Abstract : On March 3, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that the clinical trial application for teriparatide injection (acceptance number: CXSL2600294), independently developed by Yifan Pharmaceutical (Shanghai) Co., Ltd., has been formally accepted, and its registration category is Class 3.3 biological products. As the world's first approved bone-forming anti-osteoporosis drug, the domestic research and development process of teriparatide has accelerated again, and it is expected to provide more accessible treatment options for osteoporosis patients at high fracture risk in China.
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I. CDE Acceptance: Domestic Teriparatide Achieves New Progress
On March 3, the CDE (Center for Drug Evaluation) updated its "Accepted Product Information" section, showing that the clinical trial application for teriparatide injection submitted by Yifan Pharmaceutical (Shanghai) Co., Ltd. has been accepted. The drug type is therapeutic biological product, and the application type is new drug. This is an important step for Yifan Pharmaceutical in its strategy for osteoporosis treatment, and also marks the addition of a new player to the domestic teriparatide R&D race.
Teriparatide is a recombinant human parathyroid hormone (1-34) analogue that promotes new bone formation by intermittently stimulating osteoblast activity, thereby significantly increasing bone density and reducing fracture risk. The original drug was developed by Eli Lilly and Company under the brand name "Texacin," and was approved for marketing in the United States in 2002. It was the world's first approved osteogenic anti-osteoporosis drug. It entered the Chinese market in 2011 for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
“Teriparatide has a unique mechanism of action, unlike traditional anti-bone resorption drugs. It can actively ‘rebuild’ bones, hence it is known in the industry as a ‘small cannon’ for osteoporosis treatment,” said an orthopedic expert. “However, the original drug is expensive, and there are only a limited number of companies that have obtained approval in China, so there is still room for improvement in patient accessibility.”
II. Technical Features: A Breakthrough from "Inhibition of Bone Resorption" to "Promotion of Bone Formation"
Teriparatide's core innovation lies in its "bidirectional regulatory" effect on bone metabolism: when administered in small doses and intermittently, it preferentially activates osteoblasts, promoting new bone formation; while continuous administration enhances osteoclast activity, leading to bone loss. This characteristic makes it the only anti-osteoporosis drug currently available that can actively promote bone formation.
Clinical studies have shown that teriparatide can increase lumbar spine bone mineral density by approximately 9% in postmenopausal patients with osteoporosis and significantly reduce the risk of vertebral and non-vertebral fractures. Its indications have been expanded to include primary osteoporosis in men and glucocorticoid-induced osteoporosis, bringing hope of treatment to more patients.
Yifan Pharmaceutical's newly submitted teriparatide injection has undergone optimization in both process and formulation. A company representative stated that the product utilizes independently developed fermentation and purification technologies, which, while ensuring biological activity, enhances the product's stability and uniformity, laying the foundation for subsequent large-scale production.
III. Market Landscape: Accelerated Domestic Substitution and Improved Patient Accessibility
Currently, the domestic teriparatide market is mainly dominated by the original drug "Fotocin" and a few domestic generic drugs. Teriparatide products from companies such as Sinopharm and United Cell have been approved for marketing, breaking the monopoly of the original drug. However, due to the complex manufacturing process and strict clinical requirements, market supply remains relatively limited, and prices remain at a high level.
Yifan Pharmaceutical's teriparatide injection has entered the clinical trial stage, which will further promote the process of domestic substitution. With more companies entering the market, the price of teriparatide is expected to gradually decrease, benefiting more osteoporosis patients. According to the "China Osteoporosis Epidemiology Report," the prevalence of osteoporosis in people over 50 years old in my country is 19.2%, with the prevalence reaching as high as 32.1% in women. The number of patients at high risk of fracture is enormous, and the clinical need is urgent.
"The domestic research and development and launch of teriparatide will not only improve patients' access to medication, but also promote the alignment of my country's osteoporosis treatment level with international standards," said an expert from the Chinese Medical Association's Osteoporosis and Bone Mineral Diseases Branch. "In the future, with the emergence of more innovative therapies, osteoporosis will change from 'incurable' to 'preventable and treatable'."
IV. Corporate Strategy: Yifan Pharmaceutical's Strategic Upgrade from "Generic Drugs" to "Innovative Drugs"
Founded in 2002, Yifan Pharmaceutical initially started with generic drugs such as vitamins and mineral supplements, but has gradually shifted towards innovative drugs in recent years. In addition to teriparatide injection, the company has also invested in several other biopharmaceutical projects, including F-652 for the treatment of graft-versus-host disease and an IL-17A inhibitor for the treatment of psoriasis, forming a diversified pipeline from generic drugs to innovative drugs.
“We have always adhered to the ‘patient-centered’ R&D philosophy, focusing on unmet clinical needs,” said the head of R&D at Yifan Pharmaceuticals. “Teriparatide injection is an important part of our work in the field of osteoporosis. We will accelerate the clinical trial process and strive to make this product available to more patients as soon as possible.”
With the publication of the CDE (Center for Drug Evaluation) acceptance information, Yifan Pharmaceutical's teriparatide injection development progress has once again attracted industry attention. As a new representative of domestically produced teriparatide, the future development of this product is not only related to Yifan Pharmaceutical's strategic layout, but will also profoundly affect the market landscape of osteoporosis treatment in China.
In conclusion , against the backdrop of an accelerating aging population, osteoporosis has become a significant public health issue in China. Teriparatide, as a representative of bone-forming drugs, demonstrates not only the innovative capabilities of the pharmaceutical industry through its domestic research and development and market launch, but also represents a crucial step in improving patient access to medication and enhancing public well-being. We anticipate that Yifan Pharmaceutical's teriparatide injection will achieve excellent results in clinical trials and soon become another important force in the treatment of osteoporosis.

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