developing, manufacturing and marketing biopharmaceutical products primarily
in China, today announced that it has filed with the Chinese State Food and
Drug Administration (SFDA) for approval of a 36,000 IU dosage formulation of
EPIAO for the treatment of anemia associated with chemotherapy in cancer
patients. If approved, high-dose EPIAO would be the only dosage form of this
kind available in China.
High dose EPIAO is designed for the rapid restoration of hemoglobin to
normal levels among cancer patients. The 36,000 IU dosage is comparable to
the standardized dose used globally for the chemotherapy-induced anemia,
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% of the patients receiving high-dose EPIAO injections
had Hemoglobin 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
, CEO of 3SBio, said, "I am pleased to
announce that we have reached another important milestone for one of our key
pipeline products. The submission for approval of high-dose EPIAO is based on
positive data which demonstrates that an once a week injection of 36,000 IU
high-dose EPIAO is as effective as the three times per week 10,000 IU low-dose
EPIAO in treating cancer patients with chemotherapy-induced anemia. If
approved, high-dose EPIAO will provide patients and physicians in
China
with a
new, safe and more convenient treatment of anemia resulting from chemotherapy.
Furthermore, we believe that the greater convenience provided by high-dose
EPIAO treatment versus existing treatment options will be a key factor in
helping to fuel the growth of the highly under-penetrated oncology market in
China."
About the Phase III Data
The Phase III study was a multi-center, randomized, active-controlled
trial that enrolled 206 non-myeloid malignant tumor 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 Hemoglobin 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 Hemoglobin 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
Hemoglobin value, the nadir of Hemoglobin value, the time it took for the
Hemoglobin 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.
About 3SBio Inc.
3SBio Inc. is a leading, fully integrated biotechnology company focused on
researching, developing, manufacturing and marketing biopharmaceutical
products, primarily in
China.
For more information, please visit 3SBio on the web at:
http://www.3sbio.com.
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