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智翔金泰(688443):IL-17A单抗获批在即 在研管线快速推进

Zhixiang Jintai (688443): IL-17A monoclonal antibody is being approved and is progressing rapidly in the development pipeline

西南證券 ·  Apr 30

Incident: The company released its 2023 annual report. In 2023, it achieved operating income of 1,211,500 yuan, net profit attributable to shareholders of listed companies - 80 billion yuan (+39.03%), and net profit not attributable to mother - 813 million yuan (+25.96%).

GR1501 is the first domestically produced IL-17A monoclonal antibody to submit an NDA, and commercialization is imminent. In March 2023, the NDA for celizumab injection was accepted. In February 2024, the results of a phase III clinical study on moderate to severe plaque psoriasis were officially published in the authoritative international dermatology journal BJD. The data showed that the 52nd week PASI75 response rate was 96.5%, the PASI90 response rate was 84.1%, and the PGA0/1 response rate was 83.7%, showing excellent and long-lasting efficacy. The rate of recurrence was low, with a recurrence rate of 0.4% in the 52nd week of use, which indicates that GR1501 may have better long-term efficacy.

IL-4 monoclonal antibodies for moderate to severe atopic dermatitis are in phase III clinical trials. The GR1802 injection is an IL-4Rα monoclonal antibody. There are 5 indications in the clinical stage. Moderate to severe atopic dermatitis is in phase III clinical stage, and chronic sinusitis with nasal polyps, chronic spontaneous urticaria, asthma, and allergic rhinitis are in clinical stage II.

GR1801 is the first anti-rabies virus G protein dual antibody to enter phase III clinical trials in China. GR1801 is the world's first dual antibody for passive immunity against rabies. It also targets G protein sites I and III to meet WHO recommendations for anti-rabies virus antibody development — using multiple monoclonal antibodies for different antigen sites to form a “cocktail” combination to ensure effectiveness against different virus strains or different genotypes of the virus.

R&D investment continues to increase, and the research pipeline is progressing rapidly. In 2023, the company invested 620 million yuan in R&D, an increase of 36.5% over the previous year. The company is developing 15 products, of which 9 products (17 indications) have been approved for clinical use, NDA for 2 indications have been accepted, 2 indications are in phase III clinical trials, and other indications are in phase I and II clinical trials respectively. BCMA×CD3 dual antibody GR1803 is in phase I clinical; GR1603 is the first anti-IFNAR1 monoclonal antibody by a domestic company to enter phase II clinical trials; GR1901 is the first anti-CD3×CD123 dual antibody in China to launch phase I clinical trials; GR2001 is the second domestic targeted tetanus toxin monoclonal antibody to complete II clinical trials; GR2002 is the world's first approved clinical TSLP double epitope double antibody.

Profit forecasting and investment advice. The company is expected to achieve operating revenue of about 120 million yuan, 340 million yuan and 700 million yuan respectively in 2024-2026. Considering the company's strong R&D strength and broad market for autoimmune diseases, GR1801, the first innovative drug, is about to be approved, maintaining a “buy” rating.

Risk warning: risk of R&D failure, risk of commercialization falling short of expectations, industry policy risk.

The translation is provided by third-party software.


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