\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Event: Recently, 1) the oral nucleoside anti SARS-CoV2 drug VV116 tablet developed by Shanghai Junshi Biosciences Co.Ltd(688180) control company Jun Tuo bio and Wang Shan Wang Shui has launched an international multicenter, randomized, double-blind, and controlled III phase clinical trial in moderate severe New Coronavirus pneumonia patients. The first patient was enrolled in the trial and the drug was administered. VV116 tablets were used to evaluate the efficacy and safety of the standard treatment. 2) Three completed phase I clinical results of vv116 were published in the academic journal actapharmacologica Sinica (if: 6.15). The results of this study showed that vv116 showed good safety, tolerance and pharmacokinetic properties in healthy subjects.
Covid-19 oral drug vv116 has launched two international multicenter III clinical trials, with a leading progress
At present, Shanghai Junshi Biosciences Co.Ltd(688180) has carried out international phase III clinical trials for patients with mild, moderate and severe covid-19 respectively, and Shanghai Junshi Biosciences Co.Ltd(688180) has made rapid progress among Chinese pharmaceutical enterprises. The primary endpoint of this trial was the percentage of subjects who progressed to severe covid-19 or all-cause death by day 29. Previously, vv116 has completed a randomized, open and controlled phase II clinical trial in moderate and severe covid-19 subjects. The trial shows that vv116 has good safety and effectiveness, and vv116 has obtained Uzbekistan emergency use authorization (EUA). The overall clinical research progress of vv116 is advancing rapidly, and the drug is expected to be commercialized smoothly in the future to meet the clinical needs of the repeatedly fermented covid-19 epidemic.
Vv116 completed three phase I clinical trials with good safety and tolerance
Vv116 completed a total of three phase I clinical trials in China, with a total of 86 participants. Study 1 and Study 2 were single dose and multi dose incremental studies to evaluate the safety, tolerance and pharmacokinetics of single and multiple incremental oral vv116 in healthy subjects; Study 3 was used to observe the effects of diet on the pharmacokinetics and safety of vv116 in healthy subjects. In terms of drug metabolism, vv116 is rapidly hydrolyzed to its metabolite 116-n1 (maternal nucleoside) after oral administration into the human body, and the plasma 116-n1 concentration quickly reaches the peak (median tmax1.00-2.50 hours). In terms of safety, there were no reports of death, serious adverse events (SAE), AES of grade 3 or above, or AES leading to drug withdrawal / interruption in the three trials, and all AES recovered without any treatment or intervention.
Vv116 has structural advantages and good preclinical results
Vv116 is an RdRp inhibitor modified from remdesivir. In preclinical pharmacodynamics, vv116 showed significant anti covid-19 effects in vivo and in vitro. In the mouse model, vv116 takes molnupiravir as the positive control. The study found that after the use of drugs, the virus titer can be reduced below the detection limit, and the anti covid-19 virus has a strong effect. At the same time, no adverse reactions were observed in the animal toxicity study of vv116, which showed good safety. In terms of pharmacokinetics, vv116 has high oral bioavailability. After oral absorption, it is rapidly metabolized into maternal nucleoside. Pharmacokinetic property is one of the most obvious characteristics of vv116 different from remdesivir, and it is also the key scientific basis for the effective oral administration of vv116.
At the same time, 3clpro inhibitor vv993 is under development, and the two drugs are expected to be used together
The company cooperates with Wangshan wangshui to develop another oral anti covid-19 virus candidate new drug vv993. Vv993 is a 3clpro inhibitor with the same mechanism as Pfizer paxlovid. V993 has good clinical efficacy and safety according to the current research results. At the same time, vv116 and vv993 are drugs or candidate drugs developed for different key and conservative targets in the virus life cycle. In addition to their respective advantages, they also have the development prospect of combined drugs.
Profit forecast and investment rating
According to the company’s performance express in 2021, we raised the revenue in 2021 from 3.405 billion to 4.013 billion, and the net profit from – 248 million to – 740 million. We estimate that the revenue from 2022 to 2023 will be RMB 3.767 billion and RMB 4.823 billion, and the net profit attributable to the parent company will be RMB -363 million and RMB 90 million. Maintain the “buy” rating.
Risk tip: there is a risk of clinical trial failure. The sales after listing is less than expected. The performance express is the preliminary calculation. The specific data shall be subject to the official annual report disclosed by the company
