Hainan Haiyao Co., Ltd.

Company Profile

(I) Product Advantages The company has developed a robust product portfolio, holding 162 drug registration approvals. Among its marketed formulations, 18 products have passed (or are deemed to have passed) generic drug consistency evaluations. Building on this high-quality foundation, the company will fully integrate resources, revitalize dormant approvals, increase R&D investment, and launch new products to enhance competitiveness. Its Class I innovative drug for anti-hepatic fibrosis, Fluorfenidone Capsules, is currently undergoing Phase II clinical data analysis, with plans to initiate Phase III trials. Fluorfenidone—a novel anti-fibrotic small molecule of the pyridone class—is positioned as a me-better drug compared to pirfenidone (PFD), the international standard for pulmonary fibrosis. It targets chronic hepatitis B–induced liver fibrosis, an area with no globally approved anti-fibrotic drugs, thus addressing a significant unmet clinical need and offering new hope for patients. Additionally, the company’s Class I innovative anti-epileptic drug, Painingabine Tablets, is in Phase II clinical development. As a next-generation therapy targeting KCNQ channels, it aims to treat refractory epilepsy. With a clear mechanism and novel target, Painingabine is expected to provide a new therapeutic option for patients with challenging forms of epilepsy. (II) R&D Advantages The company has established multiple research institutes, including the Haikou Formulation Research Institute, Haikou Traditional Chinese Medicine Research Institute, and Chongqing API Research Institute. Its R&D team comprises over 100 professionals, including one national-level innovative talent, a chief scientist, four PhD holders, and 23 master’s degree researchers. Team members hail from prestigious institutions such as Tsinghua University/Peking Union Medical College, Peking University Health Science Center, China Pharmaceutical University, Shenyang Pharmaceutical University, Beijing University of Chemical Technology, and Nanjing University of Chinese Medicine. Through collaborations with leading domestic and international universities and research institutes, the company leverages external scientific resources effectively. It has established a joint laboratory with China Pharmaceutical University and maintains deep partnerships with Central South University and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. These collaborations support the development of both innovative and generic drugs, enable resource sharing, and foster an integrated industry-academia-research R&D ecosystem. (III) Industrial Chain Advantages The company operates three major production bases in Jiangsu, Chongqing, and Hainan, forming a complete intermediate → API → formulation supply chain. This integrated structure provides a differentiated competitive edge by reducing production costs, improving product quality, and enhancing resilience to challenges like centralized procurement and environmental regulations. This robust industrial foundation supports the company’s focus on high-end anti-infective drugs and strengthens its emergency supply guarantee capabilities, forming an “emergency supply safeguard” system. Centered around its flagship product “Fengliao Changweikang,” the company combines classic prescriptions with modern technology to develop a series of gastrointestinal drugs, expanding into the health and wellness sector and offering consumers a modern approach to healthy living. Continuous optimization of processes and technologies ensures sustained competitive advantage for key products. (IV) Drug Quality Advantages The company adheres to a strict quality policy: “High standards, strict requirements, producing medicines that the public can trust.” It maintains a quality assurance and production management system aligned with international standards, achieving a 100% pass rate in GMP inspections by the National Medical Products Administration. Guided by GMP norms and product-specific requirements, the company continuously improves its systems for drug R&D, facility design, quality management, and end-to-end production control. This ensures consistent, stable manufacturing of drugs that meet intended uses, approved processes, and quality standards. The experienced manufacturing and quality management team, equipped with advanced production technology and high-standard requirements, effectively guarantees product quality and reliability.