\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Events
On April 30, 2022, the company released the performance report for the first quarter of 2022. In Q1 2022, the company realized an operating revenue of 630 million yuan, a year-on-year decrease of 61.02%. The net profit attributable to shareholders of listed companies was -396 million yuan, and the net profit attributable to shareholders of listed companies after deducting non recurring profits and losses was -430 million yuan. The R & D investment was 511 million yuan, a year-on-year increase of 13.37%.
Event comments
The sales of key products treprizumab injection have come out of the trough and the performance has gradually recovered
At the revenue side, the revenue of Q1 company in 2022 is mainly the overseas technology license revenue of specific anti tigit monoclonal antibody (js006), the overseas franchise revenue of etecivir monoclonal antibody (js016) and treprizumab injection (trade name: tuoyi) ®， Product Code: js001) sales revenue brought by commercialization in the Chinese market. Among them, tuoyi ® After the implementation of the new price of the 2021 edition of the national medical insurance catalogue, the sales revenue in the current period reached 110 million yuan, with a significant increase year-on-year and month on month. The sales in the Chinese market have come out of the trough and gradually returned to normal. However, the increase in drug sales revenue in the current period compared with the same period of last year could not offset the impact of the decline in technology licensing revenue, resulting in a year-on-year decrease of 61.02% in operating revenue in the current period. On the profit side, the total operating cost of the company in the current period was 1.012 billion yuan, a decrease of 12.34% compared with the same period in 2021, but the technology license income in the current period also decreased compared with the same period, and the net profit attributable to the parent company and deduction of non net profit of the company were affected to a certain extent.
To promote the research and development of covid-19 small molecule drugs, oral drug vv116 has launched a number of phase III clinical trials
The company has actively carried out a number of clinical trials of vv116 targeting RdRp for patients with different degrees of covid-19: 1) a double-blind, randomized, placebo-controlled international multicenter phase II / III clinical trial for patients with mild to moderate diseases, and 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. 2) The phase III clinical trial on the safety and effectiveness of head-to-head comparison with Pfizer paxlovid in the treatment of mild to moderate covid-19 patients in China in April 2022 is also in progress, and the enrollment and administration of the first patient have been completed. 3) There is also an international multicenter, randomized, double-blind phase III trial for moderate and severe patients, and the enrollment and administration of the first patient have been completed. 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.
PD-1 received a complete reply from FDA, and the re submission of BLA application is expected to be approved
On May 2, the BLA application of treprizumab, the company’s key PD-1 antibody product, received a complete reply from FDA, requiring only one change in the quality control process that the company considers easy to complete. The company plans to resubmit its listing application before the midsummer of 2022. Although the on-site verification is blocked due to covid-19 epidemic and the specific verification time has not been determined, the overall approval prospect is relatively positive in terms of FDA’s current reply. If the successful commercialization of treprizumab in the United States, it will further promote the sales revenue growth of the company’s PD-1 products.
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 a year-on-year increase 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 a year-on-year increase of 30.2%, 153.2% and 103.2% respectively. The corresponding PE is Na / 324.57x / 159.70x. 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.
