Junshi Biological new crown drugs have a new action, CEO Li Ning: Domestic to see oral drugs

Source of this article: Time Weekly Author: Han Liming

Junshi Bio has made new moves in the field of new crown therapeutic drugs.

Junshi Bio (01877. HK；688180. SH) has reached a cooperation with Suzhou Wangshan Wangshui Biomedical Co., Ltd. (Wangshan Wangshui) to jointly undertake the research, production and commercialization of VV993, an oral anti-coronavirus candidate drug targeting 3CL protease, in addition to the five countries or regions in Central Asia.

On January 26, Junshi Bio released the above information. VV993 is also the second NEW CROWN oral drug jointly developed by Junshi Bio and Wangshan Wangshui after VV116.

3CL protease (3C-likeprotease, 3CLpro) is an indispensable proteolytic enzyme in the replication process of the new crown virus, and its amino acid sequence has hardly changed in the multiple new coronavirus variants that have emerged so far, which is an important target for the development of highly conservative anti-new coronavirus drugs.

According to Junshi Biology, VV993 can inhibit 3CL protease with a new binding mode, which is a new organic small molecule compound that is different in chemical structure from similar drug candidates in research on the basis of a series of research and optimization by researchers of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences (Shanghai Institute of Materia Medica) and the Wuhan Institute of Virology of the Chinese Academy of Sciences.

The world's fastest-growing 3CL protease inhibitor is Pfizer's oral antiviral candidate, which was authorized for emergency use (EUA) by the U.S. Food and Drug Administration (FDA) in late 2021.

Junshi Bio said that in the cell model experiment of new coronavirus infection, VV993 can effectively inhibit the replication of new coronavirus. In mouse models infected with covid-19, VV993 not only effectively reduced viral replication, but also significantly improved lung pathological changes caused by COVID-19 infection. In terms of other druggability, VV993 has a good safety profile, and no cardiotoxic and neurotoxic effects have been found. Based on the results of the current study, VV993 is a safe, oral, and effective anti-CORONAVIRUS candidate compound in animal models.

Prior to this, Junshi Bio and Wangshan Wangshui had jointly carried out the clinical development and industrialization of VV116 worldwide, and obtained the authorization for use in Uzbekistan in December 2021. At present, VV116 is conducting global multicenter clinical studies, of which 3 Phase I studies in China have been completed recently, preliminary results show good clinical safety, and international multicentre Phase II/III clinical trials for patients with mild to moderate COVID-19 are underway.

Junshi Biology once told the Times Weekly reporter, "According to experience, a drug can not do all aspects, with the understanding of the disease and the development of treatment methods, the choice of therapy may undergo a gradual substitution, or may form a set of complementary 'combination fists'." ”

The research and development of effective drugs for the new coronavirus in mainland China mainly revolves around three technical routes: blocking the virus from entering the cell, inhibiting virus replication, and regulating the human immune system, and the mainstream drug categories include neutralizing antibody drugs and oral small molecule drugs. In addition to the layout of oral small molecule drugs, Junshi Bio also lays out two neutralizing antibody drugs at the same time.

Ettexvirumab (project code: JS016) is the earliest neutralizing antibody drug in China to join the global fight against the epidemic, jointly developed by Junshi Biology and the Institute of Microbiology of the Chinese Academy of Sciences. Up to now, the dual antibody therapy composed of ettexvirumab and Eli Lilly Pharmaceuticals (LLY.NYSE) banivumab has been authorized in more than 15 countries and regions.

JS026 is the second neutralizing antibody drug of Junshi Bio's layout, and its clinical trial application was approved by the State Drug Administration of China (NMPA) in November 2021. In response to the escape of the virus variant, clinical trials of JS026 monotherapy and JS016/JS026 are being conducted. According to the preliminary results of the pseudoviral experiment, JS026 maintains neutralization activity on the Omiljung variant, and the true virus research is being further verified.

"The mechanism of action and development path of neutralizing antibody drugs are relatively clear, and the past year has made considerable contributions with the advantages of development speed, efficacy and safety." Junshi Biology told the Times Weekly reporter: "Virus mutations may affect the neutralization activity of neutralizing antibodies, at the same time, the production requirements and cost of antibody drugs are high, and the portability of transportation and use is subject to certain innate restrictions, and it is impossible to cover a wide range at the global level." ”

According to Junshi Biology, VV116 and VV993 are drugs or drug candidates developed for different key and conservative targets of the virus life cycle, in addition to being used alone to exert their respective clinical advantages or characteristics, they also have the development prospect of "combined drug antiviral, complementary efficacy".

Li Ning, CEO of Junshi Biology, said in an interview with the Times Weekly reporter: "At present, the results of domestic epidemic control are remarkable, and from the perspective of the market alone, the commercial value of antibody therapy in China will not be great. At the same time, due to the high price of neutralizing antibodies, the treatment of new crown pneumonia in China mainly relies on oral drugs. ”

It is reported that the similar antibody drugs listed overseas are mainly government procurement, and under the order of millions, the price is 2100 US dollars (equivalent to about 13371 yuan). The overseas price of COVID-19 oral drugs is about US$530-700 per course (equivalent to about RMB 3376-4459).