Company Overview - The company specializes in the development of new drugs, including HC-1119, HP518, HP568, HP501, HP515, HP537, and HP560 [8] - The first class new drug, HC-1119, is expected to be approved for sale in May 2025, leading to a modest increase in sales revenue from material and intermediate sales [8] Financial Performance - The company anticipates total revenue for 2025 to be between 19 million and 22 million yuan, influenced by the inclusion of HC-1119 in the National Medical Insurance Drug List, which will result in a significant price reduction [8] - Research and development expenses for 2025 are projected to be between 105 million and 125 million yuan, a decrease of 4.903 million to 6.903 million yuan compared to the previous year [8] - The company expects to report a net loss for 2025, although the loss will be reduced compared to the previous year when excluding non-recurring gains and losses [9] Historical Revenue and Profit Trends - Historical total revenue and net profit data indicate fluctuations, with total revenue expected to show a growth rate of -1,000% to 6,000% from 2020 to 2025 [10] - The company has experienced varying growth rates in total revenue and net profit over the years, with specific projections for 2025 indicating a continued trend of net losses [10] Valuation Metrics - The company’s valuation metrics include price-to-earnings (P/E) ratio, price-to-book (P/B) ratio, and price-to-sales (P/S) ratio, with P/E being negative during loss periods, making P/B and P/S more relevant for valuation [13]

Core Insights - The incidence of acute gout is rising globally, particularly among younger populations aged 18-35, who account for nearly 60% of cases, with a significantly higher male-to-female ratio [1][5] - By 2024, the global number of acute gout patients is expected to reach 45.4 million, with China contributing approximately 19.4 million cases; this number is projected to increase to 47.7 million globally and 22.2 million in China by 2025 [1][5] - The global acute gout drug market is expected to stabilize around $1.5 billion by 2025, with China's market size estimated at $0.1 billion [1][5] Industry Definition and Classification - Gout is a type of crystal arthritis caused by purine metabolism disorders or reduced uric acid excretion, primarily characterized by the deposition of monosodium urate crystals [2][3] - Treatment options are categorized into two main types: drugs for acute gout attacks and uric acid-lowering drugs [3][4] Current Industry Status - The acute gout drug market has remained stable despite rising patient numbers due to price increases leading to decreased sales volume [5] - The need for effective treatment is critical as uncontrolled acute attacks can lead to increased frequency and severity, impacting patients' quality of life [5] Industry Chain - The upstream of the acute gout drug industry includes raw materials, intermediates, and production equipment; the midstream focuses on drug R&D and production, while the downstream involves distribution channels and end patients [6] Regulatory Environment - The Chinese government has been enhancing policy guidance and regulation in the acute gout drug industry through various healthcare and drug management policies to promote healthy industry development [6] Competitive Landscape - Major competitors in the acute gout drug market include companies like Haichuang Pharmaceutical, Heng Rui Medicine, Yifang Bio, and Yipinhong, which are actively developing clinical pipelines for hyperuricemia and gout treatments [7][8] - The market is characterized by a strong demand for new, safe uric acid-lowering drugs, as existing treatments do not fully meet clinical needs [7] Development Trends - The acute gout drug industry in China is rapidly evolving, with market expansion and increasing competition driven by policy support, technological advancements, and market demand [10] - The industry is moving towards more precise, effective, and personalized treatment options, with a focus on domestic alternatives to improve patient outcomes [10]

Core Viewpoint - Haichuang Pharmaceutical's first innovative drug, Deuteroenzalutamide soft capsule, reported a revenue of 10.18 million yuan for the quarter, a 22.65% decrease from the previous quarter, and a net loss of 37.29 million yuan, down 25.35% quarter-on-quarter but narrowed by 30% year-on-year [2][3][4]. Financial Performance - Revenue for the quarter was 10.18 million yuan, a significant drop from 13.16 million yuan in June, indicating a failure to maintain growth [4]. - The total profit for the period was -37.29 million yuan, with a basic earnings per share of -0.38 yuan [5][8]. - Cash flow from operating activities showed a net outflow of 32.28 million yuan, primarily due to employee payments and market promotion expenses [8]. Cost Structure - Sales expenses reached 15.19 million yuan, a 218.68% increase year-on-year, leading to a high expense ratio of 606.44% [6]. - Despite a decrease in R&D expenses, the overall cost structure remains burdensome, impacting profitability [6]. Market and Product Pipeline - The company has strategically adjusted its pipeline, halting further development of the HP501 project due to intense competition in the URAT1 target market [10][11]. - The ongoing clinical trial for HP515 is expected to face significant market challenges, similar to those encountered by the abandoned HP501 project [11]. - The competitive landscape for Deuteroenzalutamide is intense, with the prostate cancer treatment market in China valued at 8.1 billion yuan in 2022, dominated by other established drugs [12][13]. Future Outlook - Analysts predict that Haichuang Pharmaceutical may not achieve profitability until 2027, with a consensus net loss forecast of 219 million yuan for 2025 [13].

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].

Core Viewpoint - Haichuang Pharmaceutical-U (688302.SH) has achieved a significant milestone by generating revenue of 13.16 million yuan in the first half of the year, marking a substantial year-on-year growth of 11,899.08% due to the launch of its first Class 1 new drug, Deuteroenzalutamide soft capsule [2][3][5]. Financial Performance - The company reported a total revenue of 13.17 million yuan for the first half of the year, compared to 0.11 million yuan in the same period last year [5]. - Despite the revenue growth, the company continues to face deep losses, with a net profit attributable to shareholders of -61.85 million yuan, and a cumulative loss of over 1.7 billion yuan since 2018 [5][6]. - The net cash flow from operating activities was -47.43 million yuan, indicating ongoing financial strain [14]. Market Response - The stock market reacted cautiously to the earnings report, with a maximum pullback of over 13% in three days, reflecting concerns about the company's commercialization capabilities and profitability outlook [2][13]. - Following the earnings announcement, the stock initially opened high but closed lower, indicating market skepticism despite a 10.43% increase on the announcement day [11][13]. Product Development and Market Position - Deuteroenzalutamide is the first domestically developed innovative drug for prostate cancer treatment, with a significant market potential projected to grow from approximately 12.98 billion USD in 2023 to 27.5 billion USD by 2032 [18]. - The drug's pricing is set at 6,500 yuan per box, with expectations for inclusion in medical insurance and clinical guidelines [10][11]. - The company has faced challenges in its research pipeline, including the suspension of the HP501 project due to intense competition in the market for URAT1 inhibitors [16][17]. Sales and Marketing Strategy - The company is in the process of building its commercialization team, with plans to cover 21 provinces through partnerships and a self-operated team of about 60 members [15]. - Sales expenses have increased significantly, accounting for 80% of revenue, highlighting the need for improved sales efficiency [14]. Future Outlook - Analysts predict that Haichuang Pharmaceutical may not achieve profitability until 2027, with a consensus forecast of a net loss of 219 million yuan in 2025 [19]. - The company faces multiple pressure points, including high R&D costs, potential pricing pressures in insurance negotiations, and a strategic contraction of its research pipeline [20].

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].

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].