Core Viewpoint - Haichuang Pharmaceutical announced the completion of the first batch of participant enrollment for its self-developed HP515 clinical phase II trial aimed at treating Metabolic Associated Steatotic Liver Disease (MASH), previously known as Non-Alcoholic Steatohepatitis (NASH) [2] Company Summary - The clinical phase II trial for HP515 has recently completed its first batch of participant enrollment [2] - As of the announcement date, there are no similar targeted products approved for market in China [2]

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has announced the completion of the first participant enrollment in the Phase II clinical trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH) [2][3] Group 1: Clinical Trial Progress - The Phase II clinical trial of HP515 has recently completed the enrollment of its first participants [2] - HP515 is an orally administered, highly selective THR-β agonist that enhances lipid metabolism in liver cells, aiming to improve conditions related to MASH [2] - The drug received approval for clinical trials in China in August 2024 and in the United States in September 2024 [2] Group 2: Phase I Clinical Trial Results - Haichuang Pharmaceutical has completed the Phase I clinical trial of HP515, showing expected results in safety, tolerability, pharmacokinetics, and pharmacodynamics [3] - In the trial, SHBG levels increased significantly in a dose-dependent manner, with an increase of 176% at the 80mg dose after 14 days [3] - Key lipid indicators showed significant improvement, with LDL-C decreasing by 39%, TC by 28%, and ApoB by 41% at the 80mg dose [3] Group 3: Future Research Directions - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity treatment [4] - Preclinical studies indicate that HP515 may enhance weight loss effects while preserving muscle mass, potentially improving the efficacy of GLP-1R agonists [4] - Data from the combination study is set to be presented at the 32nd European Congress on Obesity in May 2025 and will be featured at the 3rd Obesity & Weight Loss Drug Development Summit in June 2025 [4]

Group 1 - The State Council issued a notice regarding the holiday arrangements for 2026 [1] - The People's Bank of China will conduct a 700 billion yuan reverse repurchase operation on November 5 [1] - Public fund performance benchmark elements library and operational instructions have been distributed to industry institutions [1] Group 2 - Trina Solar signed a memorandum of understanding for a 5GWh grid-level battery energy storage system with Pacific Green [1] - ST Lingnan has been prosecuted for alleged collusion in bidding [1] - Haichuang Pharmaceutical completed the enrollment of the first batch of participants in the Phase II clinical trial of HP515, with no similar targeted products approved for market in China [1] Group 3 - Founder Securities reported that China Cinda plans to reduce its stake by no more than 1% [1] - The ChiNext Index fell nearly 2%, with the total trading volume of the Shanghai and Shenzhen markets below 2 trillion yuan [1] - The Hong Kong Hang Seng Index declined by 0.79%, and the Hang Seng Technology Index dropped by 1.76% [1]

Core Viewpoint - Haichuang Pharmaceutical has announced the completion of the first batch of participant enrollment for its clinical phase II trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH), previously known as Non-Alcoholic Steatohepatitis (NASH) [1] Company Summary - The clinical phase II trial for HP515 has recently completed its first batch of participant enrollment [1] - As of the announcement date, there are no similar targeted products approved for market in China [1]

Core Insights - Haichuang Pharmaceutical achieved significant revenue growth in the first three quarters of 2025, with a reported revenue of 23.35 million yuan, representing a year-on-year increase of 21,180.28% [1] - The company reported a net loss attributable to shareholders of 99.15 million yuan, a substantial reduction from a loss of 154 million yuan in the same period last year [1] - The approval and commercialization of the first-class new drug, Dihenzalutamide, in May 2025 marked a pivotal moment for the company, indicating a successful transition from the investment phase to the return phase [1][2] Revenue Growth and Market Strategy - The significant revenue increase is attributed to the successful market launch of Dihenzalutamide, which has become a key revenue driver for the company [1] - Haichuang Pharmaceutical employs a dual-track model of "self-operated + CSO (Contract Sales Organization)" and a four-wheel drive strategy encompassing "medical-market-access-sales" to rapidly capture market opportunities [2] - The company has established an efficient sales network covering over 500 hospitals and 240 DTP pharmacies across 30 provinces, laying a solid foundation for the rapid growth of new drug sales [2] Product Development and Clinical Trials - Dihenzalutamide has been included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines, enhancing its market recognition [2] - The product is undergoing preliminary review for inclusion in the national medical insurance directory, which, if successful, will significantly improve drug accessibility and accelerate market penetration [2] - In the metabolic disease sector, the company is advancing its key product HP515, which targets obesity and metabolic-associated fatty liver disease (MASH), with promising results from Phase I clinical trials [3] Future Prospects - The development path for HP515 focuses on three main areas: combination therapy with GLP-1 for MASH, combination therapy for obesity, and exploring its use with the company's own oral small molecule GLP-1 receptor agonist [3] - The company is expected to continue expanding its revenue scale and gradually reduce net profit losses as new drugs progress through commercialization [3] - With its innovative technology and forward-looking pipeline, Haichuang Pharmaceutical is positioned to secure a significant place in the biopharmaceutical sector [3]

