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Q1
Basic Information
Initumumab (Ceptin) was developed by Sansheng Guojian, a subsidiary of Sansheng Pharmaceutical, and submitted the drug’s marketing application as a category 2 new drug in September 2018, and in November 2018 according to the priority review scope (1 ) Seven major projects have been included in the priority review process and will be approved for listing by the NMPA in June 2020.
Compared with trastuzumab, inituzumab has the same 2 Fab segments, each with 214 amino acids, but the Fc segment has been modified with amino acids and the production process has been optimized.
Q2
Listing background
Breast cancer is a malignant tumor that occurs in the epithelial tissue of the breast.
The Frost & Sullivan report shows that in 2018, China’s anti-HER2 monoclonal antibody drug market was approximately 3.
HER2 indication research and development layout
Q3
Indications
Initumab is approved in China for HER2-positive metastatic breast cancer: it is combined with vinorelbine to treat patients with metastatic breast cancer who have received one or more chemotherapy regimens.
Q4
Treatment costs
The specification of Sepprotin is 50mg/bottle, and the current bid price is 1530 yuan.
On December 28, the National Medical Insurance Administration and the Ministry of Human Resources and Social Security officially announced the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)", which included Septopin.
Q5
Evidence-based data and core clinical
A total of 315 subjects (212 cases in the experimental group and 103 cases in the control group) were enrolled in the initumumab registration clinical study from January 2009 to January 2013.
Source: Chinese Medical Journal
The objective response rate (ORR) and disease control rate (DCR) of the experimental group were significantly higher than those of the control group.
Source: Chinese Medical Journal
In terms of safety, the incidence of neutropenia, leukopenia and red blood cell reduction was higher in the two groups, but the difference between the groups was not statistically significant.
Q6
Key points of rational drug use
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