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Butylphthalide and Soft Capsules Awarded the National Science and Technology Advancement Prize


On the afternoon of January 11th, the national science and technology congress concluded in Beijing. The butylphthalide active pharmaceutical ingredient and soft capsule project of  CSPC Pharmaceutical Group Limited (hereinwith called CSPC Pharma.) won the second place of national science and technology advancement prize.It obtained 2009 annual highest technological achievement honor of domestic pharmaceutical industry. Winning the national science and technology advancement prize, symbolizes that the innovation system of CSPC Pharma. has already stepped into a systematized and systematic new stage. This will positively promote the national medical and pharmaceutical industry upgrade, and accelerate the national advanced technology development and internationalization.
More than twenty years has passed since CSPC Pharma. began the research of butylphthalide (Commodity name: NBP). It is the third independently-developed national Class I new medicine, and the first innovation medicine which can affect several pathological stages of acute ischemic strokes. It was the major project of the Science & Technology Ministry 1035 program and the State Natural Sciences Foundation, and obtained the full support of the Science & Technology Ministry “the tenth five-year” major technological special project “the innovation medicine and the traditional Chinese medicine modernization” and planning committee’s high-tech industrialization demonstration project. The butylphthalide is a single active ingredient abstracted from celery seed and its indications are slight, moderate acute ischemic strokes. It can increase the cerebral blood flow(CBF), improve the energy metabolism of cerebral ischemia, reduce infarct area、relieve brain edema、resist thrombosis、inhibit platelet aggregation and has other drug effects. It also can improve the mitochondria function, depress apoptosis, suppress the glutamic acid release, reduce intracellular calcium, resist oxidation damage,  suppress the inflammatory response and so on. It is an innovation medicine which can interrupt several pathological stages of ischemic strokes. Its special pharmacological effects are unique in current strokes treatment medicines development. The soft capsule process developed by CSPC Pharma., is an origination around the world, which not only solved the aging of softgel shell、the compatibility between softgel shell and contents and a series of softgel development difficulties, but also built the first domestic soft capsule technology development platform. The butylphthalide phase I, II, III, IV clinical research has been smoothly completed, 2560 cases were collected, and the effectiveness reached 78%. It is currently the largest-scale clinical research managed by domestic neurology, and also the first domestic clinical research which was proceeded absolutely according to ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) standards.
Until now, the butylphthalide project totally applied for 19 patents, in which 10 patents got authorization; Applied for 8 PCT (patent agreement of partnership), which got authorization in European Union, Russia, South Korea, Singapore, Australia and other 14 countries and districts. To further expand the international market, a part of the butylphthalide patents have been successively authorized to the US, South Korea and other internationally-famous pharmaceutical companies. It created a precedent of authorizing domestic medical intellectual property rights to developed countries, elevated the international status of domestic medical and pharmaceutical industry in the Neurology field.
It is reported that, on the basis of comprehensively and deeply researching butylphthalide, CSPC Pharma. is working on the subsequent product development of butylphthalide. The research of butylphthalide tablet, butylphthalide parenteral, the laevo- butylphthalide and other dosage forms are proceeding methodically.The butylphthalide parenteral, a national Class Ⅱ New Medicine, developed by CSPC Pharma. with unique molecular microcapsule technology, which could treat stroke quickly and effectively, has finished its phase Ⅲ clinical research, and will appear on the market soon.

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