Zhongtai Securities has issued a research report maintaining a "Buy" rating on ABBISKO-B (02256). The company's core pharmaceutical product, ABSK021, recently received approval for marketing from the NMPA, becoming China's first self-developed treatment for Tenosynovial Giant Cell Tumor (TGCT), while its New Drug Application (NDA) has also been accepted by the FDA. The successful approval of this product signifies the company's official entry into the commercialization phase, validating its full-cycle innovation capabilities from research and development to market launch. Long-term follow-up data indicate that the response rate for ABSK021 continues to improve over time. Combined with the commercial collaboration with Merck, this is expected to provide the company with a stable cash flow. The main views of Zhongtai Securities are as follows.
Recent events indicate that, according to the latest announcement on the NMPA website, the NDA for the company's core product ABSK021 has been approved for the treatment of symptomatic adult TGCT patients where surgical resection may lead to functional limitations or severe complications. This drug is the first self-developed innovative drug product from ABBISKO to receive marketing approval and is also China's first self-developed systemic treatment for TGCT. Subsequently, the NDA for ABSK021 for the systemic treatment of TGCT patients was formally accepted by the FDA.
This event marks ABBISKO's formal transition from the clinical R&D stage to the commercialization stage. The company's differentiated multi-pipeline value is now entering a realization phase. The successful launch of ABSK021 represents the first complete validation of the company's innovative capabilities across the entire cycle, from target selection and molecular design to clinical development and regulatory approval, significantly enhancing the bankability of success for subsequent pipelines.
Although TGCT is a small population disease, successive readouts of ABSK021 clinical data demonstrate that under continuous treatment with this agent, patient response rates gradually strengthen as the follow-up period extends. This is expected to support a longer treatment duration for the drug in real-world settings. Furthermore, TGCT has previously lacked suitable innovative therapies. As a therapy with Best-in-Class potential in both safety and efficacy, coupled with Merck's strong oncology academic marketing capabilities, ABSK021 is anticipated to rapidly contribute substantial sales revenue for the company.
Risk warnings include potential delays in the progress of in-development new drug licensing; risks associated with clinical development timelines not meeting expectations; and the risk that publicly available information used in the research report may be outdated or not promptly updated.