Text / Chai Yan
    Monoclonal antibodies are produced in response to specific antigen specific antibody purification. It has a high degree of specificity, can specificity for tumor cells to target to the treatment, from the molecular level in the reversal of tumor malignant biological behavior, so it is called "biological missile". This kind of medicine has the characteristics of strong targeting, high specificity and low side effects, and can enhance the therapeutic effect of radiotherapy and chemotherapy, which represents the latest development direction in the field of tumor therapy. For quite a long period of time, China's target to the drug market is mainly foreign drug monopoly, in 2008, China first for the treatment of malignant tumor functional monoclonal antibody drugs teshin students (nimotuzumab) was approved, the first to break the foreign monopoly.
    EGFR over expression in a variety of solid tumors, such as head and neck cancer, lung cancer, colorectal cancer, there is a phenomenon of excessive expression of EGFR. Overexpression of EGFR was highly correlated with tumor invasion, metastasis and poor prognosis. Tai Xinsheng (Nimotuzumab), the world's first epidermal growth factor receptor (EGFR) as the target of monoclonal antibody drugs, China's first treatment of malignant tumors of human monoclonal antibodies. Teshin students can compete with EGFR blockade by EGFR and its mediated downstream signal transduction pathway, thereby inhibiting the proliferation of tumor cells, induced differentiation, promote cell apoptosis, inhibit tumor angiogenesis, enhance the efficacy of chemotherapy.
    At present, teshin students have a number of clinical studies in China, the United States, Germany, Canada, Japan, Cuba, India, 20 countries that are carrying out or already completed clinical trials about more than 100 items, has enrolled patients with nearly 5000 cases, including teshin health combined with radiotherapy, and chemotherapy in the treatment of nasopharyngeal carcinoma, head and neck cancer, glioma, colorectal cancer, pancreatic cancer, esophageal cancer, liver cancer, non small cell lung cancer and other solid tumors. Clinical study confirmed that patients with high disease control rate, survival benefit significantly, adverse reactions are mild, with a high clinical value.
1, took the treatment of head and neck cancer
     A teshin students combined with radiotherapy in treatment of advanced head and neck cancer clinical research shows, 3-year survival rate of up to 66.7%, and simple radiotherapy 3 years survival rate of only 40%, teshin students significantly increased the efficacy of radiotherapy. A teshin students in the treatment of advanced nasopharyngeal carcinoma (head and neck cancer a) clinical study, the teshin health radiotherapy combined with the effective rate was 100%, complete tumor remission rate of 90.63%. 3 years survival results show that compared with radiotherapy alone, teshin health combined radiotherapy group 3 years survival rate was 84.29%, compared with the control group increased nearly 10 percentage points, and prolong the survival time of the patients.
    Not long ago in the United States Radiation Oncology annual meeting (ASTRO) released a group of exciting research data, the effective rate of Tai Xinsheng combined with chemotherapy was 100%, the complete remission rate was 90%. Internationally, the concept of "cure" for cancer refers to patients who have had no disease for 5 years or more. Took the treatment of head and neck cancer, nasopharyngeal carcinoma, up to 90% of the tumor remission rate, the firm belief were healed. Another group analysis of the clinical study showed that the teshin students combined with radiotherapy and concurrent chemotherapy and radiotherapy curative effect quite, which is unable to tolerate intensive chemotherapy in patients with advanced head and neck cancer provides a new solution, can be free from the pain of chemotherapy.
2, took the treatment of malignant glioma
     At the 44th Annual Meeting of the American Society of Clinical Oncology annual meeting (ASCO 2008), the teshin health combined with radiotherapy significantly prolong the diffusion of endogenous pontine gliomas in children and adolescents survival phase III clinical study report, caused by the participating experts widely attention. This is a clinical study conducted in Germany, Russia, Italy and several countries, the patients were newly diagnosed patients. Results: a total of 41 cases of patients can be evaluated. Among them, 4 cases (9.8%) patients with remission (PR), 27 cases (65.8%) patients with stable disease (SD), the median disease control time (DDC) for 195 days (28-645 days. Median progression free time (PFS) was 177 days, and the median survival time was 292 days. The patient was well tolerated and no patient withdrew from the study because of the inability to tolerate. Chemotherapy is more intense, the teshin health disease control combined with radiotherapy, with time prolonging, the high quality of life.
     Held at the end of the year of 2008, the American Association for cancer research annual meeting (AACR 2008) announced a teshin health combined with radiotherapy in the treatment of malignant gliomas, randomized, controlled, double-blind, multi center clinical research, 80 cases with malignant gliomas were randomly divided into two groups. The experimental group receiving therapy combined with Ni trastuzumab treatment, the control group received radiotherapy combined with placebo treatment. The results showed that the median survival time was 16.43 months in the experimental group and the control group was 10.49 months, and the survival time of the patients was significant.
     The teshin students in advanced malignant glioma treatment made outstanding achievements, in 2004, the drug through the FDA and EU food and drug agency EMEA dual certification approved advanced glioma orphan drug designation. The drug is expected to be approved as a first-line treatment for pediatric patients with advanced malignant glioma glioma.
3, took treatment of malignant tumor of digestive system
    In just the end of the 2009 ASCO GI (American Clinical Oncology congresses gastrointestinal tumors) meeting, announced the teshin students combined with irinotecan irinotecan for irinotecan Kang after treatment failure for the metastasis of colorectal cancer patients with phase II clinical study of latest medium-term results. All of the study group patients received standard treatment (excluding received EGFR monoclonal antibody therapy), by irinotecan chemotherapy Kang disease