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Five months, eight new drugs and three medical devices on the market, and it's stepping into harvest time here!

8 new drugs, 3 medical devices approved for marketing, a number of new drugs / medical devices clinical trials to speed up the progress - the first five months of this year, Jiangning Hi-tech Zone, the biomedical track of the good news. 

Good industrial atmosphere

Become a "strong magnetic field" to attract innovative pharmaceutical projects.

January-April this year

Jiangning Hi-tech Zone on the regulation of the income of pharmaceutical enterprises

Year-on-year growth of 40% or more

Entering the "harvest period", major breakthroughs continue one after another

  Since the beginning of this year, Jiangning Hi-tech Zone, biopharmaceutical and new medical device industry almost every month there is a major breakthrough.

 Starting from 50 square meters of the basement, work hard for 3 years, Nanjing Xinke Medical Devices Co.Its self-developed breast tissue marker products, got the third class medical device registration certificate issued by the State Drug Administration, is the first three class domestic medical device certificate in the industry, filling the domestic blank.Ltd., said Guo Qi, general manager of the domestic markers, "cost-effective" to obtain the market's "high acceptance", Xinke Medical is ready to Jiangning Hi-Tech Zone Life Sciences Acceleration Belt to build another annual production capacity of 100,000 sets of breast tissue marker production line. production line.

 The year 2024 is also the "harvest year" of Jiangsu OSK Pharmaceutical Co.Since the start of the year, the company has launched four new drugs, including dexlansoprazole for injection, a category 2.2 innovative drug, and the first batch of generic drugs, eltrombopag olamine tablets, etc., and is expected to launch more than five new products in the whole year.Lin Yu, deputy general manager of OxyContin, said, "The company has more than a dozen innovative drugs in clinical phase I to phase III."

Ltd., we can see that 5 production lines of original liquid and 7 production lines of preparation are speeding up production to ensure the supply of orders. In March this year, the news came back from the other side of the ocean that the innovative biopharmaceutical - Ebergastine α injection, which is independently developed by Yiyi Biologicals and owned by Chengda Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co.Thus, Abelgrastim alpha injection has become the first innovative biologic drug that has been approved and marketed in China, the United States and the European Union, and the first innovative drug approved by a Chinese pharmaceutical company in the European Union in the year 2024.In May, Nanjing Shunxin Pharmaceutical Co., Ltd.'s Class 1 innovative drug Behmosubaisumab injection (trade name: Andeva) was approved for listing, becoming the first Class 1 innovative drug listed in the city this year.

Speed up the launch of new drugs by bridging the "last kilometer"

  Enterprise "relay running" type breakthrough, backed by the Jiangning Hi-tech Zone, the whole chain of service system, as well as to pass the new drug listing "last kilometer" of the series of initiatives.

Helping the city's first Class 1 innovative drug to be listed this year, assisting Xinke Medical to obtain the first Class 3 medical device registration certificate in China in its segment, and helping diagnostic reagent leader Yafei Long to quickly complete the change of 47 Class 2 medical device registration certificates ......

At the end of December last year, the Nanjing Sub-center of Jiangsu Provincial Drug Administration Review and Verification was inaugurated in Jiangning Hi-tech Zone. As of the end of April this year, the Nanjing sub-center has served more than 50 biomedical enterprises and undertaken more than 300 pieces of business.

Jiangning Hi-tech Zone has also created a closed-loop service system from the source of innovation, clinical research, pilot amplification to the scale of production, biopharmaceutical companies from R & D to the listing of the whole industry chain can be completed almost in the "doorstep".

"At present, the park has built a 3-square-kilometer 'Nanjing Life Science and Technology Town' mainly for small-trial and R&D, a 300,000-square-meter 'Life Science Acceleration Belt' mainly for pilot scale-up, and various types of R&D carriers, incubators, and crowdsource spaces of more than 1 million square meters. and crowdspring space of more than 1 million square meters, building up an integrated industrial system of 'small-trial R&D + pilot production + large-scale production'."

Accompanied by the provincial Drug Administration review and verification of the Nanjing Branch Center, Nanjing Tianyinshan Hospital put into operation, Nanjing Food and Drug Supervision and Inspection Institute, the Affiliated Shaw Hospital of Nanjing Medical University, and a large number of resources around the approval of medicines and equipment, clinical research is highly concentrated, Jiangning Hi-Tech Zone strenuous efforts to support the innovation of biomedical enterprises.At present, there are more than 50 new drugs under research in the park, and several Class 1 global innovative drugs have entered clinical phase III, which are expected to add tens of billions of dollars to the industrial scale after listing.
Optimizing the business environment, drug companies ride the winds of power

  Whether the business environment is good or not, enterprises have the final say. This year, a batch of domestic and foreign innovative drug companies have set up R&D centers and started factory construction in Jiangning Hi-tech Zone.

With a variety of innovative drugs in hand, Nanjing Oncology Immunity Biomedical Company, its entrepreneurial team returned to China that year to choose the site of the industry and capital circle attention. 2021, the company's executives ran around the country, and ultimately registered the company in Jiangning Hi-Tech Zone. On March 25 this year, Oncology immune scientists team, internationally renowned immunologist, the American Association for the Advancement of Science, Professor Liu Yang again announced the establishment of antibody-coupled drug innovation centers and the development of immunotherapeutic drugs innovative macromolecular drug R & D center.

As of March 2024, Oncor Immunity has invested approximately RMB 280 million in Jiangning Hi-Tech Zone, with 70 R&D personnel, three R&D projects in the clinical stage, and technology transfer and technical service revenues of over US$14 million. It is expected that with the launch of the products, the cumulative output value will not be less than 5 billion RMB in 5 years, and the cumulative tax payment will not be less than 450 million RMB.

In the first quarter, a total investment of 1 billion yuan of high-end pharmaceutical R & D and production base project of Star Hao Pharmaceutical began constructionThe project is invested and constructed by Nanjing Yingnuo Biotechnology Co., Ltd, a wholly-owned subsidiary of Beijing Xinghao Pharmaceutical Company Limited, and is the first project of Xinghao Pharmaceutical's layout in the Yangtze River Delta.

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