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On January 6th, Hengrui Pharmaceuticals entered the CDE clinical implied license list with a new clinical application for a class 1 new drug, fluoropyriparic pali capsules, which is intended to be used in conjunction with acetic acetaminophen to treat metastatic destatic prostate cancer that has not previously been treated with a new androgen receptor (AR) targeted drug.
Source: CDE Domestic Has Reported competition for PARP inhibitor track as a DNA repair enzyme in the body, PARP inhibitor is one of the hot spots in the development of anti-tumor drugs worldwide in recent years.
currently listed four PARP inhibitors worldwide: AstraZeneca's Olapari, Clovis Oncology's Rukapali, GSK's Nirapali and Pfizer's taprapari.
, AstraZeneca's Olapari was approved for listing in China in August 2018, becoming the first domestic approved PARP inhibitor.
(Related reading: "Cancer King", Olapari's market position is becoming more unshakable) At the end of December 2019, the domestic listing application for re-ding pharmaceutical toluene sulphate nirapali capsules was granted conditional approval through the priority review and approval process, and the product is called Zee, for platinum-sensitive recurrent epithelial ovarian cancer, fallopal tube cancer or primary abdominal cancer adult patients with platinum-containing chemotherapy to completely alleviate the treatment.
noteworthy, the original Nirapali was approved by the FDA in March 2017, and in September of the same year, Reding Pharmaceuticals acquired the exclusive right to develop and sell the new drug in the Chinese market.
through the efforts of re-medicating medicine, this new drug in China to accelerate the introduction of the market.
at the end of October 2019, Hengrui Pharmaceuticals submitted a domestic application for the listing of a class 1 heavy new drug fluoropyripale paleo capsules, which has been accepted by CDE and is currently "in the process of review and approval".
at the same time, Baiji Shenzhou's clinical research on PARP inhibitor BGB-290 for advanced gastric cancer and platinum-sensitive recurrent ovarian cancer is in Phase III stage, not far from the domestic declaration and listing.
in addition to the above-mentioned progress in the forefront of research products, the field of domestic PARP inhibitors there are many layout, these later with the aforementioned products competing for the domestic market.
multi-faceted layout In the list of many clinical registration and information disclosure platforms for drugs, a total of 17 clinical trials around fluoroprecine paleoli capsules have been conducted, 5 have been completed and 12 are in progress.
from the layout of indications, Hengrui Pharmaceuticals around the fluoropyri paleo capsules carried out indications including small cell lung cancer, prostate cancer, recurrent ovarian cancer, advanced stomach cancer and recurrent metastatic triyin breast cancer.
, the clinical study of fluorapa used in the treatment of recurrent ovarian cancer is in Phase III, the clinical study for prostate cancer is in Phase II, and other clinical studies are in the early stage I clinical phase.
from the layout of clinical trials, Hengrui Pharmaceuticals has continued its usual style, while adding a variety of indications of the same product, expand the potential audience of the product, enhance market competitiveness.
, it is worth noting that Olapari, which has been listed in china, has been approved for first-line treatment of patients with advanced ovarian cancer with BRCA mutation, and has entered the national health insurance directory, for Hengrui Pharmaceuticals in the listing application stage of the fluorapyri paleoli capsules and other later, the pressure is not small.
the future, how to obtain market comparative advantage through differentiated competition is a practical problem that every latecomer needs to consider in depth, which is related to the future success or failure of the product.
abundant reserves of anti-tumor drugs in the research product pipeline In recent years, Hengrui Pharmaceuticals in the field of anti-tumor drugs in the field of market share of the first, has become the country's uncontested anti-tumor drug leader.
by the end of 2019, Hengrui Pharmaceutical anti-tumor drug sector has been approved clinically/in clinical stage in the research of more than 20 new drugs, covering the current global anti-tumor drug hot areas of the main target.
with strong clinical development strength, HengRui in the future will gradually launch its me-too, me-better anti-tumor new drugs, combined with the company's excellent marketing capabilities in the domestic market, these varieties in research are the cornerstone of future performance growth.
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