Important breakthrough in new drug development of Rongchang ADC

      ADC（antibody-drug Conjugates, i.e antibody drug conjugates, are formed by the coupling of monoclonal antibodies and small molecule drugs (cytotoxins) The mechanism of action is to specifically identify tumor cell surface antigens through the targeted action of monoclonal antibodies, and then use the endocytosis of cells to make chemical drugs enter tumor cells to generate drug force, so as to kill tumor cells 。 ADC drugs began to release because of the powerful small molecule drugs entering the tumor cells, which not only significantly improved the safety of the drugs, greatly reduced the side effects, but also greatly enhanced the effectiveness The curative effect is far higher than the common monoclonal antibodies with the same target, which represents the research frontier and development direction of monoclonal antibodies and small molecule drugs Statistics show that in 2013, there were 3.12 million new cancer cases in China, and 2.7 million people died of cancer Cancer has become the number one natural enemy of people's life and health In addition to surgical resection, chemotherapy and radiotherapy, the most advanced treatment for cancer is to use targeted drugs, that is, ADC treatment At present, there are only two new ADC drugs on the market in the United States They are "adcetris brentuximab vedotin" (produced by Seattle genetic company) and "t-dm1" (produced by Genentech company) for the treatment of HER2 high expression metastatic breast cancer     In China, a new biological class I drug "recombinant humanized anti HER2 monoclonal antibody MMAE coupling agent" (rc48) for injection ", which is independently developed by Yantai Rongchang Pharmaceutical Co., Ltd and Yantai Rongchang Bioengineering Co., Ltd for the treatment of various cancers such as gastric cancer, ovarian cancer, breast cancer and non-small cell lung cancer with overexpression of HER2, has completed preclinical research and core technology in November 2013 The application for national invention patent, phase I clinical trial application was accepted on August 26, 2014 The State Administration of food and drug issued a letter on September 24, 2014 to evaluate the drug as "the first ADC anti body drug for breast cancer to be applied for clinical application, with good innovation" Please enter the fast evaluation channel Phase I clinical trials are expected to be completed by the end of 2016 Based on the research and development of "rc48", Rongchang pharmaceutical and Rongchang biology developed the "Research on antibody drug coupling (ADC) major new drugs and related technologies for malignant tumors" project, which was listed in the fourth batch of topics during the 12th Five Year Plan period of the national "major new drug creation" science and technology major project In addition to "rc48", the project also includes: 1 New anti-CD19 antibody ADC (RC58) for lymphoma and leukemia with over expression of CD19; 2 New anti-EGFR antibody ADC (rc68) for liver cancer, prostate cancer, lung cancer and rectal cancer with over expression of EGFR     The two companies have strengthened cooperation and constantly broken through the ADC drug technology problems At present, the "ADC new drug creation common technology platform" has been initially established, and four key technologies have been formed, including: 1 Large scale antibody drug coupling process; 2 Large scale ADC drug small molecule and connector molding process; 3 Antibody drug coupling characterization analysis and quality control technology; 4 Construction of suitable ADC drugs Animal model for object evaluation The establishment of common platform provides guarantee for the follow-up development of a series of ADC new drugs It can not only meet the industrialization needs of Rongchang pharmaceutical and Rongchang bio independently developed drugs, but also provide paid technical services for relevant enterprises in the industry At the same time of generating significant economic benefits, it will have important significance for improving the overall level and competitiveness of China's bio pharmaceutical enterprises