R & D Daily: the first clinical application of innovative compound liposome preparation in China has been accepted
Last Update: 2020-06-19
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[June 12, 2020, R & D news] the new crown vaccine of Moderna is determined to be a three-phase clinical trial plan, which is expected to start in July; Roche CPAM and TLR7 agonist combination therapy is approved in China; amjin / Baiji Shenzhou cooperation double anti AMG 160 is approved in the treatment of prostate cancer < br / > we focus on the latest development of pharmaceutical R & D, providing timely and accurate information reference for R & D personnel< br / >According to the results of phase I clinical study, 100 μ g dose level was selected as the vaccination dose used in phase III clinical trial to maximize immune response and minimize adverse reactions< br / > regenerant today announced the launch of the first clinical trial of regn-cov2, a research double antibody cocktail therapy developed by the company for the prevention and treatment of covid-19< br / > < br / > < br / > on November 11, mylan and biocon biology announced that the FDA of the United States has approved the new drug application of semglee in the form of small bottles and pre filled injection pens for the control of hyperglycemia in adults with type 2 diabetes and adults and children with type 1 diabetesOn the 11th, Pfizer announced that nyvepria has been approved by the FDA of the United StatesThe specific indications are: Patients with non myeloid malignant tumors who are being treated with bone marrow suppressive anticancer drugs (such as chemotherapy) related to the clinically significant incidence of febrile neutropenia, reduce the incidence of infection, showing febrile neutropenia< br / > according to the information publicized by the drug evaluation center of the State Food and Drug Administration of China, Roche's ro7049389 and ro7020531 combined therapy has obtained a number of implied permits for clinical trials in ChinaThe indications are combined therapy for chronic hepatitis B< br / > Bristol Myers Squibb recently announced that its heavyweight PD-1 inhibitor, opdivo, has been approved by the US FDA to treat unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma patients after chemotherapy with fluorouracil and platinum drugs, regardless of the expression level of tumor PD-L1< br / > today, the U.SFDA announced that it has approved the listing of Vila bio's anti-CD19 monoclonal antibody, uplizna (inebilizumab Cdon), for the treatment of patients with neuromyelitis optica pedigree disease (nmosd)< br / > on November 11, LVYE pharmaceutical announced that the clinical application of its independently developed anti-tumor innovative preparation, irinotecan fluorouridine hydrochloride liposome injection (ly01616), has been accepted by the drug evaluation center of China National Drug Administration and will soon enter the clinical trialThis is the first compound liposome drug in China< br / > on November 11, the CDE official website showed that AMG 160, a new drug jointly declared by Amgen and Baiji Shenzhou, was approved for clinical use in the treatment of adult metastatic castration resistant prostate cancer< br / > on the 12th, Zhengda Tianqing registered to start the randomized, open, parallel controlled, multicenter phase III clinical trial of tqb2450 combined with androtinib and sunitinib in the treatment of advanced renal cell carcinoma< br / > on November 11, the application for listing Acarbose Tablets in Liaoning xinshanyuan Pharmaceutical Co., Ltdwas accepted by CDEUp to now, there are still 4 types of imitated listing applications of 5 enterprises in the review and approval< br / > on November 11, green leaf pharmaceutical announced that the clinical trial application of the innovative product, irinotecan fluorouracil hydrochloride liposome injection (ly01616), has been officially accepted by CDE< br / > < br / > < br / > recently, Lijin biology announced to reach a clinical trial cooperation agreement with the subsidiary of MSD to evaluate the efficacy of lvgn6051, the second generation 4-1BB agonist of Lijin biology, and coreda, the PD-1 inhibitor of MSD, in the treatment of a variety of malignant tumors, including lung cancer, melanoma, gastrointestinal cancer and lymphoma with high MSI-H or dmmr-h.
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