--- title: "HAINAN HAIYAO: Class I new drugs lead the way in dual lines, and the success of Phase II clinical trials highlights growth potential" type: "News" locale: "en" url: "https://longbridge.com/en/news/287140856.md" description: "HAINAN HAIYAO (stock code: 000566) has achieved key results in the Phase II clinical trial of Fluorofenidone capsules, marking a new breakthrough in its innovative transformation. This drug targets liver fibrosis, has initiated Phase III clinical trials, and has been included in the list of breakthrough therapies by the National Medical Products Administration, enjoying accelerated approval policies. It is expected to fill a global treatment gap and enhance the company's core competitiveness" datetime: "2026-05-21T01:36:33.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/287140856.md) - [en](https://longbridge.com/en/news/287140856.md) - [zh-HK](https://longbridge.com/zh-HK/news/287140856.md) generator: "portal-rs" --- # HAINAN HAIYAO: Class I new drugs lead the way in dual lines, and the success of Phase II clinical trials highlights growth potential HAINAN HAIYAO (stock code: 000566), as a leading enterprise in the pharmaceutical industry of Hainan Province, has been deeply cultivated since its establishment in 1965. After nearly sixty years of development, it went public on the Shenzhen Stock Exchange in 1994, achieving a leap in capitalization. Following a strategic restructuring with Sinopharm in 2020, it has accelerated its transformation towards "innovation-driven" by leveraging the resource advantages of central enterprises, establishing an industrial pattern covering diverse fields such as chemical innovative drugs and modern traditional Chinese medicine. With the collaborative layout of its intermediates and raw material drug bases in Chongqing and Jiangsu, as well as its formulation production base in Hainan, and the advantages of a complete industrial chain for specialty antibiotics, the company is solidifying its foundation in generic and specialty drugs while vigorously advancing into the high-value-added innovative drug sector. The key achievements of two Class 1 innovative drugs from HAINAN HAIYAO mark a new breakthrough in its innovative transformation, with long-term value growth anchors becoming increasingly clear. In the innovative drug research and development track, HAINAN HAIYAO is guided by unmet clinical needs, precisely targeting two high-barrier areas: liver fibrosis and neurological diseases. Its fluorofenidone capsules and paenibacillus tablets have achieved success on dual fronts, filling global treatment gaps with their rarity and innovation, becoming an important support for the company's core competitiveness. Fluorofenidone Capsules: A Breakthrough Treatment Leading Anti-Fibrosis Innovation Fluorofenidone capsules, a Class 1 new chemical drug jointly developed by HAINAN HAIYAO and Central South University with complete independent intellectual property rights, recently achieved key results in the Phase II clinical trial for the treatment of chronic hepatitis B liver fibrosis. According to the evaluation by the Independent Data Monitoring Committee (IDMC), it successfully reached the pre-set primary research endpoint and has initiated preparations for the Phase III clinical trial, accelerating the research and development process. Notably, this drug was included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) in February 2025. This recognition not only confirms its significant advantages in efficacy and safety compared to existing therapies but also allows it to enjoy policy benefits such as priority guidance and expedited approval from the CDE, significantly shortening the time to market. Currently, there are still no effective chemical drugs for liver fibrosis globally, with clinical treatment largely relying on traditional Chinese medicine, whose efficacy remains unclear. As liver fibrosis is an essential stage in the progression of chronic liver disease to end-stage liver disease, effective therapeutic drugs targeting the fibrosis process are relatively scarce, and clinical demand is extremely urgent. Fluorofenidone, as a pyridone small molecule compound, is an upgraded version of the anti-pulmonary fibrosis drug pirfenidone, possessing a broad-spectrum anti-fibrosis mechanism that can inhibit the fibrosis process through multiple targets and pathways, providing a new treatment path for the reversal of liver fibrosis. This Phase II clinical trial verified that fluorofenidone capsules combined with tenofovir disoproxil fumarate tablets for the treatment of chronic hepatitis B liver fibrosis have clear efficacy, with the optimal dosage determined, and the efficacy remains consistent among patients with different baseline treatment backgrounds. In terms of safety, the incidence of adverse reactions is comparable to that of the placebo, with no dose-related risks, and overall safety is controllable, laying a solid foundation for the Phase III confirmatory trial. In the future, this drug can be further expanded to indications such as fatty liver and alcoholic liver disease, leveraging its broad-spectrum anti-fibrosis characteristics to cover a wider patient population, and is expected to become a heavyweight product in the global anti-fibrosis field Painegabin