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资讯 GOOD NEWS
Recently, Hybio Pharmaceutical Co., Ltd. Pingshan Branch has successfully completed the on-site inspection by the U.S. Food and Drug Administration (FDA) with a zero-deficiency conclusion (NAI, No Action Indicated). This is a special joint inspection conducted by the FDA targeting drug-device combination products, featuring broader regulatory coverage and stricter inspection criteria than routine pharmaceutical inspections. This marks the third time the Pingshan Branch has passed an official FDA on-site inspection, signifying that the base’s quality system compliance capability has reached a new level.
Three-Base Synergy
To date, all three core segments of Hybio Pharmaceutical — the Longhua Headquarters R&D Laboratory, the Wuhan API Manufacturing Base, and the Pingshan Preparation Manufacturing Base — have passed FDA on-site inspections with zero deficiencies. The Company has established a full-chain international quality compliance system covering R&D, API manufacturing and preparation manufacturing, encompassing both pharmaceutical products and drug-device combination products.
Quality for Global Reach
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Different from routine pharmaceutical cGMP inspections, this inspection complies with the dual requirements of pharmaceutical cGMP and medical device quality systems. The inspection scope covers modules including material management and control, preparation manufacturing processes, device assembly validation, design and development, full-lifecycle product risk management and control, and product traceability systems. The FDA inspection team conducted in-depth verification of core priorities such as cross-system process alignment, cross-contamination and cross-risk prevention and control, and data integrity, with significantly enhanced inspection depth and technical complexity.
Powering Overseas Expansion
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Facing high-standard regulatory requirements, the quality management system of the Pingshan Branch operated stably, full-process controls were implemented in a standardized and orderly manner, and all records were complete and traceable. The inspection was ultimately passed with zero deficiencies, fully demonstrating the Company’s compliance governance capacity for complex product modalities.
As a key component of the Company’s full industrial chain layout, the three bases have respective strategic focuses and create synergies:
- The Longhua Headquarters R&D Laboratory has built an R&D quality control system in line with international regulatory norms, consolidating the quality foundation at the R&D stage for the global filing of innovative drugs.
- The Wuhan API Manufacturing Base is equipped with large-scale peptide API production capacity. Its zero-deficiency (NAI) FDA inspection pass ensures compliant supply of API products to global markets.
- The Pingshan Preparation Base undertakes preparation manufacturing and the commercialization of drug-device combination products. Having passed various types of FDA on-site inspections on multiple occasions, it possesses mature international manufacturing and quality compliance capabilities.
Over the years, the Company has always upheld the development philosophy of "Quality First", continuously benchmarked against the world’s highest regulatory standards to build an integrated quality management system, and embedded compliance control requirements into the full-lifecycle processes of R&D, manufacturing, quality control and product release. Passing FDA inspections with zero deficiencies (NAI) across multiple bases, multiple product lines and multiple rounds represents full recognition of the Company’s full-industrial-chain quality system by regulatory authorities. It will also continuously underpin the advancement of the Company’s globalization strategy, and build a solid compliance barrier for more innovative peptide products and drug-device combination products to expand into overseas markets going forward.
关于翰宇药业
深圳翰宇药业股份有限公司（股票代码：300199）是深耕多肽创新领域二十余年的国家高新技术企业，专注于创新多肽药物的研发、生产与全球化销售。公司搭建了覆盖全球主流代谢靶点的完整管线，涵盖GLP-1单靶点、多靶点创新药及多款全球重磅多肽品种，已形成从原料药到制剂、从研发到商业化、从中国市场到全球市场的全产业链布局。包括但不限于GLP-1R/GIPR/GCGR三重受体激动剂原创新药、瑞他鲁肽、替尔泊肽、司美格鲁肽、利拉鲁肽等。
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