The first domestic bevacizumab biological analogue will be approved soon

The third phase clinical success of mosadong and Bayer heart failure drugs; the clinical application of AstraZeneca selumetinib capsule in China; the application of the first new drug albutine in China submitted by Nuo Chengjianhua; the first domestic "bevacizumab biological similar drug" came We focus on the latest development of pharmaceutical research and development, and provide timely and accurate information reference for R & D personnel Today, myovant Sciences announced that it was working on the GnRH receptor antagonist releuglix, which reached the primary end point and all key secondary end points in the three-stage study hero for patients with advanced prostate cancer Based on the positive results of the trial, myovant Sciences plans to submit a new drug application for releugolix to FDA in the second quarter of 2020 On November 19, MSD and partner Bayer announced that their heart failure drug, soluble guanosine cyclase agonist, vericiguat, reached a composite primary end point consisting of hospitalization and cardiovascular death in an international multicenter phase III clinical trial called Victoria On November 20, CDE official website showed that AstraZeneca selumetinib capsule had submitted clinical application in China It is worth noting that the new drug just submitted a new drug application to the US FDA on November 14 for the treatment of patients with type 1 neurofibromatosis related to 3-year-old and above plexiform neurofibroma These patients could not pass the surgical treatment and were awarded the priority evaluation qualification by the FDA On November 20, according to the industry's self media Drug Newsletter, Nuo Chengjianhua announced that the National Drug Administration has accepted the application of new drugs for the treatment of relapsed / refractory chronic lymphoblastic leukemia (CLL) / small lymphoblastic lymphoma (SLL) patients by albuterol (icp-022) On November 20, the review status of "bevacizumab bioequivalent drug" (acceptance No.: cxss1800017) of Qilu pharmaceutical was changed to "under approval" After two rounds of supplementary data and clinical and production site verification, it is predicted that it will be approved for market soon, which means that the first domestic bevacizumab bioequivalent drug will be successfully exported On November 20, Novartis announced that recently, new indications of dahina ® (nilotinib), a product of Novartis tumor (China), have been approved by the State Drug Administration and can be used to treat chronic myeloid leukemia in children over 2 years old Today, alphazyme announced that the US FDA has granted its in-process drug arimoclomol breakthrough therapy to treat C-type Niemann peak disease The company plans to submit a new drug application to the FDA in the first half of 2020 On November 18, Kangya Pharmaceutical Co., Ltd., a new third board pharmaceutical enterprise, issued a notice saying that it received the approval document of supplementary application for drugs on calcium dobesilate capsule approved and issued by the State Food and drug administration The drug became the first evaluated enterprise in China through the consistency evaluation of quality and efficacy of generic drugs, and the notice said that the company also became the first drug manufacturing enterprise in Northwest China through the consistency evaluation According to the data of minenet, in 2018, calcium dobesilate ranked first among the top 20 common names of terminal chemical oral blood vessel protectors in public medical institutions in China with an amount of 830 million yuan Recently, according to CDE official website, erdafitinib tablet developed by Janssen company, a subsidiary of Johnson & Johnson Group, has submitted an import clinical application in China and has been accepted This heavyweight bladder cancer treatment drug thus opened the way to market in China, and is expected to bring innovative targeted treatment programs for bladder cancer patients in China.