Gelonghui, December 2, 丨 Quanxin Bio-B (02509.HK) notice concerning the QX001S framework agreement between the company and Hangzhou China-US Huadong Pharmaceutical Co., Ltd. (“China-US Huadong”), an announcement dated September 12, 2024, and the content of the “Usinumab Commissioned Production Agreement” between China and the US Huadong and Jiangsu Safus Biotechnology Co., Ltd. (“Safus”), a supplementary agreement on the “Usinumab Commissioned Production Agreement” signed between China and the US and Jiangsu Safus Biotechnology Co., Ltd. (“Safus”), and the announcement issued by the company on November 5, 2024. China and the US East China received the “Drug Registration Certificate” approved and issued by the National Drug Administration (NMPA), and the marketing license application for usinumab injection (trade name: Xeroxin, R&D code: QX001S/HDM3001) declared by China and the US East China was approved for the treatment of moderate to severe plaque psoriasis in adults.
On December 2, 2024, the supplementary application for QX001S for pediatric plaque psoriasis was accepted.
Receiving a notice of acceptance of the supplementary application for the use of usinumab injection for pediatric plaque psoriasis is another important step forward in the development process of this drug. It is beneficial in the long term to increase product coverage and further enhance the company's core competitiveness in the field of self-exempt treatment. According to the requirements of laws and regulations relating to national drug registration, the above drugs will be transferred to the Drug Evaluation Center of the State Drug Administration for review after receiving the supplementary application from the State Drug Administration. After approval, the supplementary drug application will be issued before they can be put into production and sale. There are many uncertainties about the drug review and approval time, approval results, and future product market competition situation. The company will actively promote related work and disclose information in a timely manner according to research and development progress.