Core Viewpoint - Novartis has received approval from the National Medical Products Administration for a new indication of secukinumab, which is now approved for treating adult patients with active radiographic axial spondyloarthritis (axSpA) who have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) [1] Group 1: Drug Approval and Indications - Secukinumab is now approved for its sixth indication in China, following approvals for severe plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and hidradenitis suppurativa [1] - The newly approved indication targets axial spondyloarthritis (axSpA), a chronic inflammatory disease, specifically the early stage known as non-radiographic axial spondyloarthritis (nr-axSpA) [1] Group 2: Clinical Significance and Research - Patients with nr-axSpA typically start treatment with NSAIDs and physical therapy, but NSAIDs often only relieve symptoms without altering disease progression, leading to significant clinical and economic burdens due to delayed diagnosis [1] - Early diagnosis and treatment are crucial for improving clinical outcomes and reducing the burden on patients with nr-axSpA [1] - The PREVENT study, a global Phase III trial for secukinumab in nr-axSpA patients, demonstrated a higher ASAS40 response rate at week 16 compared to the placebo group, with improvements sustained until week 52 and good safety profile [1]

Core Viewpoint - The company, Heng Rui Medicine, has received acceptance for a new indication application for its drug SHR-A1811, aimed at treating HER2-positive breast cancer patients who have previously undergone one or more anti-HER2 therapies, and it has been included in the priority review process by the National Medical Products Administration [1] Group 1 - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for SHR-A1811, which is intended for adult patients with locally advanced or metastatic HER2-positive breast cancer [1] - SHR-A1811 is part of a Phase III clinical trial (SHR-A1811-Ⅲ-301) designed to compare its efficacy and safety against pyrotinib combined with capecitabine in HER2-positive breast cancer patients who have previously received anti-HER2 therapies [2] - The primary endpoint of the study is progression-free survival (PFS) assessed by a blinded independent review committee (BIRC), with secondary endpoints including overall survival (OS) and objective response rate (ORR) [2] Group 2 - The drug SHR-A1811 was approved for domestic market use in May 2025 for treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy [3]