Core Viewpoint - Hubei Kelun Pharmaceutical has received approval for its generic drug, Compound Potassium Hydrogen Phosphate Injection, which is now recognized as the second domestic company to pass the consistency evaluation for this product [1][5]. Group 1: Product Overview - Compound Potassium Hydrogen Phosphate Injection is primarily used as a phosphorus supplement in total parenteral nutrition therapy for patients who need to fast for more than five days due to moderate or major surgeries or other traumas [3]. - The sales of this product exceeded 300 million yuan in 2023, marking a year-on-year growth of 33.55%. In the first two quarters of 2024, sales already surpassed 200 million yuan, with a year-on-year growth rate of 33% [3]. Group 2: Market Competition - A total of 11 companies, including Shijiazhuang Fourth Pharmaceutical and Tianjin Pharmaceutical, hold production licenses for Compound Potassium Hydrogen Phosphate Injection, with Shijiazhuang Fourth Pharmaceutical being the first to pass the evaluation [5]. - There are 30 companies, including Shandong Hualu Pharmaceutical and Chenxin Pharmaceutical, that have submitted applications for the generic version of this product, indicating a competitive market landscape [6]. Group 3: Company Achievements - Since 2025, Kelun Pharmaceutical (including subsidiaries) has had 13 products approved, including Tacrolimus Sustained-Release Capsules and Chloride Injection, with some being the first to pass the evaluation for their respective categories [8].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 42.24 CNY based on a reasonable valuation level of 24 times the earnings per share for 2025 [2][5]. Core Views - The company is entering a harvest period for innovative drugs, although its main business faces short-term pressure due to the impact of centralized procurement on the infusion and generic drug segments [1]. - The company achieved a revenue of 21.81 billion CNY in 2024, reflecting a growth of 1.67%, and a net profit attributable to the parent company of 2.94 billion CNY, up 19.53% [9]. - The first quarter of 2025 saw a revenue decline to 4.39 billion CNY, down 29.42%, and a net profit of 584 million CNY, down 43.07%, primarily due to high base effects from the previous year [9]. - The ADC platform is expected to yield significant commercial results, with key products like SKB264 receiving regulatory approval for multiple indications [9]. - The antibiotic supply-demand structure remains stable, with synthetic biology products contributing to revenue growth [9]. Financial Summary - The company’s projected financials indicate a revenue increase from 21.45 billion CNY in 2023 to 29.19 billion CNY by 2027, with a compound annual growth rate of approximately 13% [4]. - The net profit attributable to the parent company is expected to grow from 2.46 billion CNY in 2023 to 3.62 billion CNY in 2027, with a notable increase in 2024 [4]. - Earnings per share are projected to be 1.76 CNY in 2025, with a gradual increase to 2.27 CNY by 2027 [4][2]. - The gross margin is expected to stabilize around 50% to 52.7% over the forecast period, indicating a solid profitability outlook [4].

关于子公司根据 SKB378/HBM9378/WIN378 的独占性许可协议 证券代码：002422 证券简称：科伦药业 公告编号：2025-045 四川科伦药业股份有限公司 二、风险提示 收到现金及股权支付的首付款的公告 创新药物研发过程周期长、环节多、能否开发成功及商业化具有一定的不确 定性，敬请广大投资者谨慎决策，注意防范投资风险。公司将根据后续进展情况 及时履行信息披露义务。 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 特此公告。 四川科伦药业股份有限公司（以下简称"公司"）近日获悉，公司控股子公 司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰"）已根据科伦博 泰及和铂医药控股有限公司（以下简称"和铂医药"）与 Windward Bio AG （"Windward Bio"）关于 SKB378/HBM9378/WIN3781订立的独占性许可协议， 收到 Windward Bio 支付的首付款，包括：（1）现金付款，该款项于 2025 年 2 月 收到，及（2）Windward Bio 母公司的股权，该股权于获得中国境内相关监管批 准并满足其 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [2][13]. Core Views - The company reported strong performance in 2024, with total revenue reaching 21.81 billion yuan (up 1.7% year-on-year) and net profit attributable to shareholders of 2.94 billion yuan (up 19.5% year-on-year) [4][5]. - The innovative drug segment is accelerating, with significant contributions from various product lines, including raw material intermediates and innovative drugs [5][6]. Financial Performance Summary - In 2024, the company achieved a total revenue of 21.81 billion yuan, with a net profit of 2.94 billion yuan and a non-recurring net profit of 2.90 billion yuan [4]. - For Q1 2025, the company reported a revenue of 4.39 billion yuan (down 29.4% year-on-year) and a net profit of 580 million yuan (down 43.1% year-on-year) [4]. - The company’s major segments, including large-volume infusion, raw material intermediates, and generic drugs, showed stable performance, with notable growth in certain product lines [6]. Segment Performance - The large-volume infusion segment generated sales of 8.91 billion yuan in 2024, despite a decline of 11.85% year-on-year, with a total volume of 4.35 billion bottles/bags [6]. - The non-infusion formulations segment saw a revenue increase of 5.41% year-on-year, reaching 4.17 billion yuan, with significant growth in specific generic products [6]. - The antibiotic intermediates and raw materials segment reported a revenue of 5.86 billion yuan, up 20.9% year-on-year, driven by increased market demand and production efficiency [6]. Innovation and Future Outlook - The successful launch of the innovative drug Jiatailai (Lukangshatuo) is expected to contribute significantly to future revenues, with multiple clinical studies ongoing for various indications [6][13]. - The company anticipates steady performance in its core business and accelerated growth in the innovative drug segment in 2025 [5][13].

