\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Event: the company announced the nomination of Ms. Zou Jianjun as the executive director of the company and the appointment of Ms. Zou Jianjun as the deputy general manager and President of global R & D. Ms. Zou Jianjun will be fully responsible for the research and development of the company.
On April 19, 2022, China clinical trial registration center showed that Suzhou Wangshan wangshui pharmaceutical registration jt001 (vv116) was a multicenter, single-blind, randomized and controlled phase III clinical study comparing the efficacy and safety of Pfizer paxlovid in the early treatment of mild to moderate covid-19 pneumonia.
On April 18, 2022, the company announced that the research results of preclinical in vivo efficacy of vv116 as a potential RSV inhibitor were published online in nature’s journal signal transduction and targeted therapy.
Viewpoint: Ms. Zou Jianjun has profound experience in pharmaceutical R & D industry and will lead the company to promote innovative R & D efficiently. Ms. Zou Jianjun received a doctor’s degree in clinical oncology from the Second Military Medical University and has 10 years of working experience as an oncologist. He has successively worked in multinational pharmaceutical companies Bayer pharmaceutical in Germany and Xinji pharmaceutical in the United States, and served as Jiangsu Hengrui Medicine Co.Ltd(600276) chief medical officer and deputy general manager from September 2015 to April 2022, during which he successfully promoted the listing of 7 innovative drugs and 17 new indications. Ms. Zou Jianjun has been engaged in clinical treatment of cancer, research and development of anti-tumor drugs and clinical research of new drugs for 30 years. Her rich leadership experience accumulated in multinational pharmaceutical enterprises and leading enterprises of innovative drugs in China will help the company promote the product pipeline under research smoothly and efficiently, consolidate the company’s advantageous position in innovative drug research and development, grasp the current development opportunities of the pharmaceutical market, and promote the steady implementation of the company’s source innovation and international development strategy.
Vv116 is further developed, leading China’s covid-19 small molecule track. Vv116 is a new oral nucleoside anti covid-19 virus drug developed by the company in cooperation with Wangshan wangshui. It has previously been approved by Uzbekistan. The global multi center phase II / III clinical trial for patients with mild and moderate covid-19 and the global phase III clinical trial for patients with moderate and severe covid-19 are being actively promoted. The clinical trial sample size of vv116 Pfizer paxlovid for covid-19 patients with mild and moderate diseases is 480 (treatment group: control group = 1:1). The test center is Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University. The primary endpoint of the trial was the time to sustained clinical recovery (up to day 28) and the percentage of subjects with covid-19 progression (defined as progression to severe / critical covid-19 or all-cause death) up to day 28. Vv116 R & D has ranked the first echelon in China. This challenge shows that paxlovid has great confidence in its clinical application, and is expected to accelerate the listing process of vv116, further expand China’s own epidemic prevention resources and help the national epidemic prevention and control.
Vv116 has excellent antiviral effect and is expected to become an effective drug for the treatment of RSV infection. It was found that vv116 had excellent antiviral effect on multiple RSV sensitive cell lines; In the mouse model, it has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, and can alleviate the pathological damage of lung tissue. At present, there is no safe and effective drug for the treatment of RSV infection in the world, and there is a huge unmet clinical demand for a long time. The results of this study reveal the application potential of vv116 for anti RSV infection and expand the application space of vv116 outside the anti covid-19 virus. It is expected to effectively expand the product coverage, extend the volume time and enhance the market value.
Profit forecast and investment rating. Without considering the commercialization of vv116 for the time being, the company’s revenue from 2022 to 2024 is expected to be 2.274 billion yuan, 3.687 billion yuan and 4.893 billion yuan respectively, with a year-on-year increase of – 43.5%, 62.1% and 32.7% respectively; The net profit attributable to the parent company is -1037 million yuan, – 811 million yuan and -231 million yuan respectively, and the corresponding EPS is -114, -0.89 and -0.25 yuan respectively. Considering the current anti epidemic situation in China and the spreading power of Omicron, the approval of vv116 will bring greater income elasticity to the company. We look forward to the reading of vv116 data. We are optimistic about the development of the company and maintain the “buy” rating.
Risk warning: risk of R & D failure; The risk that the project progress is not as expected.
