维持“增持”评级。24H1尚无产品上市销售，未产生主营业务收入，归母净利润-3.62 亿元，扣非净利润-3.64 亿元，较23 年同期净亏损略减少，主要系财务费用同比下降，确认股份支付费用同比减少。Introduction to this report:
The IL-17 monoclonal antibody was recently approved for marketing, and commercialization has officially begun. It is expected to enable early commercialization, rich research pipelines, continuous and efficient clinical progress, and is expected to enable long-term performance growth.
Key points of investment:
Maintain an “Overweight” rating. 24H1 has no products listed and sold, and has not generated main business revenue. Net profit due to mother is 0.362 billion yuan, net profit after deducting non-net profit of 0.364 billion yuan, which is a slight decrease from the net loss for the same period in '23. It is mainly due to a year-on-year decline in financial expenses, which confirms the year-on-year decrease in share payment fees.
Considering that the launch of the core product GR1501 fell short of expectations, the 2024-2026 EPS was lowered to -2.50/-1.86/-1.57 yuan (previously -1.98/-1.42/-0.95 yuan), and the target price was lowered to 40.07 yuan according to the DCF valuation method, maintaining the “gain” rating.
GR1501 was approved for listing, and commercialization began. The core product IL-17 monoclonal antibody GR1501 was approved for marketing in 2024.8 for moderate to severe plaque psoriasis in adults, and commercialization officially began. GR1501 phase III clinical FAS analysis of 420 patients showed that the 12W-Pasi 75 compliance rate in the GR1501 group and placebo group was 90.7% vs. 8.6%, PGA0/1 was 74.4% vs. 3.6%, respectively, and the 52-week GR1501 group had a recurrence rate of only 0.4%, with excellent long-term efficacy and good safety. At present, the commercialization team has begun to take shape and actively promote admission, academic promotion and market expansion. In the future, it will continue to promote through academic conferences, exhibitions, and academic activities to rapidly promote product sales. Furthermore, the indications for axial spondyloarthritis were submitted for NDA in 2024.1 and are expected to be approved for marketing in 2025.
The research pipeline is rich, and clinical progress is progressing steadily and efficiently. 24H1 invested 0.286 billion yuan in R&D, with 439 R&D personnel (+66 over the same period in 23 years), accounting for 65.13% of R&D personnel. The product matrix is rich, with 15 products under development, covering the three major fields of immunity, oncology, and anti-infection. The pipeline is progressing steadily, and clinical efficiency continues to improve. (1) Self-exempt pipeline: ① GR1802 (IL-4R monoclonal antibody): crSWnP initiated phase III in 2024.8; allergic rhinitis was approved IND in 2024.2; adolescent/child AD was approved IND in 2024.8, and various indications progressed rapidly. ② GR1603：
It is the first IFANR1 monoclonal antibody to enter the clinical stage in China. 2024.4 has completed clinical enrollment in phase II SLE. (2) Anti-infective pipeline: ① GR1801 (rabies double antibody) 2023.9 enters phase III, and 24H2 is expected to complete phase III and submit an NDA; ② GR2001 (tetanus monoclonal antibody) will initiate phase III clinical trials in 2024.8. Its clinical cycle is short, and it is expected that an NDA will be submitted in 2025.
(3) Tumor pipeline: ① GR1803 (bCmaxCD3 double antibody): 2024.5 Phase I data was disclosed in the EHA, with excellent efficacy and controllable safety. 2024.7 Phase II clinical trials have been initiated.
Catalysts: Clinical progress exceeds expectations, rapid release of core products
Risk warning: commercialization falls short of expectations, clinical progress falls short of expectations, industry policy risks
