On April 10, 2026, according to the latest announcement from the National Medical Products Administration (NMPA), Doxercalciferol Injection, developed by Nanjing Heron Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Nanjing Heron Pharmaceutical Science and Technology Co., Ltd. (hereinafter referred to as “Heron Pharma”), has been approved for marketing.
Figure 1: Delivery Information of the Approval Document for Doxercalciferol Injection Released by NMPA
The core pathophysiology of SHPT involves impaired renal function, which leads to active vitamin D deficiency and disordered calcium and phosphate metabolism, thereby stimulating the parathyroid glands to oversecrete parathyroid hormone (PTH). Excess PTH not only erodes bone, causing bone pain and fractures, but also exacerbates cardiovascular calcification, thereby significantly increasing mortality risk.
Accordingly, hypocalcemia, hyperphosphatemia, and active vitamin D deficiency constitute the core pathophysiological features of SHPT. Current pharmacological therapies achieve fundamental control of SHPT by specifically correcting these abnormalities.
Heron Pharma is proud to announce the launch of Rongfeida® (融菲达®) Doxercalciferol Injection. As a novel vitamin D receptor agonist (VDRA) with a 1α-(OH) D2 prodrug structure that undergoes one-step hepatic conversion, it is designed specifically for patients with renal insufficiency, it offers enhanced precision and stability, improved safety, prolonged action, and applicability across the full calcium spectrum. It is the only VDRA that combines the triple advantages of low dosage, high efficacy, and favorable safety profile, helping to address the long-standing dilemma in SHPT management.
In the current treatment landscape, Doxercalciferol, leveraging the gradual onset of action of its prodrug and the tissue selectivity of the VD₂ pathway, achieves “bidirectional regulation” of serum calcium levels—effectively correcting hypocalcemia while preventing excessive serum calcium evaluation. It is applicable across the full calcium spectrum, requires no patient stratification, and simplifies clinical management.
The clinical value of Doxercalciferol is not merely theoretical. In major healthcare markets including the United States, Japan, and Europe, Doxercalciferol has nearly two decades of real-world clinical experience.
United States: In dialysis centers, Doxercalciferol is frequently used as a first-line VDRA, and is particularly preferred for patient populations at higher risk of hypercalcemia.
Japan: As one of the markets with the most extensive use of active vitamin D, Doxercalciferol has been adopted by Japanese experts as a first-line treatment for SHPT in clinical practice because of its “low toxicity risk.”
Mortality benefit: A cohort study enrolling 7,731 hemodialysis patients demonstrated that Doxercalciferol and Paricalcitol were nearly equivalent in reducing mortality, and both were significantly superior to Calcitriol.
Heron Pharma focuses on the R&D for a full portfolio of high-end generic calciferol series drugs and serves as a leading global specialized supplier of active vitamin D drugs. From in-house API production to drug manufacturing, it has achieved integrated full-process control, ensuring drug quality and stable supply from the source. The launch of Rongfeida® (融菲达®) Doxercalciferol Injection reflects Heron Pharma’s deep accumulation and robust R&D capacities in the field of active vitamin D drugs.
Heron Pharma’s Vitamin D Analog Series Products:
Post time: Sep-17-2026