Just now, the National Medical Products Administration released information on drug notification documents delivered on April 21, 2026. A total of 9 application numbers received notification documents in this batch , all of which were marketing authorization applications. Among them:
Simcere Pharmaceutical received a notification for its application for Ledeqibaimab injection , the reason for which is unknown. The application for its indication is: treatment of atopic dermatitis in adults and adolescents .

Ledecibaimab is a highly potent anti -IL-4Rα monoclonal antibody that blocks IL-4Rα signaling induced by IL-4 and IL-13 , and inhibits TF-1 cell proliferation induced by IL-4 and IL-13 . It has the potential clinical significance of faster onset of action, lower dosing frequency, and higher clinical response rate.
Ledikuma is developed by Connect Biopharmaceuticals Limited in Hong Kong. In November 2023 , Simcere Pharmaceutical acquired the Greater China rights to Ledikuma with an initial payment of RMB 150 million plus potential milestone payments of up to RMB 875 million, as well as a sales commission of up to double digits.
In the pivotal Phase II study published by Connecticut , patients treated with the medication showed significant improvement in skin inflammation, and the Eczema Area and Severity Index ( EASI ), an important indicator for measuring the severity of atopic dermatitis symptoms , showed a significant decrease after treatment.
At week 16 of treatment , a significant proportion of patients achieved an EASI improvement of at least 75% from baseline ( EASI - 75 ), meaning a substantial reduction in the area of eczema on the patient's skin and a significant decrease in the severity of inflammation. As the treatment period was extended to 52 weeks, the proportion of patients achieving EASI - 75 further increased, with more patients benefiting and their skin condition continuing to improve.
In July 2025 , Simcere Pharmaceutical announced that its application for marketing authorization of the new drug Ledeqibaimab had been accepted by the National Medical Products Administration, but the reason for receiving the notification this time is still unknown.
The complete notification information is as follows:

https://mp.weixin.qq.com/s/DCCTlFHsLQzbSMhT0Q_KSg