HONG KONG – 3SBio Inc., based in China's northeast city, Shenyang, entered into a licensing agreement with Korean biotech company Pharmabcine Inc. to develop, manufacture and market the anti-vascular endothelial growth factor receptor 2 (VEGFR2) and kinase insert domain receptor antibody, tanibirumab. The deal could benefit up to 1 million cancer patients in China each year.

Besides the Greater China territory, 3SBio will also be responsible for the distribution in emerging markets of Thailand, Brazil and Russia.

"Of course the emerging markets are not as big as the China market at the moment, but we already have a few partners there and this would be an enhancement of our partnership," Jiang Fei, director of business development at 3SBio, told BioWorld Today. "Our main focus will still be China."

Financing details were not disclosed.

"Theoretically it [tanibirumab] can be used for all type of solid tumors because the therapeutic inhibits tumor angiogenesis," said Sung Woo Kim, director of strategic management group at Pharmabcine. "From that point of view, the China market is still small, which is 6 percent of the global anticancer market, but we consider the market as outpost for penetrating major markets."

Tanibirumab is an anti-VEGFR2 and KDR fully human monoclonal antibody (MAb) for the treatment of solid tumors.

VEGF and KDR are over-expressed in malignant tumors including gastric, liver, ovarian, brain, colorectal and breast cancers. Their signaling is a key regulator for tumor angiogenesis. Angiogenesis is correlated with disease progression and poor prognosis in many tumor types such as colon, lung, breast and gastric cancers. Tanibirumab binds KDR and blocks binding of VEGFR ligands. By inhibiting ligand-stimulated activation of KDR, tanibirumab is able to inhibit ligand-induced angiogenesis, proliferation and migration of human endothelial cells.

"We have made four similar deals so far, one in the therapeutic area of renal diseases and three in oncology," said Jiang. "We have partnered with two companies from Korea for their MAbs and one company from Beijing for their small molecule anticancer drug."

"But all these products are at a very early stage of development now," Jiang added.

Tanibirumab has demonstrated anti-angiogenic efficacy against several cancer types and shown cross-species cross reactivity in multiple preclinical animal models, including breast cancer, glioblastoma multiforme (GBM), lung cancer, colon cancer and hepatocellular carcinoma.

In 2011, Daejeon-based Pharmabcine conducted an open-label, non-randomized, dose-escalating phase I trial to assess the safety and pharmacokinetics of tanibirumab. As part of the trial, 26 patients in South Korea with advanced or metastatic cancer were given the drug. The trial was completed in 2013 with good safety and efficacy results.

A phase II study of tanibirumab in GBM is being planned.

The South Korean government partly funded both phase I and phase II trials through the Korea Drug Development Fund.

"We look forward to moving tanibirumab into clinical trials in China," said Jing Lou, president and CEO of 3SBio, in a statement. "3SBio continues to seek opportunities to expand our biologics pipeline, especially novel MAb candidates for refractory or metastatic cancers and other unmet medical needs."

Pharmabcine spun off from the government-funded Korea Research Institute of Bioscience and Biotechnology in 2008. In addition to Tanibirumab, the company's pipeline includes two anticancer bispecific MAbs, DIG-KT and PIG-KM, that are being prepared for preclinical study. Pharmabcine also is developing fully human single target MAbs and dual target MAbs.

Pharmabcine recently out-licensed its next generation bispecific antibody, DIG-KT to Indian pharma company Triphase Pharmaceuticals Pvt. Ltd. Triphase will develop DIG-KT for global market excluding Korea and China.