Core Viewpoint - The establishment of the Hainan Free Trade Port will provide a broader platform for companies, particularly benefiting the research and development of high-end complex formulations, biological drugs, and specialty traditional Chinese medicine products [1] Group 1: Policy Benefits - The policies supporting pharmaceutical companies are comprehensive and systematic, with direct benefits such as exemptions from import tariffs, value-added tax, and consumption tax, significantly reducing operational costs [2] - The Hainan Free Trade Port is creating a complete industrial innovation ecosystem, offering financial rewards for various stages of drug development and clinical research, thus supporting the entire chain from research to manufacturing [2] - The company has already benefited from these policies, with its new drug, Fluorofenone capsules, being included in the list of breakthrough treatment varieties by the National Medical Products Administration [2] Group 2: Innovation and Market Strategy - The company has restructured its R&D system, forming a 92-member team and developing advanced technology platforms, achieving significant progress in new drug development and leading market share in certain products [3] - The company is actively participating in national procurement and has seen growth in exports of raw materials and formulations, indicating a successful market expansion strategy [3] - The company is focusing on internal research and external introduction to enrich and optimize its product pipeline [3] Group 3: Future Development Plans - The company aims to leverage the policy dividends of the Free Trade Port to drive high-quality development, adjusting its business structure to focus on stable pharmaceutical basics, strengthening traditional Chinese medicine, and enhancing medical device development [4] - The company plans to enhance the efficiency of the entire industry chain through lean production management and aims to penetrate global markets, moving beyond domestic competition [5] - The establishment of a cross-border e-commerce platform is intended to facilitate the import of foreign products without registration and promote comprehensive domestic sales, creating a new growth engine [5]

● 本报记者 刘丽靓 "海南自贸港全岛封关运作，对公司来说将迎来更广阔舞台。"新兴际华集团旗下海南海药股份有限公司 董事长王建平在接受中国证券报记者专访时表示，相关政策出台将对公司研发的高端复杂制剂、生物药 以及特色中药产品带来利好。同时依托博鳌乐城先行区特许药械政策，缩短全球创新产品在国内的上市 时间，将有利于公司下一步引进更多国外优质创新产品，先一步占领市场。 构筑医药产业新高地 "相关政策对医药企业的支持是全方位、系统性的。"王建平坦言，最直接的利好体现在税收方面，如对 于部分货物免征进口关税、进口环节增值税和消费税等。"这些政策显著降低了公司的运营成本。" 但王建平看重的远不止于此。在他看来，自贸港真正的价值在于构建了完整的产业创新生态。"从研发 端40万至1000万元的阶段性资金奖励，到临床端博鳌乐城真实世界数据研究的政策突破，再到'乐城研 用+海口生产'模式更给予最高500万元品种奖励，海南正在形成'研发-临床-制造-转化'全链条支持体 系。"王建平说。 展望"十五五"，王建平表示："我们将充分利用自贸港政策红利，推动企业迈向高质量发展。" 王建平表示，公司将加快业务结构调整，形成"稳定化药基本盘 ...

格隆汇12月15日丨海南海药(000566.SZ)在投资者互动平台表示,公司抗肝纤维化 1 类新药氟非尼酮胶囊 完成Ⅱ期临床试验期中分析，目前氟非尼酮III期临床已开始筹备工作。抗癫痫1 类新药派恩加滨，正在 开展Ⅱa 期临床研究，目前受试者已全部出组，正在开展相关数据分析。 ...

Core Viewpoint - Hainan Haiyao has been awarded the "ESG Carbon Path Practitioner Award" for its outstanding practices in environmental, social, and governance (ESG) areas, highlighting its commitment to sustainable development and social responsibility [1][4]. Group 1: Environmental Practices - The company implements an EHS strategic goal, focusing on clean production, resource conservation, and green low-carbon transformation, significantly reducing energy consumption and pollutant emissions [4]. - During the reporting period, Hainan Haiyao did not experience any major environmental pollution incidents, demonstrating effective energy-saving and emission-reduction results [4]. - The company is continuously pursuing circular transformation to achieve carbon neutrality [4]. Group 2: Social Responsibility - Hainan Haiyao emphasizes employee health and safety, achieving zero work-related injuries and fatalities for three consecutive years, maintaining a million-hour death rate of 0% [4]. - The company actively conducts occupational disease health checks covering nearly a thousand employees and provides professional medical services through its medical sector [4]. Group 3: Governance Structure - Hainan Haiyao has established a scientific compliance system, revising its compliance management measures to enhance decision-making transparency and effectively address grievances [4]. - The company has introduced 24 new anti-corruption measures to ensure transparency in power supervision and safeguard business integrity [4]. Group 4: Future Outlook - The company plans to continue implementing its "14th Five-Year" strategic plan, focusing on high-quality development, deepening green low-carbon transformation, and innovative research and development [5]. - Hainan Haiyao aims to accelerate its position as a leading domestic manufacturer of active pharmaceutical ingredients and intermediates while strengthening its ESG integration practices [5]. - The new journey of Hainan Haiyao will further consolidate its ESG leadership and create greater environmental and social value [5].

