Core Viewpoint - Ganli Pharmaceutical Co., Ltd. has received approval for clinical trials of its biosimilar drug GLR1044, targeting a significant market for atopic dermatitis, which has a global annual sales potential of €13.072 billion [2][4] Group 1: Clinical Development and Market Position - GLR1044 is a biosimilar of Dupixent (dupilumab) and aims to enter the atopic dermatitis market, which has approximately 204 million global patients, with an estimated 75 million patients in China by 2025 [2][4] - The drug has only received clinical trial approval and has not yet begun patient enrollment, with a projected clinical trial timeline of 3 to 5 years [3][4] - Competitors such as Qilu Pharmaceutical and Innovent Biologics have advanced clinical trials for similar products, putting Ganli at a disadvantage as a "follower" in the market [3][4] Group 2: Financial Performance and Challenges - Ganli's revenue for the first three quarters of 2025 was CNY 3.047 billion, with a net profit of CNY 818 million, indicating a recovery after previous performance issues [3] - However, the company reported a significant decline in revenue and profit in Q3 2025, with total revenue of CNY 980 million, down 9.4% from Q2, and a net profit decrease of 26% [7] - The core product, insulin glargine, has seen a drop in sales volume and price, leading to concerns about maintaining profitability [8][10] Group 3: Operational and Financial Risks - The company's accounts receivable increased significantly, reaching CNY 530 million, a 147.86% rise compared to the previous year, indicating potential credit policy relaxation [11][13] - High inventory levels of CNY 1.125 billion, which account for approximately 9.3% of total assets, pose risks of depreciation due to market changes or technological updates [15][16] - The slow growth of cash flow compared to net profit raises concerns about the company's operational efficiency and financial health [15][16]

Group 1 - Gan Li Pharmaceutical has announced a collaboration with Crystal Holdings for AI peptide innovation drug development in the metabolic disease field, marking a strategic upgrade for the company [1] - The collaboration aims to combine Gan Li's deep understanding of patient needs and research challenges with Crystal Holdings' advanced AI computing capabilities to explore more efficient and intelligent research pathways [1] - The agreement will utilize Crystal Holdings' proprietary AI peptide research platform, PepiX, to accelerate the discovery and development of new peptide drugs targeting unmet treatment needs in metabolic diseases [1] Group 2 - The AI healthcare market is projected to reach approximately $11.66 billion in 2024, with a compound annual growth rate of 25.83% from 2024 to 2029 [2] - Despite rapid growth, the industry faces challenges such as the contradiction between the sensitivity of medical data and the need for sharing, algorithm transparency issues, and a shortage of interdisciplinary talent [2] - Ensuring the reliability and safety of AI systems is a critical issue in the development of the industry [2]

12月9日，甘李药业宣布与晶泰科技达成代谢疾病领域AI多肽创新药的研发合作及AI技术平台使用授权 协议。根据协议，甘李药业将基于晶泰科技的AI多肽研发专有平台PepiX™，聚焦代谢疾病领域核心未 满足治疗需求，加速新型多肽创新药物的发现与开发进程。 ...

证券日报网讯 12月8日晚间，甘李药业发布公告称，近日，公司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。 （文章来源：证券日报） ...

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]