On the evening of March 3rd, Huadong Pharmaceutical announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, had applied for the injection of ustekinumab (product name: Sailexin) ®， The supplementary application for the indication of plaque psoriasis in children (R&D code: HDM3001/QX001S) has been approved.

HDM3001 (QX001S) is the original research product Stelara ® (Xidano) ®， The biosimilar drug of ustekinumab injection works by blocking the binding of the common p40 subunit of IL-12 and IL-23 to the IL-12R β 1 receptor protein on the surface of target cells, thereby inhibiting IL-12 and IL23 mediated signaling and cytokine cascade reactions. IL-12 and IL-23 are two naturally occurring cytokines that play a crucial role in immune-mediated inflammatory diseases.

Stelara ® Developed by Johnson&Johnson in the United States, it was approved for market by the US Food and Drug Administration (FDA) in 2009. As of now, the approved indications in the United States include moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and moderate to severe active ulcerative colitis.

In August 2020, Sino US East China and Tsuen Shin Biological reached an agreement on the cooperative development and commercialization of HDM3001 (QX001S) in Chinese Mainland. HDM3001 (QX001S) is jointly developed for Phase III clinical trials by Huadong and Quanxin Biotechnology in China and the United States.

This product obtained clinical approval in 2018, completed phase I clinical trials in 2020, and completed phase III clinical research in June 2023. It was submitted for marketing by China US East China as a drug registration applicant to NMPA and was approved in October 2024 for the treatment of adult moderate to severe plaque psoriasis. It is the first approved biosimilar of ustekinumab injection in China.

In February 2025, the marketing authorization application and supplementary application for ustekinumab injection for Crohn's disease submitted by East China and the United States were accepted. In December 2024, the supplementary application for the use of ustekinumab injection for pediatric plaque psoriasis submitted by East China and the United States was accepted and recently approved