Hengrui class 1 new drug under investigation fluoxparib approved new clinical

Release date: 2020-01-07 Views: 0

Source: CPhI Pharmaceutical Online  

On January 6, a new clinical application of Hengrui Pharmaceutical's Class 1 new drug flurazole-palli capsules was entered into the CDE clinical implied approval list. This PARP inhibitor is intended to be used in combination with abiraterone acetate to treat Metastatic castration-resistant prostate cancer that has not previously been treated with new androgen receptor (AR) targeted drugs.

Source: CDE

Domestic production of race track for PARP inhibitors has been reported

As a DNA repair enzyme in the body, PARP inhibitors have been one of the hot spots in the global development of anti-tumor drugs in recent years. At present, 4 PARP inhibitors have been marketed worldwide, namely Alascal's Olaparib, Clovis Oncology's Lukapari, GSK's Nirapali, and Pfizer's Tarazolam. Among them, AstraZeneca's Olaparib was approved for listing in China in August 2018, becoming the first PARP inhibitor approved for listing in China. (Related reading: "Occupation of" King of Cancer ", Olapaly's Market Position Is Increasingly Unshakable")

At the end of December 2019, Zaiding Pharmaceutical's domestic listing application of Nirapali Tosylate Capsules received conditional approval through a priority review and approval process, with the trade name Zele, for platinum-sensitive recurrent epithelial ovarian cancer, Maintenance treatment for fallopian tube cancer or primary peritoneal cancer in adult patients after complete or partial remission of platinum-containing chemotherapy.

It is worth noting that the original research Nirapali was approved by the FDA in March 2017. In September of the same year, Zaiding Pharmaceuticals obtained the exclusive research and development and sales rights of this new drug in the Chinese market. Through the efforts of Zaiding Pharmaceuticals, this new drug was accelerated to market in China.

At the end of October 2019, Hengrui Pharmaceuticals submitted a domestic application for the first-class blockbuster new drug fluzopalyl capsules, which has been accepted by the CDE and is currently in "under review and approval".

At the same time, the clinical research of Beijin Shenzhou's research PARP inhibitor BGB-290 for advanced gastric cancer and platinum-sensitive recurrent ovarian cancer is in phase III, which is not far from the domestic application for listing.

In addition to the above-in-progress products under development, there are still many distributors in the field of domestic PARP inhibitors. These latecomers compete with the aforementioned products for the domestic market.

Multi-faceted layout under study with many indications

In the list published on the drug clinical registration and information disclosure platform, a total of 17 clinical trials have been conducted around fluzoparil capsules, 5 of which have been completed and 12 are in progress. From the perspective of the layout of the indications, the indications developed by Hengrui Medicine around fluzopalli capsules include small cell lung cancer, prostate cancer, recurrent ovarian cancer, advanced gastric cancer, and recurrent metastatic triple negative breast cancer.

Among them, the clinical research of fluzopapar for the treatment of recurrent ovarian cancer is in the phase Ⅲ phase, the clinical research for prostate cancer is in the phase Ⅱ phase, and the other clinical studies are in the early phase Ⅰ clinical phase.

From the perspective of the layout of clinical trials, Hengrui Medicine still continues its traditional style, while increasing the number of indications for the same product, expanding the potential audience of the product, and improving market competitiveness.

In addition, it is worth noting that olaparib, which has been marketed in China, has been approved for first-line treatment of patients with BRCA-mutated advanced ovarian cancer, and has entered the national medical insurance catalog. For Pali Capsules and other latecomers, the pressure is really not small. In the future, how to obtain market comparative advantage through differentiated competition is a practical issue that every latecomer needs to consider in depth, which is related to the future success of the product.

Well-stocked anti-tumor drug pipeline

In recent years, Hengrui Medicine has steadily ranked first in the market share of domestic anti-tumor drugs, and has become the undisputed leader in domestic anti-tumor drugs. As of the end of 2019, Hengrui Pharmaceutical's anti-tumor drug sector has approved more than 20 new drugs under clinical / clinical research, covering the main targets in the current hot field of anti-tumor drugs worldwide.

With strong clinical development capabilities, Hengrui will gradually launch its new me-too and me-better anti-tumor drugs in the future. Combined with the company's excellent marketing capabilities in the domestic market, these varieties under development are the cornerstone of future performance growth.

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