中经记者 苏浩 卢志坤 北京报道 | 治疗领域 | 药品 | 作用靶点 | 适应症 | 开发 区域 | 临床前 研究 | IND申报 | 临床 期 | 临床川期 | 临床川期 | NDA | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 気思扎鲁胶软胶膏 | AR (ჟ制剂) | 阿比特龙/化疗后的转移性去势抵抗性 | 中国 | | | | | | 颈批上市 | | | (HC-1119) | | 前列腺癌(mCRPC) | | | | | | | | | 癌症 | HP518 (PROTAC) | AR | 标准治疗失败的转移性去势抵抗性 前列腺癌(mCRPC) | 澳大利亚 | | | | | | | | | | | | 美国 | | | | | | | | | | | | 中国 | | | | | | | | | | | AR+三阴乳胺癌(TNBC) | 中国 | | | | | | | | | | | | 英国 | | | | | | | | | H6568 | ER | ER+乳腺癌 | 中国 | | ...

天眼查商业履历信息显示，海创药业股份有限公司，成立于2013年，位于成都市，是一家以从事医药制 造业为主的企业。企业注册资本9901.5598万人民币，实缴资本6901.0894万人民币。公司法定代表人为 Yuanwei Chen （陈元伟）。 通过天眼查大数据分析，海创药业股份有限公司共对外投资了2家企业，参与招投标项目17次，知识产 权方面有商标信息23条，专利信息71条，此外企业还拥有行政许可85个。 来源：金融界 海创药业所属概念板块包括：生物制品、四川板块、融资融券、减肥药、创新药、西部大开发。 资金流方面，海创药业近5日主力资金流出2541.89万元，区间跌幅2.2%；近10日主力资金流出7592.29 万元，区间跌幅2.56%。 8月25日，沪深两融数据显示，海创药业上周累计获融资净买入额3247.56万元，居两市第406位，上周 融资买入额1.55亿元，偿还额1.22亿元。 ...

丨 2025年8月25日 星期一 丨 NO.1 科兴制药筹划发行H股 科兴制药公告，公司正在筹划发行H股并在香港联交所上市，并与相关中介机构就本次H股上市的具体 推进工作进行商讨，相关细节尚未确定。本次H股上市能否通过审议、备案和审核程序并最终实施具有 不确定性。2025年上半年，科兴制药营业收入为7亿元，同比下降近8%，归母净利润为8034万元，同比 上升576%。 点评：科兴制药筹划H股上市，若推进顺利可拓宽融资渠道、助力国际化布局，但需经多轮审议与审 批，后续进展及市场环境将影响最终落地，长期需关注其资本运作对业务的支撑效果。 NO.2 复宏汉霖：完成HLX43晚期肺癌临床研究美国首例患者给药 复宏汉霖公告，近日完成了注射用HLX43（靶向PD-L1抗体偶联药物）在晚期非小细胞肺癌（NSCLC） 患者中的国际多中心2期临床研究的美国首例患者给药。该临床研究同时在中国进行，并计划在条件具 备后扩展至澳大利亚和日本等国家。 点评：复宏汉霖HLX43完成美国首例患者给药，作为PD-L1 ADC布局晚期肺癌，推进国际多中心临 床，有利于拓展全球市场，后续临床数据将成其商业化关键。 NO.3 圣诺生物：股东拟合计 ...

