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Jiangsu Yahong Pharmaceutical Technology Co., Ltd.
Voluntary Disclosure of the 2024 International Conference on Photodynamic Therapy and Photodiagnosis
Announcement on the release of relevant data of the international multi-center Phase III clinical trial of APL-1702
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records, misleading statements or material omissions, and bear legal responsibility for the authenticity, accuracy and completeness of its contents.
Important content tips:
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Recently, the results of the prospective, randomized, double-blind, placebo-controlled, international multicenter Phase III clinical trial (hereinafter referred to as “this study”) of APL-1702, a product of Jiangsu Yahong Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “the Company”), for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix were selected for the 2024 International Photodynamic Therapy & Photodiagnosis Conference (PDT&PD, Photodynamic Therapy & Photodiagnosis update), and the efficacy data of this study on reducing the histopathological grading of cervical precancerous lesions was released in the form of an oral report at the conference.
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Currently, the marketing application of the above-mentioned products has been accepted by the State Drug Administration. It still needs to go through review, on-site inspection of drug clinical trials, on-site inspection of drug production and approval. There is uncertainty as to whether the above-mentioned products can be successfully launched and when they can be launched. There is also a certain degree of uncertainty as to whether the products can ultimately achieve their commercial purposes after approval. The acceptance of the marketing application of the above-mentioned products will not have a significant impact on the company’s recent performance. Investors are kindly requested to make prudent decisions and take precautions against investment risks. The company will strictly fulfill its information disclosure obligations in a timely manner on the subsequent research and development progress of the project in accordance with relevant regulations.
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Risk Warning
Pharmaceutical products are characterized by high technology, high risk, and high added value. The early stage of drug research and development and the cycle from research and development, clinical trial approval to production are long and easily affected by many factors such as technology, approval, and policy. There are many uncertainties in the progress and results of clinical trials and the future market competition of products. At present, the above-mentioned products have reached the main research endpoint of Phase III clinical trials. Whether the clinical trial results can support the submission of drug marketing applications, whether they can ultimately obtain marketing approval, and when they will be approved are uncertain. There is also a certain degree of uncertainty as to whether the products can ultimately achieve their commercial purposes after approval. The release of clinical trial data this time will not have a significant impact on the company’s recent performance. Investors are kindly requested to pay attention to potential investment risks.
