派恩加滨片获得国家药品监督管理局的药物临床试验批准后，海口市制药厂有限公司已在健康受试者中 完成I期临床试验，并于2023年启动了"评价派恩加滨片添加治疗局灶性癫痫患者多次口服给药后的安全 性、耐受性、有效性和药代动力学特征的随机、双盲、安慰剂对照、剂量递增的Ⅱa期临床试验"。该研 究主要目的是评估派恩加滨片在局灶性癫痫受试者中多次口服给药后的安全性和耐受性。该研究于近日 完成了试验揭盲。结果显示派恩加滨片在局灶性癫痫患者中的安全性和耐受性良好，总体风险可控。探 索性疗效指标初步显示，派恩加滨片在局灶性癫痫患者人群中连续用药8周能有效降低患者的癫痫发作 频次。后续相关各方还需根据方案及统计分析计划的规定开展全面深入分析，并完成临床试验总结报 告。 格隆汇1月9日丨海南海药（维权）(000566.SZ)公布，全资子公司海口市制药厂有限公司与中国科学院 上海药物研究所联合研究开发的创新药派恩加滨项目，于近日完成了Ⅱa期临床试验，初步研究结果显 示达到主要及次要临床终点。派恩加滨属于化药1类，为新型抗癫痫药物，新一代KCNQ钾通道激动 剂，目前全球尚无上市品种，本品可用于难治性癫痫的治疗。 ...

另外，云南国际信托拟减持公司股份不超过1297.37万股，占公司总股本的1%。 人民财讯1月9日电，海南海药（000566）1月9日公告，公司全资子公司海口市制药厂有限公司与中国科 学院上海药物研究所联合研究开发的创新药派恩加滨项目，于近日完成了Ⅱa期临床试验，初步研究结 果显示达到主要及次要临床终点。派恩加滨属于化药1类，为新型抗癫痫药物，新一代KCNQ钾通道激 动剂，目前全球尚无上市品种，本品可用于难治性癫痫的治疗。本次仅为派恩加滨完成中国Ⅱa期临床 试验结果分析，后续尚需完成Ⅱb期及Ⅲ期临床试验，并经国家药监局批准后方可上市。 ...

海南海药公告，全资子公司海口市制药厂有限公司与中国科学院上海药物研究所联合研究开发的创新药 派恩加滨片近日完成了Ⅱa期临床试验，初步研究结果显示达到主要及次要临床终点。派恩加滨属于化 药1类，为新型抗癫痫药物，新一代KCNQ钾通道激动剂，目前全球尚无上市品种，本品可用于难治性 癫痫的治疗。 ...

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]