From 2015 to now, Lianyungang pharmaceutical company has applied for 88 new drugs and 12 first-class innovative drugs

Yesterday, it was learned from Lianyungang pharmaceutical regulatory bureau that since this year, Lianyungang pharmaceutical enterprises have applied for 88 new drugs, 12 of which are first-class innovative drugs, and have obtained 2 new drug certificates and 4 pharmaceutical production registration approvals Up to now, Lianyungang City has obtained 336 new drug certificates in total, including 3 first-class new drugs The number of first-class new drugs ranks first in prefecture level cities in China, and the number of new drugs approved each year accounts for about 30% of the total number of new drugs in the province At present, there are 42 pharmaceutical production enterprises in Lianyungang City, involving many fields such as chemical preparation, API production, Chinese patent medicine production, Chinese Herbal Pieces production and so on The profits and taxes rank the first in prefecture level cities in the province Hengrui, Kangyuan, Haosen and Zhengda Tianqing have been among the top 100 pharmaceutical companies in China for nine consecutive years Lianyungang pharmaceutical production enterprises have strong innovation ability, scientific research and development system tends to be perfect and perfect, and new drug research and development ability ranks first in prefecture level cities in China, with annual R & D investment accounting for more than 8% of sales revenue Hengrui, Zhengda Tianqing, Haosen, Kangyuan and other leading enterprises have formed a good development trend of production generation, trial production generation and pre research generation The first new drug certificate in the province a new drug irexib was developed by Hengrui pharmaceutical, a municipal enterprise In 2014, there were only 5 first-class new drugs approved nationwide, and 2 of them flowed to our city Data shows that at present, there are more than 380 products under research in Lianyungang pharmaceutical enterprises, among which there are more than 80 first-class new drugs and more than 20 in the clinical stage Kangyuan Reduning injection, Hengrui arexib and hausen "new synthesis process of important intermediate of gemcitabine, a new anticancer drug", won the gold medal of national patent Hausen pharmaceutical industry won the second prize of national science and Technology Progress Award for the project of "research and application of new antipsychotic drug olanzapine and its preparation" At the end of this year, Lianyungang is expected to achieve the first breakthrough in biological drugs In line with the national GMP indicators, Hong Kong and city enterprises have accelerated the improvement of drug production quality management standards More than 7 billion yuan has been invested in the new industrial base and technological transformation of pharmaceutical enterprises in Lianyungang In addition, Hengrui, hausen, Zhengda Tianqing, Deyuan, guike, Suyun and other enterprises also invested in the construction of API production base and medical equipment production base in Dapu Industrial Zone, and the production technology guarantee level of major pharmaceutical enterprises is at the leading level in China Up to now, 28 workshops of 8 sterile preparation and sterile API enterprises in the city have passed the new GMP certification The pass rate of 28 workshops of 10 non sterile preparation enterprises is 96.4%, and that of 42 workshops of 10 API enterprises is 95.2% Among them, the small volume injection of Zhengda Tianqing and the large volume injection of Hengrui obtained the first and second GMP certificates of the new version of the state Good production quality standards have driven the pace of internationalization of pharmaceutical enterprises in Gangcheng At present, the new bases of Hengrui, Haosen and Zhengda Tianqing are all built according to the advanced standards of Europe and the United States More than 20 APIs, preparations and injections have passed the quality certification abroad, among which Hengrui and Zhengda Tianqing APIs and preparations have passed the FDA certification of the United States with zero defects Hengrui's antitumor drugs, irinotecan injection and oxaliplatin injection, are respectively the first domestic injections approved to be listed in the United States and the European Union Howson's antitumor drug, gemcitabine hydrochloride freeze-dried powder injection, is the first domestic freeze-dried powder injection approved to be listed in the United States.