Policy level: continue to encourage innovation
The policy encourages the field of traditional Chinese medicine. Many policies have been issued from the aspects of talent training, medical insurance payment, review and approval, encouraging innovation and so on. In recent years, the State Council, the general office of the State Council and many subordinate departments have issued relevant policies, which shows the importance the state attaches to the field of traditional Chinese medicine.
Medical insurance negotiations include multiple traditional Chinese medicines. Since the implementation of the medical insurance negotiation, 61 new traditional Chinese medicine drugs have been successfully included, and the medical insurance has treated chemical drugs, biological drugs and new traditional Chinese medicine drugs with definite curative effect equally. Since the beginning of routine medical insurance negotiations in 2017, a total of 337 drugs have been successfully negotiated, with traditional Chinese medicine accounting for 18%.
R & D level: clinical standards and chemical drugs converge, and the number of new drugs on the market increases steadily
Scientific clinical trial design to ensure the effectiveness of new drugs. Since the drug review reform in 2015, the clinical trials of traditional Chinese medicine have also been more standardized. Taking 11 Traditional Chinese medicine listed in 2021 as an example, 8 of them are randomized controlled trials, and the endpoints of most clinical trials are the same as those of similar chemical drugs. The research and development of new traditional Chinese medicine takes a long time. Of the 11 Traditional Chinese medicine listed in 2021, 6 take about 15 years from ind to listing.
Under the new review and approval system, the number of new drugs on the market showed a steady growth trend. In 2021, there were 13 new Chinese medicine drugs on the market in China, reaching the highest point after the drug review reform after 2015. At present, there are more than a dozen traditional Chinese medicines applying for ind every year, and it is expected that innovative traditional Chinese medicines will be listed one after another every year in the future.
Innovative Chinese medicine related companies
In terms of the number of new traditional Chinese medicine drugs declared for listing, Jiangsu Kanion Pharmaceutical Co.Ltd(600557) , Shijiazhuang Yiling Pharmaceutical Co.Ltd(002603) , Shandong Buchang Pharmaceuticals Co.Ltd(603858) are the listed companies with the largest number of new traditional Chinese medicine drugs listed after 2001, 18, 11 and 10 respectively. In terms of the number of ind declared after 2015, Jiangsu Kanion Pharmaceutical Co.Ltd(600557) has the largest number, reaching 12; 4 Yangtze rivers; Shijiazhuang Yiling Pharmaceutical Co.Ltd(002603) , Tasly Pharmaceutical Group Co.Ltd(600535) are three.
The policy encourages the innovative medicine sector of traditional Chinese medicine. Under the background of standardized review and approval, the number of innovative drugs of traditional Chinese medicine listed has increased steadily. From the perspective of the number of applications, this trend will still be maintained in the future. The long-term growth of innovative drugs of traditional Chinese Medicine can be expected. It is suggested to actively pay attention to innovative drug companies of traditional Chinese medicine.
Risk tip: the risk of drug R & D failure, the progress of drug R & D and declaration is less than expected, and the medical insurance and sales of drugs after listing are less than expected.
