Domestic PD-1 drugs achieve zero breakthrough! Opdivo was approved, followed by MSD, Hengrui, Junshi, Xinda, etc

On June 15, the official website of the State Drug Administration issued the notice of approval of the listing of PD-1 antibody drugs, approving the injection of nevuliumab Injection (trade name: opdivo) is an import registration application for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose EGFR gene mutation is negative and anaplastic lymphoma kinase (ALK) is negative, who have been treated with platinum containing chemotherapy for disease progression or intolerability As we all know, opdivo is the first PD-1 / PD-L1 drug approved by Bristol Myers Squibb in the world On December 22, 2014, opdivo was approved by FDA for listing With its advantages in non-small cell lung cancer indications, the market share has been in a leading position On November 2, 2017, Bristol Myers Squibb submitted its listing application (jxss1700015) to the drug review center (CDE) and received the acceptance, making opdivo the first immunotherapy PD-1 / PD-L1 drug to submit its listing application in China It is reported that the State Drug Administration has accelerated the completion of technical review and on-site verification of clinical trial data of the drug in accordance with the priority review procedure Prior to the industry assessment, it is expected that opdivo will be approved by China's drug regulatory authorities for listing in 2018 From CDE acceptance to approval, within half a year, PD-1 drugs have achieved "zero breakthrough" in the Chinese market, fully reflecting the high-level and high demand innovative drugs under the background of regulatory reform of registration and approval, In order to meet the clinical needs, it provides a huge systematic support, which is of positive significance to solve the accessibility of clinical medication for cancer patients in China Mosadon follows The research focus in the field of tumor immunotherapy is mainly focused on the immunosuppressant such as anti programmed death-1 (PD-1) receptor, which is different from the traditional chemotherapy and targeted therapy, mainly through overcoming the immunosuppression in patients and reactivating their own immune cells to kill tumors It is a new anti-tumor treatment concept Opdivo can block the binding of PD-1 of T-lymphocytes with PD-L1 on the surface of tumor cells, release the immunosuppression of tumor cells on immune cells, and make immune cells play the role of anti-tumor cells again to kill tumor cells At present, opdivo has been approved for nine tumor indications in the world, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, renal cell carcinoma, classic Hodgkin's lymphoma, urothelial carcinoma, colorectal cancer (MSI-H or D MMR), gastric cancer and liver cell carcinoma 　　 There are five monoclonal antibody drugs against PD-1 or PD-L1 in the world In addition to opdivo, the monoclonal antibody drugs targeting PD-1 also include pembrolizumab (trade name keytruda) of mosadon, while the monoclonal antibody drugs targeting PD-L1 are tecentriq (atezolizumab), bavencio (avelumab) and imfinzi (durvalumab) 。 As the two main market competitors in the field of PD-1 McAb, the war between Bristol Myers Squibb and MSD has extended from overseas to China Three months after Bristol Myers Squibb submitted its application for the listing of opdivo, keytruda, a monoclonal antibody of MSD PD-1, also submitted its application for listing (jxss1800002) in February 2018, and obtained the acceptance of CDE According to the relevant information, the drug has been registered and carried out 8 clinical trials in China, involving 5 major tumor types, including lung cancer, melanoma, gastric cancer, esophageal cancer and liver cell cancer With opdivo's priority review of quick listing cases, we believe that within a few months, keysruda of MSD will also be listed, so as to provide more treatment options for doctors and patients Domestic pharmaceutical companies actively strive for the first because of the different indications declared by different anti PD - (L) 1 monoclonal antibody varieties, and each disease has its own clinical characteristics, so it needs accurate evaluation In February 2018, the CDE official website released the basic requirements for data on application for listing of anti-PD-1 / PD-L1 monoclonal antibody varieties, and proposed clear policy guidance and supporting support such as "pre NDA meeting", "priority review" and "review acceleration" for the R & D and application problems of anti-PD-1 / PD-L1 monoclonal antibody varieties The key to complex drugs with complex mechanisms lies in how to grasp the scale of risk and benefit, which is also a new problem for regulation As one of the major breakthroughs in the field of tumor treatment in recent years, Pd - (L) 1 mAb has an important investment value in solid tumor treatment, with a high degree of industry concern, a large number of domestic research manufacturers, and unprecedented fierce competition In April 2018, CDE released the announcement of drug registration application to be included in the priority review procedure (the 28th batch), and the three domestic anti-PD-1 antibody drugs, carrelizumab (Hengrui), treprizumab (Junshi) and sindelimab (Xinda), which are of great concern, were included in the priority review list, This is the first echelon in this field in China to re regulate the application data and then enter the road of listing again In addition to the above three enterprises, up to now, more than 20 domestic PD - (L) 1 monoclonal antibodies have submitted clinical or registration applications to the regulatory authorities, which are in different stages of development For the immunotherapy products represented by anti-PD - (L) 1 antibody, standing on the clinical treatment criterion, one step to the left is hell, and one step to the right is heaven It is generally agreed in the industry that many indications can be done before the first drug is approved However, once a drug is approved for marketing, the requirements for subsequent declaration will be different, and the threshold of safety and efficacy may be further improved Zhou Xinhua, CEO of Jiahe biology and expert of "thousand talents plan", said in an interview that the most basic attribute of drugs is safety, no safety, and effectiveness is nonsense Compared with the global drugs on the market, the new drugs must have better safety and better efficacy "The innovation environment reconstructs the innovation standard In the future, the regulatory authorities will probably issue guidelines for specific tumor end-point indicators Domestic products need to have good clinical trial quality, data authenticity, integrity and traceability, which is essential to meet the cost-effectiveness."