Tablets: Innovative Target Opens New Pathways for Epilepsy Treatment The company's wholly-owned subsidiary Haikou Pharmaceutical Factory, in collaboration with the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, has developed the Class 1 new drug Painegabin Tablets, which recently successfully completed Phase IIa clinical trials and achieved primary and secondary clinical endpoints, marking a milestone in the treatment of focal epilepsy with Painegabin Tablets. As a new generation KCNQ potassium channel agonist, the proposed indication for this drug is focal epilepsy that cannot be controlled or tolerated by other antiepileptic drugs. Currently, there are no products targeting the same site available on the global market, making it a new target antiepileptic drug that breaks existing treatment limitations with its novel mechanism of action. Currently, about 30% of epilepsy patients do not respond well to existing drug treatment regimens, indicating a significant unmet need in the field of epilepsy treatment. Painegabin Tablets exert their antiepileptic effects by precisely regulating neuronal excitability, effectively overcoming the risk of pigment deposition compared to the withdrawn first-generation drugs targeting the same site, with superior brain distribution and better drug activity, as well as significantly improved safety and tolerability. The Phase IIa clinical trial employed a randomized, double-blind, placebo-controlled, dose-escalation design, with results showing no serious adverse reactions. After 8 weeks of continuous medication in the three dosage groups, patients experienced a significant reduction in seizure frequency compared to the baseline period, demonstrating a dose-dependent relationship and confirming the scientific basis and clinical therapeutic potential of its mechanism of action. Currently, the drug holds a compound invention patent and a PCT international patent, establishing a technological barrier covering Europe and the United States, providing assurance for subsequent international layout. The company will accelerate the advancement of Phase IIb and III clinical trials for Painegabin Tablets, while also planning to expand into the fields of pediatric epilepsy and comorbid depression, further broadening the indication boundaries, with the potential to provide safer and more effective treatment options for millions of patients with neurological diseases worldwide, becoming a core driver of the company's international strategy. Collaboration between Industry, Academia, and Research + Policy Empowerment Builds a Long-term Ecological System for Innovative Development The breakthrough progress of two Class 1 innovative drugs is not an isolated achievement but a necessary result of HAINAN HAIYAO's long-term commitment to building an innovation system and deepening collaboration between industry, academia, and research. The company leverages its cooperative advantages with top research institutions such as the Shanghai Institute of Materia Medica and Central South University to establish a closed-loop innovation model of "basic research - systematic R&D - achievement transformation." Universities and research institutes focus on core aspects such as early drug screening and lead compound research, while the company undertakes achievement transformation oriented towards product launch, with pilot tests, mass production, and other industrialization verification and clinical research work progressing steadily, forming an efficient collaborative innovation engine. At the same time, the company attracts high-level research talents, continuously improving its innovative R&D system to provide solid support for pipeline expansion. With a clear innovation strategy, solid R&D strength, and the added benefits of free trade port policies, HAINAN HAIYAO is steadily transforming from a "combination of imitation and innovation" to an innovative pharmaceutical enterprise, helping to establish itself as a benchmark enterprise for biomedical innovation and development in Hainan's free trade port. The layout achievements of the two Class 1 innovative drugs have already demonstrated their long-term growth potential. In the future, with the continuous advancement of the research pipeline and industrialization, the company is expected to fill global clinical gaps and serve a large number of patients while creating stable and sustainable value returns for shareholders, leading the high-quality development of Hainan's pharmaceutical industry into a new stage ### Related Stocks - [000566.CN](https://longbridge.com/en/quote/000566.CN.md) ## Related News & Research - [Knight Therapeutics Announces Regulatory Approval of TAVALISSE® in Colombia](https://longbridge.com/en/news/297703563.md) - [Ships adopt makeshift anti-drone defences as Black Sea attacks intensify](https://longbridge.com/en/news/297784645.md) - [REG - Bytes Technology Grp - Holding(s) in Company](https://longbridge.com/en/news/297621542.md) - [Cupid share price in focus on board approval to set up manufacturing venture in South African](https://longbridge.com/en/news/297455298.md) - [08:46 ETAsendia USA Helps Retailers Navigate New EU Customs Rules with Free e-Book and Webinar](https://longbridge.com/en/news/297788892.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**