NCPC Secures NMPA Approval for Dual-Strength Roxadustat Capsules for Renal Anemia

HEBEI, May 28, 2026 - North China Pharmaceutical Co., Ltd.(NCPC) has received drug registration certificates for its 20mg and 50mg roxadustat capsules from China’s National Medical Products Administration (NMPA). The approval, which automatically qualifies the product under the country’s generic drug quality and efficacy consistency evaluation, grants the company full manufacturing and commercialization rights, marking a major breakthrough in its chronic kidney disease(CKD) anemia treatment portfolio.

China bears a substantial public health burden from CKD, with a 10.8% prevalence rate among adults translating to approximately 130 million affected patients. Renal anemia, one of the most prevalent complications of CKD, severely diminishes patients’ quality of life and significantly increases the risk of cardiovascular events and mortality.

Roxadustat capsules are indicated for anemia caused by chronic kidney disease, covering both dialysis and non-dialysis patient populations. The drug operates by mimicking the body’s hypoxic physiological response to stimulate endogenous erythropoietin (EPO) production while simultaneously improving iron absorption and utilization, enabling effective anemia correction. As an oral therapy unaffected by food intake, it delivers a marked improvement in patient medication adherence compared to traditional injectable alternatives.

The launch of dual-strength formulations enables clinicians to precisely titrate dosages based on patients’ body weight and treatment phase, addressing unmet needs for personalized care. This will optimize clinical treatment protocols, expand domestic therapeutic options, and elevate the standard of care for CKD patients across China.

As a key milestone in NCPC’s strategic focus on nephrology and high-quality generic drug development, the approval further strengthens the company’s hematological and hematopoietic system drug pipeline.

Moving forward, NCPC will continue to advance the research and development of clinically urgent medications, consistently delivering safe, effective, and accessible treatment solutions for patients, and supporting the advancement of the Healthy China Initiative.