Nanjing Jiangning pharmaceutical company’s new drug was approved for listing.

It is reported that Kangzhou Medicine was established in Jiangning High-tech Zone in October 2017. The intimate rent and decoration subsidies in the park, as well as the policy of scientific and technological talents, helped enterprises to save a lot of expenses in the growth stage and attracted biomedical talents with international standards to settle in. At that time, China’s MAH (drug listing permit holder) system had just been piloted for more than a year, and Kangzhou Medicine became the first "listing permit holder under the MAH system" enterprise in the province.

It is understood that before the implementation of the MAH system, only pharmaceutical companies with production capacity are eligible to apply for drug marketing licenses. After implementation, R&D institutions can also apply for drug marketing licenses, and hold their own drug numbers and entrust relevant pharmaceutical companies to produce and sell.

With the help and support of Jiangning High-tech Zone, in 2018, taking advantage of the "east wind" of the policy, three products, namely, Kangzhou Pharmaceutical Atosiban Acetate Injection, Terlipressin for Injection and Carbetocin Injection, were initiated for project research. Among them, Atosiban Acetate Injection, which is used to protect the fetus, advanced the fastest, and was first approved for listing in March 2021. In February and April 2023, it was used to treat complications of liver cirrhosis, respectively.

Ganarik acetate injection listed by Kangzhou Medicine this time is a generic drug of four categories, and it is the second domestic one approved for listing, which is regarded as having passed the consistency evaluation. The drug is a down-regulating drug in the field of assisted reproduction, belonging to gonadotropin-releasing hormone antagonist. It is used in women receiving controlled ovarian stimulation scheme of assisted reproduction technology to prevent premature luteinizing hormone peak. Kangzhou Pharmaceutical Ganarik Acetate Injection is prepared by a new process, which can replace imported products, provide patients with a higher choice of quality and price ratio, and reduce the economic burden. At present, Kangzhou Medicine has established a product line consisting of dozens of products, covering reproduction, digestion, metabolism and other fields, and many products are to be declared.

In the field of biomedicine, Jiangning has more than 1,300 enterprises of various types, covering key areas such as research and development and production of innovative drugs, cell and gene therapy, CRO/CDMO and new medical devices, and has built an industrial innovation system for biomedicine and new medical devices. Biomedical characteristic industrial base was rated as the characteristic industrial base of national torch plan.

At present, Jiangning District is accelerating the establishment and improvement of the "R&D+Clinical+Production+Application" bio-pharmaceutical industry life-cycle ecosystem, and constantly cultivating a number of new enterprises and new products in innovative drugs, high-end medical devices, immune drugs and other sub-areas, and striving to make the scale of bio-pharmaceutical industry account for more than 1/4 in the city.