Core Viewpoint - Novartis announced on February 3 that its innovative biological agent, Cosentyx, has received approval from the National Medical Products Administration for a new indication to treat adult patients with active radiographic axial spondyloarthritis who have inadequate response to non-steroidal anti-inflammatory drugs [1] Group 1 - The new indication is specifically for adult patients with active radiographic axial spondyloarthritis [1] - The approval is significant as it addresses a patient population that has not responded adequately to traditional non-steroidal anti-inflammatory drugs [1] - This development may enhance Novartis's position in the market for treatments targeting inflammatory conditions [1]

Core Viewpoint - The company announced that its subsidiary, Stone Pharma Biotech Co., Ltd., has achieved positive topline analysis data from a Phase III clinical trial for its drug, Secukinumab Injection, aimed at treating moderate to severe plaque psoriasis [1][2] Group 1: Product Development - Secukinumab Injection is a fully human IgG1 monoclonal antibody that specifically binds to IL-17A, a key molecule in the pathogenesis of psoriasis, thereby inhibiting inflammatory signals [1] - The product is a biosimilar to Cosentyx® (Secukinumab), which has been approved in China for multiple indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa [1] Group 2: Clinical Trial Details - The clinical trial was a multicenter, randomized, double-blind, parallel, positive-controlled equivalence study designed to verify the consistency of efficacy between Secukinumab Injection and Cosentyx® in treating moderate to severe plaque psoriasis [2] - The study enrolled patients with moderate to severe plaque psoriasis, randomly assigning them in a 1:1 ratio to either the trial group (Secukinumab Injection) or the control group (Cosentyx®) [2] - The primary endpoint was the proportion of patients achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI-75) score from baseline at week 12, which the study successfully met [2] Group 3: Safety and Future Plans - The study demonstrated clinical equivalence between the two products, with good safety profiles and no new or unexpected safety signals, indicating potential for long-term safety in patients [2] - Detailed data from the study will be presented at upcoming academic conferences and published in journals [2]

該產品是本集團開發的全人源Ig G1單克隆抗體藥物，為司庫奇尤單抗注射液（ 可善挺® ）的 生物類似藥。可善挺®在中國獲批的適應症包括6歲及以上斑塊狀銀屑病、銀屑病關節炎、 強直性脊柱炎及化膿性汗腺炎，其療效與安全性已獲得廣泛認可。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 司庫奇尤單抗注射液III期臨床試驗獲得頂線分析數據 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布 ， 本 公 司 附 屬 公 司 石 藥 集 團 巨 石 生 物 製 藥 有 限 公 司 開 發 的 司 庫 奇 尤 單 抗 注 射 液（「 該 產 品」）在用於治療中度至重度斑塊狀銀屑病的等效性III期臨床試驗中獲得頂線分析數據。 銀 屑 病 是 一 種 免 疫 相 關 的 慢 性 、 炎 症 性 、 系 統 性 疾 病 。 目 前 ， 中 國 約 有 超 700 萬 銀 屑 病 患 者。全人源白介素(IL) -1 ...

Core Viewpoint - The announcement from XinNuoWei (300765.SZ) indicates that its subsidiary, Giant Biopharmaceutical Co., Ltd., has achieved positive topline results in a Phase III clinical trial for its drug, a biosimilar to Cosentyx, which is expected to meet long-term safety requirements for patients [1] Group 1: Product Development - The drug developed by Giant Biopharmaceutical is a fully human IgG1 monoclonal antibody injection [1] - The biosimilar is designed to treat conditions including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa, which have been widely recognized for their efficacy and safety [1] Group 2: Clinical Trial Results - The key study has met its predefined primary endpoint, demonstrating clinical equivalence to Cosentyx [1] - Safety analysis showed no new or unexpected safety signals, indicating a favorable safety profile for the drug [1] - Detailed data from the trial will be presented at upcoming academic conferences and in journals [1]