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Author: Armstrong
On October 26, 2021, the listing application of Lepu Bio's PD-1 monoclonal antibody Pritlizumab (HX008) for the treatment of MSI-H/dMMR solid tumors was accepted by NMPA, which is the second adaptation of the product declaration Disease
.
Previously, the listing application for the second-line treatment of melanoma was officially accepted by CDE on July 5, 2021
Pratlizumab is a humanized anti-PD-1 monoclonal antibody, its own advantage lies in the use of a design strategy to extend the half-life, innovative use of antibody engineering technology to introduce the S254T/V308P/N434A mutation in the Fc of IgG4, to Figure reduces the number of administrations, reduces the cost of treatment, and further improves the patient's drug compliance
.
Phase I clinical results show that the half-life of the product is 17.
Judging from the indications of MSI-H solid tumor accepted by Lepu Biologics this time, this submission is mainly based on a single-agent treatment of highly microsatellite instability (MSI-H) or mismatch repair defect (dMMR).
) The results of a pivotal phase II clinical study carried out in advanced solid tumors.
Patients receive an intravenous injection of 200 mg of Pratrolizumab every three weeks until the disease progresses, intolerable toxicity occurs or the drug is discontinued
.
The project was led by Professor Huang Jing from the Cancer Hospital of the Chinese Academy of Medical Sciences, 27 participating units, and a total of 100 subjects were enrolled
MSI-H/dMMR
MSI-H/dMMRAt present, anti-PD-1/L1 therapy has a low overall effect on solid tumors that do not distinguish between groups.
People with higher efficiency based on tumor biomarker enrichment are a development direction of anti-PD-1/L1 therapy
.
Primary anti-PD-1 / L1 therapy of tumor biomarker comprises the expression level of PD-L1, MSI-H / dMMR, mutant tumor burden (TMB) and the like
According to statistics, in some common cancers in China, the number of new MSI-H solid tumor patients each year is about 312,000, which is equivalent to the number of new breast cancer cases each year.
It is calculated based on the total number of patients and the proportion of patients with MSI-H tumors treated with drugs.
It is estimated that in 2030, the number of potential users of MSI-H/dMMR solid tumors is expected to reach 187,000
.
At present, only 3 anti-PD-1 monoclonal antibodies have been approved at home and abroad for the treatment of MSI-H/dMMR tumors, and domestic PD-1/PD-L1 has not been approved for this indication
Distribution ratio of MSI-H/dMMR in 18 cancer types
Summarize
SummarizeLepu Biotechnology Co.
, Ltd.
is an innovative biopharmaceutical company based in China and facing the world, focusing on the field of tumor treatment
.
In recent years, Lepu Bio has been committed to continuously building differentiated market pipelines through independent innovation and strategic cooperation, establishing and strengthening independent production capabilities, and realizing domestic commercialization of product pipelines through the establishment of professional sales and marketing teams.
Facing the increasingly fierce PD-1 market, Pratlizumab continues to cover more indications, especially gastric cancer, lung cancer, breast cancer, liver cancer and other key tumor types.
Among them, the second-line treatment of gastric cancer has carried out registered phase III clinical studies.
.
In addition, Lepu Biotech is also committed to developing innovative ADC pipelines and oncolytic virus products with highly differentiated competitive advantages, and actively exploring combination therapies to provide patients with better treatment options
.
The acceptance of the NDA application of Pratlizumab for two consecutive indications also lays the foundation for the PD-1 combination therapy of Lepu Biologics, according to the announcement of the pre-clinical data of immune combined chemotherapy/targeted or immune combined ADC on ASCO and CSCO As a result, the mechanism of immune combined with ADC products is gradually verified.
