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].

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].

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]

Core Viewpoint - Haichuang Pharmaceutical reported significant revenue growth in the first half of 2025, with a revenue of 13.17 million yuan, marking a year-on-year increase of 11,899.08% [1] Financial Performance - The company recorded a net profit attributable to shareholders of -61.85 million yuan, an improvement from -100 million yuan in the same period last year [1] - Previous years (2020-2023) showed zero revenue, with only 366,800 yuan in revenue for 2024 [1] Product Development - The company achieved a breakthrough with its core product, Deuteroenzalutamide soft capsule, which was approved for market release in May 2025 for the treatment of metastatic castration-resistant prostate cancer [1] - The product is a first-class new drug developed independently by the company and supported by a national major new drug creation technology project [1] Market Strategy - During the reporting period, the company initiated commercialization preparations and established a four-wheel drive strategy [1] - In June, the product was first shipped nationwide, and the first prescription was issued, with ongoing efforts for market access and medical insurance inclusion planned for 2025 [1] Research and Development Progress - The company disclosed progress on multiple drugs in development, including HP518, which has commenced Phase I/II clinical trials in China and completed Phase I trials in Australia [1] - HP515 tablets have completed Phase I clinical trials in China, with preliminary data indicating good safety [1] - The company has adopted a global synchronized development strategy, establishing global branches and clinical teams, with a product pipeline that includes 334 patent applications, of which 129 have been authorized [1] Investment and Market Performance - The company acknowledged the high costs and long cycles associated with innovative drug development, expecting R&D expenses to remain elevated, and the unprofitable status may continue, potentially increasing cumulative unrecouped losses [1] - The innovative drug sector has been favored this year, with Haichuang Pharmaceutical's stock price increasing by over 100% [1] - As of June 30, three institutions entered the top ten circulating shareholders, while the top two shareholders slightly reduced their holdings in the second quarter [1]

Core Viewpoint - Haichuang Pharmaceutical-U reported significant revenue growth in the first half of 2025, primarily driven by the launch of its first new drug, but still faces challenges in achieving profitability due to competition and ongoing R&D costs [1][2]. Financial Performance - The company achieved revenue of 13.167 million yuan, a year-on-year increase of 11,899.08% [2][3]. - The net profit attributable to shareholders was -61.853 million yuan, a reduction in losses by 38.40% compared to the same period last year [3]. - The company reported a decrease in R&D expenses by 30.96 million yuan, contributing to the reduction in losses [3]. Product Development - The newly launched drug, Dihenzalutamide soft capsule, generated over 10 million yuan in revenue within a month of its approval [1][2]. - The company plans to include Dihenzalutamide in the national medical insurance by 2025 to enhance product accessibility [4]. - Haichuang Pharmaceutical announced the suspension of the HP501 project, which had already invested over 80 million yuan, due to increased competition in the market [5][6]. Market Competition - The Dihenzalutamide soft capsule faces competition from similar androgen receptor inhibitors and generic drugs, with several competitors already in advanced clinical stages [4][7]. - The company noted that the HP501 project was lagging behind competitors, prompting the decision to halt further investment [6][7]. Future Outlook - The company aims to continue advancing other projects, such as HP518, which is in the clinical trial phase for treating metastatic castration-resistant prostate cancer [8].

