China's First Domestically Developed IL-17A Inhibitor, Secukinumab Biosimilar Saikilimab, Approved for Ankylosing Spondylitis Indication

Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhixiang Jintai”) announced that the company’s independently developed Class 1 new drug, selicrelumab injection (brand name:Jin Lixi^®) Officially ApprovedAnkylosing Spondylitis (Radiographic Axial Spondyloarthritis) Indication. This is Seliqimab Injection (Jin Lixi^®) Following its approval in August 2024 for the treatment ofModerate-to-Severe Plaque PsoriasisThe second indication subsequently approved becameThe First Domestically Developed IL-17A Inhibitor Approved for This Indication in China。

Secukinumab Injection (Jin Lixi^®) is a recombinant fully human anti-IL-17A monoclonal antibody independently developed by Zhixiang Jintai. This product specifically binds to the IL-17A cytokine in serum, blocks the interaction between IL-17A and IL-17RA, and inhibits the onset and progression of inflammation, thereby achieving therapeutic effects in autoimmune diseases characterized by IL-17A overexpression, such as plaque psoriasis and axial spondyloarthritis. The approved indication for ankylosing spondylitis (radiographic axial spondyloarthritis) was supported by a Phase III clinical study led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.

Professor Zeng Xiaofeng, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Executive Director of the Chinese Medical Doctor Association and President of the Rheumatology and Immunology Branch; Principal Investigator of the Phase III Clinical Trial in China for the Ankylosing Spondylitis Indication of SecukinumabIt was pointed out that “ankylosing spondylitis (AS) is a chronic inflammatory disease affecting approximately 5 million patients in China, severely impairing their quality of life and imposing a substantial physical and psychological burden. The emergence of IL-17A inhibitors has ushered in a new era of precise targeted therapy for AS; however, all previously available IL-17A inhibitors for AS treatment were imported drugs. The market launch of secukinumab injection, an IL-17A inhibitor independently developed in China, has broken the long-standing monopoly held by similar imported products, providing a new therapeutic option for Chinese patients with ankylosing spondylitis.”

Secukinumab Injection (Jin Lixi^®) The development process relied on Zhixiang Jintai’s independently developed dual-vector phage display platform. As a Class 1 innovative biologic drug in China, the approval of secukinumab injection for the new indication of ankylosing spondylitis will bring new hope to a vast number of patients with this condition. Meanwhile, this achievement represents another significant breakthrough for domestically produced innovative drugs in the field of autoimmune disease treatment, highlighting the growing strength of Chinese R&D.