Introduction to this report:
Celizumab was released rapidly after being marketed at the end of August, and commercialization results were initially shown. The research pipeline is progressing steadily. The NDA for rabies virus bispecific antibodies is imminent, which is expected to contribute to performance growth points. Maintain an “Overweight” rating.
Key points of investment:
Maintain an “Overweight” rating. 2024Q1-3's revenue was 12.4879 million yuan, with a net loss of 0.546 billion yuan; of these, Q3 revenue was 12.4752 million yuan, mainly due to the main business revenue generated by IL-17 monoclonal antibody GR1501, which was approved for listing in August 2024, with a net loss of 0.184 billion yuan. The performance slightly exceeded expectations. Considering the rapid release of core products, the 2024-2026 forecast EPS was raised to -1.83/-1.51/-0.90 yuan (originally -2.50/-1.86/-1.57 yuan), the target price was maintained at 40.07 yuan, and the “increase” rating was maintained.
Core products were rapidly released, and commercialization results were gradually reflected. 2024.8.27 The first product, Celikizumab for psoriatic indications, was approved for commercialization. As the first and only product in the pipeline, it is estimated that Q3 revenue will mainly be contributed by Celikizumab. Revenue contributed 12.4752 million yuan in revenue around January alone. At a price of 798 yuan/branch, the estimated sales volume is about 0.0156 million yuan. The first domestically marketed same-target drug, scuchiumab, was launched domestically in 2019, with sales of about 0.5 billion yuan in 2020. Based on the 2020 price of 2,998 yuan/branch, it is estimated that the sales volume for the full year of 2020 is about 0.1668 million units, and the average monthly sales volume is expected to be about 0.0139 million units. Comparatively speaking, the initial launch pace of Celiac monoclonal antibody was excellent. As of 2024/10/31, a total of 5 domestic IL-17 monoclonal antibodies have been approved for psoriasis. They have achieved good sales revenue in an environment where market competition is gradually fierce, and their commercialization capabilities have been initially verified. In addition, the Celizumab AS indication was submitted for NDA in 2024.1 and is expected to be approved for marketing in 2025, which is expected to further contribute to increased performance in the future.
The research pipeline is progressing steadily, and there is sufficient backup capacity. 2024Q1-3 R&D costs 0.44 billion yuan (+0.63%), and various models continue to advance steadily in the research pipeline: ① GR1801 (rabies dual antibody):
2023.9 enters phase III, and is expected to complete phase III in 24Q4 or 25H1; ② GR1802 (IL-4R monoclonal antibody): ADs for adolescents and children were approved in August, CRSWnP initiated phase III clinical trials; ③ GR2001 (tetanus monoclonal): 2024.6 was included in breakthrough therapy, phase III clinical trial started in August; ④ GR1803 (CD3xbCMA double antibody):
Phase II clinical trials started in July 2024 and were included as breakthrough therapy by CDE in August. The backup pipeline is sufficient, and it is expected that it will continue to contribute new impetus to growth in the future.
Catalysts: Sales volume of core products exceeds expectations, clinical progress progresses rapidly Risk warning: Market competition intensifies, commercialization falls short of expectations, risk of failure in new drug development