\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Events
On May 18, 2022, the journal emerging microbes & infections published the clinical research data of Junshi vv116 on Omicron infected subjects. The study was completed by the national infectious diseases Medical Center, Shanghai Key Laboratory of infectious diseases and biosafety emergency response, Professor Zhang Wenhong’s team of Huashan infection, Professor Fan Xiaohong’s team of Shanghai public health clinical center and Lingang laboratory. The effect of vv116 on the negative time of nucleic acid in patients with non severe Omicron infection was evaluated and positive results were obtained.
Event comments
Vv116 significantly shortened the time of nucleic acid negative conversion in patients diagnosed within 5 days
The research team conducted this open, prospective cohort study from March 8, 2022 to March 24, 2022 to assess its safety and efficacy in Chinese subjects infected with Omicron. 136 hospitalized patients diagnosed as covid-19 were included in this study. 60 patients in the treatment group received vv116 (300mg, bid for 5 days), and 76 patients in the control group only received standard treatment. Except for the high proportion of symptomatic patients in the control group, there was no significant difference in baseline characteristics between vv116 group and the control group (P = 0.021). The median time from the first positive test to the first administration was 5 days (range: 2-10 days). The nucleic acid negative time of patients treated with vv116 within 5 days after the first positive test was shorter than that of the control group (8.56 vs 11.13 days). Cox regression analysis showed that the corrected HR was 2.37 [95% ci1.50-3.75, P 0.001]. In the subgroup of symptomatic patients, the nucleic acid negative time in vv116 group was shorter than that in the control group (P = 0.016). A total of 9 adverse events were reported in vv116 group, and no serious adverse events occurred, of which 7 cases were mild abnormal liver function, which were not solved by intervention. Vv116 is a safe and effective oral antiviral drug, which has better curative effect in the early stage of Omicron infection.
The three key clinical projects are progressing smoothly and can be expected in the future
The company has actively carried out a number of clinical trials of vv116 targeting RdRp for patients with different degrees of covid-19: 1) the phase III clinical trial on the safety and effectiveness of head-to-head comparison with Pfizer paxlovid in the treatment of mild and moderate covid-19 patients in China in April 2022 is rapidly advancing. 2) A double-blind, randomized, placebo-controlled international multicenter phase II / III clinical trial for mild to moderate patients has completed the enrollment and administration of the first patient. At the same time, at the end of April 2022, the clinical research center of the Chinese University of Hong Kong cooperated with CUHK hospital to carry out the vv116 Hong Kong clinical trial, which was the first clinical study of oral drugs developed for covid-19 pneumonia in Hong Kong. 3) There is also an international multicenter, randomized, double-blind phase III trial for moderate and severe patients. The enrollment and administration of the first patient have been completed in March. At the end of 2021, vv116 has been approved for use in Uzbekistan. Another candidate anti covid-19 oral drug vv993 targeting 3CL protease in the same pipeline is also in the preclinical development stage, which is worth looking forward to. On the whole, the company has a comprehensive layout in the field of anti covid-19 drugs, which is in a leading position in China. It is expected to provide more treatment options for covid-19 patients worldwide in the future.
Investment advice
We estimate that the operating revenue of the company from 2022 to 2024 will be 3.468 billion yuan, 4.811 billion yuan and 6.286 billion yuan respectively, with year-on-year growth of – 13.8%, 38.7% and 30.7% respectively. The net profit attributable to the parent company will be – 504 million yuan, 268 million yuan and 544 million yuan respectively, with year-on-year growth of 30.2%, 153.2% and 103.2%, and the corresponding PE is Na / 363.46x/178.84x. We are optimistic about the sales prospect of the company’s existing tumor pipeline products and the market space of covid-19 related drugs, At the same time, we are also optimistic about the company’s global integrated R & D system, rich pipelines and continuously optimized commercialization team. Maintain the company’s “buy” rating.
Risk tips
Industry policy risk; Product R & D risk; Uncertainty of drug sales, etc.