Core Viewpoint - The company, Kelun Pharmaceutical, is set to present six clinical research results at the 2025 American Society of Clinical Oncology annual meeting, showcasing advancements in cancer treatment [1] Group 1: Clinical Research Results - Kelun Biotech, a subsidiary of Kelun Pharmaceutical, will present data on antibody-drug conjugate Lukanasatuzumab targeting TROP2, monoclonal antibody Tagolisumab targeting PD-L1, and RET inhibitor KL590586 [1] - Lukanasatuzumab demonstrated a confirmed objective response rate of 45.1% in a randomized clinical study for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), with a median progression-free survival of 6.9 months [1] - Tagolisumab combined with gemcitabine and cisplatin showed a 53% reduction in the risk of disease progression or death in a randomized, double-blind Phase 3 clinical study for recurrent or metastatic nasopharyngeal carcinoma [1] - KL590586 achieved a confirmed objective response rate of 63.0% in a Phase I clinical study for patients with advanced RET gene mutation medullary thyroid carcinoma (MTC) [1]

证券代码：002422 证券简称：科伦药业 公告编号：2025-044 四川科伦药业股份有限公司 关于子公司在 2025 年美国临床肿瘤学会年会上 公布的六项创新药物研究成果的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）近日获悉，公司控股子公 司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰"）将于 2025 年 5 月 30 日至 6 月 3 日期间在美国伊利诺伊州芝加哥市举行的 2025 年美国临床肿瘤 学会(ASCO)年会上公布六项由科伦博泰主导的临床研究成果，包括其抗人滋养 细胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT)(佳泰 莱®)、抗程序性细胞死亡配体 1(PD-L1)单克隆抗体塔戈利单抗(tagitanlimab)(科泰 莱®)以及转染过程中重排(RET)抑制剂 KL590586（A400/EP0031）的相关数据。 具体研究情况如下： 1.芦康沙妥珠单抗(sac-TMT)用于经治的晚期表皮生长因子受体(EGFR)突变 非小细胞肺癌（NSCLC）患 ...

证券代码：002422 证券简称：科伦药业 公告编号：2025-043 四川科伦药业股份有限公司 | 股东姓 | 是否为控股股 东或第一大股 | 本次解除质 | 占其所持股 | 占公司总股 | 起始日 | 解除日 | 质权人 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 押股份数量 | | | | | | | 名 | 东及其一致行 | （股） | 份比例 | 本比例 | | | | | | 动人 | | | | | | | | 刘革新 | 是 | 2,673,000 | 0.71% | 0.17% | 2024/5/22 | 2025/5/22 | 华泰证券（上海） | | | | | | | | | 资产管理有限公司 | | 刘革新 | 是 | 1,280,000 | 0.34% | 0.08% | 2024/5/22 | 2025/5/22 | 华泰证券（上海） | | | | | | | | | 资产管理有限公司 | | 刘革新 | 是 | 2,781,000 | 0.73% | 0.17% | 2024/5/22 | 2025/5/ ...

证券代码：002422 证券简称：科伦药业 公告编号：2025-042 四川科伦药业股份有限公司 关于子公司核心产品芦康沙妥珠单抗(sac-TMT)的新增适应症 上市申请(sNDA)获国家药品监督管理局受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 OptiTROP-Breast02 是一项随机、开放标签、多中心 3 期临床研究，评估芦 康沙妥珠单抗(sac-TMT)单一疗法(5mg/kg 每两周一次(Q2W))对比研究者选择化 疗方案用于治疗局部晚期或转移性 HR+/HER2- (免疫组织化学[IHC]0、IHC 1+或 IHC 2+/原位杂交[ISH]-) BC 患者的有效性和安全性。根据预设的期中分析，该 3 期临床研究达到主要疗效终点，与研究者选择化疗方案相比，芦康沙妥珠单抗 (sac-TMT)单一疗法在主要终点由盲态独立评审委员会(BIRC)评估的无进展生存 期(PFS)方面具有显著统计学意义和临床意义的改善，显著降低疾病进展或死亡 风险。同时，芦康沙妥珠单抗(sac-TMT)显示出总生存期(OS)获益趋势。 2025 年 5 月 16 ...

证券代码：002422 证券简称：科伦药业 公告编号：2025-041 四川科伦药业股份有限公司 关于公司注射用比阿培南/氯化钠注射液获得药品注册批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）子公司湖南科伦制药有限 公司的化学药品"注射用比阿培南/氯化钠注射液"于近日获得国家药品监督管 理局的药品注册批准，现将相关情况公告如下： 一、 药品基本情况 药品批准文号：国药准字H20254124 上市许可持有人：湖南科伦制药有限公司 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 2. 药品相关情况 1. 药品名称：注射用比阿培南/氯化钠注射液 剂型：注射剂 规格：粉体室：0.3g（按C15H18N4O4S计）；液体室100ml：氯化钠0.9 g 申请事项：药品注册（境内生产） 注册分类：化学药品3类 受理号：CYHS2303536 粉液双室袋是国际上先进的输液产品，其中粉体和液体分别位于两个独立的 腔室，保证混合前各腔室药品的稳定性， ...

Core Viewpoint - Kolon Pharmaceutical's subsidiary has received drug registration approval for its injectable product, marking a significant milestone in the domestic pharmaceutical market [1] Company Summary - Kolon Pharmaceutical (002422.SZ) announced that its subsidiary, Hunan Kolon Pharmaceutical Co., Ltd., has obtained approval from the National Medical Products Administration for its injectable drug "Injectable Biapenem/Sodium Chloride Injection" [1] - This product is the first of its kind in China to be approved in a dual-chamber bag packaging format [1] - The drug features a broad antibacterial spectrum, stability against β-lactamase, and strong antibacterial activity, while exhibiting lower nephrotoxicity and central nervous system toxicity [1]