On the evening of May 17, Hengrui Pharmaceutical issued an announcement stating that the company had received the U.S. Food and Drug Administration (FDA) regarding the use of carrelizumab in combination with apatinib for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma. Complete Response Letter to the Application for Biological Products Licensing (BLA).
In the response letter, the FDA stated that it would conduct a comprehensive evaluation based on the company's complete response to inspection defects in the production site; and due to travel restrictions in some countries, the FDA stated that it would not be possible to complete all necessary Biological Research Monitoring Program (BIMO) clinical inspections for the project during the review cycle.
It is understood that this marketing 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, and 95 centers in 13 countries/regions around the world participated.
Hengrui Pharmaceutical said that the company plans to actively maintain close communication with the FDA and re-submit the marketing application as soon as possible, so that the product can be approved for marketing in the United States as soon as possible.
The reporter learned from industry insiders that the complete reply letter is commonly referred to as the CRL in the industry. The FDA will detail possible defects and risks in the CRL and make suggestions. If the applicant can complete the changes within the specified time, CRL does not actually affect the final approval. In other words, the U.S. marketing process for Hengricarlizumab has been delayed.
(Article sourcecrashbandicootps2: China Securities Journal·China Securities Taurus)