lottojackpotprize| Hengrui Pharmaceutical's U.S. marketing of carrelizumab delayed
Chen Cheng, a reporter from the Securities Times
On the evening of May seventeenthLottojackpotprizeHengrui Pharmaceutical (600276) (600276) announced that the company has received a complete reply (CRL) from the U.S. Food and Drug Administration (FDA) regarding the application for biological product licensing (BLA) of carrazumab combined with apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients. In its reply, FDA indicated that it would conduct a comprehensive assessment based on the enterprise's complete response to defects in the production site inspection; and due to travel restrictions in some countries, FDA indicated that the necessary biological research monitoring plan (BIMO) clinical tests for the project could not be completed within the review cycle.
According to industry insiders, FDA details the possible defects and risks in CRL, and puts forward a proposal. If the applicant can complete the changes within the specified time, CRL will not actually affect the final approval. In other words, the US listing of Hengrikarelli's bead monoclonal antibody has been delayed. Hengrui Pharmaceutical said that the company plans to actively maintain close communication with FDA and resubmit its listing application as soon as possible, so that the product can be approved in the United States as soon as possible.
It is understood that the listing application is based on the positive results of an international multicenter phase III clinical study (CARES-310 study). The study was led by Professor Qin Shukui of Nanjing Tianyinshan Hospital affiliated to China Pharmaceutical University, with the participation of 95 centers from 13 countries around the world. The results showed that Carrilizumab combined with apatinib had significant survival benefit and tolerable safety in the treatment of advanced unresectable or metastatic liver cancer, and the median overall survival time (mOS) was 22.LottojackpotprizeIn one month, the risk of death was significantly reduced by 38%.
In early 2023, Carrilizumab combined with apatinib was approved by the State Drug Administration (NMPA) for first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma. Of all the approved indications for first-line treatment of hepatocellular carcinoma, carrazumab combined with apatinib has become the longest median OS study to date.
Carellizumab (trade name)LottojackpotprizeErica) is a humanized PD-1 monoclonal antibody independently developed by Hengrui Pharmaceutical, which was approved for market by the State Drug Administration (NMPA) in May 2019. Carrelizumab has high affinity for PD-1 and can significantly prolong the overall survival time of patients for 11 months in a variety of solid tumor treatment studies. at present, 9 indications have been approved in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal carcinoma and lymphoma. it is a domestic PD-1 product with the leading number of approved indications and covering tumor species.
Apatinib (trade name: Aitan) is a small molecular tyrosine kinase inhibitor for vascular endothelial growth factor receptor (VEGFR) developed by Hengrui Pharmaceuticals. It was approved by the State Drug Administration (NMPA) in October 2014. At present, three indications have been approved in China. they are monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two kinds of systematic chemotherapy, advanced hepatocellular carcinoma that has failed or intolerable after at least first-line systematic treatment, and combined with carraizumab for unresectable or metastatic hepatocellular carcinoma.