Focus on source innovation, leading technology platform to build differentiation pipeline: Dizhe Pharmaceutical, formerly known as AstraZeneca PLC Asian R & D Center, operated independently in October 2017, and the core team shifted. The company has excellent transformation science research capabilities and has successfully built a number of transformation science-related technology platforms, including tumor central nervous system metastasis research platform, tumor immunity and radiotherapy combined therapy research platform and so on. Backed by the leading platform, the company has a total of 5 drug candidates in the clinical stage, of which Shuvotini and Golixitinib are in the clinical stage of global registration, and suvotinib is in the stage of listing.
The clinical value of suvotinib is prominent, and domestic approval is imminent: suvotinib is an EGFR-TKI independently developed by Dizhe Pharmaceuticals, and its molecular design is aimed at the treatment of EGFR Exon20ins non-small cell lung cancer. so far, it is the first and only domestic innovative drug in the field of lung cancer that has been recognized as a breakthrough therapy by both China and the United States. Suvotinib is effective in the treatment of EGFR Exon20ins non-small cell lung cancer with an overall response rate of 61%. In patients with baseline brain metastasis, the response rate is 48.5% (15max 31). Domestic production has been reported in January 2023, and it is expected that Q3 will be approved as soon as 2023. The global multicenter clinic is progressing steadily. It is expected that Q4 will be completed in 2023 and H2 will be approved as early as 2024.
Golixitinib differentiation competition, layout hematoma field: Golixitinib is a new specific JAK1 tyrosinase inhibitor, which was granted its global invention patent by AstraZeneca PLC in 2017. it is the first and only JAK1 specific inhibitor in the global registered clinical stage in the field of T-cell lymphoma. Golixitinib can strongly and selectively inhibit JAK1 tyrosine kinase, which is more than 200 times higher than that of JAK2 and 400 times more than that of JAK3 and TYK2. The total set of ORR and DCR used for the treatment of r peripheral T-cell lymphoma reached 43.8% and 25.0% respectively, which was higher than the current domestic standard therapy. Domestic Q3 is expected to complete the domestic new drug listing declaration as soon as 2023.
Investment advice: the company's core assets Shuvotini and Golixitinib are expected to be approved within the past two years, and the core sales team has been basically set up. We expect the company to achieve operating income of 1.1x410 million yuan respectively in 2023-2025, covering it for the first time and giving it an "overweight" rating.
Risk hints: there is uncertainty in the progress and results of clinical trials; uncertainty in drug approval; uncertainty in drug commercialization; risk of policy uncertainty.