The latest proposed priority review list announced 3 domestic PD-1 varieties in the column!

Medicines Network April 24 - On April 23, cDE's official website published the 28th batch of drug registration applications to be included in the priority review process public listSeveral of the recent lying PD-1 varieties are on the list, such as The Careli-Bead monoantigen (PD-1), The Trepri monoantigen (PD-1) of Junshi Bio, and The SindyLi monoantigen (PD-1) of Sinda Biothe 28th batch of drug registration applications to be included in the priority review process public ity listsource: CDE official website
it is worth noting that today to be included in the priority review procedure drug registration application publicity (28th batch) list of Hengrui PD-1 single anti-Camrelizumab injection (SHR-1210), the same day its listing application (CXS1800009) received CDE acceptanceso far, five companies have applied for listing in China, and BMS's Opdivo has been the first to qualify for the priority reviewthe first tier after the addition of competitors
according to Insight database, Hengrui's SHR-1210 (Camrelizumab) as early as 2015/1/19 to submit a clinical application, 2/2/4 2016 to obtain clinical approval, the indications for advanced solid tumorIn subsequent clinical trials, Hengrui registered 20 SHR-1210-related clinical studies involving single and co-use treatments for a variety of tumor indicationsAmong them, non-small cell lung cancer, esophageal cancer, hepatocellular carcinoma has reached phase III stageApril 19, Cinda Bio resubmitted the PD-1 single anti-Sindili single injection application (CXSS1800008) was officially accepted by the Drug Review CenterIt comes just over two months after Cindy's single-listing application was voluntarily withdrawnThe industry believes that preparation must be more adequate, and the results are worth looking forward toOn December 13, 2017, Cinda Bio submitted the initial listing application of Cindy Mono-injection (IBI308) to be accepted by CDE, and is also the first domestic PD-1/PD-L1 single-resistance listing applicationBaiji Shenzhou also recently announced that it has achieved the first phase 2 clinical trial of a patient with advanced hepatocellular carcinoma (HCC or liver cancer) in a previously treated patient with pD-1 antibody tislelizumab data show that to date, there are 164 new PD-1 products in the global market, 1502 clinical trials involving PD-1/L1, including 1105 joint drug studies The process of research and development of PD-1/L1 products by Chinese pharmaceutical companies is intensifying At present, there are more than 10 enterprises to carry out clinical trials, including Junshi Bio, Cinda Bio, Hengrui Pharmaceuticals, Baiji Shenzhou in the first echelon of research and development, followed by four leaders and a number of new Chinese domestic companies, the competition is extremely fierce Statistics say that there are currently 25 domestic PD-1/PD-L1 single resistance is in the process of intense progress 　Domestic enterprises PD-1/PD-L1 single anti-research and development status list
(data source: rice net comprehensive finishing, statistics of domestic clinical trials) domestic varieties are expected to compete with imported varieties in the same starting line
according to PharmCube forecast, in the first half of 2019, Cinda Bio, Junshi Bio, Baiji Shenzhou and Hengrui Pharmaceuticals will all put its PD-1/L1 on the market 　　PD-1 has become a superstar in the anti-tumor drug market and a shining star in cancer immunotherapy Opdivo and Keytruda have had combined sales of $8.757 billion in 2017 in just three full years since it went on sale in 2014 According to Evaluate Pharma, Opdivo and Keytruda are expected to total revenue of more than $19.4 billion in 2022, with a COMPOUND growth rate of 17% in 2017-2022, making it the market's largest anti-tumor target drug as the pioneer of cancer immunotherapy, PD-1/PD-L1 monoantigen has been sought after by the market since the date of listing, becoming a battleground for pharmaceutical companies Who will become the first PD-1/PD-L1 single-resistant approved listed company in China? industry analysis that according to the clinical progress and the time of submission of the listing application, Junshi Bio, Hengrui Pharmaceuticals, Baiji Shenzhou and Cinda Bio, including domestic anti-PD-1 single resistance and imported varieties only 4-6 months difference, the future approval of the listing time will not be much difference Domestic varieties are expected to compete with imported varieties in the same starting line, and by virtue of cost-effective advantages, occupy the main market