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Heji Pharmaceutical-the world's first ITK inhibitor IND to enter the clinical stage received clinical trial approval
Time of Update: 2021-12-09
S. October 26, 2021/PRNewswire/ - Heji Pharmaceuticals announced that its first ITK inhibitor in the world to enter the clinical development stage, the clinical use of CPI-818 for oral administration The trial application was approved by the NMPA Drug Approval Center for clinical trial approval, and it is intended to be used for relapsed/refractory T-cell lymphoma .
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Hengrui Medicine's "Remazolam" 3rd indication enters "under approval"
Time of Update: 2021-12-09
On November 8, Hengrui Medicine's application for the new indication of "Remazolam Tosylate for Injection" entered the approval stage and is expected to be approved in the near future .
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Shiyao Forces 14 Class 1 New Drugs Intensive Attack This Year
Time of Update: 2021-12-09
Author: Jun Chen Zuo ShiOn October 26, CSPC Zhongqi Pharmaceutical's clinical application for SYHX2001 tablets submitted as a new drug category 1 was accepted by the CDE, and the product was declared for clinical use in China for the first time .
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The first in China!
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn November 1, the clinical application of the bispecific antibody HLX35 targeting EGFR and 4-1BB dual targets by Henlius was officially accepted by the State Food and Drug Administration .
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Boehringer Ingelheim's first-in-class immune drug Spesolimab submitted a marketing application in China for the treatment of generalized pustular psoriasis
Time of Update: 2021-12-09
Shanghai, October 26, 2021/PRNewswire/ - On October 25, 2021, Boehringer Ingelheim announced that it has formally submitted a listing application for the new immune drug Spesolimab to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration , Used to treat the onset of generalized pustular psoriasis (GPP) .
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Pfizer sells mid-term TYK2 inflammation drugs or withdraws from competition with Bristol-Myers Squibb
Time of Update: 2021-12-09
After studying a large number of leading inhibitors of inflammatory diseases, Pfizer recently announced that it is preparing to sell its investment portfolio to a new company in exchange for a 25% stake in the startup .
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Suzhou Ruibo Biotechnology Co., Ltd. uses ArisGlobal's LifeSphere® MultiVigilance solution to improve its clinical trial data management
Time of Update: 2021-12-09
Ruibo Bio will use the Chinese and English versions of ArisGlobal's LifeSphere Multivigilance to manage its drug safety data and meet the regulatory requirements for its products to enter the clinical trial phase .
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Boehringer Ingelheim launches new product Willine
Time of Update: 2021-12-09
Yangzhou, October 28, 2021/PRNewswire/ - Boehringer Ingelheim, a global leader in the field of animal health, announced the official listing of the first domestic vaccine to prevent Marek's disease an
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Hengrui Medicine's new generation AR inhibitor listing application plans to be reviewed first!
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn October 28, the CDE official website showed that the listing application of Hengrui SHR3680 tablets was planned to be included in the priority review and started to be publicized for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden .
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Pfizer's new crown oral drug clinically successfully neutralizes antibodies and vaccine stocks fall again across the board
Time of Update: 2021-12-09
On November 5, Pfizer followed suit and announced that its new oral drug Paxlovid in the Phase 2/3 clinical EPIC-HR study interim analysis reduced hospitalization or mortality by 89% .
The next day, following the announcement of Pfizer's new crown oral drug data, it fell by nearly 20%.
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Facing Alzheimer's disease, what can be done besides waiting for new drugs to come out?
Time of Update: 2021-12-09
Patients receiving cognitive rehabilitation therapy are more likely to achieve goals in daily life and are more independent .
Retrieved November 7, 2021, from https:// guide-setting-reaching-goals[2] Living with Dementia, My Life, My Goals.
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The KRAS G12C inhibitor imported by Zai Lab exceeds RMB 300 million for clinical application
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn November 1, the CDE official website showed that the clinical application of Mirati/Zai Lab's highly selective and potent oral KRAS G12C small molecule inhibitor MRTX849 tablets (adagrasib) was officially accepted by the State Food and Drug Administration .
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World Acromegaly Day: ASO drugs show efficacy
Time of Update: 2021-12-09
newsnewsToday ASO manufacturer Ionis announced a phase II clinical result of acromegaly of its liver-targeted growth hormone receptor (GHR) trans-nucleic acid drug Cemdelirsen (IONIS-GHR-L) .
The results of placebo, low and high dose groups were 141 days of blood growth hormone binding protein (GHBP).
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U.S. FDA accepts Junshi Bio-Treplimumab's application for the treatment of nasopharyngeal carcinoma
Time of Update: 2021-12-09
S. Food and Drug Administration (FDA) has accepted Terry Pritimumab combined with gemcitabine/cisplatin is used as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and a single agent for second-line and above two indications after platinum-containing treatment for recurrent or metastatic nasopharyngeal carcinoma Product License Application (BLA) .
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Cefprozil API, a wholly-owned subsidiary of Guobang Pharmaceutical, obtained CEP certificate
Time of Update: 2021-12-09
Cefprozil is a second-generation broad-spectrum cephalosporin drug.
The biggest feature of cefprozil is that it is safe to use and can be administered orally, making it a first-line anti-infective drug for children .
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The first domestic extracorporeal membrane oxygenation equipment has been successfully applied in clinical practice
Time of Update: 2021-12-09
The First Affiliated Hospital of Xi’an Jiaotong University stated that the domestic ECMO was successfully applied in clinical practice, breaking the monopoly of foreign products in this field, achieving a breakthrough in the independent research and development of major domestic medical devices , and breaking the "card" for the treatment of critically ill patients with cardiovascular disease.
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The review date of Legendary Bio's BCMA CAR-T cell therapy was postponed by the U.S. FDA for 3 months
Time of Update: 2021-12-09
In a brief statement, Nanjing Legend and Yang Sen stated that the postponement is to "enough time to review information on an updated analytical method following a recent FDA information request .
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Boehringer Ingelheim and King's College London join forces to advance new treatment concepts for major depression and schizophrenia
Time of Update: 2021-12-09
Ingelheim, Germany and London, England, November 3, 2021/PRNewswire/ - Boehringer Ingelheim and the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King's College London announced a new collaboration on September 27 , The collaboration focused on understanding the brain circuit dysfunction of major depression (MDD) and schizophrenia (SZ), which can lead to cognitive impairment in patients .
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【Big Data Perspective】The innovation pattern of China's biopharmaceuticals
Time of Update: 2021-12-09
Figure 2 Distribution of innovative biological drug treatment fields declared in 2016-2020 (according to generic names)Approval pattern of innovative biopharmaceuticals in ChinaFigure 3 shows the changes in the number of generic names of innovative biopharmaceuticals approved by China and the United States .
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The implementation rules for the management of Chinese medicine formula granules are issued in many places. A large number of Chinese medicines are included in the medical insurance
Time of Update: 2021-12-09
With the advancement of the time for traditional Chinese medicine formula granules to enter the medical insurance, all provinces have begun to act01 A large number of drugs will be included in medical
