Wanbang Biopharmaceutical Signed Product Cooperation Agreement with D-Pharm in Israel
Fosun Pharma has always attached great importance to R&D and innovation, positively seeking opportunities for cooperation with world-famous enterprises. On 8th Nov., 2009, Jiangsu Wanbang Biochemical Pharmaceutical Company (hereinafter referred to as Wanbang Pharmaceutical), the backbone enterprise with Fosun Pharma as its holding company, signed with D-Pharm Co. Ltd., the biotech company listed in Israel, a cooperation agreement for the two sides to R&D and sell the drug of DP-b99 for treatment of acute ischemic stroke in China. It is the first time for a Chinese local pharmaceutical enterprise to be permitted to introduce a new compound which has been approved to carry out Phase III clinical study in USA. It is also a historical breakthrough for Wanbang Pharmaceutical to cooperate with D-Pharm to carry out clinical trials and develop innovative drugs in China in accordance with the standards of FDA and ICH.
According to statistics, there are currently over 7 million stroke patients in China (among whom two thirds suffer from acute ischemic stroke) with more than 2.5 million new patients and 1.5 million deaths annually. Stroke is the leading cause of disease-related disability and the second leading cause of death for Chinese people. However, no drug other than the thrombolytic of tPA (which is applicable to only less than 3% acute ischemic stroke) is approved for treatment of stroke in US and Europe. DP-b99 is one of the most mature new compounds for treatment of acute ischemic stroke in current research all over the world. In Phase Ⅰand Ⅱ clinical study mainly in Germany, DP-b99 has shown good security as the proportion of fully recovered patients in the treatment group is twice of that of the normal control group. In addition, the product has a particularly good treatment effect on moderate to severe acute ischemic stroke patients, showing a time for treatment as long as 9 hours.
Wanbang Pharmaceutical will cooperate with D-Pharm to (after approved by SFDA) conduct a large-scale, randomized double blind controlled and polycentric Phase Ⅲ clinical study in East Asia region , mainly in China. The study will be performed strictly in accordance with the Good Clinical Practice (GCP) issued by U.S. Food and Drug Administration (FDA) and relevant requirements of State Food and Drug Administration (SFDA). The results of the study may be used for new drug application to FDA and SFDA. Wanbang Pharmaceutical has the permanent and exclusive right to the product in China. When the product is released, D-Pharm will provide Wanbang with pharmaceutics which will be sold exclusively by Wanbang in China. After the production facilities of Wanbang pass the certification of relevant authorities, D-Pharm will supply Wanbang with raw materials and production technology while Wanbang is responsible for pharmaceutics production to supply markets home and abroad. In addition, the cooperation between the two sides also includes R&D of follow-up new dosage and the registration and sale of common name products, etc.
Yifang Wu, President of Jiangsu Wanbang Biochemical Pharmaceutical Company, said that DP-b99 is a well-designed brain nerve cell protective agent. As the product’s treatment effect and security have been verified by Phase Ⅰand Ⅱ clinical trials with a time for treatment as long as 9 hours, and U.S. FDA has approved of the polycentric Phase Ⅲ clinical study of this product (MACSI experiment) in US and Europe, this product is very likely to become a heavy weight product of extraordinary significance. According to the strategy ,Wanbang Pharmaceutical will realize the transition from marketing-driven operations to innovation and marketing dual-driven ones in a step by step manner in the coming 5 to 10 years. This cooperation is not only an important step for Wanbang Pharmaceutical to cater for the globalization in the area of innovative drugs, but also a useful exploration to achieve this strategy.
According to statistics, there are currently over 7 million stroke patients in China (among whom two thirds suffer from acute ischemic stroke) with more than 2.5 million new patients and 1.5 million deaths annually. Stroke is the leading cause of disease-related disability and the second leading cause of death for Chinese people. However, no drug other than the thrombolytic of tPA (which is applicable to only less than 3% acute ischemic stroke) is approved for treatment of stroke in US and Europe. DP-b99 is one of the most mature new compounds for treatment of acute ischemic stroke in current research all over the world. In Phase Ⅰand Ⅱ clinical study mainly in Germany, DP-b99 has shown good security as the proportion of fully recovered patients in the treatment group is twice of that of the normal control group. In addition, the product has a particularly good treatment effect on moderate to severe acute ischemic stroke patients, showing a time for treatment as long as 9 hours.
Wanbang Pharmaceutical will cooperate with D-Pharm to (after approved by SFDA) conduct a large-scale, randomized double blind controlled and polycentric Phase Ⅲ clinical study in East Asia region , mainly in China. The study will be performed strictly in accordance with the Good Clinical Practice (GCP) issued by U.S. Food and Drug Administration (FDA) and relevant requirements of State Food and Drug Administration (SFDA). The results of the study may be used for new drug application to FDA and SFDA. Wanbang Pharmaceutical has the permanent and exclusive right to the product in China. When the product is released, D-Pharm will provide Wanbang with pharmaceutics which will be sold exclusively by Wanbang in China. After the production facilities of Wanbang pass the certification of relevant authorities, D-Pharm will supply Wanbang with raw materials and production technology while Wanbang is responsible for pharmaceutics production to supply markets home and abroad. In addition, the cooperation between the two sides also includes R&D of follow-up new dosage and the registration and sale of common name products, etc.
Yifang Wu, President of Jiangsu Wanbang Biochemical Pharmaceutical Company, said that DP-b99 is a well-designed brain nerve cell protective agent. As the product’s treatment effect and security have been verified by Phase Ⅰand Ⅱ clinical trials with a time for treatment as long as 9 hours, and U.S. FDA has approved of the polycentric Phase Ⅲ clinical study of this product (MACSI experiment) in US and Europe, this product is very likely to become a heavy weight product of extraordinary significance. According to the strategy ,Wanbang Pharmaceutical will realize the transition from marketing-driven operations to innovation and marketing dual-driven ones in a step by step manner in the coming 5 to 10 years. This cooperation is not only an important step for Wanbang Pharmaceutical to cater for the globalization in the area of innovative drugs, but also a useful exploration to achieve this strategy.