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8000万元投入“打水漂”?新药研发7年后宣布暂停
Core Viewpoint - Haichuang Pharmaceutical announced the suspension of the HP501 project due to intense market competition and the presence of multiple competing products targeting the same URAT1 pathway [2][3][5]. Drug Development Pipeline - HP501, a small molecule chemical innovation drug developed by Haichuang, is a URAT1 inhibitor aimed at treating hyperuricemia and gout, with clinical trials initiated in 2018 [4]. - The project had received a clinical trial notification from the National Medical Products Administration (NMPA) in November 2018 and entered Phase II clinical trials in September 2020 [4][5]. - Despite initial optimism, the project fell behind competitors, leading to its suspension in August 2025 after an investment of 81.1125 million yuan [2][5]. Market Competition - The market for URAT1 inhibitors has become increasingly competitive, with several domestic companies having received approvals for similar products and others in advanced clinical stages [5]. - Notable competitors include Fuji Yakuhin Co Ltd and Hengrui Medicine, which have launched or are in the process of launching their own URAT1 inhibitors [5]. Strategic Focus - Following the suspension of HP501, Haichuang plans to focus on advancing the development of other projects, particularly HP518 and HP537 [6][7]. - HP518 is the first oral AR PROTAC drug in clinical trials in China, targeting metastatic castration-resistant prostate cancer (mCRPC), with ongoing clinical trials and positive safety and efficacy signals reported [7][8]. - The company aims to leverage its expertise in PROTAC drug development to enhance the progress of its pipeline projects [8].
海创药业暂停HP501研发 8000万元投入付诸东流
Core Viewpoint - Haichuang Pharmaceutical has decided to suspend the development of its self-developed drug HP501 due to intense market competition and the presence of similar products already approved for the URAT1 target [2][6]. Group 1: Project Development and Market Competition - HP501, a small molecule chemical innovation drug, is a URAT1 inhibitor that showed superior biological activity compared to similar drugs in preclinical studies [3]. - The project has faced significant delays, with its clinical progress lagging behind competitors, leading to the decision to halt its development [5][6]. - As of the announcement, several domestic companies have launched products targeting the URAT1 pathway, increasing competitive pressure on HP501 [6][7]. Group 2: Financial and Strategic Adjustments - The company has invested approximately 81.11 million yuan (about 11.5 million USD) into the HP501 project before deciding to suspend it [2]. - Following the suspension, Haichuang Pharmaceutical plans to redirect the remaining funds, approximately 122 million yuan (about 17.3 million USD), towards the development of other projects, specifically HP518 and HP537 [7][8]. - HP518 is the first oral AR PROTAC drug in clinical trials in China, with ongoing studies showing promising safety and efficacy signals in treating metastatic castration-resistant prostate cancer (mCRPC) [7][8].
海创药业股份有限公司2025年半年度报告摘要
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]
海创药业: 2025年半年度报告
Zheng Quan Zhi Xing· 2025-08-13 12:20
Core Viewpoint - The report highlights Haichuang Pharmaceutical's focus on innovative drug development, particularly in the areas of cancer and metabolic diseases, utilizing advanced technologies such as PROTAC and deuterated drugs to address unmet clinical needs [5][9]. Financial Performance - The company reported a revenue of 13.17 million yuan for the first half of 2025, a significant increase of 11,899.08% compared to the same period last year [4]. - The total profit for the period was a loss of 61.85 million yuan, which is an improvement from a loss of 100.40 million yuan in the previous year [4]. - The net profit attributable to shareholders was also a loss of 61.85 million yuan, showing a reduction in losses by 33.63% compared to the previous year [4]. Product Development - The company’s first core product, deuterated enzalutamide soft capsules (HC-1119), received approval from the NMPA and generated sales revenue of 13.07 million yuan [4][8]. - HC-1119 has shown significant clinical benefits, including a 42% reduction in the risk of disease progression or death in patients with metastatic castration-resistant prostate cancer (mCRPC) [8][9]. - The company has a robust pipeline of drugs in various stages of development, including HP518 and HP568, targeting different cancer types and mechanisms [6][10]. Market Strategy - The company is implementing a comprehensive commercialization strategy that includes academic promotion and building a competitive marketing team to enhance brand awareness and market access [9]. - The product HC-1119 has been launched in major cities, marking its entry into the clinical application phase and providing new treatment options for prostate cancer patients [9][10]. Research and Development Focus - Haichuang Pharmaceutical emphasizes innovation in drug development, particularly in addressing the challenges of drug resistance in prostate cancer treatment through its PROTAC technology [10]. - The company aims to leverage its advanced research platforms to enhance its global competitiveness in the pharmaceutical market [5][9].
