维持“增持”评级。 公司发布2023 年业绩快报，实现收入121.15 万元(主要为技术服务收入)；归母净利润-8.01 亿元，亏损增加39.03%，主要由于多款产品进入临床及核心产品进入关键临床加大研发费用。考虑到上述因素，下调2023-25 年EPS 至-2.19/-1.98/-1.42 元(原-2.04/-1.35/-1.15 元)，根据DCF 估值法，维持目标价43.66 元，维持“增持”评级。Introduction to this report:
The company released the 2023 performance report. The performance is in line with expectations. The GR1501 psoriasis data is excellent. It is expected that 2024H1 will be approved. AS has submitted an NDA in January 2024. Multiple pipelines have entered a critical period, and future growth momentum is strong.
Key points of investment:
Maintain an “Overweight” rating. The company released the 2023 performance report, achieving revenue of 1,211,500 yuan (mainly revenue from technical services); net profit to mother - 801 million yuan, and losses increased by 39.03%, mainly due to the entry of various products into clinical trials and core products entering key clinical trials to increase R&D expenses. Taking into account the above factors, the 2023-25 EPS was lowered to -2.19/-1.98/ -1.42 yuan (previously -2.04/-1.35/ -1.15 yuan), and the target price was maintained at 43.66 yuan according to the DCF valuation method, maintaining the “overholding” rating.
GR1501 psoriasis is expected to be approved 2024H1, and ankylosing spondylitis will submit an NDA in January 2024. GR1501 published psoriatic phase III results in 2024.2 in the authoritative journal BJD in dermatology. In the FAS analysis, the GR1501 group and 12W-Pasi 75 in the placebo group were 90.7% and 8.6% respectively, and the PGA 0/1 was 74.4% and 3.6%, respectively. The data performance was excellent, reaching the main clinical end point of phase III; 52 weeks of follow-up revealed that 52W-Pasi 75 was 96.5%, the recurrence rate was only 0.4%, and the long-term efficacy was excellent. GR1501 is the fastest-progressing IL-17A produced in China. The indications for psoriasis were submitted for the NDA in 2023.3. We expect 2024H1 to be approved for marketing, and is expected to be the first domestically produced IL-17A, with a clear first-mover advantage; ankylosing spondylitis submitted an NDA in January 2024 and accepted by the CDE, and we expect it to be approved for marketing in 2025.
Other pipelines are progressing steadily, and multiple pipelines have entered critical clinical stages. ① GR1802 (IL-4Rα mAb):
Moderate to severe AD in adults entered stage III on 2023.12, and both spontaneous urticaria and crSWnP were enrolled in phase II. Furthermore, the new indication allergic rhinitis was approved by IND in 2024.2, and the indications continued to expand. ② GR1801 (rabies dual antibody): 2023.9 completed phase III trial enrollment, and it is expected that 2024H2 can submit an NDA; ③ GR2001 (tetanus monoclonal antibody): the first phase II patient was enrolled in 2023.10. Currently, phase II clinical enrollment has been completed, and the overall progress is fast; ④ GR2002 (TSLP dual antibody):
Phase I enrollment was completed in 2023.9; ⑤ GR2102 (RSV monoclonal antibody): IND approved in 2024.2.
Catalysts: GR1501 approved for marketing, GR1802 data readout, other pipeline entry key clinical risk tips: risk of R&D failure, risk of falling short of expectations in commercialization