Hengrui Medicine's PD-1 monoclonal antibody anti-cancer new drug submits two more marketing applications

On March 26, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced the latest announcement on the website of Hengrui Medicine’s PD-1 antibody injection carrelizumab, which submitted two new indications for marketing applications and was accepted by the CDE.

Screenshot source: CDE official website

Carrelizumab is a humanized anti-PD-1 monoclonal antibody independently developed by Hengrui Pharmaceuticals.

First-line treatment for advanced esophageal cancer

This is a randomized, double-blind, placebo-controlled, multi-center phase 3 clinical study called ESCORT-1st, which aims to evaluate carrelizumab for injection or placebo combined with paclitaxel and cisplatin for advanced esophageal cancer Effectiveness and safety of first-line treatment.

According to the press release, paclitaxel combined with cisplatin is a commonly used first-line treatment for patients with advanced unresectable, recurring, and metastatic esophageal cancer in China.

First-line treatment for squamous non-small cell lung cancer

This is a randomized, double-blind, phase 3 controlled clinical study named SHR-1210-III-307, which aims to evaluate carrelizumab for injection or placebo combined with paclitaxel and carboplatin for advanced or metastatic The effectiveness and safety of first-line treatment of squamous NSCLC.

According to the press release, the first-line systemic treatment of advanced squamous NSCLC in China is mainly platinum-containing dual-agent chemotherapy.

According to public information, the 4 indications that Karelizumab has previously been approved in China are:

Treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma who have undergone at least second-line chemotherapy;

Treatment of advanced hepatocellular carcinoma patients who have previously received sorafenib treatment and/or oxaliplatin-containing system chemotherapy;

The combination of pemetrexed and carboplatin is suitable for the first-line treatment of EGFR gene mutation-negative and ALK-negative, non-resectable locally advanced or metastatic non-squamous NSCLC;

Previously received treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma who had disease progression or intolerance after first-line chemotherapy.

In addition, carrelizumab has two new indications for marketing applications that are currently under review, and have been included in the priority review by CDE, which are used for disease progression or intolerance after previous second-line and above chemotherapy.

In addition to the above indications, Hengrui Medicine is also carrying out a number of clinical studies of carrelizumab worldwide, involving cancers such as triple-negative breast cancer, gastric cancer, advanced urinary system tumors, and gynecological tumors.