中经记者苏浩卢志坤北京报道 2018年11月，海创药业自主研发的高尿酸血症和痛风1类新药HP501缓释片获得国家药监局颁发的《临 床试验通知书》。公司满怀希望地宣布，这款具有自主知识产权的URAT1抑制剂将为中国1.3亿高尿酸 血症患者带来新希望。 然而，近七年后，2025年8月13日，海创药业在发布年中财报的同时宣布了一则消息：拟暂停HP501项 目的研发推进。此时，该项目已投入募集资金8111.25万元。 决定背后的原因是残酷的市场竞争：国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该 靶点的Ⅲ期临床研究正在进行。 8月22日，海创药业方面在接受《中国经营报》记者采访时表示，募投项目子项目调整是基于公司实际 情况并结合当前市场竞争格局、行业发展趋势等多重因素决定的。上述调整将更好地维护公司和广大投 资者的利益，符合公司的长远发展及规划。不会对公司当期经营业绩产生重大影响，不存在损害股东利 益的情形。 从临床到落寞 据了解，HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1（URAT1）抑制 剂。临床前研究结果显示，其生物活性优于同类药物，展现了优良的药代动力学和毒理学性质。 ...

Company Overview - Haichuang Pharmaceutical-U's stock price is reported at 61.39 yuan, down 1.08% from the previous trading day, with a trading volume of 1.44 billion yuan [1] - The company operates in the biopharmaceutical sector, focusing on innovative drug development, particularly utilizing PROTAC technology and deuterated technology [1] Financial Performance - For the first half of 2025, the company reported revenue of 13.17 million yuan, representing a significant year-on-year increase of 11,899.08%, primarily driven by the approval and sales of its first Class 1 new drug, deuterated enzalutamide soft capsules, which generated sales revenue of 13.07 million yuan [1] Market Activity - On August 21, the company experienced a net outflow of 5.73 million yuan in principal funds, with a cumulative net outflow of 9.66 million yuan over the past five days [1]

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [2][4]. Core Views - The company's first product, Deuteroenzalutamide soft capsule, has commenced commercialization, contributing revenue of 13.07 million yuan in Q2 2025. This product is the first domestically approved innovative drug for metastatic castration-resistant prostate cancer (mCRPC) [3][4]. - The company is actively investing in innovative drug research and development, with a focus on differentiated pipeline development. In H1 2025, the R&D expenditure was 56.97 million yuan, with several promising candidates in the pipeline [4][6]. - Revenue projections for 2025, 2026, and 2027 are estimated at 159 million yuan, 380 million yuan, and 586 million yuan, respectively, with corresponding net profits of -195 million yuan, -99 million yuan, and 13 million yuan [6][7]. Summary by Sections Recent Performance - The company reported a revenue of 0.13 million yuan for H1 2025, a significant increase from 110,000 yuan in the same period last year. However, the net profit attributable to the parent company was -62 million yuan [3]. Product Development - Deuteroenzalutamide soft capsule is a self-developed androgen receptor (AR) inhibitor, approved by the National Medical Products Administration in May 2025. Clinical trials indicate a 42% reduction in the risk of disease progression or death compared to other endocrine therapies [4]. R&D Investment - The company is committed to continuous investment in innovative drug development, with a focus on unique therapeutic areas. The pipeline includes HP518, HP501, and HP515, targeting various conditions such as high uric acid levels and obesity [4][6]. Financial Forecast - The financial outlook suggests a gradual improvement in performance, with expectations of revenue growth and a return to profitability by 2027. The projected P/E ratio for 2027 is 497.41X, indicating high growth potential [6][7].

Group 1 - A-share market sees weakness in certain biopharmaceutical stocks, with notable declines in several companies [1] - Nanmo Bio falls by 9%, while Shanghai Yizhong drops over 7% [1] - Nocare Health declines by over 5%, and Sunshine Nuohe and Guangshengtang both decrease by over 4% [1] - Haichuang Pharmaceutical, Baicheng Pharmaceutical, Yaokang Bio, and Qianyan Bio all experience declines of over 3% [1]

