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Milestone: FDA approves first ever China-made biologic for use in U.S. trials

By Cornelia Zou, Staff Writer

HONG KONG ‑ The U.S. FDA has, for the first time ever, approved the use of a biologic product made by a Chinese company in U.S. investigational new drug trials.

R&D services giant Wuxi Pharmatech Inc. (NYSE:WX) got the green light for HIV therapy drug ibalizumab (TMB-355), which it is manufacturing for Taiwan Taimed Biologics Inc., of Taipei, Taiwan.

“Taimed is pleased with the speed and excellent execution of this project to ensure the success of this important drug,” said Taimed CEO James Chang. “We look forward to the next phase of collaboration with Wuxi to successfully bring the drug to marketing approval”.

Ibalizumab is a humanized monoclonal antibody (MAb) that belongs to an emerging class of HIV therapies called viral-entry inhibitors. It binds to the CD4 molecule, the primary receptor for HIV infection, to interfere with the penetration of the virus into the cells. It is the first entry-blocking humanized MAb used to treat HIV infection.

Wuxi and Taimed reached an agreement on the manufacturing of ibalizumab in support of phase II and phase III clinical trials globally in August 2012. Although Taimed is developing the drug, Wuxi is providing a range of services, including manufacturing at its facilities in Wuxi.

Taiwanese biopharmaceutical company Taimed was founded in 2007 by former Vice Premier Tsai Ing-wen and David Ho, a prominent HIV/AIDS researcher. The company is based out of the Hsinchu Biomedical Park in Northern Taiwan.

Shortly after it was founded, Taimed signed a licensing agreement with San Francisco-based Genentech Inc. for ibalizumab shortly after the company was founded. Genentech is now part of the Roche Group.

Other drug candidates Taimed is developing include TMB-607, an HIV-1 protease inhibitor and TMB-571, a small molecule inhibitor of influenza virus neuraminidase against H1N1 and H5N1 influenza viruses.

Two months after the agreement was inked, Wuxi announced the establishment of a biologics manufacturing facility to produce drugs like ibalizumab. It was the first biologics producing facility in China that met current Good Manufacturing Practice (cGMP) standards from the U.S., the European Union and China.

The automated filling line of Wuxi Pharmatech’s manufacturing facility can accommodate two to 50 ml liquid and lyophilized vial products for global clinical trials and product launches.

“Besides manufacturing, we offer fully integrated development services from target to product approval and regulatory support, but no marketing services for now,” Aaron Shi, associate director of corporate communications at Wuxi told BioWorld Today. “For ibalizumab specifically, we also help in late phase development and regulatory support.”

The cooperation between the Taiwanese and Chinese companies has made it possible to speed up the development of the promising drug.

Wuxi last month kicked off construction of its new cell therapy facility in Philadelphia and got FDA approval for its analytical and stability testing facilities in Shanghai.

The new facility in the Philadelphia Navy Yard consists of 45,000 square feet of clinical and commercial manufacturing space and will support Wuxi Pharmatech’s existing cGMP facility for the manufacture of cell therapies.

Wuxi Pharmatech’s expansion in the U.S. will help support growing customer demand for its products with single-source contract development and increased manufacturing capacity for allogeneic and autologous cell-based therapeutics. The new U.S. facility is expected to start operating in the second quarter of 2015.

At the end of April, Wuxi Pharmatech passed U.S. FDA inspection for general GMP approval of its drug analytical and stability testing facilities in the Shanghai Waigaoqiao Free Trade Zone.

This approval translates into regulatory advantages and potential faster approval for Wuxi’s clients.

See Thursday's BioWorld Today for More on This Story.