公告显示，截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚期前列腺癌的 临床试验。目前国内外暂无同类产品获批上市。 北京商报讯（记者 丁宁）11月24日晚间，海创药业（688302）发布公告称，公司收到中国国家药品监 督管理局药品审评中心核准签发的《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用 于治疗晚期前列腺癌的Ⅰb/Ⅱ期临床试验。 ...

HP518由靶蛋白配体、E3连接酶配体及连接子构成，通过诱导AR泛素化并依赖蛋白酶体降解AR蛋白， 从而实现对AR信号通路的深度抑制，达到抗肿瘤的目的。其具有PROTAC类药物的典型优势，包括催 化性、高选择性及良好安全性。HP518片作为新型PROTAC口服药物，已有临床前研究结果显示， HP518片对耐药的AR突变体及野生型AR蛋白均具有高降解活性，并对AR依赖的前列腺癌细胞具有优异 的抑癌活性，有望克服前列腺癌治疗中由突变引起的耐药问题，可为该群体患者提供新的治疗手段。 海创药业(688302.SH)发布公告，近日，公司收到中国国家药品监督管理局药品审评中心核准签发的 《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用于治疗晚期前列腺癌的Ⅰb/Ⅱ期临 床试验。截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚期前列腺癌的临 床试验。目前国内外暂无同类产品获批上市。 ...

HP518由靶蛋白配体、E3连接酶配体及连接子构成，通过诱导AR泛素化并依赖蛋白酶体降解AR蛋白， 从而实现对AR信号通路的深度抑制，达到抗肿瘤的目的。其具有PROTAC类药物的典型优势，包括催 化性、高选择性及良好安全性。HP518片作为新型PROTAC口服药物，已有临床前研究结果显示， HP518片对耐药的AR突变体及野生型AR蛋白均具有高降解活性，并对AR依赖的前列腺癌细胞具有优异 的抑癌活性，有望克服前列腺癌治疗中由突变引起的耐药问题，可为该群体患者提供新的治疗手段。 智通财经APP讯，海创药业(688302.SH)发布公告，近日，公司收到中国国家药品监督管理局药品审评 中心核准签发的《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用于治疗晚期前列腺 癌的Ⅰb/Ⅱ期临床试验。截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚 期前列腺癌的临床试验。目前国内外暂无同类产品获批上市。 ...

Core Viewpoint - The report outlines the ongoing supervision and financial performance of Hai Chuang Pharmaceutical Co., Ltd., highlighting its focus on innovative drug development in oncology and metabolic diseases, while also addressing the associated risks and challenges in achieving profitability and market acceptance [1][2][3]. Group 1: Continuous Supervision and Financial Performance - The continuous supervision by CITIC Securities has not revealed any major issues within the company during the reporting period [2]. - The company reported a revenue of 13.17 million yuan for the first half of 2025, with a net loss of 61.85 million yuan, indicating ongoing financial challenges [2][11]. - Research and development expenses for the period amounted to 56.97 million yuan, reflecting a significant investment in drug development [8][20]. Group 2: Risks and Challenges - The company faces risks related to its lack of profitability, as it is heavily invested in R&D with long timelines for product commercialization [2][3]. - There is a risk of significant revenue decline or losses due to ongoing R&D expenditures and the uncertain approval timelines for new drugs [2][3]. - The company’s core product, Deuterated Enzalutamide soft capsules, was approved for sale in May 2025, but the commercial success remains uncertain due to competition and market acceptance challenges [5][11]. Group 3: R&D and Product Pipeline - The company has established four core technology platforms, including PROTAC and deuterated drug development, which are crucial for its innovative drug pipeline [13][19]. - The Deuterated Enzalutamide soft capsule is the first domestically approved drug for treating metastatic castration-resistant prostate cancer, marking a significant milestone for the company [13][21]. - The company is actively pursuing clinical trials for multiple products, including HP518, which has received fast-track designation from the FDA for treating AR-positive triple-negative breast cancer [15][22]. Group 4: Fundraising and Financial Management - The total amount raised through public offerings was approximately 1.06 billion yuan, with a significant portion already utilized for R&D and operational expenses [26]. - As of June 30, 2025, the company had a remaining balance of 117.24 million yuan in its fundraising account, indicating ongoing financial management efforts [26][27]. - The company has implemented a structured approach to manage and utilize the raised funds effectively, ensuring compliance with regulatory requirements [26].