The application for listing of axitinib tablets independently developed by Guangzhou Keruite Pharmaceutical Co., Ltd. Pharmaceutical Co., Ltd. was accepted.
Release time:
2024-10-18
Guangzhou Keruite Pharmaceutical Co., Ltd. Pharmaceutical Co., Ltd. is a chemical pharmaceutical company located in Guangzhou, China, focusing on the field of anti-tumor drugs, hereinafter referred to as "Keruite Pharmaceutical".
Recently, independently developed by Keruite Pharmaceuticals.axitinib tabletsApplication for marketing authorization has been successfully obtainedState Drug AdministrationofAccepted.This marks another important step in the development and marketing of the drug.
After scientific and rigorous process research and clinical trials, our company has fully verifieditsSafety and effectiveness. The test results show that the product conforms to the national regulationsThe quality standard requirements,andachieved in clinical trialsIt'sResults of bioequivalence with the original developed agent.
The acceptance of this listing application is an affirmation of the research and development strength and drug innovation ability of Keruite Pharmaceuticals. After accepting the application, the drug regulatory department will organize experts to review the application and decide whether to approve the drug market according to the review results. Keruite Pharmaceuticals stated that it will actively cooperate with the review work of the drug regulatory authorities, and continue to pay attention to policy changes and review progress to ensure that axitinib tablets can be successfully marketed and provide patients with more treatment options.
About axitinib
axitinib, developed by Pfizer in the United States, was2012Year01Monthly acquisitionFDAApproved for Listing, Trade Name“Inlyta”. In2015It was approved for the first time in China to be listed in China.
Axiatinib is used for advanced renal cell carcinoma that has previously received a tyrosine kinase inhibitor or cytokine treatment failure (RCC) adult patients. At present, the U.S. Food and Drug Administration (FDA) approved targeted drugs includeMultitargeted Tyrosine Kinase Inhibitors(such as sofitinib, axitinib), mammalian target complexes of rapamycin-1Kinase inhibitors (such as temsilimus and everolimus), humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibodies (such as bevacizumab), etc. Among them, targeted therapy using tyrosine kinase inhibitors is widely used in clinical 1. second-line therapy.
About Keruite
Guangzhou Keruite Pharmaceutical Co., Ltd.("Keruite Pharmaceutical") is a subsidiary of the Seven-Up Group, established inIn 2013, it is a modern comprehensive pharmaceutical enterprise integrating R & D, production and marketing. The R & D center is located in Guangzhou High-tech Industrial Development Zone, and the self-built factory is located in Huangpu District, GuangzhouYonghe Development Zone, covering an area of about 13000 ㎡, the construction of oral solidPreparation workshop, API workshop and its supporting Class A warehouse and environmental protection station 4 main buildings.
After years of precipitation, the company has built a research and development team with high educational level and strong technical force, and has established a perfectGMP andEHS management system. CurrentlyIt has successfully overcome the technical barriers of more than ten kinds of anti-tumor drugs such as lenalidomide, erlotinib, imatinib and sunitinib, and has developed its own production advantages of raw materials and preparation products.
Keruite Pharmaceuticals"Life first, quality first" as the mission, "better quality to create better health" as the quality policy, and constantly implement the quality objectives. The company first obtained the "Drug Production License" in 2022, the current production license includes API, tablets, hard capsules, and passed the GMP of tablets and hard capsules in 2023.Compliance check.As a key part of the health industry, the purpose of Keruite Pharmaceutical is to reduce the medical expenses of cancer patients, provide patients with safe, effective and affordable high-quality drugs, and reduce the medical burden for the country.
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Address: Room 803, Building B3, Science and Technology Enterprise Accelerator, No.11 Kaiyuan Avenue, Huangpu District, Guangzhou
Telephone:020-8985 8964
Address: No.80, Spring Equinox Road, Huangpu District, Guangzhou
Telephone:020-8328 9091
Adverse Drug Reaction/Event Feedback E-mail:pvreport@bio-current.com