海创药业: 关于首次公开发行股票部分募投项目子项目调整的公告
Zheng Quan Zhi Xing· 2025-08-13 12:19
Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. plans to adjust certain sub-projects within its "Innovative Drug R&D Project" to enhance the efficiency of fundraising usage while maintaining the total investment amount for the project [1][2] Fundraising Overview - The company issued 24,760,000 shares at a price of RMB 42.92 per share, raising a total of RMB 1,062.70 million, with a net amount of RMB 995.91 million after deducting issuance costs [1] - The funds are managed in a dedicated account as per regulatory requirements [1] Project Adjustments - The first adjustment of fundraising amounts was made on June 7, 2022, due to the net amount being lower than initially planned [2] - A second adjustment was approved on April 4, 2024, to further optimize the allocation of funds for the "Innovative Drug R&D Project" and the "R&D Production Base Construction Project" [2] Current Fund Usage - As of June 30, 2025, the cumulative investment in the projects has reached RMB 99.51 million, with the R&D production base construction project exceeding its planned investment due to interest income from cash management [3][5] Sub-Project Adjustments - The company has decided to suspend the further development of the HP501 sub-project, a small molecule chemical innovative drug, due to increased competition in the market [6] - Remaining funds of RMB 121.73 million will be redirected to ongoing projects HP518 and HP537 [6] Ongoing Projects - HP518 is the first oral AR PROTAC drug in clinical trials in China, with a completed Phase I study and ongoing Phase II trials [7][8] - HP537 has received approval for clinical trials in China and the U.S. [8] Rationale for Adjustments - The decision to adjust sub-projects is based on market competition and the company's strategic planning to enhance fundraising efficiency [6][9] Impact of Adjustments - The adjustments are expected to improve overall R&D efficiency and resource allocation without significantly impacting the company's current operating performance [9] Decision-Making Process - The adjustments were approved by the company's board and supervisory committee and will be submitted for shareholder approval [9][10]
海创药业: 中信证券股份有限公司关于海创药业股份有限公司变更部分募集资金投资项目的核查意见
Zheng Quan Zhi Xing· 2025-08-13 12:19
Group 1 - The company, Hai Chuang Pharmaceutical Co., Ltd., has made adjustments to its fundraising investment projects due to the net amount raised being lower than initially planned, aiming to enhance the efficiency of fund utilization [2][4] - The total amount raised from the initial public offering was RMB 106,269.92 million, with a net amount of RMB 99,511.33 million after deducting issuance costs [1][2] - The first adjustment to the fundraising projects was made in June 2022, followed by a second adjustment in April 2024, which included changes to the amounts allocated to specific projects [2][4] Group 2 - The company has decided to suspend the further development of the HP501 subproject under the "Innovative Drug R&D Project" due to increased competition in the market for URAT1 target products [5][6] - The remaining funds from the "Innovative Drug R&D Project" will be redirected to ongoing projects HP518 and HP537, with a total of RMB 12,172.60 million remaining for these projects as of June 30, 2025 [4][5] - The company is focusing on the development of PROTAC technology, which is considered revolutionary in the biopharmaceutical field, and aims to advance the clinical progress of its projects [5][6] Group 3 - The company has received regulatory approvals for its core product HC-1119, which is aimed at treating prostate cancer, and has multiple products in various stages of clinical research [5][6] - The clinical trial for HP518 has completed its Phase I study in China, and the Phase II trial is currently enrolling participants, with positive safety and efficacy signals reported [6][7] - The adjustments made to the fundraising projects are aligned with the company's long-term strategic goals and are not expected to significantly impact current operating performance [7][8] Group 4 - The decision to adjust the fundraising projects was approved by the company's board of directors and supervisory board, and will be submitted for shareholder approval [8] - The sponsor, CITIC Securities, has confirmed that the decision-making and approval processes comply with relevant regulations [8]