Core Viewpoint - Ganli Pharmaceutical (603087) announced the approval of clinical trials for its investigational drug GLR1044 injection by the National Medical Products Administration, marking a significant step in its development pipeline [1] Group 1: Company Developments - Ganli Pharmaceutical's wholly-owned subsidiary, Ganli Pharmaceutical Shandong Co., received the clinical trial approval notice for GLR1044 injection [1] - GLR1044 injection is a biosimilar to Dupixent (dupilumab), aimed at treating moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription therapies [1]

Core Viewpoint - Ganli Pharmaceutical (603087.SH) announced that its wholly-owned subsidiary, Ganli Pharmaceutical Shandong Co., Ltd., has received the Clinical Trial Approval Notice from the National Medical Products Administration for the investigational drug GLR1044 injection, a biosimilar to Dupilumab, aimed at treating moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription drugs [1]. Group 1 - The approval notice for GLR1044 injection has the acceptance number CXSL2500849 and the notice number 2025LP03316 [1]. - GLR1044 injection is a biosimilar of Dupilumab, which is used for treating atopic dermatitis [1].

Core Viewpoint - Ganli Pharmaceutical (603087.SH) has received approval from the National Medical Products Administration for its investigational drug GLR1044 injection, a biosimilar to Dupilumab, aimed at treating moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription medications [1] Group 1 - Ganli Pharmaceutical's wholly-owned subsidiary, Ganli Pharmaceutical Shandong Co., Ltd., received the clinical trial approval notice for GLR1044 injection [1] - The acceptance number for the approval is CXSL2500849, and the notice number is 2025LP03316 [1] - GLR1044 injection is a biosimilar to Dupilumab, which is used for treating adults with moderate to severe atopic dermatitis [1]

Group 1 - Company Gannee Pharmaceutical (甘李药业) announced that its wholly-owned subsidiary received the clinical trial approval for the investigational drug GLR1044 injection from the National Medical Products Administration [1] - GLR1044 injection is a biosimilar to Dupilumab (达必妥®) and is indicated for the treatment of moderate to severe atopic dermatitis in adults, particularly for cases where topical prescription medications are ineffective or not recommended [1] - The drug can be used alone or in combination with topical corticosteroids [1] Group 2 - Atopic Dermatitis (AD) is a common chronic inflammatory skin disease affecting approximately 204 million people globally, with an adult prevalence rate of about 10.6% in China [2] - The incidence of AD has been increasing annually, with nearly 30% of patients classified as moderate to severe, amounting to over 67 million individuals in 2020 [2] - The number of moderate to severe AD patients is projected to exceed 75 million by 2025, with the disease potentially lasting for decades, particularly in severe cases [2]

证券代码：603087 证券简称：甘李药业 公告编号：2025-080 甘李药业股份有限公司 关于获得《药物临床试验批准通知书》的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，甘李药业股份有限公司（以下简称"公司"、"甘李药业"）全资子 公司甘李药业山东有限公司收到国家药品监督管理局（以下简称"国家药监局"） 下发的关于在研药品 GLR1044 注射液的《药物临床试验批准通知书》，受理号 为 CXSL2500849，通知书编号为 2025LP03316。现将相关情况公告如下： 一、药物基本情况 1、产品名称：GLR1044 注射液 3、注册分类：治疗用生物制品 3.3 类 4、申请事项：境内生产药品注册-临床试验申请 5、适 应 症：用于治疗外用处方药控制不佳或不建议使用外用处方药的成 人中重度特应性皮炎。本品可与或不与外用皮质类固醇联合使用。 6、批准意见：根据《中华人民共和国药品管理法》及有关规定，经审查， 2025 年 9 月 28 日受理的 GLR1044 注射液临床试验申请符合药品注册的有关要 求，同意 ...

Group 1 - Company Gannee Pharmaceutical (甘李药业) announced that its wholly-owned subsidiary received the clinical trial approval for the investigational drug GLR1044 injection from the National Medical Products Administration [1] - GLR1044 injection is a biosimilar to Dupilumab (达必妥®) and is indicated for the treatment of moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription medications [1] - The drug can be used alone or in combination with topical corticosteroids [1] Group 2 - Atopic Dermatitis (AD) is a common chronic inflammatory skin disease affecting approximately 204 million people globally, with an adult prevalence rate of about 10.6% in China [2] - The incidence of AD has been increasing annually, with nearly 30% of patients classified as moderate to severe, totaling over 67 million individuals in 2020 [2] - The number of moderate to severe AD patients in China is expected to exceed 75 million by 2025, with the disease potentially lasting for decades in adults [2]

Core Viewpoint - Ganli Pharmaceutical has received approval from the National Medical Products Administration for its investigational drug GLR1044 injection, a biosimilar to Dupixent (dupilumab), aimed at treating moderate to severe atopic dermatitis in adults [1] Group 1 - Ganli Pharmaceutical's wholly-owned subsidiary in Shandong has been granted a clinical trial approval notice for GLR1044 injection [1] - GLR1044 injection is intended for patients with inadequate control or for whom topical prescription medications are not recommended [1] - As of September 30, 2025, Ganli Pharmaceutical has invested a total of 65.7245 million RMB in the GLR1044 project [1]

Core Viewpoint - Ganli Pharmaceutical has received approval from the National Medical Products Administration for its investigational drug GLR1044 injection, which is a biosimilar to Dupilumab, aimed at treating moderate to severe atopic dermatitis in adults [1] Group 1: Drug Approval - The National Medical Products Administration issued a clinical trial approval notice for GLR1044 injection, with acceptance number CXSL2500849 and notice number 2025LP03316 [1] - GLR1044 injection meets the registration requirements for drugs and is authorized to commence clinical trials [1] Group 2: Drug Indication - The drug is indicated for the treatment of moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription medications or for whom topical prescription medications are not recommended [1] - GLR1044 can be used alone or in combination with topical corticosteroids [1]

Core Viewpoint - Ganli Pharmaceutical announced that its wholly-owned subsidiary, Ganli Pharmaceutical Shandong Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for the investigational drug GLR1044 injection, which is intended for the treatment of moderate to severe atopic dermatitis in adults [1] Group 1: Product Development - The product GLR1044 is a biosimilar to Dupilumab [1] - As of September 30, 2025, the company has invested a total of 65.7245 million yuan in research and development for this project [1] Group 2: Market Context - Currently, only the original manufacturer Sanofi's Dupilumab injection has been approved for market release in China [1] - The global sales of Dupilumab are projected to be 13.072 billion euros for the fiscal year 2024 [1]

Market Overview - The biopharmaceutical sector experienced a decline of 1.72% on December 2, with Aopumai leading the drop [1] - The Shanghai Composite Index closed at 3897.71, down 0.42%, while the Shenzhen Component Index closed at 13056.7, down 0.68% [1] Individual Stock Performance - Dongbao Bio (300239) closed at 5.80, up 1.05% with a trading volume of 93,700 shares and a transaction value of 53.99 million yuan [1] - Aopumai (688293) saw a significant drop of 8.01%, closing at 50.32 with a trading volume of 33,400 shares and a transaction value of 171 million yuan [2] - Other notable declines included Kanghong Pharmaceutical (002773) down 3.78% and Watson Bio (300142) down 3.17% [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 456 million yuan from institutional investors, while retail investors saw a net inflow of 270 million yuan [2] - Notable stocks with significant capital inflows included He Yuan Bio (688765) with a net inflow of 17.69 million yuan from institutional investors [3] - Conversely, stocks like Rongchang Bio (688331) and Shenzhou Cell (688520) also saw mixed capital flows, indicating varied investor sentiment [3]