Group 1 - The company conducted an investor relations activity focusing on the progress of innovative drug research and development, overseas rights cooperation, resolution of industry competition, and layout in the health sector [2] - The company is currently conducting Phase IIa clinical trials for the innovative drug Painegabine, with 100% enrollment of the target 36 participants, and expects to unblind and read results by the end of 2025 [2] - The company has completed the Phase II clinical trial for Fluofenone and is preparing for Phase III clinical trials, with data expected to be read out by the end of this year [2] Group 2 - The company is actively seeking suitable partners for overseas rights cooperation for Painegabine [2] - The company is addressing industry competition commitments with a focus on resolution [2] - The company has partnered with AFT Pharmaceuticals from New Zealand to become the exclusive sales agent for five products and signed a strategic cooperation agreement with Malaysia's Aikang International Group to leverage the Hainan Free Trade Port policy [2] Group 3 - The company plans to focus on the neuropsychiatric field, introducing a long-acting injection of Paliperidone for schizophrenia treatment, and aims to develop a product cluster [2] - The company is enhancing its product pipeline in traditional Chinese medicine, focusing on gastrointestinal health products, and aims to expand overseas registration and sales [2] - The company is deepening collaborations with universities and research institutions to explore high-end formulations and international partnerships [2]

Clinical Trials and Drug Development - The company is conducting Phase IIa clinical trials for the drug Paenagabin, with a target enrollment of 36 cases, which has been fully achieved at a 100% completion rate. Preliminary data shows promising therapeutic effects [2][3] - The Phase II data for Paenagabin is expected to be unblinded and results read out by the end of 2025 [2][3] - The Phase II clinical research for another drug, Fluorofenone, has completed subject enrollment and data cleaning, with results expected to be revealed by the end of this year [3][4] - Preparations for the Phase III clinical trials of Fluorofenone are underway, anticipated to start between the end of this year and early next year [3][4] Market Expansion and Partnerships - The company is actively seeking international partners for the commercialization of innovative drugs, with future expansion dependent on the Phase II clinical results of Paenagabin [3][4] - A strategic cooperation agreement has been signed with Malaysia's Aikang International Group to introduce high-quality health products and promote traditional Chinese medicine products in the Malaysian market [3][4] Product Development and Focus Areas - The company plans to focus on the neuropsychiatric field, introducing a long-acting injection for the treatment of schizophrenia, thereby forming a product cluster in this area [4] - The company aims to expand its gastrointestinal product line, particularly the Gut Health series, targeting grassroots medical institutions and increasing user base [4] - There is a commitment to deepen collaborations with universities and research institutions to enhance competitiveness in high-end formulations [4] Risk Management - There are uncertainties regarding the success of subsequent clinical trials for innovative drugs and the potential for obtaining approval from the National Medical Products Administration [4] - The company emphasizes the importance of timely information disclosure regarding the progress of innovative drugs and encourages investors to make cautious decisions [4]

Core Viewpoint - Hainan Haiyao's stock price decreased by 1.27% to 6.20 yuan on August 13, with a trading volume of 450,581 hands and a transaction amount of 279 million yuan [1] Company Overview - Hainan Haiyao operates in the chemical pharmaceutical industry, focusing on drug research, production, and sales. The product line includes antibiotics, anti-tumor drugs, and cardiovascular medications [1] Clinical Development - The company is currently conducting phase II clinical data analysis for Fluorofenone [1] Product Inclusion in National Procurement - Three of the company's drugs, including injectable Cefazolin Sodium, Rosuvastatin Capsules, and Desloratadine Oral Solution, have been included in the National Medical Insurance Administration's 11th batch of centralized procurement [1] Capital Flow - On August 13, the net outflow of main funds was 29.35 million yuan, with a cumulative net outflow of 97.31 million yuan over the past five days [1]

Group 1 - The company is currently conducting data analysis for the Phase II clinical trial of Fluorofenone [1] - Investors are advised to pay attention to the relevant announcements disclosed by the company regarding the clinical trial report [1]