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company has made significant progress in innovative drug development, with the successful launch of Deutetrabenazine soft capsules, which are approved for treating metastatic castration-resistant prostate cancer (mCRPC) [9] - The company is expected to achieve revenue of 0.8 billion, 3.0 billion, and 5.0 billion RMB in 2025, 2026, and 2027 respectively, indicating a strong growth trajectory [9] Financial Performance - For the first half of 2025, the company reported total revenue of 0.13 million RMB and a net profit of -0.62 billion RMB, showing a reduction in losses compared to the same period last year [9] - Revenue growth rates are projected to be 21,708.1% in 2025, 275.0% in 2026, and 66.7% in 2027 [7][10] - The company is expected to continue incurring losses, with net profits projected at -221 million RMB in 2025, -85 million RMB in 2026, and -9 million RMB in 2027 [7][10] Research and Development Progress - The company has developed HP518, the first oral AR PROTAC drug in clinical trials in China, with clinical trial applications approved by both the NMPA and FDA [9] - HP515, another drug for treating MASH, has also progressed well, with clinical trial applications approved and ongoing patient enrollment [9] Market Performance - The company's stock has shown a performance of -7% over the last 12 months, compared to a 25% increase in the chemical pharmaceutical sector [4]

Investment Rating - The report does not explicitly state an investment rating for the industry, but it indicates a positive trend in the pharmaceutical and biotechnology sector with a weekly increase of 3.08% [3][8]. Core Insights - The pharmaceutical and biotechnology sector outperformed the Wind All A index and the CSI 300 index during the week of August 11 to August 15, with notable gains in medical research outsourcing (7.77%), hospitals (5.59%), and medical consumables (4.47%) [3][8]. - The upcoming launch of the commercial insurance innovative drug directory is expected to activate the domestic high-end payment market for innovative drugs, with 121 drug names passing preliminary review [3][8]. - The World Conference on Lung Cancer (WCLC) will take place from September 6 to 9, showcasing significant research advancements in lung cancer, with domestic research playing an increasingly important role [3][8]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 3.08%, outperforming the Wind All A index (2.95%) and the CSI 300 index (2.37%) [3][8]. - Medical research outsourcing, hospitals, and medical consumables led the sector's gains, while offline pharmacies, blood products, and medical circulation experienced declines [3][8]. - Notable individual stock performances included Sino Medical (69.1%), Innovation Medical (51.5%), and Guangsheng Tang (40.7%) for gains, while *ST Suwu (-16.8%), ST Sansheng (-15.2%), and Nanhua Biological (-14.2%) faced significant losses [3][11]. Industry News and Key Company Announcements - The National Medical Insurance Administration announced the preliminary review of the 2025 National Basic Medical Insurance drug directory and the commercial insurance innovative drug directory [3][13]. - Novo Nordisk received accelerated FDA approval for its therapy Wegovy for treating non-alcoholic steatohepatitis (NASH) [3][13]. - Yunnan Baiyao approved a full acquisition of An Guo Shi Ju Yao Tang Pharmaceutical Co., Ltd. for 660 million RMB to enhance its traditional Chinese medicine business [3][15]. - Insmed's DPP1 inhibitor Brensocatib received FDA approval for treating non-cystic fibrosis bronchiectasis [3][14].

Group 1 - The company has approved a special report on the storage and actual use of raised funds for the first half of 2025, ensuring compliance with relevant regulations [7][17][46] - The total amount raised from the public offering was RMB 1,062,699,200, with a net amount of RMB 995,113,315 after deducting issuance costs [7][25] - As of June 30, 2025, the company has used RMB 871,447,067.89 of the raised funds, with a remaining balance of RMB 147,244,678.39 [8][9] Group 2 - The company has adjusted the investment projects related to the raised funds, specifically suspending further development of the HP501 project due to market competition [27][31] - The remaining funds from the "Innovative Drug R&D Project" will be redirected to ongoing projects HP518 and HP537 [27][30] - The adjustments are aimed at improving the efficiency of fund usage and aligning with the company's long-term strategic goals [31][33] Group 3 - The company has decided to cancel its supervisory board, with its functions being transferred to the audit committee of the board of directors [48][69] - Amendments to the company's articles of association have been proposed to align with the new Company Law and improve governance [49][80] - The company has also revised several internal governance documents to enhance management efficiency and compliance with updated regulations [81]