The application for the listing of baiva bead monobial-like drugs was accepted by the FDA

Source: Pharmaceutical Mission, January 28, Baotai Bio issued a press release saying that the FDA has accepted the BAT1706 (Beval pearl monobial-like drug) injection biological products market application (BLA), the adaptation of the application includes metastatic colorectal cancer, non-squamous non-small cell lung cancer, relapse glioblastoma, metastatic renal cell carcinoma and persistent, relapsed or metastatic cervical cancer.
Shengfeng Lee, founder and chief executive officer of Bat1706, said bat1706's approval by the FDA was a major milestone.
So far, BAT1706's application for market has been accepted by China's National Drug Administration (NMPA), the European Medicines Agency (EMA) and the FDA, highlighting the commitment of Baatea Bio to the development of high-quality drugs that meet global standards, and they look forward to BAT1706 reaching cancer patients worldwide as soon as possible.
according to the press release, BAT1706 is a beval-beaded monoantigen injection developed by Baotai Bio in accordance with the guidelines of China NMPA, FDA, and EU EMA Biosynthics. according to
public information, the adaptations approved in Europe and the United States include metastatic colorectal cancer, non-squamous non-small cell lung cancer, relapsed glioblastoma, metastatic renal cell carcinoma, persistent, relapsed or metastatic cervical cancer, epithelial ovarian cancer, fallopian or primary peritonal cancer, metastatic breast cancer and liver cell carcinoma.
through a series of preclinical matching studies, clinical pharmacodynamic ratio studies and international multi-center Phase 3 clinical trials, BAT1706 has been fully confirmed to be highly similar in clinical efficacy, safety and immunogenicity to the original drug beva bead monoantigen.
it is worth mentioning that Baotai Bio has reached a cooperation agreement with Baiji Shenzhou to authorize Baiji Shenzhou to develop, produce and commercialize BAT1706 in China, including Hong Kong, Macao and Taiwan.
BAT1706 is the second biosychable drug submitted for listing by Biotay, the company's first biosynthetic drug, Greli (Adamo single resistance), which has been approved for sale in China for the treatment of rheumatoid arthritis, strong spina bifida, psoriasis, Crohn's disease and vineitis.
its biosynthic drug product pipeline also includes toad monoanti, Golimu monoanti, Usnu monoanti, Skuchiyu monoantigen, etc., and a number of new generation of innovative antibody drugs for tumors are at different stages of clinical development.
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