3SBio Inc. a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced that the Chinese State Food and Drug Administration (SFDA) has approved its 36,000 IU dosage formulation of EPIAO for the treatment of anaemia associated with chemotherapy in cancer patients. High-dose EPIAO is the only dosage form of this kind available in China. The approval provides patients in China with an additional treatment option which has been available since 2004 in the United States and 2006 in the United Kingdom.

High-dose EPIAO is designed for the rapid restoration of haemoglobin to normal levels among cancer patients. The 36,000 IU dosage is comparable to the standardized dose used globally for chemotherapy-induced anaemia, allowing for less frequent administration than lower dosage forms, which in turn is expected to provide greater convenience for both patients and caregivers.

The clinical trial examined the safety and efficacy of a weekly subcutaneous injection of 36,000 IU EPIAO in oncology patients compared with a regimen of three times per week administration of 10,000 IU EPIAO. The results showed that 70 per cent of the patients receiving high-dose EPIAO injections had haemoglobin improvement of 1-2 g/dL from baseline, similar to those receiving three times per week dosing of 10,000 IU EPIAO. More importantly, the weekly administration of 36,000 IU EPIAO demonstrated equivalent safety and tolerability profiles as the three times per week 10,000 IU EPIAO.

Commenting on the news, Dr Jing Lou, chief executive officer of 3SBio, said: “Our new 36,000 IU formulation of EPIAO is the highest dose EPO formulation on the market in China, and EPIAO remains the only EPO product approved in China for the treatment of chemotherapy-induced anaemia. Less frequent injection provides chemotherapy patients and their physicians a new, safe and more convenient treatment option, encouraging the use of EPIAO in the under-penetrated oncology market. High-dose EPIAO is a continuation of our strategy of seeking label extensions that differentiate our products from those of our competitors, helping to ensure that EPIAO remains the first choice for hospitals throughout China.”

The phase III study was a multi-centre, randomized, active-controlled trial that enrolled 206 non-myeloid malignant tumour patients. The testing group, including 104 patients, was given 36,000 IU EPIAO subcutaneously once a week for eight weeks. The control group, including 102 patients, was given 10,000 IU EPIAO three times a week for eight weeks. The primary endpoint of the study was the improvement of the haemoglobin level for > 1-2 g/dL compared to the baseline level.

The trial result shows that 70% of patients on high-dose EPIAO injections had haemoglobin improvement of at least 1-2 g/dL from baseline level, similar to those receiving three times per week dosing of 10,000 IU EPIAO. In addition, the patients were assessed with the peak haemoglobin value, the nadir of haemoglobin value, the time it took for the haemoglobin level to increase for more than 1g/dL and 2g/dL, and the need for blood transfusion for each group. There was no significant difference between the two groups in these secondary endpoints.

In addition, the safety of high-dose EPIAO was comparable to the 10,000 IU EPIAO. The most common adverse effect related to high-dose EPIAO was low fever. The patients recovered within a short period of time.