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智翔金泰-U(688443):加大研发投入 赛立奇单抗获批在即

Zhixiang Jintai-U (688443): Increased investment in R&D, celiac monoclonal antibody is about to be approved

國信證券 ·  Nov 13, 2023 07:42

Increase investment in research and development, and advance the research pipeline in an orderly manner. In the first three quarters of 2023, the company achieved net profit of 568 million yuan. Various expenses such as R&D investment, operation management, and sales team building increased compared to the same period last year. Among them, the total R&D expenditure for the first three quarters reached 435 million yuan (+34.1% year-on-year), and a number of ongoing research projects have progressed.

An innovation-driven biopharmaceutical company with a broad layout in various fields. Founded in 2015 and headquartered in Chongqing International Biotechnology City, Zhixiang Jintai is an innovative biopharmaceutical enterprise driven by antibody drug discovery technology. The company focuses on treatment fields such as autoimmune diseases, infectious diseases, and tumors, etc., and currently has complete antibody drug development and production capabilities from molecular discovery, process development and quality research, clinical research to commercial production.

The core variety GR1501/celiac monoclonal antibody is about to be approved, leading the domestic progress. GR1501 is the first domestically produced anti-IL-17A monoclonal antibody reported to be produced in China. Ph3 clinical data for moderate/severe plaque-like psoriasis indications is excellent. The proportion of subjects who reached PASI75 in week 24 was 98.6%, and the proportion of subjects who reached PGA (0~1) was 84.4%. Currently, there are 3 IL-17 targets and 2 IL-23-related target psoriasis antibody drugs on the market in China. Both are imported products. Only GR1501 from China and SHR-1314 from Hengrui Pharmaceutical have been reported for pre-production. meter Approved for listing in early 2024. The indications for central axial spondyloarthritis have been enrolled in the Ph3 clinical trial. It is expected that 2025Q3 will be commercialized domestically. Ph2 clinical data show that the ASAS20 response rate under FAS reached 72.5%-77.5% at 16 weeks, reaching the main clinical end point. Currently, only the domestic varieties of Zhixiang Jintai's GR1501 and Hengrui Pharmaceutical's SHR-1314 are in the Ph3 clinical stage.

GR1801 is the first anti-rabies virus G protein double antibody product to enter the clinical stage in China.

GR1801 targets rabies virus G protein I and III epitopes and uses a dual antibody design using the scFv+Fab structure. Ph2 clinical data show good broad-spectrum neutralizing activity, safety, and efficacy. Domestic commercialization is expected in 2025Q4, which is expected to be a good complement to existing passive immunization preparations.

Investment suggestions: The company's core type of GR1501/celiac monoclonal antibody is the first domestically produced IL-17A monoclonal antibody reported for production, moderate/severe plaques, psoriasis indications, and central axial spondyloarthritis indications, which are expected to be approved for listing in early 2024 and 2025Q3, leading domestic progress; GR1801 is the first anti-rabies virus G protein double antibody product to enter the clinical stage in China, and is expected to achieve domestic commercialization in 2025Q4, contributing to increased performance. It is estimated that in 2023-2025, the company's net profit will be -6.83/-6.20/- 536 billion yuan respectively. Using the absolute valuation method, it is estimated that the company's price range is 36.13 to 38.72 yuan, which is 4% to 12% higher than the current stock price. It was covered for the first time, and a “increase in holdings” rating was given.

Risk warning: valuation risk, profit prediction risk, risk of product development failure under development, risk of product commercialization not meeting expectations, etc.

The translation is provided by third-party software.


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