Company Overview - Hainan Haiyao's stock price closed at 6.50 yuan on August 5, down 0.06 yuan, a decrease of 0.91% from the previous trading day [1] - The trading volume on that day was 413,556 hands, with a transaction amount of 269 million yuan [1] - The stock price fluctuated between 6.44 yuan and 6.60 yuan, with a volatility of 2.44% [1] Business Operations - Hainan Haiyao operates in the pharmaceutical manufacturing industry, focusing on drug research, production, and sales [1] - The company's product line includes antibiotics, anti-tumor drugs, and cardiovascular medications across various therapeutic areas [1] - The company is registered in Haikou City, Hainan Province [1] Clinical Development - On August 5, the company announced on an interactive platform that its innovative drug, Fluorofenone, requires Phase III clinical trials, with the specific launch date to be determined based on the progress of these trials [1] Shareholder Information - As of July 31, the total number of shareholders was 87,580, an increase of 17,700 from July 20 [1] - The number of shares held by the Shenzhen Stock Connect remained at 7.7945 million shares, accounting for 0.60% of the circulating share capital [1] Capital Flow - On August 5, the net outflow of main funds was 29.6253 million yuan, representing 0.39% of the circulating market value [1] - Over the past five trading days, the cumulative net outflow reached 59.3909 million yuan, accounting for 0.78% of the circulating market value [1]

Core Viewpoint - The 37th Academic Exchange Conference on Spleen and Stomach Diseases organized by the Chinese Association of Traditional Chinese Medicine was successfully held, showcasing the latest clinical research and developments in the treatment of gastrointestinal diseases, particularly highlighting the unique product "Fengliao Stomach and Intestine Kang Granules" from Hainan Haiyao Co., Ltd [1][2]. Group 1: Company Developments - Hainan Haiyao presented its unique traditional Chinese medicine product, Fengliao Stomach and Intestine Kang Granules, at the conference, which has shown promising results in clinical evaluations [1][2]. - The clinical study of Fengliao Stomach and Intestine Kang Granules demonstrated its effectiveness in treating adult acute diarrhea, showing a trend of better efficacy compared to the control group [2]. - The product has received multiple registrations and certifications, including five registration approvals and two invention patents, and has been recognized in twelve treatment guidelines [2]. Group 2: Market Trends - The sales of digestive system medications in China's urban retail pharmacies have shown steady growth, with a rebound in the first quarter of 2025 reaching nearly 15 billion yuan, a year-on-year increase of 2.29% [3]. - The market for traditional Chinese medicine in digestive diseases has remained stable, with significant growth in specific categories, such as stomach medications, which accounted for 24.09% of the market share [3]. - The increasing willingness of consumers to use natural and low-side-effect traditional Chinese medicine products is expected to enhance the market prospects for Hainan Haiyao's flagship products [3]. Group 3: Research and Development - Hainan Haiyao has established a robust R&D system, focusing on innovative drugs, formulations, and traditional Chinese medicine, with significant investments in major disease areas [5][6]. - The company has invested 397 million yuan in R&D over the past three years, with 124 million yuan allocated in 2024, representing 12.48% of its revenue [5]. - Two key innovative drugs, Fluorofenone and Painegabin, are currently in Phase II clinical trials, indicating the company's commitment to advancing its drug development pipeline [6].

Core Viewpoint - Hainan Haiyao (000566.SZ) announced uncertainty regarding the success of clinical trials for its innovative drugs, Paiengabin and Fluorofenidone, and their potential approval by the National Medical Products Administration [1] Group 1 - The company held an investor communication event on May 24, 2025, to discuss the clinical status and characteristics of its innovative drugs [1] - The future success of the clinical trials for Paiengabin and Fluorofenidone is uncertain, as is the likelihood of receiving market approval [1] - The company commits to timely information disclosure regarding the progress of its innovative drugs [1]

