"Medical quick reading society" Hengrui pharmaceutical pyrrolidine maleate tablets approved clinical

Pyrrolidine maleate tablets of Hengrui medicine have been approved for clinical use; kangfang biology has submitted listing application to Hong Kong Stock Exchange; amoxicillin capsule, a subsidiary of Fosun medicine, has been evaluated; zynquista used for type 1 diabetes has been rejected by FDA for a second appeal Daily fresh medicine news, speed reading club and you pay attention to! On February 2, Tianjin Medical Insurance Bureau issued the implementation plan for promoting drug online procurement in designated medical institutions of medical security in Tianjin The scope of drug online procurement includes all drugs listed and sold in China Tianjin will implement price limited online procurement, drug shortage procurement, benchmark price online procurement and monitoring online procurement (Tianjin Medical Insurance Bureau) Recently, Shandong drug regulatory bureau issued the measures for the administration of drug retail chain enterprises in Shandong Province and the measures for the administration of drug retail enterprises at different levels and classifications in Shandong Province, which came into effect on December 1 This is another big pharmaceutical province after the Ministry of Commerce and Guangdong Province issued the classified management policy of drugstores The retail market resources will also be faced with re division and competition (Shandong Provincial Drug Administration) On April 4, kangfangbio filed an application for listing with Morgan Stanley and JPMorgan Chase as its co sponsors (billion euro) On March 3, junshibio announced that it had signed a drug development and licensing contract with Hangzhou DUOXI Biotechnology Co., Ltd According to the agreement, junshibio obtained the license to use dac-002 (recombinant humanized anti trop2 monoclonal antibody tub196 coupling agent for injection) from Hangzhou duoxibio through exclusive licensing, and was responsible for the follow-up clinical trials, drug registration, commercial production, sales and other commercial activities of dac-002 in the licensing area (Sina Medical News) On December 2, according to the announcement of the Hong Kong stock exchange, Corning Jerry will offer 17942000 shares in Hong Kong and 160 million shares in the international market from December 2 to 5, with a price of HK $9.1-10.2 per share and 1000 shares per hand It is expected to be listed and traded on December 12, 2019 (HKEx announcement) The company and its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd recently received the notice of clinical trial on pyrrolidine maleate tablets approved and issued by the State Food and drug administration, and will carry out clinical trial in the near future, Hengrui pharmaceutical announced Thursday Up to now, the R & D cost of the product project has been about 707.63 million yuan (meter net) On April 4, Guilin South pharmaceutical Co., Ltd., a subsidiary of Fosun Pharmaceutical, received the approval document for supplementary application of amoxicillin capsule (approval document No.: 2019b04284) issued by the State Food and drug administration, which passed the conformity evaluation of generic drugs (Sina Medical News) On March 3, the listing application of adamumumab injection (cxss1800025) submitted by Haizheng Pharmaceutical Co., Ltd changed to "under approval", which is expected to be approved in the near future The indications declared by Haizheng pharmaceutical are ankylosing spondylitis, rheumatoid arthritis and plaque psoriasis (medicine cube) On March 3, CDE official website announced the new clinical trial implied license drugs, among which tqb303 of Zhengda Tianqing was listed, and the indication was breast cancer and other advanced solid tumors Tqb303 is a class 1 new drug independently developed by Zhengda Tianqing Its clinical application was accepted by CDE in September 2019 with acceptance numbers of cxhl1900301, cxhl1900302 and cxhl1900303 (CPHI Pharma online) On March 3, China Resources 39 announced that its wholly-owned subsidiary, Zhongyi pharmaceutical, had received the approval document for supplementary drug application of azithromycin tablets approved and issued by the State Food and drug administration, which passed the consistency evaluation of quality and efficacy of generic drugs (Sina Medical News) Keji biology announced today that China's State Food and Drug Administration implicitly authorized it to research "recombinant humanized anti claudin 18.2 monoclonal antibody injection (ab011)" for clinical trials in the treatment of claudin 18.2 (cldn18.2) positive solid tumor patients (American news agency) Today, Bojian announced that the humanized IgG1 monoclonal antibody biib059 significantly reduced the disease activity of patients with skin lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) compared with placebo in the phase 2 trial lilac, reaching the main end point of the study (yaomingkant) The US FDA approved the combination of tecentriq (atezolizumab) and chemotherapy (Abraxane [paclitaxel protein binding; nab paclitaxel] and carboplatin) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC), no EGFR or ALK mutations, Roche Group member gene Taike announced today (yaomingkant) The US FDA has accepted and granted priority review to a supplementary biologicals licensing application (SBLA) from keytruda, an anti-PD-1 therapy, Merck said recently The SBLA applied for approval of keytruda as a single drug therapy for specific high-risk non muscle invasive bladder cancer (NMIBC) patients, specifically: NMIBC patients who are not eligible for cystectomy or who have chosen not to undergo cystectomy, who are non responsive, high-risk, with in situ cancer (CIS), with or without papillary lesions (Sina Medical News) Today, ardelyx announced that its NHE3 inhibitor, tenapanor, significantly improved the blood phosphorus concentration of patients with chronic kidney disease in the key phase 3 trial of hyperphosphoremia in dialysis patients, reaching the main end point of the study Ardelyx plans to submit a new drug application for the indication to regulators by mid-2020 (yaomingkant) Recently, asikon KY announced that its monoclonal antibody aslan004 targeting the α 1 subunit of IL-13 receptor (IL-13 α 1) has obtained positive results in the proof of concept test for the treatment of atopic dermatitis (yaomingkant) Recently, Cyrus biotechnology in Seattle announced a cooperation agreement with the broad Institute of MIT and Harvard to jointly optimize CRISPR gene editing technology and help develop innovative therapies (yaomingkant) In March this year, the FDA rejected the application of zynquista (sotagliflozin), a dual effect SGLT1 / 2 inhibitor of lexicon and Sanofi, combined with insulin for adults with type 1 diabetes Although the drug has been approved by the European Union for this indication, the latest FDA Statement once again breaks the hopes of the two companies in the United States to expand the drug to patients with type 1 diabetes Nine months later, zynquista was rejected by the FDA again (Sina Medical News)