Traditional Chinese Medicine Goes Global

China’s traditional medicine manufacturers have begun looking toward foreign markets for their products. This past week, an anti-dementia drug called NJS became the first such product to be patented by a foreign firm.

Patented by London-based Phytopharm, NJS is based on traditional Chinese medicine and has been under development at the Beijing-based China Military Medical Academy for the past ten years.

Phytopharm is a British pharmaceutical and functional foods company whose product leads are generated from medicinal plants. The firm plans to develop and commercialize NJS in Europe, the United States and Asia as a prescription drug to enhance memory and concentration.

The move by Phytopharm is being regarded as a step forward for the centuries old traditional Chinese medicine industry.

"It is the first time that China has sold a TCM patent license to a foreign firm and it represents a major stride toward international credibility," China Military Medical Academy President Sun Jianzhong told the state-owned Xinhua news agency.

“For now, we will just get the patent for the compound itself, but we will also extend patents to formulation, technology, manufacturing and so on in the future,” Phytopharm CEO Daryl Rees said in an interview with PharmAsia News.

Rees added that under terms of the collaboration and license agreement, the Institute in Beijing will receive milestone payments on achievement of predefined goals and royalties on any product sales. However, he declined to disclose the financial terms of the agreement.

Phytopharm also will pay to register the NJS patent in the European Union, he added.

The Institute of Radiation Medicine at the Academy of Military Medical Sciences has already filed for patent protection for NJS in several areas outside of China.

“The NJS drug is already patented in the United States and Korea, but is still in the process in the EU, Japan and Canada,” said Kang Liping, a researcher with the NJS research group at the Military Medical Academy. “The British company might extend the patent to other developed countries such as Australia.”

China’s Military Medical Academy has finished the preclinical development for NJS and will now rely on Phytopharm to conduct clinical trials and develop the drug in international markets, Kang told PharmAsia News.

“Our company is going to pay for cost of the clinical trials, and it will take four or five years to finish,” Rees said. “Initially, the trials will be conducted in China and then in the EU.” Phytopharm will conduct “further preclinical trials,” in addition to initially taking the product into Phase I trials, he said.

The manufacturing location for the new drug has not yet been decided, but Rees predicted it will likely be in China.

Phytopharm is not the only international company looking to China for products based on traditional Chinese medicines.

In March, French Foreign Minister Philippe Douste-Blazy and Chinese Health Minister Gao Qiang signed a memorandum of understanding in Beijing to develop traditional Chinese herbal medicines.

Under the MOU, three French companies – Ethypharm, Pierre Fabre and Servier – will  collaborate with three Chinese companies – Ley’s Shanghai, Tianjin’s Tasly Group and SinoBioway Group – in a joint effort to enter the European market.

Until now, traditional Chinese medicines have had a hard time entering Western markets. “At present, no traditional Chinese medicine products have got registrations successfully in Europe,” Ethypharm China General Manager Philippe Malecki told PharmAsia News.

“However, if a product is classified as a supplement or a nutraceutical by the local ministry of health or FDA, the process is much less stringent,” he noted.

In China, traditional medicines benefit by a special protected status. In Western countries, “the drugs have to follow the Western allopathic drug registration process,” said Malecki. “Plus, if the plants are not in the European-North American pharmacopoeia, then they need a new drug approval.”

“The registration depends a lot on the claim and indication,” he said.

- Ying Huang

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