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资讯 2026.11
Expanding Orthopedic Footprint
Broadening Product Pipeline Portfolio
Hybio Pharmaceutical Co., Ltd. (Stock Code: 300199) has received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA). Teriparatide (H) Injection (specification: 2.4ml:0.6mg, registration classification: Class 3 chemical drug) has been officially approved for marketing. As the first teriparatide generic product approved via the chemical synthesis route in China, this product marks another milestone in the industrialization of the Company’s peptide synthesis technology, and brings a new high-quality treatment option to the domestic osteoporosis treatment field.
About Teriparatide
Safeguarding Bone Health
Teriparatide is a recombinant human parathyroid hormone (1-34) analog. As a clinically recognized bone formation stimulant, it is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures. It can significantly reduce the risk of vertebral and non-vertebral fractures in patients, and is one of the core treatment regimens for high-risk osteoporosis populations.
Previously, all teriparatide FDF marketed in China were declared via the biologics pathway. This time, Hybio Pharmaceutical submitted the registration application as a Class 3 chemical drug and successfully obtained approval, achieving the first breakthrough in the chemical synthesis development pathway of this product in China.
01
Building Differentiated Advantages
Relying on the Company’s years-deep peptide solid-phase synthesis technology platform, this product is manufactured via a full chemical synthesis process. Compared with the biological expression pathway, it has prominent advantages in product purity control, batch-to-batch quality consistency and large-scale production efficiency, enabling the delivery of pharmaceutical products with more controllable quality and more stable supply for clinical use.
As a backbone enterprise with a full industrial chain layout of peptide drugs in China, Hybio Pharmaceutical possesses a complete technical system and mature industrialization experience in peptide chemical synthesis, formulation development, large-scale production and other links. The successful approval of Teriparatide (H) Injection is another authoritative verification of the strength of the Company’s core technology platform, and lays a solid foundation for the differentiated development of more peptide products in the future.
02
Enhancing Orthopedic Sector Layout
The marketing approval of Teriparatide (H) Injection further enriches the Company’s peptide FDF product pipeline, formally enters the orthopedic osteoporosis treatment track, and effectively enhances the Company’s market competitiveness in the field of orthopedic treatment.
In recent years, the Company has continuously expanded its therapeutic boundaries around its core peptide technology platform. Its product pipeline has covered multiple areas with strong clinical demand, including metabolic diseases, digestive tract diseases and orthopedics, with continuously releasing synergies between R&D and commercialization. Going forward, the Company will fully advance the pre-marketing preparation and commercial promotion of the product, to facilitate its rapid launch and benefit more patients.
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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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