R & D Daily: apatinib hengruimesylate, shr0302 base ointment obtained the approval of clinical trial

Apatinib and shr0302 base ointments of Hengrui mesylate were approved for clinical trials; nilaparil, an inhibitor of PARP, was approved for the treatment of patients with homologous recombination deficient ovarian cancer; the biological production standard of Bluebird was approved by EMA for gene therapy zynteglo to be put on the market We focus on the latest development of pharmaceutical research and development, and provide timely and accurate information reference for R & D personnel On October 24, Hengrui pharmaceutical announced that it had recently received the notice of clinical trial of apatinib mesylate and shr0302 base ointment approved and issued by the State Drug Administration On October 24, Hengrui Medicine issued a notice that the phase III clinical study of pirolinib maleate combined with capecitabine in the treatment of advanced breast cancer was reviewed and confirmed by the independent data supervision committee The main end point of the study, the progression free survival period evaluated by the independent image evaluation committee, reached the mid-term analysis excellence judgment standard preset in the scheme, and the safety was acceptable On October 24, the U.S FDA announced that it approved the extended indications of GlaxoSmithKline's niraparib (trade name zejula) for the treatment of advanced ovarian cancer patients who have received more than three kinds of chemotherapy The tumors of these patients were positive for homologous recombination defects Today, pliant therapeutics, a biomedical company dedicated to the development of new therapies for fibrotic diseases, announced a strategic R & D cooperation agreement with Novartis to jointly develop the α V β 1 integrin inhibitor, pin-1474, and three other integrin candidates Pln-1474 is a preclinical drug candidate developed by pliant for the treatment of liver fibrosis caused by nonalcoholic steatohepatitis Today, axovant gene therapies announced at the 27th Annual Meeting of the European Association of gene and cell therapeutics that preliminary clinical data show that gene therapy axo-aav-gm2 has the potential to alleviate the disease progression of children with taysacks disease (TSD) Axo-aav-gm2 not only enables children with TSD to reach a normal development milestone, but also improves the myelination of the brain Today, arvinas, a well-known company in the field of protein degradation therapy, released the latest data of its protac therapy In two phase 1 clinical trials, the leading therapies arv-110 and arv-471 achieved good tolerance results On October 23, Beida registered to launch a domestic phase I study of bpi-17509, a new late solid tumor drug, to evaluate the safety, tolerance and pharmacokinetic characteristics of bpi-17509 tablets in the treatment of patients with late solid tumors, to determine the recommended dose for phase II trial, and to evaluate the preliminary antitumor effect of bpi-17509 tablets 84 people are planned to join the group Recently, Bluebird announced that the European drug administration has approved its fine commercial drug manufacturing specification for gene therapy zynteglo In May this year, zynteglo was conditionally approved by the European Union for the treatment of HSC donors who are suitable for hematopoietic stem cell transplantation but do not have human leukocyte antigen matching, patients over the age of 12 years old and non β 0 / β 0 genotype transfusion dependent β thalassemia.