肾脏-Boji Medical Technology Co., Ltd

Renal System

Clinical Research Services Pre-Clinical Research TCM FC-RS Therapeutic Areas Global New Drug Development Services Ongoing Project Transfer

Tumor

Anti-infective

Pain

Ophthalmology

Urology/Andrology

Cardiovascular System

Endocrinology and Metabolism

Nervous system

Respiratory System

Renal System

Skin System

Orthopedics

Digestive System

INTRODUCTION

Kidney diseases encompass a spectrum of conditions affecting renal function, ranging from mild impairment to end-stage renal disease (ESRD), which requires dialysis or kidney transplantation for survival. The prevalence of kidney diseases is rising alongside the increase in chronic conditions such as hypertension and diabetes. Biologics and chemical drugs play a significant role in treating conditions like renal anemia and hyperphosphatemia.

Boji Pharma possesses extensive operational capabilities and expert resources in nephrology projects, having accumulated substantial experience in Phase Ib/II/III clinical trials. This expertise is particularly strong in the application of biologics and chemical drugs for treating renal anemia and hyperphosphatemia in end-stage dialysis patients. The company is proficient in managing dialysis modalities—including hemodialysis and peritoneal dialysis—and dialysis techniques throughout trial implementation.

Clinical Research Project Experience

Renal anemia
Hyperphosphatemia
Hemodialysis and Peritoneal Dialysis

PROJECT EXPERIENCE

Approval Granted for New Dosage Form and Indications of Erythropoietin Injection (1ml:10000IU) by North China Pharmaceutical

In January 2024, the National Medical Products Administration approved the new specification and the indication “red blood cell mobilization during the perioperative period” for Human Erythropoietin Injection (1ml:10000IU) submitted by North China Pharmaceutical Jintan Biotechnology Co., Ltd.

Leveraging its expertise in clinical research for biological products, the company delivered high-quality clinical research services tailored to the product's clinical characteristics and market demands, effectively ensuring the successful approval of the new specification and indication.

Sinovac Biotech Secures Approval for New Indications and Dosage Forms of Erythropoietin Injection

In February 2022, Sinovac Biotech Ltd. received the “Approval Notice for Supplementary Application of Drug” issued by the National Medical Products Administration for its supplementary application to add the indication “Treatment of Anemia Caused by Chemotherapy in Patients with Non-Myeloid Malignancies” and the new specification of 36,000 IU/1 ml/vial for its human erythropoietin injection. This new specification significantly reduces the frequency of administration for patients, improving treatment adherence while maintaining therapeutic efficacy. The company provided clinical research support for this supplemental application.

Assisted in the successful approval and market launch of Intravenous Immunoglobulin (pH 4)

In July 2020, the Class 3 biological product—Intravenous Human Immunoglobulin (pH4)—submitted by Xinjiang Deyuan Biological Engineering Co., Ltd. received marketing approval from the National Medical Products Administration (Approval Number: National Drug Approval No. S20200016). This product is indicated for primary immunoglobulin G deficiency, secondary immunoglobulin G deficiency (such as severe infections and neonatal sepsis), and autoimmune diseases (such as primary immune thrombocytopenia and Kawasaki disease). As the sole blood products manufacturer in the Xinjiang Uygur Autonomous Region, the approval of this product fills a gap in the region's blood products sector.

Leveraging its extensive experience and professional team, Boji Pharmaceutical provided scientific and rigorous management services for the clinical trials of this project, ensuring their smooth execution.