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2021-09-14

Yi Bao (Human Erythropoietin for Injection) for Cancer-related Anemia Indication Officially Approved


On September 14, 2021, Wanbang Biopharma announced that the new indication of Yi Bao (Human Erythropoietin for Injection) was recently officially approved by the National Medical Products Administration (NMPA) for the treatment of anemia caused by chemotherapy in patients with non-myeloid malignancies.

Chemotherapy-related anemia (CRA) refers primarily to anemia that occurs in cancer patients during disease progression and treatment and is characterized by a decrease in the RBC count per unit volume in peripheral blood, a decrease in hemoglobin concentration, or a decrease in hematocrit (HCT) below normal levels. [1,2]

Anemia occurs in 30% to 90% of tumor patients, and its incidence and severity are related to factors such as patient age, tumor type, stage, course of disease, treatment regimen, drug dose, and presence/absence of infection during chemotherapy. [3] CRA can lead to hypoxic-ischemic changes in multiple organs and reduced immunity, exacerbate disease progression, and affect the prognosis and quality of life of patients. [4] Bleeding, hemolysis, nutritional malabsorption, hereditary diseases, renal insufficiency, endocrine disorders and long-term multiple treatments are the main causes of CRA. Malignant tumors themselves can also cause or aggravate anemia through a variety of pathways. -2

In clinical practice, erythropoietin (EPO) is widely used in the treatment of CRA and is an important means to treat CRA. When exogenous EPO is injected into the body, it is absorbed into the bone marrow and activates the EPO receptors on erythroid progenitor cells, which recruit JAK-2 protein kinase and activate downstream STAT-5, PI-3K/AKT and MAPK signaling pathways to induce the expression of anti-apoptotic proteins, activate genes that promote cell proliferation, stimulate mitosis and inhibit apoptosis of erythroid progenitor cells, thereby promoting erythroid progenitor cell proliferation and differentiation into proerythroblasts. At the same time, EPO can promote the maturation and release of reticulocytes and promote erythropoiesis. [1]

Yi Bao (Human Erythropoietin for Injection) was marketed in 1998 and is the first approved EPO in China. It has previously been approved for anemia caused by renal insufficiency, including hemodialysis, peritoneal dialysis and non-dialysis patients with chronic renal failure (CRF). The product has been supplied to the market for more than 20 years and is used by nearly 300,000 patients each year.

Yi Bao is similar to the imported innovator drug, with exact efficacy and fewer side effects; it is a highly stable human erythropoietin manufactured by a lyophilized powder injection process. Tests have proved that the biological activity of Yi Bao can be stable at 4°C for at least more than 2 years, and there is no significant change in the in vivo activity of Yi Bao within 6 months when stored at room temperature or 37°C. Wanbang Biopharma has exclusively built a leading whole-process cold chain system from manufacturing to distribution. Wanbang Biopharma strictly controls every link from manufacturing to warehousing to transportation, so as to ensure stable product quality. It is the only EPO manufacturer with independent whole-process cold chain transportation.

The new indication for the "treatment of anemia caused by chemotherapy in patients with non-bone marrow malignant tumors" and a new strength of 10000 IU added for Yi Bao will bring more affordable options with exact efficacy for patients with non-bone marrow malignant tumors in China.

In the future, Wanbang Biopharma will continue to fulfill the mission that "We are dedicated to a healthier life", provide high-quality and affordable disease solutions and drugs for the majority of clinical experts and patients, and continuously develop all-round and full-cycle health management for patients. "

About Wanbang Biopharma

Jiangsu Wanbang Biopharmaceuticals Co., Ltd. (Wanbang Biopharma) is a core member enterprise of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, stock code: 600196-SH, 02196-HK). Currently, Wanbang Biopharma holds and controls 20 subsidiaries and has established more than 9 manufacturing sites across China, covering a total area of nearly 1,000 mu.

Wanbang Biopharma focuses on the R&D, production and sales of drugs in the therapeutic fields of hyperglycemia, hypertension, hyperlipidemia, hyperuricemia, anti-tumor, etc. The Company has established a first-class R&D and manufacturing site in China for genetic engineering drugs for prokaryotic and eukaryotic cells. The R&D of recombinant human insulin and its analogs, recombinant human erythropoietin and other recombinant protein drugs take the leading position in China. Through equity participation, Wanbang Biopharma has established an R&D laboratory of small molecule innovator drugs in San Francisco, USA, which is also in the leading position in the field of small molecule and high-difficulty generic drugs development.

The Company invests about 10% of the sales revenues for the R&D of new products annually; it has a professional R&D team with over 300 personnel, applies for more than forty national patents and launches several new products into the market every year. At present, the Company has over ten products with annual sales revenue of more than RMB 100 million.

For more information, please visit the official website: //www.chinawanbang.com