Other Name: rhEPO
EPIAO is an injectable recombinant human erythropoietin (rhEPO). Erythropoietin (EPO) is a natural growth factor produced in healthy kidneys that regulates production of red blood cells. EPIAO and other rhEPO products are used to stimulate the production of red blood cells in patients with anemia.
Patients with CKD, particularly late-stage patients undergoing dialysis treatments, often suffer from anemia because their kidneys are not able to produce sufficient amounts of EPO. Cancer patients receiving chemotherapy treatments may also suffer from anemia, which sometimes forces them to cease chemotherapy treatments. EPIAO and other rhEPO products can be used to treat such anemias, thereby improving the life quality for CKD and cancer patients and reducing the need for blood transfusions. In addition, EPIAO can be administered to surgery patients to prevent or ameliorate anemia caused by blood loss during surgeries.
Launched in 1998, EPIAO was one of the first CFDA-approved rhEPO products marketed in China. EPIAO has been approved by the CFDA for three indications: the treatment of anemia associated with CKD, the reduction of allogeneic blood transfusion in surgery patients and the treatment of CIA. EPIAO is the only rhEPO product approved for all three indications in China.
• In 1998, EPIAO’s first indication, the treatment of anemia associated with CKD, was approved by the CFDA. EPIAO is included in the National Medical Insurance Catalogue as a Category B drug for the treatment of anemia associated with CKD.
• In 2000, EPIAO’s second indication, the reduction of allogeneic blood transfusion in surgery patients, was approved by the CFDA. EPIAO is included in three provincial medical insurance catalogues (Hubei, Shaanxi and Zhejiang) for the reduction of allogeneic blood transfusion in surgery patients.
• In 2001, EPIAO’s third indication, the treatment of CIA in cancer patients with non-myeloid malignancies, was approved by the CFDA. EPIAO is included in eight provincial medical insurance catalogues (Fujian, Hainan, Heilongjiang, Hubei, Jilin, Liaoning, Shaanxi and Shanghai) for the treatment of CIA.
EPIAO is manufactured at our mammalian cell-based production plant in Shenyang.
We offer different dosages of EPIAO to provide treatment flexibility and convenience for both patients and caregivers. We developed the 36,000 IU EPIAO product to allow for less frequent administration than lower dosage forms. Our 36,000 IU dosage EPIAO product is the only approved rhEPO product at this dosage level in China and is typically used for the treatment of CIA.
All of our approved dosages of EPIAO, other than 36,000 IU, are available in both the vial format and the pre-filled syringe format. Launched in June 2007, the pre-filled syringe EPIAO has been an important addition to our product portfolio because of its enhanced safety, ease of use and flexibility for self-administration at home.
A study published in September 2008 by the Journal of Pharmaceutical Sciences demonstrated the manufacturing quality of EPIAO. The study, which was sponsored by Amgen Inc., compared its innovator rhEPO product, Epogen, with a dozen rhEPO brands marketed by Asia-based companies. We believe that the published results of the study showed that, among the surveyed rhEPO products, EPIAO was one of the most similar to Epogen in terms of the tested biochemical and biophysical properties, including protein isoform variations and protein aggregation.
We hold a PRC patent related to EPIAO, which is valid until 2023. The patent covers the composition and production method of a stable rhEPO preparation. Because rhEPO is an unstable substance, protective agents are added to increase its stability and extend its useful shelf life. In 2005, EPIAO was recognized as a well-known brand by the Shenyang municipal government and a well-known trademark by the Shenyang Municipal Administration for Industry and Commerce. The following table sets forth the material awards EPIAO has received:
|First Class Award for the Advancement of Science||Shenyang municipal government||1998|
|Second Class Award for the Advancement of Science||Liaoning provincial government||1999|
|Third Class Award for the Conversion of Technological Achievements||Liaoning provincial government||2007|
According to IMS, EPIAO has been ranked as the number one rhEPO product in China since 2002 in terms of sales. In 2012 and 2013, EPIAO maintained its dominant rhEPO market share by sales of 42.9% and 43.6%, respectively, which exceeded the combined market shares of the next six largest competitors in China.
In 2014, we started multi-center biosimilar clinical trials for EPIAO in Russia and Thailand.