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亚虹医药-U(688176):持续推进管线进展

Yahong Pharmaceutical-U (688176): Continuing pipeline progress

財通證券 ·  Sep 4

Incident: Recently, the company released its 2024 semi-annual report. 2024H1 achieved operating income of 80.493 million yuan and net profit attributable to shareholders of listed companies - 0.184 billion yuan.

APL-1702 submitted an NDA and actively sought opportunities to go overseas. The marketing application for APL-1702 was accepted by the China Drug Administration in May 2024, and the company is actively promoting its marketing review and approval process. At the same time, based on the excellent results of the APL-1702 international multi-center phase III study and potentially huge unmet clinical needs, the company has initiated the development of HPV virus clearance indications and will actively promote the following tasks: the company plans to submit a pre-listing communication application to EMA in the fourth quarter of 2024; at the same time, the company is also actively seeking opportunities for APL-1702 to cooperate in developing overseas markets.

APL-1401 is actively promoting the recruitment of test subjects. The phase Ib clinical trial of APL-1401 for the treatment of moderately active UC was approved by the FDA in November 2022 and approved by the NMPA clinical trial in August 2023. The clinical trial is currently actively promoting the recruitment of subjects. The company expects to complete phase Ib observation in 2025 and is actively seeking partners to jointly carry out global clinical development of APL-1401.

Investment advice: The company is a global innovative pharmaceutical company focusing on urogenital tumors and other major diseases. We expect the company to achieve revenue of 0.2/0.36/0.61 billion yuan in 2024-2026, maintaining an “gain” rating.

Risk warning: risk of changes in industry policies, risk of new drug development, risk of uncertain marketing of products under development, risk of poor progress in internationalization, risk of market competition, etc.

The translation is provided by third-party software.


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