A large number of new drug applications received by CDE

Solanezumab injection solanezumab, an anti amyloid monoclonal antibody, is also one of the most promising pipeline drugs in Eli Lilly If it can be successfully listed, it is expected to bring nearly $1.4 billion in sales revenue to Eli Lilly in 2020 Although two previous phase III clinical studies of solanezumab, expetion1 (n = 1012) and expetion 2 (n = 1040), failed to improve the cognitive and life self-care ability of AD patients, Lilly finally decided to gamble again, and completed the recruitment of expetion 3 (n = 2100) in 2015 to evaluate the effect of solanezumab on mild AD patients On March 15 of this year, Lilly accident announced to modify the clinical endpoint of the expedition3 study, adjust the original composite primary endpoint of "cognitive function + life self-care ability", only retain "cognitive ability" as the primary endpoint, and adjust "life self-care ability" as the secondary endpoint, once again let the outside world question the development prospect of this drug (see: In the middle of Lilly's revision of the end point of phase III study of Alzheimer's drug solanezumab, lack of confidence?) Cobimetinib is a small molecule MEK inhibitor It has obtained the orphan drug and priority evaluation qualification granted by FDA, and was approved by FDA on November 10, 2015 It was combined with zelboraf (vemurafenib) for the first-line treatment of BRAF mutation positive advanced melanoma Emisizumab injection (ace910) is a kind of bispecific antibody It was awarded the breakthrough drug qualification of treating hemophilia A by FDA on September 4, 2015 The existing a hemophilia drugs usually need frequent injection, which is easy to produce the inhibitor of coagulation factor VIII Emicizumab is mainly aimed at patients with hemophilia A with FVII suppressor According to the results of ace001jp study I published in the New England Journal of Medicine on May 25 this year, the weekly subcutaneous injection of emicizumab has a higher safety for patients with hemophilia A A, and has a better benefit in preventing patients from bleeding Roche and its holding subsidiary sinopharma are currently carrying out phase III research in patients with hemophilia A with FVII suppressor In November last year, AstraZeneca acquired ZS pharmaceutical company for us $2.7 billion and obtained zs-9 (sodium zirconate cyclosilicate), which is a heavy-duty drug under research Zs-9 is a potassium binding agent developed for the treatment of common hyperkalemia in patients with chronic kidney disease or heart failure It is regarded as the best in class hyperkalemia treatment drug, and the peak sales are expected to exceed US $1 billion Unfortunately, on May 27, the FDA rejected zs-9's application for listing due to production problems (see: zs-9, a blockbuster new drug, was rejected, and AstraZeneca helped relypsa) Avastin (bevacizumab) is the best-selling anti VEGF monoclonal antibody in the world Its mechanism is to inhibit tumor angiogenesis, which is suitable for the treatment of a variety of solid tumors In 2015, the global sales volume was 6.945 billion US dollars Several domestic enterprises have applied for the production of recombinant anti VEGF humanized monoclonal antibody, among which Qilu pharmaceutical and Jiangsu Taikang have applied for production, as shown in the original title of the figure below: a large wave of heavy weight new drug application clinical