Opdivo is about to approve second line of indications in China for esophageal cancer

Recently, the star target PD-1 came with good news, Opdivo (O drug) is about to be approved in China for the second indication, for esophageal cancer second-line treatmentaccording to theaccording to the NMPA official website, the processing status of the new indications application (acceptance number: JXSS1900001/02) has been changed to "in approval" and the probability of new indications will be approved in October(Source: NMPA official website)the first PD-1 single anti-
in China On June 15, 2018, Navuriu Mono-Anti (general name: Nivolumab, commodity name: Opdivo/Odivo) approved for listing by NMPA (receiving number: JXSS1) 700015/16), for second-line treatment in adult patients with epidermal growth factor receptor (EGFR) gene mutation negative and mesodegeneratic lymphoma kinase (ALK) negative, advanced or intolerant local late stage or metastatic non-small cell lung cancer (NSCLC) after previous lycinatted chemotherapyOpdivo is the first PD-1/L1 monoresist to be approved for listing in ChinaOpdivo approved specific information(source: FDA, NMPA)specifically for Chinese patients esophageal cancerfrom the table above can be seen, Opdivo in the United States has not been approved esophageal cancer, mainly because of the Chinese and Western countries have a large difference in the disease spectrum, digestive system tumors are a domestic characteristicthe high incidence of digestive system tumors, stomach cancer, esophageal cancer and liver cancer ranked second to fourth in the incidence, the total number of annual diseases in these three major tumors reached 1.62 million, PD-1/L1 antibody treatment is also relatively sensitive, the statistics of ORR generally between 15-20%the incidence of digestive tumors in the country(Source: CA CANCER J CLIN 2016)a brokerage analyst based on patient base, permeability, patient's relative survival benefits and economic factors, estimated that the total space for stomach cancer, liver cancer and esophageal cancer is estimated to be about 12.2 billion yuan"OK"in the first half of 2019, Opdivo sales of $3.6 billion, Keytruda (K drug) sales of $4.9 billion, O drug since the loss of the first-line treatment NSCLC began to be overtaken by K drugs, the gap is likely to grow O drug and K medicine is like the relationship between "both Yu He Shengliang" O drug market early indications strong expansion, ahead of K drug: in 2014, O drug, K drug to melanoma as the entry point was approved in the same year, in 2015 both won non-small cell lung cancer (NSCLC) indications, and then, O drug took renal cell carcinoma, classic Hodgkin lymphoma head and neck squamous cell carcinoma and other indications, and k drug only 3 indications K drug later came to the fore, NSCLC first-line therapy was approved, opening the road to reverse: K drug in 2017 has won including stomach cancer, including five major indications and heavy NSCLC first-line therapy, sales accelerated growth, and finally in 2018 Q2 anti-O drug O drug in 2018 Q3 announced the failure of NSCLC first-line therapy, the patient group handed over to K drug 2017Q4-2019Q2 Q2 quarter-quarter CAGR is 14.5% of K medicine and 6% of O drug It is expected that O medicine missn nSCLC first-line therapy and then difficult to compete with K drugs O drug, K drug FDA approved for indications (Source: FDA) June 2018, O drug approved in China, become the first PD-1/PD-L1 drug approved in China, for epidermal growth factor receptor (EGFR) gene mutation negative and intersodes lymphoma kinase (ALK) negative, previously accepted platinum-containing programme after chemotherapy progress or intolerance of late-stage or non-metastatic Second-line treatment for adult patients of NSCLC; In July 2018, K-drug was approved as the first indication in the country for second-line treatment of patients with late local or metastatic melanoma in the post-disease progression; and in April 2019, K drug 2nd indication was approved for the combination of pemequce, cisplatin first-line treatment of EGFR and ALK-negative metastatic non-small non-small cells (NSCC) it is worth mentioning that K medicine also has new indications will soon be approved, reference article "Keytruda in China will soon be approved a third indication, first-line treatment of PD-L1-positive non-small cell lung cancer." industry analysis pointed out that lung cancer is the largest market for PD-1 drugs, with a series of precision-designed clinical trials, starting from PD-L1 high expression patients, the first to enter the single-sided first-line lung cancer market Today, PD-L1 high expression using K drug single, low expression using K drug / chemotherapy combination is standard therapy domestic listed and reported production of PD-1/PD-L1 single resistance at present, a total of 2 domestic imports, 3 domestic PD-1 single resistance approved Domestic listed and reported PD-1/PD-L1 mono-resistance (Source: CDE)