Kadcyla of Roche is approved to fill the gap of ADC drugs in China

Recently, the State Drug Administration has updated the status of the application of Romer's her2-adc drug for injection (ADO trastuzumabemtanine, trade name kadcyla ®) to "under approval", which is expected to be approved for listing in the near future On March 27, 2019, kadcyla's listing application in China was undertaken by CDE with the acceptance number of jxss1900012 / 13, and entered the priority review channel in June 2019 If it is approved, enmetrastuzumab will be the first ADC drug on the market in China Kadcyla is composed of trastuzumab and immunogen's cytotoxic DM1 by a stable linker to deliver DM1 to HER2 positive breast cancer cells Kadcyla was approved to market in 2013, and is the first and only antibody drug conjugate approved as a single preparation for the treatment of HER2 positive metastatic breast cancer patients who have received Herceptin and paclitaxel chemotherapy (alone or in combination) Antibody drug conjugate (ADC) is a new type of targeted anti-tumor drug It uses monoclonal antibody to target the connected cytotoxic drugs to tumor cells, so as to enhance the therapeutic activity of antibody, increase the targeting of cytotoxic drugs to tumor cells, and reduce its toxic and side effects on normal tissues At present, no ADC drugs have been approved for marketing in China, and the number of HER2 as the target in the research of ADC drugs in China is the largest HER2 is a member of the human epidermal growth factor receptor (EGFR) family protein HER2 positive breast cancer accounts for about 20% - 25% of all breast cancers This type of breast cancer has high invasiveness and poor prognosis According to frost Sullivan, from 2014 to 2018, the number of patients with advanced HER2 positive breast cancer in China increased from 15700 to 16900, with a compound annual growth rate of 1.8% It is estimated that by 2023, the number of patients with advanced HER2 positive breast cancer in China will reach 18200, and then the number of patients will continue to grow at a compound annual growth rate of 1.0%, reaching 19600 by 2030 In addition to Roche, a number of domestic enterprises have begun to layout ADC drug market, including baiaotai, Rongchang biology, Hengrui medicine, Zhejiang medicine, Shiyao, Fosun medicine, Shanghai cross-linking, etc., among which the rapid progress is bat8001 (phase III) of baiaotai and rc48 (phase II) of Rongchang biology, others are in phase I clinical stage Table 1: the original version of anti HER2 McAb ADC drugs entering clinical stage II or above in China has reduced eruption