Zhitong Financial APP learned that Sino-Thai Securities released a special research report on COVID-19 's oral medicine, which focuses on Junshi Biology (01877), which is in the III period and has potential. It is recommended to pay attention to other advanced therapies and pharmaceutical enterprises, such as Frontier Biology (688221.SH), Pharmaceutical Development-B (09939), Xiansheng Pharmaceutical (02096), Shensheng Pharmaceutical (002317.SZ), Guangshengtang (300436.SZ), etc. At the same time, we should pay attention to the CDMO industry chain of related drugs and the enterprises of authorized generic drugs / API in non-European and American countries.
The main points of Zhongtai Securities are as follows:
With the attack of Omicron, there have been frequent outbreaks all over the country.
On November 26th, WHO defined Omicron as the fifth "concerned mutant" (VOC). In less than two months, Omicron spread rapidly around the world and has replaced Delta as the mainstream strain. According to the announcement of the National Health Commission, the Omicron mutant was first introduced into Hong Kong on November 27, 2021, and was first imported into the mainland of China on December 9. Recently, cases of O'Micron mutant infection have been reported in many places, among which the imported cases of omicron in Tianjin have caused large-scale local infection, and the situation of prevention and control of the epidemic situation of COVID-19 in China has become more severe after the import of omicron.
There is an urgent need for domestic oral medicine, which is in an important strategic position.
Since the outbreak of COVID-19, seeking effective drug treatment has been a priority. Compared with macromolecular drugs (such as neutralizing antibody drugs, etc.), small molecular oral drugs have the advantages of direct antiviral effect, low production cost and drug use cost, easy to meet storage and transportation conditions, convenient use, good patient compliance and so on. Oral new crown drugs are expected to become a more convenient choice for the treatment of COVID-19 in the future. At present, two small molecular drugs have been approved by EUA in the world, and China is not among them in the generic drug licensing agreement signed with MPP (Drug Patent Pool) by Mershadong Mupivier and Pfizer Inc PAXLOVID;. Therefore, domestic COVID-19 oral drugs are in a very important strategic position for domestic epidemic prevention and control.
A variety of therapeutic drugs are in the clinical stage, and Junshi biology, the development of pharmaceutical industry, and real biology are leading the way:
1) Junshi Biological VV116: in December 2021, the Ministry of Health of Uzbekistan has approved the emergency use authorization of VV116, and the global phase II/III clinical preparation is under way.
2) Proclomide: on December 27th, 2021, the company announced the results of the mid-term analysis of the global phase III clinical trial, which showed that it was not statistically significant, and the company planned to continue to recruit high-risk patients.
3) the real organism Azvudine: the preliminary analysis data are good, and the global III phase trial is under way.
3CL hot targets, a number of inhibitors are in the early clinical stage:
1) Frontier Biological FB2001: in cooperation with Shanghai Institute of Medicine, Chinese Academy of Sciences, Phase I clinical has been approved in China and the United States.
2) SIM0417 of Xiansheng Pharmaceutical Co., Ltd.: it shows good antiviral activity and safety before clinic.
3) Guangshengtang: signed a cooperative development contract with Wuxi Apptec and is expected to complete the preclinical development of Q4 in 2022.
4) Genting Xinyao: a down payment of US $2.5 million, with a maximum total price of US $200 million for the introduction of 3CL drugs from EDCC. The clinical trial of EDDC-2214 is expected to start in the second half of this year.
Risk hint
The risk of novel coronavirus variation, the significant risk of epidemic prevention and control, the risk that the clinical progress is not as expected, and the risk that the research report information is not updated in time.
This article is edited from Sino-Thai Securities Research, author: Zhu Jiaqi; Zhitong Financial Editor: Huang Xiaodong.