Zhongtai: Maintain a "buy" rating on ABBISKO-B (02256) and promote the listing of ABSK021 in the United States and China.

Zhongtai recently released a research report stating that it maintains a "buy" rating on ABBISKO-B (02256). The company's core product, ABSK021, has recently received approval from the NMPA for listing, becoming the first domestically developed drug in China for the treatment of tenosynovial giant cell tumors. Its NDA has also been accepted by the FDA. The approval of this product marks the company's entry into the commercialization stage and validates its full-cycle innovation capabilities from research and development to market. Long-term follow-up data shows that the efficacy of ABSK021 continues to improve over time, and with the commercial cooperation with Merck, it is expected to provide stable cash flow for the company. Key points from Zhongtai include: Recent events Recently, according to the latest announcement from the NMPA, the NDA for the company's core product ABSK021 has been approved for the treatment of symptomatic adult tenosynovial giant cell tumors (TGCT) that may result in limited functionality or severe complications after surgical removal. This drug is the first domestically developed drug marketed under the company Hengyu Pharmaceutical, and the first domestically developed systemic treatment drug for tenosynovial giant cell tumors (TGCT) in China. Subsequently, the NDA for ABSK021 for systemic treatment of TGCT patients has also been officially accepted by the FDA. Commercialization of small molecule novelties marks a point of platform value validation This event signifies that Hengyu Pharmaceutical has officially transitioned from the clinical research and development stage to the commercialization stage. The company has differentiated multiple value pipelines entering the realization stage, and the successful listing of ABSK021 has fully validated the company's complete cycle innovation capabilities from target selection, molecular design, clinical development to approval. This greatly enhances the feasibility of successful pipeline development in the future. Long-term follow-up data as strong evidence-based medicine to create ABSK021 as a strong cash flow engine Although TGCT is a rare disease, previous clinical data from ABSK021 has shown that patients undergoing continuous treatment with this drug have seen increased relief rates over time (Phase III clinical study: ABSK021 50 mg QD vs placebo ORR = 54.0% vs 3.2% at week 25; at a median follow-up of 14.3 months, patients in the ABSK021 treatment group showed an ORR of 76.2% based on RECIST v1.1 criteria; Phase I clinical study: 6-month ORR = 68.0%, with follow-up of over a year, the ORR for 50 mg QD and 25 mg QD were 87.5% and 66.7% respectively). This is expected to support longer treatment periods in the real world for this type of disease. Furthermore, as TGCT has previously lacked suitable innovative therapies, ABSK021, as a safe and effective treatment, combined with Merck's strong academic marketing capabilities in oncology, is expected to quickly contribute significant sales revenue to the company. Risk warnings Risks include delays in the authorization progress of investigational new drugs, delays in clinical development progress, and risks of information lag or inadequate updating in publicly available data used in research reports.