Monoclonals in China

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In late 2009 a Chinese-American friend asked me if I might consider working on a project in China, to which I responded enthusiastically “yes.” The business concept is to develop a contract manufacturing organization (CMO) in China to capitalize on an emerging China market, take advantage of the lower costs of manufacturing that China’s skilled labor force has to offer, and produce products in compliance with FDA and EMEA standards for international and/or domestic distribution. As my simplistic generalization, I thought that since China manufactures so many products for the West, why not pharmaceuticals? At that time I was naïve in thinking this was a novel concept, because Big Pharma was already in China doing this and had been for years. (As an aside: I recently saw a quote from the new FDA commissioner stating that 40% of all prescription drugs sold in the US are produced outside the US.)

The difference is that there are no therapeutic monoclonal antibodies produced in China for international distribution. This is my focus, and the big initial hurdle was getting the financing to do this, which as it turns out, my business partner had already been scouring the landscape to find money. He looked for incentives in Beijing, Shanghai, and Suzhou with some success, but then he came upon China Medical City.

China Medical City is in Taizhou, Jiangsu Province, and is an initiative from the Central Government to build the largest Medical Science technology park in China. I was told that ¥100,000,000,000 (~$15 billion) was earmarked for this project, which will contain all aspects of product development, from R&D to manufacturing to marketing and distribution, both domestically and abroad. It is 85 sq km, with its own municipal government, police and a provincial office for the SFDA to facilitate regulatory filings. I first visited China Medical City (CMC) in May 2010, where we discussed some of the business terms as well as site selection to determine if this was an appropriate environment to set up a CMO. Not only did it appear that it would work, but there was a terrific amount of enthusiasm on the part of the CMC leadership, since it fit into the overall strategic vision for what China Medical City was to become.

In June a contract was signed to establish a cooperative joint venture with the local government and commit sufficient funding to build and staff a 20,000 sq. meter cGMP manufacturing facility. We would provide the Western management team with the required experience, and the Chinese government would provide the funding and infrastructure support to get the company up and running. I moved to China in August 2010, and since then have been working with design firms to engineer the facility, and I’ve been pounding the pavement to find potential customers and strategic partners to participate in and ensure our success. By the way, I did not speak Chinese before moving, but am slowly learning the language as best as my aging brain will allow.

In subsequent posts I will be happy to answer any questions to elaborate on my personal and business experiences in China.

David Wilson