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智翔金泰(688443):自免、感染及肿瘤领域广泛布局 国产IL-17A进度领先

Zhixiang Jintai (688443): Leading the progress of domestic IL-17A with extensive layout in the fields of immunity, infection and oncology

國信證券 ·  Feb 20

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

The core product GR1501/Celiac monoclonal antibody is about to be approved, leading domestic progress. GR1501 is the first domestically produced anti-IL-17A monoclonal antibody to be declared for marketing in China. The Ph3 clinical data for moderate to severe plaque psoriasis are excellent. The proportion of subjects who reached PASI75 and PASI90 in the 52nd week was 96.5%/84.1%, respectively, and the proportion of subjects who reached PGA (0~1) was 84.4%. The curative effect was remarkable and long-lasting. Currently, there are 3 IL-17 related targets and 2 IL-23 related target psoriatic antibody drugs on the market. They are all imported products. Domestic products are only GR1501 from Zhixiang Jintai and SHR-1314 from Hengrui Pharmaceutical. The company's products are expected to be approved for marketing in 2024H1. Indications for axial spondyloarthritis have been submitted for an NDA application and are expected to be commercialized domestically in 2025. Ph2 clinical data shows that the response rate of ASAS20 under FAS collection reached 72.5%-77.5%, reaching the main clinical end point. Currently, only domestic products such as GR1501 from Zhixiang Jintai and SHR-1314 from Hengrui Pharmaceutical have been declared for marketing.

GR1801 is the world's first anti-rabies virus G protein dual antibody product to enter clinical stage. GR1801 targets rabies virus G protein I and III epitopes and uses a scFv+Fab double antibody design. Ph2 clinical data shows good broad-spectrum neutralizing activity, safety, and efficacy. Currently, Ph3 clinical enrollment has been completed. Domestic commercialization is expected in 2025Q4, which is expected to further improve the existing passive immunization strategy for rabies.

Investment suggestions: The company's core product GR1501/Celizumab is the first domestically produced IL-17A monoclonal antibody to be declared for marketing. It is expected to be approved for marketing in 2024H1 and 2025Q3, respectively, leading domestic progress; GR1801 is the world's first anti-rabies virus G protein double antibody product to enter the clinical stage. It is expected that 2025Q4 will achieve domestic commercialization and contribute to increased performance. According to the company's performance forecast, we adjusted the profit forecast. The company's net profit for 2023-2025 is estimated to be -7.82/-7.09/-600 million yuan (-6.83/-6.20/-536 million yuan), respectively. Using an absolute valuation method, the company's price range is 35.37 to 37.99 yuan, with room for 7% to 14% increase from the current stock price. Maintain an “Overweight” rating.

Risk warning: risk of valuation, risk of profit forecasting, risk of failure in product development under development, risk of product commercialization falling short of expectations, etc.

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