The biomedicine and new medical device industry is an important field for the development of new quality productivity, and it is also one of the four leading industrial clusters in our region to build a "5+4+5" innovative industrial cluster.
As an important core of the city's pharmaceutical industry, after years of cultivation and jointing, the listing of new drugs and new medical devices in Jiangning High-tech Zone is showing an accelerated trend. In the first quarter of this year, 4 new drugs and 2 new medical devices in the park were approved for marketing, and at the same time, a number of new drugs are on the way to listing, continuously injecting strong momentum into the high-quality development of the whole region.
Jiangsu Aosaikang Pharmaceutical Co., Ltd
It is an innovation- and R&D-driven integrated pharmaceutical company that focuses on product development, production and sales in four major therapeutic areas: digestion, anti-tumor, anti-infection, and chronic diseases.
In the first quarter of this year, the company's three new drugs have been approved for marketing, among them, dexlansoprazole for injection (Ouriray) is a national class 2 new drug, which took 10 years to conduct preclinical pharmacodynamic toxicology studies and complete phase I., II, III. clinical studies, mainly used for the treatment of gastric ulcers, duodenal ulcers, reflux esophagitis, and has an inhibitory effect on Helicobacter pylori; Chronic immune (idiopathic) thrombocytopenia that does not respond well to immunoglobulins, and toremifene citrate tablets (Ovieli) are indicated for the treatment of estrogen receptor-positive or unknown metastatic breast cancer in postmenopausal women.
The new quality productivity is the quality of advanced productivity in which innovation plays a leading role and conforms to the new development concept, and it is also the direction that Aosaikang Pharmaceutical has been working towards.
Aosaikang Pharmaceutical Co., Ltd. takes "research as the source, health as the foundation" as its corporate philosophy, takes the national key talents and teams as the guide, and always takes R&D and innovation as the primary driving force for development. Since its settlement in 2003, with the strong support and precise service of Jiangning High-tech Zone, Aosaikang Pharmaceutical has developed more than 100 varieties of drugs on the market, and a number of new drugs have been included in the new version of the national medical insurance catalog.
current
Jiangning High-tech Zone is vigorously developing new quality productivity
Strive to build an urban innovation district
Biomedicine and new medical devices
It is the characteristic leading industry of Jiangning High-tech Zone
It is also one of the main driving points for the development of new quality productivity in the park
Jiangning High-tech Zone
Actively build a full-chain and ecological service corridor for biomedical enterprises, and create the only full-closed-loop service system in the province from source innovation, clinical research, pilot scale-up to large-scale production.
At present, the park has built a 3-square-kilometer "Nanjing Life Science and Technology Town" with small-scale test and R&D as the main body, a 300,000-square-meter "Life Science Acceleration Belt" with pilot scale up as the main body, and more than 1 million square meters of various R&D carriers, incubators, and maker spaces, building an integrated industrial system of "small-scale R&D + pilot production + large-scale production".
As of the end of March this year, it has served more than 50 biomedical enterprises in Jiangning High-tech Zone, and undertook more than 300 businesses in the jurisdiction, including serving Xinke Medical to obtain the first Class III medical device registration certificate in China in the subdivided field, and helping Yahuilong, a leading enterprise in diagnostic reagents, to quickly complete the change of 47 Class II medical device registration certificates. With the settlement of the Nanjing Branch of the Provincial Food and Drug Administration, the commissioning of Nanjing Tianyinshan Hospital, and the high concentration of resources around drug and device approval and clinical research such as Nanjing Food and Drug Administration and Shaw Hospital Affiliated to Nanjing Medical University, the biomedical and new medical device industry ecology of Jiangning High-tech Zone has been further optimized, which can better help enterprises develop and grow, and also promote the continuous emergence of innovative achievements of new drugs and new medical device enterprises.
In the first quarter of this year, in addition to the three new drugs listed by Aosaikang Pharmaceutical, new medical devices such as Shunxin Pharmaceutical's new drug tedizolid phosphate for injection, Boshi Medical's second-class medical device adaptive optical fundus imaging system, and Xinke Medical's third-class medical device breast tissue marker were also approved for listing.
In addition, a number of innovative products of biomedical enterprises in Jiangning High-tech Zone are accelerating on the road to listing. Triassic 3D printed gastric retention drug and another 3D printed drug have been approved for clinical trials in the United States and China respectively, Jiqun Pharmaceutical and Qingpu Biotech have been approved and accepted for clinical trial applications respectively, Aosaikang's innovative drug ASK120067 will be approved for marketing soon, and Claudin18.2 ASKB589 the first domestic company to enter phase III clinical trials. Shunxin Pharmaceutical's new drug and new indication were applied for marketing, Legend Biotech's cell therapy product cilta-cel was approved for the second-line indication in the United States, and Anke Immunology made significant progress in the research and development of three innovative antibody and cell therapy drugs...... At present, there are nearly 50 new drugs under development in Jiangning High-tech Zone, and a number of Class 1 global innovative drugs have entered the third phase of clinical trials, and it is expected that the new industrial scale will exceed 10 billion yuan after listing.
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