Core Viewpoint - Hainan Haiyao Co., Ltd. has transformed its R&D innovation system, focusing on both innovative and generic drug development, while actively expanding its product lines in the health sector through a combination of in-house R&D and external partnerships [1][2]. Group 1: R&D and Product Development - The company has significantly increased its R&D investment, adhering to a strategy of "combining imitation and innovation," leading to substantial progress in generic drugs and formulations [1]. - Recent achievements include the successful consistency evaluation of injectable cefoperazone sodium, enhancing market competitiveness, and the registration approval of linezolid tablets, expanding the raw material drug product line [1]. - Since 2021, Hainan Haiyao has passed consistency evaluations for 18 varieties and 38 specifications of generic drugs, improving overall drug quality [1]. Group 2: Innovative Drug Development - Hainan Haiyao is advancing two Class 1 innovative drugs, including the anti-fibrosis drug fluvoxamine capsules, which has reached the primary endpoint in Phase II clinical trials and is set to enter Phase III trials [2]. - The company is also developing an anti-epileptic drug, paenagabin tablets, with a significant patient base in China, where approximately 9 million people suffer from epilepsy, indicating a substantial market opportunity [2]. Group 3: International Collaboration - Leveraging the advantages of the Hainan Free Trade Port, Hainan Haiyao has established exclusive distribution agreements with AFT Pharmaceuticals Ltd., enhancing its product pipeline in the health sector [3]. - The collaboration includes innovative dietary supplements and a long-acting injection for schizophrenia, expanding the company's offerings in the neuropsychiatric field [3]. Group 4: Traditional Chinese Medicine - Hainan Haiyao has a long history of exploring traditional remedies, developing modern strategies to enhance the value of classic formulas [4]. - The company has achieved multiple registrations and patents for its flagship product, Fengliao Gastrointestinal Health series, and plans to strengthen its gastrointestinal product line [4]. Group 5: Future Outlook - The company aims to continue selecting traditional Chinese medicine projects and establish a modern production platform, fostering the growth of its TCM segment [4]. - Hainan Haiyao is well-positioned to integrate classic formulas with modern technology, expanding its reach in the health sector and providing innovative health solutions to consumers [4][5].

Group 1 - The 2025 American Society of Clinical Oncology (ASCO) annual meeting showcased over 70 original research results from China, highlighting the increasing recognition of Chinese innovative drugs in the capital market [1] - Chinese innovative drug companies are entering a profitable phase, with significant business development (BD) transactions contributing to substantial profit returns, leading to a systematic increase in valuations for innovative drugs [1][2] - The number of original innovative drugs developed by Chinese companies has surged from 124 in 2015 to 704 in 2024, positioning China as a global leader in original drug research and development [1] Group 2 - From 2015 to 2024, the number and value of outbound licensing transactions by Chinese pharmaceutical companies have consistently increased, reaching a peak of $51.9 billion in total transaction value in 2024 [2] - Notable transactions include the $6.05 billion deal between 3SBio and Pfizer for the PD-1/VEGF dual antibody drug, setting a record for Chinese innovative drugs entering international markets [2] - The leading position of Chinese companies in new technologies such as bispecific antibodies and antibody-drug conjugates is expected to drive further significant BD transactions in the coming years [2] Group 3 - The recognition of domestic innovative drugs and the influx of large BD deals have heightened investor interest in companies operating in the innovative drug sector [3] - Companies like Hunan Warner Pharmaceutical and Hunan Fosheng Pharmaceutical are actively advancing their innovative drug projects, with several candidates in various stages of clinical trials [3] - Multiple listed companies have reported progress in the innovative drug field, with a significant number of products entering clinical stages, including 24 key products from Changchun High-tech and ongoing trials for new drugs from Hainan Haiyao [3] Group 4 - The innovative drug industry is currently experiencing a dual wave of technological breakthroughs and global expansion, with leading companies expected to drive industry transformation [4] - The development of innovative drugs requires substantial technical accumulation and financial backing, emphasizing the need for professional research and careful selection of quality innovative drug companies for investment [4]

Core Insights - Hainan Haiyao has made significant progress in the development of two innovative drugs: Fluorofenidone capsules for organ fibrosis diseases and Paenagabin tablets for neurological disorders [2][3] - Fluorofenidone capsules have been included in the National Medical Products Administration's list of breakthrough therapies as of February 2025, with Phase I clinical trials confirming safety and tolerability, and Phase II trials achieving primary endpoints [2] - Paenagabin tablets, a new generation KCNQ potassium channel agonist, have shown excellent safety and tolerability in Phase I trials, with ongoing Phase IIa studies [2] Company Strategy - Hainan Haiyao is committed to enhancing its strategic layout in emerging industries, focusing on the development of innovative drugs and increasing R&D investment [3] - The company aims to transform from a "generic-innovative combination" model to an "innovation-driven" development approach, positioning itself as a benchmark for innovative development in Hainan Free Trade Port [3] - Future plans include leveraging the advantages of Hainan Free Trade Port's biopharmaceutical policies to introduce high-end foreign medical products and promote the company's innovative products internationally [3]

Group 1: Financial Performance and Strategy - The company aims to achieve profitability by enhancing R&D efforts and accelerating the launch of new products, with a focus on collaboration with universities and research institutions [1][2] - The company plans to optimize its international business management and deepen market penetration in Southeast Asia, Africa, and Latin America, enhancing its international operational capabilities [2][7] - The company is committed to reducing operational costs through strict budget management and cost-cutting measures [2][7] Group 2: Product Development and Clinical Trials - The company is advancing the clinical trials of its drugs, with the fluorofenone capsule expected to enter Phase III trials in the second half of 2025, having met its primary research endpoints in Phase II [4] - The company is conducting Phase IIa clinical research for the pain relief drug, with ongoing patient recruitment for different dosage cohorts [4][6] - The company is focusing on building a comprehensive product pipeline in the neuropsychiatric field and enhancing its traditional Chinese medicine offerings [3] Group 3: Market Challenges and Responses - The company has experienced a significant decline in sales revenue due to a slowing pharmaceutical market and economic conditions [6][7] - The company is actively participating in national procurement initiatives to maximize market potential and is focusing on key products and markets to drive growth [6][7] - The company acknowledges the challenges posed by strict regulatory requirements in drug approval processes, particularly for new epilepsy medications [5][6]