HENGRUI PHARMA (01276.HK): Class 1 Innovative Drug Ivarmacitinib Sulfate Tablets Approved for Fifth Indication, Completing Full-Disease-Spectrum Coverage of Axial Spondyloarthritis

NewTimeSpace News: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) issued an overseas regulatory announcement stating that the Company has recently received a notice from the National Medical Products Administration (NMPA) approving the addition of a fifth indication for the Company's self-developed Class 1 innovative drug, ivarmacitinib sulfate tablets (SHR0302 tablets). The newly approved indication is for adult patients with active non-radiographic axial spondyloarthritis who have an inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) and exhibit objective signs of inflammation (manifested by elevated C-reactive protein and/or abnormal magnetic resonance imaging).

The announcement disclosed that the drug is in tablet form with a specification of 4mg, registered as a Category 2.4 chemical drug under acceptance number CXHS2500141, and is a prescription drug. Ivarmacitinib sulfate tablets had previously been approved for four indications in China, including adult patients with active ankylosing spondylitis with inadequate response or intolerance to one or more TNF inhibitors, adult patients with moderate-to-severe active rheumatoid arthritis, adult patients with moderate-to-severe atopic dermatitis with inadequate response or intolerance to topical or other systemic treatments, and adult patients with severe alopecia areata. Following the approval of this new indication, the product has achieved full-disease-spectrum oral targeted management coverage of axial spondyloarthritis.

In respect of the disease background, axial spondyloarthritis (axSpA) is a chronic inflammatory disease primarily affecting the axial skeleton, with enthesitis as an important pathological feature. It is classified into ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) based on whether sacroiliitis is clearly visible on X-ray, with approximately 10% of patients with nr-axSpA progressing to AS within two years. For patients with inadequate response or intolerance to NSAIDs and objective evidence of inflammation, guidelines recommend JAK inhibitors as one of the targeted treatment options. Ivarmacitinib sulfate tablets is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive biological effects by inhibiting JAK1 signal transduction.

The approval of this new indication is based on a multicenter, randomized, double-blind, placebo-controlled pivotal Phase III study (SHR0302-305), which involved 47 research centres nationwide and enrolled 304 adult patients with active nr-axSpA who had inadequate response or intolerance to NSAIDs, with the relevant data presented as an oral presentation at the 2026 EULAR Annual Meeting. The announcement noted that for nr-axSpA, AbbVie's upadacitinib extended-release tablets (RINVOQ) has been approved globally, but no JAK1 inhibitor self-developed by a domestic enterprise has been approved for marketing; according to the EvaluatePharma database, the global sales of upadacitinib extended-release tablets in 2025 amounted to approximately USD 8.304 billion. As of now, the cumulative R&D investment in the ivarmacitinib sulfate related projects amounts to approximately RMB 1,234.8 million (unaudited).

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.