By Zhixing
Anti-PD-1 monoclonal antibodies could be called springing up on overseas cancer drug market, and are very popular with pharmaceutical enterprises, however, it is hard to find such monoclonal antibody in China. This situation may be soon ended, as it has been reported recently that the Opdivo might become the first anti-PD-1 monoclonal antibody marketed in China, and be approved by CFDA in 2018 Q1 at the soonest. Furthermore, unwilling to lag behind, Chinese pharmaceutical enterprises have competed to conduct relevant phase III clinical studies, such as IBI308 of Innovent Biologics, BGB-A317 of BeiGene, and SHR-1210 of Hengrui Pharmaceuticals.
BMS -Opdivo
As the world’s first marketed anti-PD-1 monoclonal antibody, Opdivo (nivolumab) was first approved in Japan, and then approved by FDA in 2014 for melanoma, and has also been approved by FDA so far for non-small cell lung cancer (NSCLC), classical Hodgkin's lymphoma, head and neck squamous cell carcinoma, renal cell carcinoma, bladder cancer, colorectal cancer, gastric cancer, and hepatocellular carcinoma.
Generally, years after having been marketed overseas, new drugs will then be marketed in China, due to the strict drug policy and approval process in China, however, the opinions introduced last year will change this phenomenon. The State Council of China issued the Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices in October 2017, which is of milestone meaning to the innovative development of China’s pharmaceutical industry, and clearly mentions that overseas clinical trial data are accepted for the imported innovative drugs. The introduction of the opinions will accelerate the marketing of new drugs on the Chinese market, and improve the Chinese cancer patients’ plight of long-term no access to drugs.
Not long after the introduction of the opinions, BMS filed the marketing application (JXSS1700015) for Opdivo as second-line therapy for NSCLC to the Center for Drug Evaluation of China Food and Drug Administration (CDE) in November 2017, which was included in the priority review by reason of "having significant therapeutic advantages compared to existing treatment means" in December 2017. Both the extensive indications and excellent clinical data of Opdivo are the evidence that it will be approved by CFDA, and Opdivo’s receiving of approval will only be a matter of time owing to the changes of relevant policy in China. It is believed that the approval will be granted in 2018 Q1. Let’s wait and see.
Hengrui Pharmaceuticals-SHR-1210
Early in April 2017, Hengrui Pharmaceuticals has announced the launch of the open-label, randomized, multicenter, Phase III clinical study of the anti-PD-1 antibody: SHR-1210 in combination with pemetrexed and carboplatin as first-line therapy in patients with advanced or metastatic non-squamous NSCLC, with the current status of in progress (recruiting), with 54 hospital institutions and 412 patients participating in the study, and primary endpoint of PFS, and secondary endpoint of ORR, DCR, and DoR, etc. In the same month, Hengrui Pharmaceuticals also launched the randomized, open-label, positive drug-controlled, multicenter, Phase III clinical study of SHR-1210 vs investigator’s choice of chemotherapy to treat advanced or metastatic esophageal cancer, with 44 hospital institutions and 438 patients participating in this study at present.
Hengrui Pharmaceuticals announced the launch of the randomized, double blind, placebo-controlled, multicenter, Phase III clinical study of SHR-1210 as second-line therapy in patients with advanced hepatocellular carcinoma (HCC) on December 22, 2017, with the primary endpoint of OS, and secondary endpoint of ORR, DoR, DCR, and TTP, etc., with the current status of in progress (having not recruited).
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