SHANGHAI - 3SBio filed an application for the approval of NuLeusin with China's State FDA Nov. 10, hoping to make it the first product of its kind on the Chinese market, the Shenyang-based company announced.

The application has been filed for an approval for the treatment of late-stage metastatic renal cell carcinoma. If approved, NuLeusin - 3SBio's second-generation recombinant human interleukin-2 - is expected to be the only treatment of its kind available in China.

The company's first generation interleukin-2 product, InLeusin , was launched in the Chinese market in 1996.

"We have submitted the NuLeusin BLA package for SFDA approval and we are targeting a 2010 launch," 3SBio COO David Chen told PharmAsia News.

"Onyx and Bayer's Nexavar [sorafenib] and Pfizer's Sutent [sunitinib], which are competitors for NuLeusin, are both available in China," Chen said. "However, NuLeusin is expected to be the only immunotherapy available to treat end-stage renal cancer patients in China."

In comparison to Novartis' interleukin-2 Proleukin , a treatment available in the U.S., NuLeusin demonstrated similar levels of efficacy with a much lower dosage, the company said.

"Proleukin is available in many countries," Novartis Oncology Spokesman Geoffrey Cook told PharmAsia News.

He said it is available in Europe, South America, Canada, the U.S., the Middle East. In Asia Pacific it is available in Hong Kong, India, Korea, New Zealand, Singapore and Taiwan.

"We do not have plans to seek additional approvals of Proleukin as it already is widely available," Cook said. "In China, there are multiple generic products already on the market."

"From our interviews with [key opinion leaders], oncologists believe that many patients should benefit from this therapy," Chen said. "A 60 percent disease control rate with good safety and tolerability profile is impressive."

Phase III studies for NuLeusin involved a multi-center, open-label, single-arm study carried out in nine first-tier hospitals in Beijing.

The study enrolled 75 patients with post surgery renal cell carcinoma metastasis into two six-week treatment cycles, with a two-week break between each cycle.

The results of the Phase III study demonstrated an overall efficacy of 12.73 percent.

"Today's submission comes only a little over one month following our submission for high dosage EPIAO and once again demonstrates our research and development capabilities and our strong ability to execute on our business plan," 3SBio CEO Jing Lou said in a statement.

"In addition, NuLeusin is expected to further expand 3SBio's existing presence in the rapidly growing oncology market in China," he added.

It's unclear whether 3SBio is being overly optimistic about its products, since the company previously reported development delays for both EPIAO and NuLeusin (Also see "3SBio Growth Driven By EPO With Shaky Future" - Scrip, 25 February, 2008.).

In May this year, 3SBio and AMAG Pharmaceuticals signed a development and commercialization agreement for ferumoxytol, an intravenous iron replacement therapeutic agent being developed to treat iron deficiency anemia in chronic kidney disease patients (Also see "3SBio And AMAG Ink Deal To Develop Ferumoxytol In China" - Scrip, 5 June, 2008.).

The company's R&D pipeline is focused on innovative products with a clear market focus in nephrology and oncology supportive care markets, according to Chen.

Ferumoxytol will go into registration trials in the first half of 2009. 3SBio will file a BLA for recombinant human thrombopoietin injection TPIAO , indicated for chemotherapy-associated thrombocytopenia, by the end of 2008.

"We want to maximize sales of our lead product, EPIAO, in the Chinese market and maximize sales of our innovative TPIAO and other existing products in the nephrology and oncology markets in China," he said. "Also, we want to acquire or in-license new technologies, products or companies, while developing and commercializing candidates in our product pipeline."

Chen added that the company will also continue to expand beyond the Chinese domestic market and will expand its sales and marketing network.

-Ying Huang (pharmasia@elsevier.com)

3SBio Files For Approval For Interleukin-2 NuLeusin

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