The incidence of TGCT has increased in recent years, and a large number of patients are in urgent need of effective therapeutic drugs. according to epidemiological data, the incidence of TGCT has increased from 28 / million to 49 / million from 1998 to 2012. The number of new cases in China and the United States is about 60,000 and 14000 every year, and there are a large number of patients in urgent need of drug treatment. At present, surgical treatment is mainly used for TGCT, but there are still some patients who can not be resected, and there may be a risk of recurrence after surgical resection. The targeted therapy strategy of CSF-1R may be a promising strategy for the treatment of TGCT. As of June 2023, the only CSF-1R targeted drug approved for the treatment of TGCT in the world is Pecidatinib, which has been given a black box warning by FDA due to safety problems.
The preliminary validity data of ABSK021 Ib phase is much better than that of similar competitions. compared with the same target pacidostinib and Vimseltinib,ABSK021, the accelerated clinical development shows significant advantages in therapeutic efficacy and safety. In terms of therapeutic efficacy, the preliminary ORR of the ABSK021 Ib clinical trial was 77.4%, which was higher than 39% of pesidatinib and 38% of Vimseltinib. In terms of safety, ABSK021 has no obvious hepatotoxicity and shows good safety.
FGFR pipeline is rich in accumulation and is expected to continue to introduce high-quality varieties.
The company has strong self-research ability and sufficient reserve of clinical / preclinical projects. The company's FGFR pipeline is a global leader, with 5 types of wild-type and mutant patients with various subtypes of FGFR in the field of drug therapy. Among them, ABSK011 achieved good curative effect in patients with 2L liver cancer. Preliminary clinical data of phase Ⅰ showed that for patients with high expression of FGF19 (FGFR4 ligand), ORR reached 22.2%.
ABSK091 obtained 44% ORR data in patients with 2L urothelial cancer with FGFR3 mutation, and the effect was significant.
Profit Forecast and Investment rating
We expect the company's operating income from 2023 to 2025 to be 0 billion, 0 billion and 183 million yuan, with a net profit of-463 million,-806 million and-656 million yuan. Corresponding to a reasonable market capitalization of HK $4.563 billion, the target price is HK $6.50, which is covered for the first time and given a "buy" rating.
Risk hints: innovative variety research and development failure risk; profit below-expected risk; policy and regulatory risk; subjective risk measurement