Research and development daily Henrui Pharmaceutical CDK 4/6 inhibitor Phase 3 clinical research reached the main...

2020.12.25 Research and Development NEWS: Hengrui Pharmaceutical CDK 4/6 Inhibitor Phase 3 clinical research reached the main end point; Lilly CDK4/6 inhibitor Abemaciclib is on the market in China; Hutchison Whampoa "Sovantini Capsules" is about to be approved for market; 13 varieties through a one-way evaluation of two drugs as the first to be evaluated at the same time ... 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) "Drug Research and Development" Hengrui Pharmaceutical CDK 4/6 inhibitor Phase 3 clinical research reached the main endpoint 24, Hengrui Pharmaceutical announced that it in the study CDK 4/6 inhibitor SHR6390 tablets in a patient with advanced breast cancer in Phase 3 clinical end.
results showed that SHR6390 combined fluoravis groups significantly extended patients' progression-free survival compared to placebo combined fluoravis groups.
Green Leaf Pharmaceuticals Class 1 new drug LY03012 completed Phase I clinical research recently, Green Leaf Pharmaceuticals announced its Class 1 new drug LY03012I phase I study, the results show that healthy subjects take 80 to 400mg a single time, 7 days after taking 80 to 320mg a day after the overall safety, tolerance is good.
LY03012 is known to treat chronic pain such as nerve pain, fibromyalgia and osteoarthritis around diabetes.
Drug Approval: Lilly CDK4/6 inhibitor Abemaciclib domestic listing in recent days, Lilly CDK4/6 inhibitor Abemaciclib tablets (i.e., Abesili tablets) of the listing application changed to "in-approval" in the NMPA status, which means that the second DOMESTIC CDK4/6 inhibitors are about to be approved.
Merca East CTLA-4 monoantigen/PD-1 monoantitherapy clinical application was accepted on the 25th, CDE website publicity shows that Mercadon in China submitted a class 1 new drug MK-1308A injection clinical trial application, and was accepted.
according to publicly available information, MK-1308A is a joint treatment of MK-1308 and pembrolizumab, of which MK-1308 is an anti-CTLA-4 antibody introduced from Kangfang Bio, pembrolizumab is Merca East's star anti-cancer drug PD-1 inhibitor PD-1 inhibitor Ttruta.
Hutchison Whampoa "Sovantini Capsules" will soon be approved for listing recently, Hutchison Whampoa Pharmaceuticals Class 1 new drug Sovantini capsules in The domestic listing application entered the "in the approval" stage, is expected to be approved by NMPA in the near future.
is intended to be marketed as the treatment of advanced non-pancreatic neuroendocrine tumors.
Hengrui Pharma submits a new fluorine Pali adaptive drug listing application for the maintenance treatment of ovarian cancer Hengrui Pharmaceutical polyadenosine phosphate cytolycolytase (PARP) inhibitor fluorine palli capsule new adaptive disorder (registered classification: 2.4) The listing application was accepted by CDE, it is expected that the declaration of the adaptive disorder is: single drug for relapsed ovarian cancer (including fallopian tube cancer, primary peritina cancer) platinum-containing therapy to achieve full or partial remission maintenance treatment.
Hengrui Pharmaceutical subsidiary SHR-1819 injection to obtain drug clinical trial approval notice Hengrui Pharmaceutical subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. recently received approval from the State Drug Administration to issue the SHR-1819 injection "Drug Clinical Trial Approval Notice", will be launched in the near future for asthma clinical trials.
The domestic autonomous CAR-T therapy was included in the breakthrough treatment varieties According to the official website of the National Drug Administration Drug Review Center, the source biological CAR-T cell therapy product CNCT19 cell injection (anti-CD19 chimed antigen-infused antigen-cell injection) was approved to be included in the "breakthrough therapy drug" (CDE acceptance number: CXSL1800106), the intended adaptation is a recurring or refractory lymphatic acute leukemia.
clinical applications for CDK 4/6 inhibitors introduced by Jia and Bio were recently announced on the CDE website, and a class 1 new drug introduced by Jia and Bio from G1 Therapeutics was declared clinically tested and accepted in China.
, according to publicly available information, lerociclib is a potential "best-in-class" oral CDK 4/6 inhibitor and is currently conducting Phase 1/2 clinical trials worldwide.
13 varieties through the consistent evaluation of the two drugs for the first evaluation at the same time 25, the official website of the State Drug Administration shows 13 generic drugs through the consistent evaluation, of which, Zhejiang Hudison and Shandong Runze injection of cephalosporine sodium, Beijing Ted and Nanjing Jianyou's benzene shun aku ammonium injection are the first simultaneous evaluation varieties.
Bayda Pharmaceuticals two new class 1 drug clinical applications have been CDE to undertake Beda Pharmaceuticals two class 1 new drugs BPI-361175 tablets, BPI-21668 clinical applications have been CDE contractor.
this year, Beda Pharmaceuticals has been making continuous progress in the development of innovative drugs, following Ektinistinib, the second class 1 new drug Ensatinib was approved for market, 5 new class 1 drug clinical applications were accepted.
Sichuan pharmaceutical companies to take more than 10 billion anti-thrombosis drugs! According to the official website of the State Drug Administration, Yuandong Bio's hydrochlorocarbon tablets were approved for listing in a generic category 4.
of clopidogrete tablets in china's public medical institutions has exceeded 10 billion yuan in recent years, according to data from The New York Post.
, Sanofi has the largest market share, at 46.74 per cent.
FDA approved the first oral new drug for bladder overactive disorder Urovant Sciences recently announced that the FDA has approved a daily 75mg gemtesa (vibegron) for the treatment of patients with acute urinary incontinence, uremia, and frequent urinary bladder overactive disorder.
, Gemtesa marks the first FDA-approved oral brand of OAB since 2012, and the first product approval for Urovant Sciences.
The new drug Fentepla for rare childhood epilepsy has been approved by the European Union, and Zogenix announced that the European Commission has approved Fenfluramine oral solution as an add-on to other anti-epileptic drugs for the treatment of seizures associated with Dravet syndrome in patients aged ≥2 years.
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