Celexa (ustekinumab biosimilar) / Huadong Medicine, Qyuns Therap - LARVOL DELTA

Huadong Medicine's first domestically produced ustekinumab injection, Celestron, was approved for marketing in the treatment of pediatric plaque psoriasis [Google translation] (Sina Corp) - "On March 3, 2025 , Hangzhou Sino-US Huadong Medicine Co., Ltd. (hereinafter referred to as 'Sino-US Huadong'), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as 'the Company'), received the 'Notice of Approval of Drug Supplementary Application' approved and issued by the National Medical Products Administration (NMPA). The supplementary application for ustekinumab injection ( trade name: Celexa , R&D code: HDM3001/QX001S) submitted by Sino-US Huadong for the new indication of pediatric plaque psoriasis was approved."

China approval • Psoriasis

The first domestically produced ustekinumab new indication application was accepted [Google translation] (Eastmoney.com) - "On the evening of February 12, Huadong Medicine(000963) announced that the marketing authorization application and supplementary application for ustekinumab injection (intravenous infusion) and ustekinumab injection (R&D code: HDM3001-2/QX001S) for Crohn's disease submitted by its wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as 'Sino-US Huadong') have been accepted by NMPA."

China filing • Crohn's disease

Approved! The first in China! [Google translation] (Sina Corp) - "On November 5, 2024, Hangzhou Sino-US Huadong Pharmaceutical Co...a subsidiary of Huadong Medicine Co., Ltd...received the 'Drug Registration Certificate' approved and issued by the National Medical Products Administration (NMPA). The marketing authorization application for ustekinumab Injection Celexa (R&D code: QX001S/HDM3001), jointly developed by Sino-US Huadong and Jiangsu Quanxin Biopharmaceutical Co., Ltd...was approved for the treatment of moderate to severe plaque psoriasis in adults."

China approval • Immunology • Psoriasis

The first domestically produced ustekinumab was declared for listing! Huadong Medicine seizes the blue ocean market in the field of autoimmunity [Google translation] (Stockstar) - "...Huadong Medicine disclosed in an announcement that the ustekinumab biosimilar HDM3001, which was jointly developed with its joint-stock company Quanxin Biotechnology, has officially submitted a Biological Products License Application (BLA). This means that HDM3001 is expected to become the first ustekinumab biosimilar to be marketed in China."

Non-US regulatory • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis