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 | | ...

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。 ...

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]

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]

Core Viewpoint - Haichuang Pharmaceutical (688302) is focusing on the sales strategy of its drug, Dihenzalutamide, which is expected to fill a clinical gap in treating specific mCRPC patients and has significant market potential in China [1][2]. Group 1: Sales Strategy and Market Position - The sales strategy for Dihenzalutamide revolves around a "medical-market-access-sales" four-wheel drive model, emphasizing the establishment of new standards and accumulation of real-world data [1]. - The drug has a differentiated competitive advantage compared to competitors, significantly improving the primary endpoint by extending rPFS by 5.5 months and reducing the risk of imaging progression or death by 42% [1][2]. - The prostate cancer market in China is projected to reach 50 billion by 2030, indicating substantial market potential for Dihenzalutamide [1]. Group 2: Clinical Research and Development - Dihenzalutamide has been included in the CSCO guidelines in 2023 and is expected to be included again after product approval in 2025 [2]. - The company has been exploring protein degradation technology since 2016 and has developed a mature PROTC and molecular glue technology platform [2]. - HP518 is the first oral R PROTC drug in clinical trials in China, with the first subject enrolled in a Phase II trial expected to complete by December 2024 [2]. Group 3: Financial and Operational Outlook - The company plans to maintain annual R&D expenditures at around 200 million over the next 2-3 years, with cash reserves of 880 million as of March 2025 [2]. - The company is considering refinancing needs based on product commercialization and progress of ongoing projects [2]. - An experienced business development team has been established overseas to advance various business development activities [2].

Group 1 - Mingyuan Investment recently conducted research on a listed company, Haichuang Pharmaceutical, which has received approval for its core product, Deutetrabenazine soft capsules, a first-class new drug for treating mCRPC, significantly extending patients' progression-free survival [1] - The clinical trial for HP515, aimed at treating MSH, is currently ongoing in China, with preliminary data indicating good safety of the drug [1] - The company is also conducting a Phase II clinical trial for HP518, which has received fast track designation in the United States [1] - Haichuang Pharmaceutical has established a four-wheel drive commercialization strategy, combining self-built teams with external collaborations to comprehensively advance product commercialization preparations [1] Group 2 - Mingyuan Investment Management Co., Ltd. was established in 2014 in Shanghai, with a registered capital of 10 million yuan, founded by Dr. Qiu Huiming, who has extensive experience in hedge funds on Wall Street [2] - The company has obtained the private securities investment fund manager qualification and observation member qualification approved by the Asset Management Association of China [2] - Mingyuan Investment focuses on quantitative investment, leveraging strong data mining, statistical analysis, and software development capabilities to build a systematic trading and asset management platform [2] - The investment scope includes stocks, futures (index and commodity futures), and options, with a diverse strategy development team and a robust strategy library [2] - The company aims to explore and research quantitative investment strategies suitable for the characteristics of the Chinese capital market, integrating global leading financial institutions' experiences and technologies [2]

Investment Rating - The report does not specify a clear investment rating for the company [1] Core Views - The company has made progress in its research pipeline, particularly with the drug HC-1119, which is expected to receive approval by the end of 2024 [8] - The company reported a revenue of 0.367 million yuan for 2024, with a net profit attributable to the parent company of -199.5 million yuan, indicating a reduction in losses compared to previous periods [8] - The company is advancing its PROTAC drug development, with significant milestones achieved in clinical trials for various indications [8] Financial Summary - **Revenue Forecast**: The company is projected to achieve revenues of approximately 159 million yuan in 2025, 379.7 million yuan in 2026, and 580 million yuan in 2027, reflecting a growth rate of 43,243.59% in 2025 [3][10] - **Net Profit**: The net profit attributable to the parent company is expected to improve from -150.64 million yuan in 2025 to a positive 5.37 million yuan in 2027, with a growth rate of 105.93% in 2027 [3][11] - **Earnings Per Share (EPS)**: EPS is projected to improve from -1.52 yuan in 2025 to 0.05 yuan in 2027 [3][11] - **Return on Equity (ROE)**: ROE is expected to turn positive at 0.56% by 2027, improving from -14.46% in 2025 [3][11] Research and Development Progress - The company has completed patient enrollment for its oral AR PROTAC drug HP518 in a Phase II clinical trial for mCRPC, and it has received FDA fast track designation for another indication [8] - The clinical trial for HP568 targeting ER+/HER2- advanced breast cancer has received approval from the NMPA and is set to begin patient dosing [8] Investment Recommendations - The report suggests monitoring the company closely due to the anticipated approval of its first innovative drug, 德恩鲁胺 (Deenluzumab), which has already been accepted for NDA [8]

Core Viewpoint - PROTAC drugs target and degrade pathogenic proteins, offering significant clinical value and potential as oral small molecule drugs, with ER PROTAC and AR PROTAC being the most advanced targets in clinical development [1][2]. Group 1: PROTAC Overview - PROTAC utilizes E3 ubiquitin ligase to ubiquitinate target proteins, leading to their degradation by the proteasome, which allows it to tackle "undruggable" targets and proteins that develop resistance mutations [2]. - PROTACs have high selectivity for targets and catalytic properties, enabling low-dose and low-frequency administration [2]. Group 2: ER PROTAC - The fastest progressing ER PROTAC is Arvinas' ARV-471, which has been licensed to Pfizer for over $2 billion and is expected to read out phase 3 clinical data in Q1 2025 [3]. - ARV-471 has shown excellent efficacy in phase 2 trials among patients who have previously used fulvestrant and chemotherapy, with further phase 3 trials planned in 2025 in combination with CDK4/6 inhibitors [3]. Group 3: AR PROTAC - BMS's BMS-986365 is the fastest progressing AR PROTAC, currently in phase 3 clinical trials, addressing issues of resistance and short survival in prostate cancer patients [4]. - Phase 2 clinical data for BMS-986365 showed clinical benefits in mCRPC patients with both AR LBD wild-type and mutant, with PSA50 rates of 27% and 55% respectively [4]. - Arvinas' ARV-766 has been licensed to Novartis for $1.16 billion, achieving a PSA50 of 43% in phase 2 trials among AR LBD mutant patients [4]. Group 4: Investment Focus - PROTAC drugs possess unique advantages and have been validated over 20 years of exploration, with the upcoming phase 3 data for ARV-471 expected to lead to significant breakthroughs in the field [6]. - Domestic pharmaceutical companies are actively engaging in PROTAC development, demonstrating international competitiveness and first-mover advantages [6].