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浦东新区2024年获批上市I类新药   2024-05-26

 



Shanghai’s Pudong New Area has released the first list of innovative drugs and medical devices that it recommends this year, creating conditions for the products to enter hospitals as soon as possible.

Within a month after the products on the list come onto the market, medical and health institutions in Pudong will hold a meeting with pharmaceutical committees to buy the medicines and devices they need and to start using them right away, Bai Yun, director of the health commission of Pudong, told Yicai last Wednesday. The commission also provides financial support for hospitals in Pudong that use drugs on the list.

Keluping, a melanoma treatment developed by Shanghai KeChow Pharmaceuticals, was given the greenlight by regulators to go to market on March 15 and was included by the Pudong health commission on the list of recommended products, Bai said.

The first prescription of the drug has already been made under the recommendation list mechanism, Chairman Tian Hongqi said.

Pudong district is also taking a number of other moves to support the biopharmaceutical sector, which is its leading industry and was worth CNY378.1 billion (USD48.4 billion) last year.

Pudong district and the Shanghai Hospital Development Center are setting up the Shanghai Research Institute for Clinical Innovation and Transformation in Shanghai’s Zhangjiang hi-tech zone to accelerate the industrialization of clinical results, according to the deal inked yesterday. The institute is expected to open at the end of next month.

The institute is aimed at accelerating the transformation of innovative drugs into commodities, said Ling Gang, chief engineer of the Pudong committee on science, technology and economics.

It will set up a team that will study how to form a market-oriented incentive mechanism and explore how to use publicly available medical big data to speed up the development of new drugs and to work out ways for innovative drugs to enter hospitals faster, Ling said.

Pudong is also implementing methods such as the mutual recognition of medical ethics review results between medical institutions in the district to make the review of medical ethics more efficient. It has also launched a system for recruiting subjects for clinical trials to help new drug developers find clinical trial volunteers as soon as possible.

Some 24 innovative drugs by bio-pharmaceutical companies based in Pudong have been approved to go to market so far, including three this year. And there are 16 at the application stage.

Source: Yicai Global

 


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