Medicines
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Skyline Therapeutics’s SKG0106 Approved by NMPA for Clinical Trials
October 2023 , Skyline Therapeutics announced that the clinical trial application (IND) of SKG0106 is approved by the China National Medical Products Administration (NMPA) for the treatment of neovascular age-related macular degeneration (nAMD). SKG0106 was approved by the U.S. Food and Drug Administration (FDA) earlier this year to conduct a global Phase I/IIa clinical trial for the treatment of neovascular age-related macular degeneration (nAMD). The global clinical trial has been launched. SKG0106 is a distinctively designed recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease. It encompasses a proprietary novel…
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Narlumosbart for Injection approved with conditions for marketing by China NMPA
Sep, 2023. the class 1 new drug Narlumosbart for Injection(JMT103) developed by Shanghai JMT-Bio Technology Co. Ltd is approved by China NMPA . This drug is indicated for the treatment for adult patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Narlumosbart Injection is a recombinant human anti-receptor activator of NF-κB ligand (RANKL) monoclonal antibody. It can inhibit the activity of RANKL through specifically binding to RANKL on the cell membrane, thereby inhibiting its involvement in mediating osteolysis…
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Sunvozertinib Tablets Approved in China for NSCLC by China NMPA
Aug, 2023. China NMPA approved the Category 1 innovative drug Sunvozertinib Tablets (Chinese trade name:SHUWUZHE) of Dizal (Jiangsu) Pharmaceutical Co., Ltd for use in adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy. Non-small cell lung cancer (NSCLC) is the most common type of cancer in China, with the highest incidence and mortality rates. EGFR is the most common driver gene mutation in NSCLC, and the EGFR Exon20ins mutation is the most…
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6 Factors that Cause Liquid Chromatography Peak Diffusion
The main differences gas chromatography (GC) and liquid chromatography (LC) are primarily due to the differences in the properties of gas and liquid.Below are 6 Factors that mainly Cause Liquid Chromatography Peak Diffusion.
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Retagliptin Phosphate Tablets approved by China NMPA for type 2 diabetes
Jun,2023. Retagliptin Phosphate Tablets, the Class 1. New drug from Jiangsu Hengrui Pharmaceuticals Co., Ltd for the treatment of type 2 diabetes, is approved by China NMPA.
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Skyline Therapeutics Receives FDA Clearance of IND for SKG0106 for Age-related macular degeneration (AMD)
July 2023, Skyline Therapeutics announced that the U.S. FDA has cleared its IND application for Phase I/IIa clinical trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD). Global Phase I clinical trial will be initiated soon. Age-related macular degeneration (AMD) is a progressive disease that can severely impair central vision and is a leading cause of irreversible blindness in the elderly. Neovascular age-related macular degeneration (nAMD), characterized by the formation of choroidal neovascularization (CNV), bleeding, and exudation, accounts for up…
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Different Types of Ampoules for Pharmaceutical Industry
Ampoule is a small glass container used to hold liquid medicine .There are many types of ampoules, here we briefly introduce different types of ampoules for pharmaceutical industry.
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Eccogene Completes 180 Million CNY in Series B Round Financing
June, 2023,Eccogene (Shanghai) Co. Ltd. (Eccogene) announced that it has received 180 million yuan (approximately $25 million USD) in Series B financing.
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KarXT: Karuna plans to submit a New Drug Application (NDA) this year
When will KarXT be available on the market? Karuna’s drug for schizophrenia,KarXT attracted public attention so much. Investors and patients have great concern on KarXT release date and KarXT FDA approval timeline. According to the most recent news, Karuna plans to submit a New Drug Application (NDA) for KarXT within this year.
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REGORAFENIB: Gastrointestinal cancer drug legends
Regorafenib was first approved by the FDA in September 2012. It is an oral multi-kinase inhibitor developed by Bayer that targets angiogenic, stromal and oncogenic receptor tyrosine kinase. New application of it is also under research according to the public information [ClinicalTrials.gov Identifier: NCT03793361(Study ID Numbers EREMISS)