Roche enmetrastuzumab is about to be approved as the first ADC drug to be marketed in China

Recently, the marketing application of enmetrazumab for Roche injection (acceptance No.: jxss1900012 / 13) was in the state of "in approval" in nmpa After data supplement, it is expected to be approved as the first ADC drug to be listed in China The anti trastuzumab emtansine (trade name kadcyla) is an antibody conjugate (i.e ADC drug) which is made up of trastuzumab, an anti HER2 targeted drug, and metanxine, a chemotherapy drug that inhibits microtubule aggregation, which is connected by thioether linker It has the killing characteristics of "biological missile" targeting tumor cells Developed by Roche and immunogen, the drug was approved by FDA in 2013 for the treatment of HER2 positive advanced breast cancer patients who had received trastuzumab and paclitaxel chemotherapy failure Since kadcyla went public, its annual sales have increased year by year (see the table below) According to Roche 2019 H1 financial report, kadcyla's sales in the first half of 2009 reached 636 million Swiss francs, ranking 11 in Roche's product sales list in the first half of 2019 According to this, kadcyla's global sales in 2019 is expected to exceed 1 billion Swiss francs, becoming a real heavyweight product ADC drugs are composed of monoclonal antibody, linker and cytotoxic small molecule drugs These drugs fill the gap between antibody drugs and traditional chemotherapy drugs, improve the specificity of drugs and improve the treatment window In recent years, many domestic and foreign enterprises have laid out this field, but up to now, only six ADC drugs have been approved to be listed in the world In addition to kadcyla, they are Mylotarg and besponsa of Pfizer / Wyeth, adcetris of Takeda / Seattle genetics, lumoxiti of AstraZeneca and pilivy of Roche (see the table below for details) However, no ADC drug has been approved for marketing in China Among them, entetrazumab for injection of Roche is in the stage of marketing application CDE started to undertake the listing application of entetrazumab for injection in March last year, and included it in the priority review and approval process in July of that year In addition to Roche, a number of domestic enterprises have begun to layout ADC drug market (see the table below) The highest development stage is bat8001 (phase III) of baiaotai and rc48 (phase II) of Yantai Rongchang, and others are in phase I clinical stage Among them, bat8001 of baiaotai is the conjugate of recombinant human anti erbB2 / neu / HER2 monoclonal antibody and medetonin derivative At present, phase III test of HER2 positive breast cancer is being carried out, and phase II clinical single arm test of HER2 positive metastatic urothelial cancer is being carried out for rc48-adc developed by Rongchang, Yantai Original title: the first ADC drug in China, Roche's "enmetrastuzumab" will be approved soon