Recently, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, received the "Notice of Acceptance" issued by the National Medical Products Administration. The company submitted the Class 1 new drug Vunakizumab Injection (SHR-1314) The drug marketing authorization application was accepted by the NMPA. This product is used for adult patients with active ankylosing spondylitis whose conventional treatment is not effective.

This application for marketing is based on a multi-center, randomized, double-blind, placebo-controlled adaptive seamless phase II/III clinical trial (SHR-1314-302). Research shows that Vunakizumab injection provides statistically significant and clinically meaningful improvements in active ankylosing spondylitis compared with placebo. At the same time, SHR-1314 injection is safe and well tolerated in the long-term treatment of patients with active ankylosing spondylitis.

About SHR-1314-302 Research

In November 2023, the main research endpoint of the Phase III clinical trial (SHR-1314-302) of SHR-1314 injection for the treatment of active ankylosing spondylitis in subjects with poor efficacy of conventional treatments met the superiority standard preset in the protocol. The study was led by the Chinese People's Liberation Army General Hospital and 38 centers across the country participated.

This study is divided into stage I (Phase II) and stage II (Phase III). A total of 548 subjects with active ankylosing spondylitis were enrolled and received SHR-1314 injection or placebo.

The research results show that this study achieved the primary and secondary research endpoints. Compared with placebo, this product has a statistically significant and clinically meaningful improvement in active ankylosing spondylitis. At the same time, SHR-1314 injection is safe and well tolerated in the long-term treatment of patients with active ankylosing spondylitis.

About ankylosing spondylitis

Ankylosing spondylitis (AS) is a chronic inflammatory disease with a relatively insidious onset. Most patients gradually develop low back or sacroiliac pain and/or morning stiffness. The disease mainly affects the sacroiliac joints, spinal apophyses, paraspinal soft tissues and peripheral joints. In severe cases, spinal deformity and ankylosis may occur. AS can be accompanied by extra-articular manifestations in multiple systems such as the thorax, lungs, heart, and iris. The prevalence of AS in my country is about 0.3%, and the male to female ratio is about 2 to 3:1 [1]. Most of the patients are young adults, which has a huge impact on the physical and mental health of the patients and brings a huge burden to society.

Currently, AS cannot be cured. Its treatment goals are to relieve symptoms and signs, restore functions, prevent joint damage, improve patients' quality of life, and prevent complications of spinal diseases. The treatment of AS includes non-pharmacological treatment, drug treatment and surgical treatment. Non-steroidal anti-inflammatory drugs (NSAIDs) are the first-line drugs for the treatment of AS. For AS patients whose disease is still active or intolerant after NSAIDs treatment, biologic drugs are recommended [2]. However, there are still some patients with active AS who have poor treatment results.

About Vunakizumab injection (SHR-1314)

SHR-1314 injection is a recombinant humanized monoclonal antibody targeting human IL-17A independently developed by Hengrui. It is intended to be used to treat autoimmune diseases related to the IL-17 pathway and can bind to IL-17A. , blocking its interaction with IL-17R, leading to the blockade of downstream inflammatory signaling. SHR-1314 injection has currently carried out clinical studies including plaque psoriasis, psoriatic arthritis, etc. to evaluate its effect on various autoimmune diseases. Among them, the study on plaque psoriasis has been completed and achieved the primary research endpoint and key secondary research endpoints. Its marketing authorization application has been accepted by the NMPA in April 2023.

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