powerballrecord|智翔金泰(688443)：IL-17A单抗获批在即 在研管线快速推进

Event: the company releases its 2023 annual reportPowerballrecordRealized operating income of 121 in 2023Powerballrecord.15 million yuan, attributable to the net profit of shareholders of listed companies-8.Powerballrecord0 billion yuan (+ 39.03%), deducting non-return net profit-813 million yuan (+ 25.96%). GR1501 is the first domestic IL-17A monoclonal antibody to be submitted to NDA, which will be commercialized soon. In March 2023, Serizumab injection NDA was accepted. In February 2024, the results of the clinical study of Serizumab injection in the III phase of moderate and severe plaque psoriasis were officially published in the international authoritative journal BJD of dermatology. The data showed that in the 52nd week, the response rate of PASI75 was 96.5%, the response rate of PASI90 was 84.1%, and the response rate of PASI90 was 83.7%.PowerballrecordIt has excellent and long-lasting curative effect. The rate of recurrence is low, with a recurrence rate of 0.4% at the 52nd week of treatment, indicating that GR1501 may have a better long-term effect. Moderate and severe atopic dermatitis with IL-4 monoclonal antibody is in III stage. GR1802 injection is IL-4R α monoclonal antibody, and 5 indications are in clinical stage. Moderate and severe atopic dermatitis is in III clinical stage. Chronic sinusitis with nasal polyps, chronic spontaneous urticaria, asthma and allergic rhinitis are in II clinical stage. GR1801 is the first double antibody against rabies virus G protein in phase III clinic in China. GR1801 is the first double antibody for passive immunization against rabies in the world, targeting G protein sites I and III at the same time, meeting WHO's recommendation on the development of antibodies against rabies virus-using multiple McAbs against different antigen sites to form a "cocktail" combination to ensure effectiveness against different virus strains or different genotypes of viruses. The investment in R & D continues to increase, and the pipeline research and development is advancing rapidly. The company's R & D investment in 2023 was 620 million yuan, an increase of 36.5% over the same period last year. The company is working on 15 products, of which 9 products (17 indications) have been approved to enter the clinic, 2 indications NDA has been accepted, 2 indications are in phase III clinical, and other indications are in phase I and II respectively. BCMA × CD3 double antibody GR1803 is in phase I clinical; GR1603 is the first domestic enterprise to enter phase II clinical trial of anti-IFNAR1 monoclonal antibody; GR1901 is the first domestic phase I clinical start of anti-CD3 × CD123 double antibody; GR2001 is the second domestic II clinical targeted tetanus toxin monoclonal antibody; GR2002 is the first approved clinical TSLP double epitope double antibody. Profit forecast and investment advice. It is estimated that the operating income of the company from 2024 to 2026 is about 1.2,34,700 million yuan respectively. Considering the strong R & D strength of the company and the vast market for autoimmune diseases, GR1801, the first innovative drug, is about to be approved to maintain its "buy" rating. Risk hints: research and development failure risk, commercialization less than expected risk, industry policy risk. [disclaimer] this article only represents the views of a third party and does not represent the position of Hexun. Investors operate accordingly, at their own risk.

[disclaimer] this article only represents the views of a third party and does not represent the position of Hexun. Investors operate accordingly, at their own risk.