Group 1: Clinical Trials and Results - The company is conducting Phase IIa clinical trials for the drug Paiengabin, with 12 subjects enrolled in the first dose group, showing a 25.47% reduction in seizure frequency over 28 days compared to baseline [5] - In Phase I clinical studies, Paiengabin demonstrated linear pharmacokinetics across doses of 2.5-25 mg, with no serious adverse events reported [3][4] - The Phase IIa trial results are still blinded, and final efficacy data will be available post-unblinding [5] Group 2: Drug Characteristics and Comparison - Paiengabin is a KCNQ potassium channel agonist, designed to overcome the limitations of the previously marketed drug Retigabine, which was withdrawn due to safety concerns [6] - Non-clinical studies indicate that Paiengabin has superior chemical stability and better distribution in the brain compared to Retigabine, enhancing its efficacy against epilepsy [7] Group 3: Future Development and Market Strategy - The company plans to explore expanding Paiengabin's indications based on Phase II clinical outcomes and market demand, potentially including severe depression caused by KCNQ mutations [9] - The patent for Paiengabin is held by the Shanghai Institute of Materia Medica, with exclusive rights for clinical development and commercialization in mainland China [9] - The company is considering international rights transfer for Paiengabin, depending on the outcomes of the Phase II trials [9] Group 4: Fluorofenone Clinical Trials - Fluorofenone's Phase I clinical trials have shown good safety and tolerability in healthy subjects, with adverse events primarily mild to moderate [10] - The Phase II mid-analysis for Fluorofenone included 156 subjects, with a 55.6% reduction in Ishak fibrosis scores after 48 weeks [11] - The company anticipates entering Phase III clinical trials for Fluorofenone in the second half of 2025, with the drug included in the list of breakthrough therapies by the National Medical Products Administration [11]

Core Viewpoint - Hainan Haiyao Co., Ltd. is accelerating its transformation into an innovative R&D pharmaceutical manufacturer, focusing on the development of new drugs and leveraging the Hainan Free Trade Port policies to enhance its product pipeline and contribute to public health [2][3][4]. Group 1: Innovation and R&D - The company has made significant progress with two new drugs, Fluorofenidone and Paenangin, marking a shift towards innovative drug development [2]. - Hainan Haiyao is committed to developing strategic emerging industries, establishing platforms for large molecule CDMO and national-level testing, and expanding its pipeline for rare and prevalent diseases [2][4]. - The company has increased its R&D investment and has achieved notable success in the generic drug sector, with 34 specifications of 16 products passing consistency evaluations since 2021 [4]. Group 2: International Collaboration and Product Introduction - Hainan Haiyao is actively introducing high-quality foreign products to enrich its product pipeline and enhance medical service levels, establishing partnerships with international biopharmaceutical companies [3]. - The company is negotiating with several global pharmaceutical giants to select products with advanced technology and significant market potential for introduction into China [3]. Group 3: Talent Development and Research Infrastructure - Hainan Haiyao has recruited over 90 high-level R&D talents from prestigious universities both domestically and internationally, establishing a new drug R&D system that integrates production, learning, and research [3]. - The company has set up specialized teams for overseas product introduction and technical analysis to accelerate the integration of advanced biopharmaceutical products [3].

Group 1: Collaboration and Research Development - The company collaborates with China Pharmaceutical University to establish a joint laboratory focused on innovative and generic drug development, aiming to enhance the scientific reliability and authority of new drug research [2] - The joint laboratory is currently in the early stages of drug screening and optimization, working on clinical candidate discovery and the establishment of an in vitro bioactivity evaluation platform [2] Group 2: Clinical Trials and Drug Development - The company is conducting Phase IIa clinical trials for the drug Paenagabin, with 70 cases enrolled in Phase Ia and 20 cases in Phase Ib [4] - Paenagabin is positioned as a me-better drug compared to Retigabine, which was withdrawn from the market due to stability and safety issues; Paenagabin shows higher activity and better distribution in the brain [3] - The company plans to expand the indications for Paenagabin based on Phase II clinical results and market demand, potentially including severe depression caused by KCNQ mutations [3][4] Group 3: Future Prospects and Market Strategy - The company anticipates entering Phase III clinical trials for the drug Fluorofenidone in the second half of 2025, which has been included in the list of breakthrough therapies by the National Medical Products Administration [5] - Fluorofenidone is expected to expand its indications to include patients with liver fibrosis caused by metabolic liver diseases, depending on clinical trial outcomes [5][6] Group 4: Shareholder Information - The reduction of shares by Yunnan International Trust is a passive action based on prior agreements and will not affect the company's long-term operations and development [6]