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Recently, Maiwei (Shanghai) Biotechnology Co.
, Ltd.
received the "Notice of Acceptance" approved and issued by the State Drug Administration, and the clinical trial application of 8MW2311 for injection was accepted
.
1.
Basic information of drugs Drug name: 8MW2311 for injection Application matters: Registration clinical trial acceptance number of domestically produced drugs: CXSL2200091 National applicant: Maiwei (Shanghai) Biotechnology Co.
, Ltd.
Approval conclusion: According to the "Administrative Licensing Law of the People's Republic of China" Article 32, upon examination, decided to accept the case
.
2.
Other related conditions of the drug 8MW2311 for injection is a polyethylene glycol conjugated human interleukin-2 immune agonist, which is used for the treatment of advanced malignant tumors
.
After injection of 8MW2311 into the body, it can stimulate the phosphorylation of the downstream transcription factor STAT5, and effectively stimulate the proliferation of killer T lymphocytes CD8+ T cells, thereby exerting its medicinal effect
.
The results of preclinical studies have shown that 8MW2311 is enriched in tumor tissues and has the pharmacological effect of preferentially activating CD8+ T cells, showing sustained and effective tumor inhibition in a variety of tumor models, and interacting with immune checkpoint drugs (such as anti-tumor drugs).
PD-1 antibody) in combination can show a significantly enhanced synergistic tumor inhibitory effect
.
After entering clinical trials, the company will explore the therapeutic value of 8MW2311 for injection in advanced malignant tumors
.
, Ltd.
received the "Notice of Acceptance" approved and issued by the State Drug Administration, and the clinical trial application of 8MW2311 for injection was accepted
.
1.
Basic information of drugs Drug name: 8MW2311 for injection Application matters: Registration clinical trial acceptance number of domestically produced drugs: CXSL2200091 National applicant: Maiwei (Shanghai) Biotechnology Co.
, Ltd.
Approval conclusion: According to the "Administrative Licensing Law of the People's Republic of China" Article 32, upon examination, decided to accept the case
.
2.
Other related conditions of the drug 8MW2311 for injection is a polyethylene glycol conjugated human interleukin-2 immune agonist, which is used for the treatment of advanced malignant tumors
.
After injection of 8MW2311 into the body, it can stimulate the phosphorylation of the downstream transcription factor STAT5, and effectively stimulate the proliferation of killer T lymphocytes CD8+ T cells, thereby exerting its medicinal effect
.
The results of preclinical studies have shown that 8MW2311 is enriched in tumor tissues and has the pharmacological effect of preferentially activating CD8+ T cells, showing sustained and effective tumor inhibition in a variety of tumor models, and interacting with immune checkpoint drugs (such as anti-tumor drugs).
PD-1 antibody) in combination can show a significantly enhanced synergistic tumor inhibitory effect
.
After entering clinical trials, the company will explore the therapeutic value of 8MW2311 for injection in advanced malignant tumors
.
