证券研究报告 | 公司研究 gszqdatemark 2025 08 20 年 月 日 康缘药业（600557.SH） 三靶点有序推进，创新研发多点开花 在当前时点，我们认为公司创新药持续推进，对重点产品管线进行了更新 梳理。 收购中新医药，获【三靶点减肥药】在内四款创新产品。2024 年康缘药业 股收购中新医药 100%股权，对价 2.7 亿元，对手方为康缘集团、南京康 竹。中新医药已获取 4 个创新药的 6 个临床批件，均进入临床阶段。技术 平台：拥有分子设计技术平台，从细胞因子、融合蛋白、单克隆抗体类别 药物的分子发现和分子改造，形成具有可持续的创新型生物药分子发现能 力。 化药生物药有序推进，各领域多点开花。1）心脑血管领域：SIPI-2011 片 治疗室性心律失常，与上海医药工业研究院合作，处于Ⅱ期临床。2）心脑 血管领域：注射用 AAPB 治疗急性缺血性脑卒中，处于 I 期临床。3）神经 领域：氟诺哌齐治疗阿尔茨海默症。4）生物药拥抗体、溶瘤病毒、重组蛋 白和融合蛋白四个平台。自免领域 KYS202002A（CD38 单抗）针对骨髓瘤 和红斑狼疮，展开中美双报，KYS202004A（TNF-α/I ...

Group 1: Drug Approvals and Innovations - Eli Lilly's drug Tirzepatide has received approval for a third indication in China, becoming the first and only prescription drug for treating moderate to severe obstructive sleep apnea in obese adults [1] - Diligent Pharma's innovative lung cancer drug, Shuwotai, has been granted accelerated approval by the FDA for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations [2] - Xiansheng Pharmaceutical's drug Enzashu has been approved in China as the first targeted therapy for all populations of platinum-resistant ovarian cancer, addressing a significant treatment gap in this area [3] Group 2: Financial Performance and Market Trends - Nuotai Bio expects a net profit of 300 to 330 million yuan for the first half of 2025, representing a year-on-year increase of 32.06% to 45.27%, driven by significant sales growth in peptide raw materials [4] - The recent surge in net profit forecasts from several companies, including Nuotai Bio, reflects the ongoing strong market demand for GLP-1 weight loss drugs [4] - Kangyuan Pharmaceutical's KYS2301 gel has received clinical trial approval for atopic dermatitis, marking a significant advancement in the treatment options available for this condition [5][6]

Core Viewpoint - The company has received approval for clinical trials of KYS2301, a novel drug targeting atopic dermatitis, which presents significant market potential as it is the first CCR8-targeting peptide inhibitor globally [1] Company Summary - The company announced the receipt of a clinical trial approval notice from the National Medical Products Administration for KYS2301, a first-class chemical new drug [1] - KYS2301 is a specific inhibitor of chemokine receptor 8 (CCR8) and is intended for the treatment of atopic dermatitis [1] - The total research and development investment for KYS2301 has reached approximately 44.93 million yuan [1] Industry Summary - Atopic dermatitis is a common chronic relapsing inflammatory skin disease, with the global patient population reaching 649 million in 2019 and expected to grow to 755 million by 2030 [1] - Currently, there are no marketed peptide drugs targeting the CCR8 receptor, indicating a strong market opportunity for KYS2301 [1] - The company is required to complete Phase I-III clinical trials and compile submission materials for product registration following the receipt of the clinical trial notice [1]