Shanghai Junshi Biosciences Co.Ltd(688180) vv116 has excellent preclinical effect as an RSV inhibitor, and its indications are expected to be expanded

\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )

Event:

Recently, the preclinical and in vivo pharmacodynamic research results of vv116 as a potential respiratory syncytial virus (RSV) inhibitor were published in nature’s journal signal translation and targeted therapy (if: 18.187).

Vv116 showed excellent antiviral effect in RSV sensitive cell lines

Vv116 has excellent antiviral effect on multiple RSV sensitive cell lines. In the mouse model, vv116 has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, and can alleviate the pathological damage of lung tissue. This study provides a valuable clinical candidate for the treatment of RSV infection. At present, there is no safe and effective drug for the treatment of RSV infection on the market all over the world, and there is a huge unmet clinical demand for a long time.

Vv116 covid-19 has excellent clinical data, and the phase II / III clinical progress is smooth

Vv116 has completed three phase I clinical studies carried out in China, with good safety performance, and the severity of AE is generally mild (CTCAE level). Previously, vv116 has obtained the emergency use authorization (EUA) of Uzbekistan based on the positive results of the clinical study of 450 patients with moderate and severe covid-19 in Uzbekistan. Both studies showed that vv116 had good safety and effectiveness. At present, the company is carrying out two vv116 international phase II / III clinical trials, aiming at covid-19 mild to moderate and severe patients respectively. At present, the first patient has been enrolled and administered. According to the clinical trials registration information, they are expected to be completed this year.

Shanghai Junshi Biosciences Co.Ltd(688180) R & D pipelines are increasingly abundant, and treprizumab has been approved with multiple indications

Shanghai Junshi Biosciences Co.Ltd(688180) at present, it has three commercial products of treprizumab, etecivir and adalimumab, and has a number of products under development in clinical trials. Among them, the company’s core product treprizumab (PD-1) has been approved for four indications: second-line melanoma, third-line nasopharyngeal carcinoma, second-line urothelial carcinoma and first-line nasopharyngeal carcinoma, of which the first three have been included in medical insurance. At the same time, the listing application of two new indications: first-line esophageal squamous cell carcinoma and first-line non-small cell lung cancer has been accepted by nmpa. In addition, multiple adjuvant treatment indications of treprizumab have entered the late stage of research and development. Three phase III clinical trials of adjuvant treatment after radical resection of locally advanced hepatocellular carcinoma, combined with etoposide and platinum first-line treatment of extensive small cell lung cancer, combined with bevacizumab versus sorafenib first-line treatment of advanced hepatocellular carcinoma were completed; Teripulimab combined with standard chemotherapy as an adjuvant treatment after radical resection of gastric or esophagogastric adenocarcinoma. The phase III clinical study has completed the administration of the first patient.

Profit forecast and investment rating

We estimate that the company’s revenue from 2022 to 2024 will be RMB 2.75 billion, RMB 3.251 billion and RMB 4.368 billion, and the net profit attributable to the parent company will be RMB -592 million, – 494 million and – 308 million. Maintain the “buy” rating.

Risk tips: the risk of repeated epidemic, the risk of changes in medical insurance policies, the risk of failure of clinical trials, and the risk that the sales of drugs after listing are less than expected

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