Announcement on Voluntary Disclosure of Obtaining Drug Clinical Trial Approval Notice for Oral PROTAC Drug HP518 Tablets Combined with Anti-tumor Drugs for the Treatment of Advanced Prostate Cancer
Securities code: 688302 Securities abbreviation: Haichuang Pharmaceutical Announcement number: 2025-050
Haichuang Pharmaceutical Co., Ltd.
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents in accordance with the law.
Important content reminder:
Recently, Haichuang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received the "Drug Clinical Trial Approval Notice" approved and issued by the Drug Evaluation Center of the State Drug Administration of China, agreeing to conduct a Phase Ib/II clinical trial of HP518 tablets combined with anti-tumor drugs for the treatment of advanced prostate cancer. So far, HP518 tablets have been approved for clinical trials in advanced prostate cancer in three countries: China, Australia and the United States. At present, no similar products at home and abroad have been approved for marketing.
The relevant information is now announced as follows:
1. Basic information on drugs
Drug name HP518 tablets
Dosage form tablet
Application matters Registration and clinical trials of domestically produced drugs
Applicant Haichuang Pharmaceutical Co., Ltd.
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the clinical trial application for HP518 tablets accepted on September 4, 2025 meets the relevant requirements for drug registration, and it is approved to carry out phase Ib/II clinical trials in combination with anti-tumor drugs for the treatment of advanced prostate cancer.
2. Other information about drugs
HP518 is an oral PROTAC drug independently developed by the company based on the core technology platform of Proteolysis Targeting Chimera (PROTAC) that targets androgen receptor (AR) degradation. It is intended to be combined with anti-tumor drugs to treat advanced prostate cancer.
HP518 is composed of target protein ligands, E3 ligase ligands and linkers. It induces AR ubiquitination and relies on proteasome degradation of AR proteins, thereby achieving deep inhibition of the AR signaling pathway and achieving anti-tumor purposes. It has the typical advantages of PROTAC drugs, including catalysis, high selectivity and good safety profile. HP518 tablets are a new PROTAC oral drug. Preclinical research results have shown that HP518 tablets have high degradation activity against drug-resistant AR mutants and wild-type AR proteins, and have excellent tumor suppressor activity against AR-dependent prostate cancer cells. It is expected to overcome the drug resistance problem caused by mutations in the treatment of prostate cancer and provide new treatment methods for this group of patients.
Previously, HP518 has completed phase I clinical studies in Australia and China, and has now completed the enrollment of all participants in China's phase II clinical trials. The clinical trial application for HP518 has also been approved by the U.S. Food and Drug Administration (FDA) in 2023. In July 2024, the application for HP518 tablets to treat AR-positive triple-negative breast cancer was granted Fast-track designation by the United States Food and Drug Administration (FDA).
According to data released by GLOBOCAN 2022, prostate cancer is a common malignant tumor of the urinary system, ranking second in male cancer incidence and fifth in cancer mortality worldwide. In 2022, the number of new cases of prostate cancer worldwide reached 1.467 million. In recent years, the incidence of prostate cancer in China has shown an upward trend, and the number of new cases of prostate cancer in China will reach 134,000 in 2022. As China's population ages, the number of prostate cancer patients is on the rise. According to Sullivan, the domestic prostate cancer market will reach 50 billion by 2030.
3. Risk warning
The above-mentioned drugs obtaining the "Drug Clinical Trial Approval Notice" will not have a significant impact on the company's recent operating performance. After the drug obtains the "Drug Clinical Trial Approval Notice", it still needs to conduct clinical trial research and undergo review and approval by the State Food and Drug Administration before it can be produced and marketed.
Since pharmaceutical products are high-tech, high-risk, and high-value-added, the early stage of drug research and development and the product development, clinical trial approval, and production have long cycles and many links, and are easily affected by some uncertain factors. Investors are advised to make prudent decisions and pay attention to guarding against investment risks.
The company will actively promote the above-mentioned research and development projects and perform its information disclosure obligations on the subsequent progress of the projects in a timely manner in strict accordance with relevant regulations. For relevant company information, please refer to the announcements published in the company's designated disclosure media "Shanghai Securities News", "Securities Times", "Securities Daily" and the website of the Shanghai Stock Exchange.
Announcement is hereby made.
Board of Directors of Haichuang Pharmaceutical Co., Ltd.
November 25, 2025