\u3000\u3 Guocheng Mining Co.Ltd(000688) 180 Shanghai Junshi Biosciences Co.Ltd(688180) )
Events
On March 19, 2023, the first clinical trial of cov3-16 was completed in cooperation with cov3-16, cov3-16, cov3-19, cov3-16, cov3-16. On the same day, the phase I clinical data of the drug in China was published in the internationally authoritative journal Nature.
Comments
Covid-19 drug preemptive machine, international level R & D and judgment power have been verified Shanghai Junshi Biosciences Co.Ltd(688180) ‘s covid-19 neutralizing antibody has been listed in the United States and has won millions of orders; The company’s covid-19 small molecule research and development is also in a clinical leading position in China. Vv116 is the oral deuterated version of redcivir. In 2021, vv116 became the first covid-19 small molecule oral drug approved for emergency use in Uzbekistan; At present, it is in the phase 3 clinical of global multicenter. The other vv993 is a small molecule drug with the same target as Pfizer paxlovid, which aims at the inhibition of 3CL protein, but does not need ritonavir, and can take effect alone; It has been approved to enter phase 1 clinical practice.
Vv116 China Phase 1 clinical data release, covid-19 small molecule is advancing rapidly. ① The drug carried out three phase I studies in 86 Chinese healthy subjects: Study 1 (single incremental dose study), study 2 (multiple incremental dose study) and Study 3 (food effect study). ② After oral administration of vv116, the peak plasma concentration of 116-n1 reached rapidly (median tmax1.00-2.50h); In the dose range of 25-800mg, AUC and Cmax increase in an approximate dose ratio, while drug absorption saturation may be achieved at the dose of 800mg. The subject’s standard diet had no effect on the Cmax and AUC of vv116; After multiple administration, vv116 reached an effective antiviral concentration at the dose level of 200 to 600 mg bid. ③ The results showed that vv116 was rapidly absorbed orally, repeated administration could maintain the effective antiviral concentration, and ordinary diet had no effect on drug exposure.
There are abundant pipelines under research, with a fixed increase of nearly 4 billion. In addition to the approved PD-1, adalimumab, covid-19 neutralizing antibody and small molecule drugs, the company is developing 45 pipelines, and the R & D expenditure in 2021 is nearly 2.1 billion yuan. The catalysts in 2022 are: ① approved: PD-1, nasopharyngeal carcinoma in the United States, non-small cell lung cancer in China; ② New indications of PD-1 submitted for listing: Sino US first-line treatment of small cell lung cancer and liver cancer, postoperative adjuvant therapy, esophageal squamous cell carcinoma in the United States; ③ Data readout: a number of new indications of PD-1, psck9 (ngoreximab), BTLA, IL-17A, PARP and PD-1 / TGF- β And so on.
Profit forecast and investment suggestions
We maintain the company’s profit forecast. The company’s sales revenue in 2021 / 22 / 23 is 4.01/31.5/4.59 billion yuan, and the net profit attributable to the parent company is -739 / – 285 / 23 million yuan. Maintain the “buy” rating.
Risk tips
The risk that the R & D process and the sales volume of medical insurance do not meet the expectations; Regulatory policies and the lifting of the ban on restricted shares.
