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2020.12.18 Research and Development NEWS: K drug in combination with LENVIMA treatment of advanced endometrial cancer PHASE III. Phase III clinical reached a double major endpoint; FDA approved GSK's Benlysta as the first lupus nephritis therapy; Yangzijiang Pharmaceutical Group iodized saline injection two supplementary applications were approved; target drug Devimistat approved treatment of acute myeloid leukemia mitigation rate of nearly half ... We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
(click on the title, read the original text) K drug joint LENVIMA treatment of advanced endometrial cancer III. Phase III clinical reached a double major endpoint 16, Mercadon and Japan's Akishi jointly announced that the joint phase III clinical trial KEYNOTE-775 / Study 309 achieves the dual primary endpoint of total survival (OS) and progressive lifetime (PFS) and the secondary therapeutic endpoint of objective remission rate (ORR) in patients with advanced endometrial cancer who have received at least one type of platinum drug treatment in the past.
Tianmai Bio/Oramed Joint Development ORMD-0801 officially launched Phase III Clinical Recently in the United States, Hefei Tianmai Bio and Israel Oramed jointly developed recombined human insulin intestinal capsule (ORMD-0801) approved by the United States FDA, officially launched Phase III clinical in the United States! This marks the pace of oral insulin on the market in the world's two largest pharmaceutical markets (China and the United States) is getting closer! Drug Approval: First-line treatment of esophageal cancer Keytruda combination therapy was approved by the FDA for priority review today, Mercadon announced that the U.S. FDA has accepted a supplementary biologics license application for the heavy PD-1 inhibitor Keytruda, used in combination with chemotherapy, first-line treatment of local late-stage non-removable or metastatic esophageal cancer and gastroesophageal cancer patients.
the FDA at the same time grants priority review eligibility for this application.
FDA approved GSK's Benlysta as the first lupus nephritis treatment today, GlaxoSmithKline announced that the FDA has approved Benlysta's extended adaptation for the treatment of active lupus nephritis patients undergoing standard therapy.
this is the first FDA-approved treatment for LN.
Yangzijiang Pharmaceutical Group iodized kesha alcohol injection two supplementary applications were approved today, the Official Website of the State Drug Administration shows that Yangzijiang Pharmaceutical Group's iodized kesha alcohol injection two supplementary applications were approved for evaluation.
Up to now, iodized kesha alcohol injections have been evaluated by three enterprises, of which Shanghai Staili Pharmaceuticals and Zhengda Tianqing Pharmaceutical Co., Ltd. have been approved for filing listing applications in categories 4 with imitations, and have been evaluated as such;
a day after Gilead Tecartus' treatment package lymphoma was approved in Europe, Gilead subsidiary Kite Pharmaceuticals announced that the European Commission had granted a conditional marketing license for CAR-T cell therapy Tecartus (formerly KTE-X19).
Tecartus is an in vitro anti-CD19, inlay antigen-subject T-cell therapy (CAR-T) suitable for adult patients with relapsed or refractic heterocytic lymphoma after two or more systematic treatments.
FDA approved immuno-optimized HER2 monoantitherapy listed for treatment of metastasis HER2-positive breast cancer 17, MacroGenics announced that the U.S. FDA has approved its immuno-optimized anti-Margenza monoclonal antibody Margenza listed, in combination with chemotherapy, to treat metastasis HER2-positive breast cancer adult patients.
Margenza is a monoclonal antibody optimized for Fc, targeting the HER2 protein.
can inhibit tumor cell proliferation, reduce the shedding of HER2 extracellular areas and mediate antibody-dependent cytotoxicity.
target drug Devimistat has been approved for the treatment of acute myeloid leukemia mitigation rate nearly half recently, the FDA announced the award of Devimistat (CPI-613) fast-track identification for the treatment of patients with acute myeloid leukemia.
acute myeloid leukemia (AML) is one of the most common types of leukemia, characterized by a large number of abnormal cells in the bone marrow and blood rapid growth, resulting in disruption of hematocyte function, and eventually develop cancer.
days before the acceptance of the application for the registration of the three types of market applications for the imitation of the staic acid butorphine injection of guorui pharmaceutical industry, the official website of CDE showed that the application for the listing of the imitation of the stony acid butorphine injection of the national pharmaceutical group Guorui pharmaceutical industry was accepted.
, the only chinese pharmaceutical group, Guorui Pharmaceuticals, has been approved for evaluation.
Priut Pharmaceuticals isopropyl tobly bromide inhalation aerosol imitation 4 class listing applications were accepted recently, CDE official website shows that four Trump Reiter Pharmaceuticals isopropyl tobly bromide inhalation aerosols to mimic 4 classes of listing applications were accepted.
isopropyl propylene bromide inhalation aerosol treatment category belongs to anti-asthma drugs.
brand landscape, Grigg Ingham has the largest market share, accounting for more than 90%.
(Xinhua) -- Researchers at Sweden's Karolinska Institute have developed a new type of target mitochondrial DNA (mtDNA) inhibitor to replace mitochondrial inhibitors that were previously "two-and-a-half" in a new study that has no significant effect on healthy cells.
inhibitors prevent the proliferation of cancer cells and reduce tumor growth in mice, but do not have a significant effect on healthy cells.
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