Hengrui Pharmaceuticals Karelli zumab liver cancer indications approved, the country ushered in the first liver cancer PD-1 immunotherapy.

3Month4Day, HengruiMedicine independent research and developmentPD-1 inhibitorsCarilizumab(Erica®)Liver cancer indicationsOfficially acquiredNMPA Approval, for the treatment of patients who have received sorafenib treatment and/or oxaliplatin-containing systemic chemotherapy in patients with advanced hepatocellular carcinoma. This is the second indication that karelizumab has been successfully approved in China.,CarilizumabIt has also become the first approved liver cancer indication in China.PD-1 inhibitors.

Carrilizumab is a humanized-PD-1 monoclonal antibodies that can be linked to humanPD-1receptor binding and blockingPD-1/PD-L1restore the body's anti-tumor immunity, thus forming the basis of cancer immunotherapy. The drug was2019Year5Approved for Listing in China, TreatmentPatients with relapsed or refractory classical Hodgkin's lymphoma after at least second-line systemic chemotherapy.It is the No.5PD-1Monoclonal, also the third approved domesticPD-1Anti-cancer drugs.This time Carilli zumab was approved for hepatocellular carcinoma indications, of great concern.

Liver cancer is a major cancer type with the top incidence and mortality in the world.800000 new patients, more70A million patients died as a result. China is one of the major countries with liver cancer,According to statistics, the incidence and mortality of primary liver cancer in China accounted for the global54.6 per cent and53.9%. Hepatocellular carcinoma is the most common liver cancer, and patients with advanced hepatocellular carcinoma do not survive more6 months.In the past two years, the emergence of some new targeted drugs and immunotherapy drugs has brought new treatment options to patients.

Currently, in the United States,in the field of hepatocellular carcinoma,nivolumab (nivolumab) and pembrolizumab (Pembrolizumab) hasRespectively in20179month and2018Year11Monthly AmericanFDAApproved for hepatocellular carcinoma with prior sorafenib treatment. However, there is no similar in ChinaPD-1/L1McAb Approved Indications for Hepatocellular Carcinoma, CarrilizumabFinally in this springto break this situation,Become the first approved liver cancer indications in ChinaPD-1 inhibitors.

According to a press release from Hengrui Pharmaceuticals, the approval of the liver cancer indication is based on a national multi-center treatment of advanced hepatocellular carcinoma in China with previous systemic treatment failure.Phase 2 clinical study results. According to Hengrui Medicine2019Year6At that time, the company had submitted a hepatocellular carcinoma for injectable carrilizumab.2clinical trial report, apply for conditional approval for listing, and be.CDEIncluded in the priority review.

2Month26Day, led by Professor Qin Shukui and Professor Ren Zhenggang, the results of the study of carrilizumab monotherapy for advanced liver cancer were officially published in The Lancet.• Oncology. It is reported that this is the first clinical study in the field of liver cancer immunotherapy in China to reach the top of the journal, which is undoubtedly an affirmation of karelizumab; it is also the largest sample size in the world so farPD-1Inhibitors for the treatment of hepatitis B virus (HBV) One of the clinical studies of advanced liver cancer with high infection rate. It is reported that the clinical study a total of from the country13at the home hospital.220patients with liver cancer.

The study data results were: objective response rate14.7%；6month survival rate74.4%; median survival13.8months; and according to the blind independent center evaluation (BICR), disease control rate for all patients (DCR)44.2%. Moreover, the therapy has a good safety profile and is well tolerated by patients. Of particular concern is that after the progress of carellizumab treatment, the continuous use of carellizumab can still bring benefits to patients, providing more hope for survival for advanced liver cancer with few treatment options.

Karelli zumab Becomes China's First Approved Indications for Liver CancerPD-1 inhibitors demonstrate the steady progress of Chinese scholars, original research drugs and clinical research, and will lead the development of immunotherapy for liver cancer in China. In addition, accordingCDEIn2019Year9Monthly public information: karelizumab single-drug second-line treatment of advanced esophageal squamous cell carcinoma, and combined with pemetrexed plus carboplatin first-line treatment of advanced or metastatic non-squamous cell non-small cell lung cancer, these two new indications of the listing application is also included in the priority review because of "obvious therapeutic advantages. Looking forward to the approval of more indications in the future to benefit more patients and contribute more Chinese strength to the fight against cancer!