Pharmaceutical Business review

ScinoPharm, NKF partner to enter Chinese market for new drugs

The two firms aim to exploit business opportunities in the Chinese market for new drugs.

Under the deal, ScinoPharm will be responsible for the development and manufacturing of the Active Pharmaceutical Ingredient (API) for Regadenoson.

Both the firms will jointly develop the injection technology and conduct clinical trials, while NKF will take charge of the actual sterile injection production and drug certificate applications with the China Food and Drug Administration.

ScinoPharm CEO Dr Chen Yung Fa said: "ScinoPharm is pleased to become a strategic partner of NKF in order to advance the company’s original expertise in generic API’s further into the development of new drugs, thus enhancing the company’s market value and long-term competitiveness.

"This is ScinoPharm’s first new drug development project in Chinese market, thus furthering the implementation of the company’s strategy to become a fully integrated pharmaceutical company."

The application for approval of human clinical trials in China is expected in late 2015 and the drug products are scheduled to be commercialized by 2020.

After the launch, the two firms will share the profits of the products produced as part of the agreement.

In 2008, Regadenoson was approved for sale in the US, but its drug license has not yet been applied in China.

As per the classification of chemical drug registration in China, the drug requires human pharmacokinetic studies and at least 100 pairs of randomized and controlled clinical trials.