. The approved indications in China include metastatic colorectal cancer and HNSCC. As of 2022, the global market size of cetuximab has reached 1.73 billion US dollars, and the sales in China have reached 2.253 billion yuan. Due to reasons such as drug accessibility, the clinical demand for cetuximab has not been met. A140 solution for infusion has the same amino acid sequence and mechanism of action as cetuximab, and its proposed indications are consistent with Erbitux?. The A140 solution for infusion will provide significantly increased accessibility once the Application is approved, and will bring compliant, safe, and effective treatment options to more patients.   In recent years, due to factors such as population aging and unhealthy lifestyles caused by improved living standards (such as sedentary lifestyle, high-fat and high-protein diets, etc.), the incidence of colorectal cancer in China has been on the rise. According to the epidemiological data of cancer released by the National Cancer Center of China in 2022, there were 408,000 new cases of colorectal cancer and 196,000 deaths in China. The incidence and mortality rates of colorectal cancer ranked second and fourth among all malignant tumors, respectively. Currently, cetuximab is one of the main treatment options for metastatic colorectal cancer with the primary tumor located in the left half of the colon and expressing wild-type RAS EGFR. Head and neck squamous cell carcinoma (HNSCC) is the most common malignant tumor in the head and neck area. In 2022, there were about 78,000 new cases of HNSCC and over 40,000 deaths in China. The incidence and mortality rates of HNSCC ranks seventh and sixth among all malignant tumors in Chinese men, respectively. Since cetuximab was approved globally for first-line treatment of recurrent or metastatic HNSCC and used in combination with radiotherapy for locally advanced HNSCC, it has allowed many HNSCC patients worldwide to receive treatment plans containing cetuximab, which improved their quality of life and extended their life expectancy.   The application for registration of A140 solution for infusion is based on information from a series of studies, including pharmacologic comparative study, non-clinical comparative study, and clinical comparative study. The Phase III clinical safety and efficacy study of A140 is a randomized, double-blinded, parallel-controlled, multi-centered Phase III clinical study comparing the efficacy, safety and immunogenicity of A140 and the original cetuximab combination chemotherapy regimen (mFOLFOX6 regimen) for first-line treatment of RAS wild-type metastatic colorectal cancer.     About Kelun-Biotech Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America. For more information, please visit https://kelun-biotech.com/.

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