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R&D Process of Monoclonal Antibody of Hualan Bio

R&D Process of Monoclonal Antibody of Hualan Bio

On July 16, 2018, Hualan Genetic Engineering Co., Ltd. (hereinafter referred to as the "Hualan Gene") which is a subsidiary of Hualan Bio received the acceptance notice of the new drug clinical application for "Recombinant Anti-EGFR All-Human Monoclonal Antibody Injection" issued by the CFDA. "Recombinant Anti-EGFR All-Human Monoclonal Antibody Injection" is suitable for the treatment of metastatic colorectal cancer with RAS wild genotype. The application for the clinical study of "Recombinant Anti-EGFR All-Human Monoclonal Antibody Injection" was accepted, indicating that "Recombinant Anti-EGFR All-Human Monoclonal Antibody Injection" has completed the pre-clinical study and entered the registration application procedure. According to the relevant regulations of the drug registration, "Recombinant Anti-EGFR All-Human Monoclonal Antibody Injection" will be reviewed by the CFDA bureau after being accepted for clinical research. 

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TAG:  Hualan Bio, Monoclonal Antibody, CFDA, Hualan Genetic Engineering Co., Ltd.