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 (688302) reported significant revenue growth in Q3 2025, driven by the launch of its first Class 1 new drug, HC-1119, for prostate cancer treatment, marking its entry into commercialization [1] Group 1: Financial Performance - For the first nine months of 2025, the company achieved revenue of 23.35 million yuan, a year-on-year increase of 21,180% [1] - The net loss narrowed to 99 million yuan from a loss of 154 million yuan in the same period last year [1] Group 2: Product Development and Market Entry - The drug HC-1119 was approved for sale in late May 2025, generating its first sales revenue [1] - HC-1119 has been included in the 2025 edition of the CSCO Prostate Cancer Diagnosis and Treatment Guidelines, gaining clinical recommendation status [1] - The product has passed the initial review for inclusion in the national medical insurance directory, which could enhance drug accessibility and market penetration [1] Group 3: Market Potential - Prostate cancer is a prevalent cancer among men in China, with 134,000 new cases reported in 2022, indicating a large and growing patient base [1] - The domestic market for second-generation anti-androgens is projected to exceed 4 billion yuan by 2024, with an estimated overall market size of 50 billion yuan by 2030 [1] Group 4: Sales Strategy - The company employs an innovative "self-operated + CSO" dual-track model, supported by a "medical-market-access-sales" four-wheel drive strategy [2] - A robust sales network has been established, covering over 500 hospitals and 240 DTP pharmacies across 30 provinces and cities in China [2] Group 5: Clinical Trials - The Phase I clinical trial for HP515, aimed at treating metabolic-associated fatty liver disease (MASH), has met its expected goals [2] - Initial results show significant improvements in multiple blood lipid indicators, with LDL-C reduction of 39%, TC reduction of 28%, and ApoB reduction of 41% at an 80 mg dosage [2] Group 6: Future Development Plans - The company is advancing to Phase IIa clinical trials for HP515, focusing on three main directions: combination therapy with GLP-1 for MASH, obesity treatment, and exploring combinations with its own oral small molecule GLP-1 receptor agonist [3]

Group 1 - The A-share pharmaceutical and biotechnology index fell by 0.36%, underperforming the CSI 300 index by 1.75 percentage points and the ChiNext index by 2.37 percentage points, ranking 28th among 31 sub-industries [4] - The Hong Kong Hang Seng Healthcare Index dropped by 1.43%, underperforming the Hang Seng Index by 4.83 percentage points [4] Group 2 - Recent progress in drug development includes NDA applications for HRS9531 by Heng Rui Pharmaceutical and several other drug applications by companies like Zhi Xiang Jin Tai and Kang Ning Jie Rui [5] - Clinical trials are ongoing for various drugs, including the phase III trial of Velolizumab by Shu Tai Shen and phase II trials for HP515 by Hai Chuang Pharmaceutical and mesutoclax by Nuo Cheng Jian Hua [5] Group 3 - The National Medical Products Administration announced a significant reduction in IND approval time to 30 days, enhancing the efficiency and predictability of clinical research for innovative drugs [6] - The government's support for the entire innovative drug development chain is being implemented, aiming to establish a high-quality development system for innovative drugs in China [6] Group 4 - The investment strategy for 2025 emphasizes structural selection of investment opportunities, focusing on the core contradiction between payment willingness and ability [7] - Three payment channels within the pharmaceutical industry are identified: in-hospital payments, out-of-pocket payments, and overseas payments, with a positive outlook on policy support for in-hospital payments and expanding public demand [8]

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]

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].