China Patent NewsPending successful achievement of efficacy and safety endpoints in the Phase II ACT-NMIBC study and required regulatory approval, China, among other major medical markets; including: Canada, the United States and the European Union, are getting in line for use of this advanced PDT technology in the treatment of patients diagnosed with Bacillus Calmette Gurin ("BCG")-Unresponsive NMIBC. No mention of GBM but might be the plan if OPTIFERRIN not clinically approved in NA. China's oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from RMB83.4 billion in 2013 to RMB139.4 billion in 2017, representing a CAGR of 13.7%. It is expected to further grow to RMB262.1 billion in 2022 at a CAGR of 13.5% from 2017, and to RMB654.1 billion in 2030 at a CAGR of 12.1% from 2022. While the majority of the top ten oncology drugs globally in 2017 are either molecularly targeted drugs or immuno-oncology drugs, seven out of the top ten oncology drugs in China are chemotherapy drugs and only three are molecularly targeted drugs. This difference between the global market and the China market suggests significant potential for molecularly targeted drug and immuno-oncology drug market growth in China. Three drugs among the top10 oncology drugs globally were recently approved in China in 2018, indicating China is at its early stage of its paradigm shift to molecularly targeted drugs and immuno-oncology drugs. Among all types of cancers, lung cancer, liver cancer, stomach cancer, colorectal cancer and breast cancer are the top five cancer types in China by incidence rate, accounting for more than 50% of the annual incidence in the aggregate. The incidences of lung cancer, colorectal cancer and esophageal cancer are expected to grow at higher CAGRs than the others. Such higher CAGR for lung cancer is attributed to the growing smoking population and air pollution. As for colorectal and esophageal cancer, the higher CAGRs are attributable mainly to increasingly prevalence of unhealthy dietary habits. mAbs (including fusion proteins) only accounted for 5.4% of China's biologics market in 2017, while globally the figure was 43.2% in the same year, representing a sizable market potential. With the inclusion of more mAbs into the NRDL, sales revenue of China's mAbs market is expected to grow to RMB69.6 billion in 2022, representing a CAGR of 42.6% from 2017 to 2022, which will outpace the growth of China's overall biologics market. The diagram below illustrates the size of China's mAb market from 2013 to 2017 and the estimated market size from 2018 to 2022. In addition to monotherapies, PD-1/L1 inhibitors have shown significant potential in combined therapies. PD-1/PD-L1 inhibitors market is still at an early stage of development but has strong growth potentials. The market size of PD-1 and PD-L1 inhibitors together is estimated to grow to RMB37.4 billion in 2022, representing a CAGR of 534.4% from 2018 to 2022, and further increase to RMB98.4 billion in 2030, representing a CAGR of 12.8% from 2022 to 2030. In December 2018, the State Drug Administration ( NMPA ) announced that it would conditionally approve the listing of the first domestically produced PD-1 monoclonal antibody, tripril monoclonal antibody injection. Tripril monoclonal antibody was developed by Suzhou Zhonghe Biomedical Co., Ltd. (A subsidiary of Shanghai Junshi Biosciences Co., Ltd.) to treat local progression or metastatic melanoma after previous standard treatment failure. Currently, there are 6 PD-1/PD-L1 listed in the world, of which 2 PD-1 drugs, namely Opdivo of Bristol - Myers Squibb and Keytruda of Mercadon, have been approved for listing in China in 2018.