Taytacip: Using lupus erythematosus as a starting point to create a major FIC free product. Titacip is the first domestically produced biologic agent approved to treat systemic lupus erythematosus (SLE). Judging from a non-head-to-head comparison of registered clinical trials, it has BIC potential among SLE innovative biopharmaceuticals approved globally. In addition, titacip has currently deployed 6 phase III clinical studies. Indications include systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and optic neuromyelitis spectrum disease (NMOSD), dry syndrome (SS), nephropathy (IgAN), myasthenia gravis (MG) For SLE, NMOSD, SS, iGaN, and MG are deployed in overseas markets. The domestic RA phase III clinical phase has reached the clinical end and has received a CDE supplementary marketing application. Advancing clinical research on multiple indications and the accumulation of domestic real-world data will facilitate the future potential overseas licensing of Titacip, and large FIC products will inevitably emerge.
Verdicitumab: Early data have been read out in patient segmentation for dominant indications. The company promoted the marketing of viducitumab as the first domestically produced ADC through terminal gastric cancer, and opened up the second growth curve of the product through a differentiated layout for urothelial cancer. The company has set a new transaction amount record for overseas cooperation with domestic pharmaceutical companies regarding overseas licensing of verdicitumab to Seagen. Currently, the company is advancing the frontline and expansion of verdicitumab combined immunotherapy for gastric cancer and urothelial cancer, and has read ideal early data. The HER2 status test is relatively mature and has broad clinical consensus. Vitacitulizumab is relatively mature and has broad clinical consensus. Monoclonal antibody market prospects It can be expected.
Actively expanding the field of new diseases, ophthalmic dual antibodies and mesothelin ADC are worth looking forward to. RC28-E is a global FIC variety, targeting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). RC28-E can simultaneously block VEGF and FGF2 activity. Compared with single-target inhibitors, it is more effective in inhibiting fundus angiogenesis associated with various eye diseases, and is expected to provide solutions including reducing dosage and frequency of medication. RC28-E is currently in two phase III clinical trials for AMD and DME. The design is similar to Roche's latest explosive Vabysmo phase III clinical design. If RC28-E can be approved for marketing, it has advanced and complete evidence-based medical evidence; RC88 currently has advanced and complete evidence-based medical evidence; RC88's main indication is end-line ovarian cancer. The innovation is that it uses differentiated target mesocortin and bridging coupling technology. The related patent “covalent ligators of antibody-drug conjugates and their preparation methods and applications” shows that covalent thiol coupling can improve the stability and limitations of ADCs and ADC It is degraded in blood circulation, so it can reduce its toxicity, and is expected to play a role in expanding the treatment window.
Profit forecasting and investment advice. We expect revenue of $16.1/21.7/2.89 billion for 2024-2026, respectively. Using the segmented valuation method, Rongchang Biotech (9995.HK) has a total valuation of RMB 24.1 billion, taking RMB 1 = HK$1.1 billion, with a total valuation of HK$26.5 billion. It was covered for the first time and gave it a “buy” rating.
Risk warning: Overseas licensing progress falls short of expected risk; clinical development progress falls short of expected risk; there is a risk that public data used in research reports may be delayed or not updated in a timely manner