Introduction to this report:
2024EHA revealed phase I data for Zhixiang Jintai BCMaxCD3 dual antibody GR1803. Compared with existing dual antibody treatments, ORR has significant advantages. Currently, MM has not met huge demand, and the GR1803 market potential can be expected.
Key points of investment:
Maintain an “Overweight” rating. The company disclosed GR1803 (BcMaxCD3 dual antibody) phase I data on 2024EHA, with excellent efficacy. Maintain the 2024-26 forecast EPS-1.98/-1.42/-0.95 yuan. According to the DCF valuation method, considering that the pipeline is expected to increase its performance, the target price was raised to 54.07 yuan to maintain the “gain” rating.
MM did not meet high demand. The BCMA dual antibody is safe and inexpensive, but the curative effect is not as good as CAR-T.
According to WHO, there were 187,900 new MM patients worldwide in 2022 (incidence rate 2.4/100,000), and traditional treatments failed to address important issues such as recurrence and survival. MM has large market space, and Johnson & Johnson's CD38 monoclonal antibody sales in 2023 reached 9.7 billion US dollars. In recent years, BCMA has become a popular target for MM, and treatments are mainly CAR-T and dual antibodies. Taking Carvykti (CAR-T) and Tecvayli (dual antibody) as an example, ORR = 98% vs 63%, and the treatment cost is about 465,000 vs 375,000 US dollars, respectively. In addition, Carvykti was given a black box warning by the FDA. Therefore, although dual antibodies are less effective than CAR-T, they are less expensive and safer.
The efficacy data of GR1803 is excellent, and its advantages are obvious compared with the dual antibodies already on the market. The overall phase I clinical safety of GR1803 was manageable, and the incidence of ≥G3 TEAE was 96% (48/50; 94.5% vs. 70.7% for Tecvayli and Elrexfio, respectively). ORR = 85% (63% vs. 61% for Tecvayli and Elrexfio, respectively) in 40 patients whose efficacy could be assessed. The median follow-up time was 28 w, ORR = 96% (22/23), VGPR = 43%, and CR = 13% in 23 patients who could evaluate efficacy in the 180 ug/kg group. The median follow-up time of 13 EMM patients was 20w,180ug/kg group ORR= 100% (13/13), VGPR = 54%, and PR= 46%.
GR1803 has the advantages of good efficacy and controlled safety, and is expected to become a new treatment with more potential.
Carvykti (2021.3 approved) and Tecvayli (2022.10 approved) had 24Q1 sales of US$160.130 million, respectively, with rapid double antibody release. It is expected that GR1803 will increase its performance after launch.
GR1501 is expected to be approved by the end of the year, and other pipelines under development are progressing steadily. GR1501 is the fastest-progressing IL-17A produced in China. Psoriatic indications are expected to be approved for marketing in 2024H1; AS is expected to be approved for marketing in 2025. Furthermore, multiple pipelines such as IL-4R and rabies antibodies are progressing steadily.
Risk warning: risk of failure in new drug development, risk of development progress falling short of expectations