Reed Pharma Announces Nirapali (Zhele) Approved for Listing in Macau, China
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, thePharmaceutical(http://announced that Nirapali (ZL2306) has been approved for the market in Macau, China, for the treatment of platinum-sensitive, recurrent high-level plasma ophthalcusal ovarian cancer patients who are fully or partially reactive with platinum chemotherapynilapaliit is understood that Nirapali is aproduct(http://introduced by Reed Pharmaceuticals from partner TESARO, an efficient and selective daily oral small molecular polymerization (ADP-ribose) PARP 1/2 inhibitorNirapari was approved in the United States in March 2017 and in Europe in November of the same year for the maintenance of patients with recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritonal cancer who have fullor or partially alleviated platinum chemotherapyOn October 22, 2018, Nirapali was approved in Hong Kong for the maintenance treatment of all platinum-sensitive relapsed ovarian cancer patients, regardless of whether BRCA mutated with THE PARP inhibitor, which was announced in December of the same yearIn December 2018, Nirapali submitted to the State Drug Administration aapplication fornew drug(http:// and was included in the priority review approval list in January 2019The studyat the (http:// of the 2019 American Association for Cancer Research (AACR) Conference in Atlanta, USA, in April, and Reding Pharmaceuticals published the results of the Nirapali Phase I Clinical Trial (http:// of random, open, multi-center edited clinical conducted by several hospitals in the country results show edgesing the pharmacokinetic characteristics of Nirapari in the chinese ovarian cancer population to be similar to those in the Caucasus Nilapali has linear pharmacokinetic characteristics, i.e drug (http:// exposure increases linearly with the increase in the dose taken, which facilitates clinicians to estimate drug exposure and adjust the dose of the drug The drug half-life of ni
rapali is longer than multiple PARP inhibitors of the same class, averaging about 36.4 hours, providing the patient with the possibility of taking the drug only once a day, helping to improve patient compliance after the of drug (http:// on the market Population pharmacokinetics suggestthat race has little effect on nilapali's pharmacokinetic characteristics, and the patient's baseline weight may be a covariate variable for Nirapali's drug exposure In terms of safety
Nirapali is similar to Caucasian ovarian cancer patients in China, with overall well-tolerated and effective control of adverse reactions The patient's baseline weight may be a co-variable of nilapali's drug exposure, and the good pharmacokinetic properties provide the basis for better efficacy, while also providing a theoretical basis for clinicians to effectively control adverse drug reactions
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