Core Viewpoint - Haichuang Pharmaceutical (688302) reported significant revenue growth in the first half of 2025, achieving operating income of 13.17 million yuan, a year-on-year increase of 11,899.08%, while reducing net losses to 61.85 million yuan from 100 million yuan in the same period last year [1] Group 1: Financial Performance - The company achieved a substantial increase in revenue compared to previous years, where it had minimal revenue, with 2020, 2021, and 2023 annual revenues being zero and only 366,800 yuan in 2024 [1] - The net profit loss decreased significantly from 100 million yuan in the previous year to 61.85 million yuan in the current reporting period [1] Group 2: Product Development - Haichuang Pharmaceutical's first core product, HC-1119, a deuterated enzalutamide soft capsule for prostate cancer, received NMPA approval in May 2025 [1] - The drug is a first-class new drug developed for treating metastatic castration-resistant prostate cancer (mCRPC) and has received support from the National Major New Drug Creation Technology Major Project [1] Group 3: Commercialization Strategy - The company has established a four-pronged commercialization strategy focusing on "medical-market-access-sales" and has built a commercial channel network [2] - By June 2025, the company achieved national product launch and the first prescription issuance [2] - Haichuang is actively preparing for market access and medical insurance inclusion, aiming for inclusion in the 2025 national negotiations to enhance product accessibility [2] Group 4: Research and Development Progress - The company disclosed progress on several in-development drugs, including HP518, which targets advanced prostate cancer and has received NMPA approval for clinical trials [3] - HP518's clinical trial application was approved by the FDA in the U.S., and results from Australian trials will be presented at major oncology conferences [3] - HP515, another drug for non-alcoholic fatty liver disease, has completed its Phase I clinical trial in China, showing promising safety and efficacy results [4] Group 5: Intellectual Property and Global Strategy - Haichuang Pharmaceutical has a global development strategy, with 334 invention patents filed globally, of which 129 have been granted [4] - The company has established global branches and clinical teams in China, the U.S., and Australia to enhance management and execution of overseas clinical trials [4] Group 6: Market Performance - The innovative drug sector has seen significant interest in the capital market, with Haichuang's stock price increasing over 100% since the beginning of the year [5] - New institutional investors have entered the top ten circulating shareholders, while the two largest shareholders slightly reduced their holdings in the second quarter [5]

Core Insights - Haichuang Pharmaceutical Co., Ltd. reported a revenue of 13.17 million yuan for the first half of 2025, driven by the sales of its first class 1 new drug, Deuteroenzalutamide soft capsules [1] - The company focuses on innovative drug development in cancer and metabolic diseases, utilizing PROTAC technology and deuterated technology [1] - Deuteroenzalutamide soft capsules, approved by the National Medical Products Administration (NMPA) on May 29, 2025, generated sales of 13.07 million yuan by June 30, 2025 [1] Company Developments - The drug is the first domestically approved innovative treatment for metastatic castration-resistant prostate cancer (mCRPC) and has received significant support from national projects [1] - The company has conducted over 100 academic meetings across 30 provinces, targeting more than 500 hospitals and 240 DTP pharmacies to promote Deuteroenzalutamide [2] - Plans are in place to include the drug in the national medical insurance negotiations by 2025 to enhance accessibility [2] Clinical Trials and Future Prospects - Several other drugs developed by the company are in clinical trial stages, including HP518 for mCRPC, which completed its first patient enrollment in a Phase II trial in December 2024 [2] - HP515, a selective THR-β agonist for treating metabolic-associated steatotic liver disease (MASH), received NMPA approval for clinical trials in August 2024 and completed its Phase I trial with promising safety and efficacy data [2] - Clinical research data on HP515 combined with GLP-1R agonists for obesity was presented at major conferences, indicating potential benefits in fat reduction and weight maintenance [3]

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 - 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].

Summary of Key Points Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has provided a detailed report on the management and usage of raised funds as of June 30, 2025, highlighting the total amount raised, its allocation, and the management protocols in place to ensure compliance and security of the funds [1][2]. Fundraising Overview - The company raised a total of RMB 1,062,699,200.00 through the issuance of 24,760,000 shares at RMB 42.92 per share, with a net amount of RMB 995,113,315.68 after deducting issuance costs [1][2]. - As of June 30, 2025, the cumulative usage of the raised funds amounted to RMB 871,447,067.89, leaving a balance of RMB 147,244,678.39, which includes RMB 23,578,430.60 from cash management [1][2]. Fund Management Practices - The company has established a fundraising management system to regulate the storage, management, and usage of the raised funds, ensuring compliance with relevant regulations [1][2]. - A tripartite supervision agreement has been signed with the underwriter and banks to clarify the rights and obligations of all parties involved in the management of the funds [1][2]. Actual Usage of Funds - The report indicates that there were no instances of using raised funds to replace pre-invested amounts or to temporarily supplement working capital during the reporting period [2][3]. - The company has approved the use of up to RMB 170 million of temporarily idle funds for cash management, investing in high-security and liquid financial products [2][3]. Project Delays and Adjustments - The company has postponed the completion date for certain fundraising projects, including the "R&D Production Base Construction Project" to December 31, 2025, and parts of the "Innovative Drug R&D Project" to December 31, 2026, due to implementation progress considerations [2][3]. - No changes have been made to the investment projects or their total amounts, ensuring that the adjustments do not adversely affect the company's operations or shareholder interests [3][4].