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丽珠集团:莱康奇塔单抗注射液上市许可申请获受理
Xin Lang Cai Jing· 2025-12-24 09:12
丽珠集团公告,控股子公司珠海市丽珠单抗生物技术有限公司收到国家药品监督管理局核准签发的《受 理通知书》,丽珠单抗与北京鑫康合生物医药科技有限公司联合开发的"莱康奇塔单抗注射液"的境内生 产药品注册上市许可申请获国家药监局受理。该药品拟用于适合接受系统治疗或光疗的中重度斑块状银 屑病成人患者。 ...
丽珠集团:完成6.00亿元A股股份回购,将注销减少注册资本

Xin Lang Cai Jing· 2025-12-24 09:12
丽珠集团公告称,截至2025年,公司已完成A股股份回购,通过集中竞价交易方式回购16,193,259股, 占总股本1.79%,使用资金6.00亿元(不含交易费用),购买最高价41.99元/股,最低价33.21元/股。回 购符合方案及法规要求,不会对公司产生重大不利影响。回购股份将全部注销并减少注册资本,公司将 办理相关手续及变更登记。 ...
丽珠医药(01513) - 海外监管公告-关於A股股份回购结果暨股份变动公告

2025-12-24 09:06
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準 確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而刊發。 茲載列麗珠醫藥集團股份有限公司於深圳證券交易所網站刊發之《麗珠醫藥集團股份 有限公司關於 A 股股份回購結果暨股份變動公告》,僅供參閱。 承董事會命 麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.* 公司秘書 劉寧 中國,珠海 二零二五年十二月二十四日 於本公告日期,本公司的執行董事為唐陽剛先生 ( 總裁 ) 及徐國祥先生 ( 副董事長及副總裁 ); 本 公司的非執行董事為朱保國先生 ( 董事長 ) 、陶德勝先生 ( 副董事長 ) 、林楠棋先生及邱慶豐先 生 ; 本公司的職工董事為冉永梅女士;而本公司的獨立非執行董事為白華先生、羅會遠先生、 崔麗婕女士及王智瑤女士。 * 僅供識別 证券代码:000513、01513 证券简称:丽珠集团、丽珠医药 公告编号:2025-080 ...
丽珠医药莱康奇塔单抗申报上市 用于治疗斑块状银屑病
智通财经网· 2025-12-24 06:11
Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]
丽珠医药(01513)莱康奇塔单抗申报上市 用于治疗斑块状银屑病
智通财经网· 2025-12-24 06:09
Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]
健康元(600380):首次覆盖报告:呼吸龙头再起航,创新+国际化开启成长新篇章
Western Securities· 2025-12-24 05:15
公司深度研究 | 健康元 呼吸龙头再起航,创新+国际化开启成长新篇章 健康元(600380.SH)首次覆盖报告 大型综合医药集团,创新+国际化开启新篇章。公司始创于 1992 年,保健品 业务起家,通过收并购不断开拓商业版图,经过 30 余年逐步发展为大型综 合医药集团。近年来,公司加快布局国际化及创新转型,一方面推动海外生 产基地建设,同时通过合作引进等方式快速丰富研发管线,聚焦呼吸常见疾 病,同时拓展镇痛、抗感染等领域布局。 制剂集采压力出清,新品放量助力主业拐点向上。近年来受艾普拉唑系列产 品、盐酸左沙丁胺醇吸入溶液等大单品降价影响,公司主业短暂承压,目前 核心产品降价压力基本出清,后续随着妥布霉素吸入溶液、玛帕西沙韦等新 品陆续放量,公司主业有望拐点向上。 加快创新管线布局,聚焦呼吸大适应症。多年深耕呼吸领域,近年来随着公 司创新转型进程加速推进,公司通过合作引进快速扩充在研管线,覆盖支气 管扩张、流感、COPD 等呼吸常见适应症。目前改良新药妥布霉素吸入溶液 以及流感新药玛帕西沙韦胶囊已获批,另外 TSLP 单抗、MABA 双靶点吸入 溶液、PREP 抑制剂等核心药物已进入 2 期临床。 丽珠集团: ...
2025年1-10月中国化学药品原药产量为304.9万吨 累计增长1.3%
Chan Ye Xin Xi Wang· 2025-12-22 03:36
Core Viewpoint - The report highlights the trends and statistics in the Chinese chemical pharmaceutical industry, indicating a slight decline in production while maintaining overall growth in the sector [1]. Industry Summary - As of October 2025, the production of chemical pharmaceutical raw materials in China reached 313,000 tons, showing a year-on-year decrease of 1.6% [1]. - From January to October 2025, the cumulative production of chemical pharmaceutical raw materials was 3,049,000 tons, reflecting a cumulative growth of 1.3% [1]. - The report is based on data from the National Bureau of Statistics and is compiled by Zhiyan Consulting, a leading industry consulting firm in China [1]. Company Summary - Listed companies in the sector include Heng Rui Medicine, East China Pharmaceutical, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical [1].
丽珠集团:NS-041片新增“治疗抑郁症”适应症获临床试验批准
Zheng Quan Ri Bao· 2025-12-21 13:38
Core Viewpoint - Lijun Group's subsidiary, Lijun Pharmaceutical Factory, has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression [2] Group 1 - The approval includes a new indication for NS-041 tablets specifically targeting the treatment of depression [2] - The clinical trial approval notification numbers are 2025LP03436 and 2025LP03437 [2]
丽珠医药(01513.HK):NS-041片新增治疗抑郁症适应症获得药物临床试验批准通知书
Ge Long Hui· 2025-12-21 10:46
Core Viewpoint - Lijun Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of NS-041 tablets for the treatment of depression, expanding its indications beyond epilepsy [1] Group 1: Company Developments - Lijun Pharmaceutical's wholly-owned subsidiary, Lijun Group Lijun Pharmaceutical Factory, has been granted a clinical trial approval notice for NS-041 tablets, specifically for the treatment of depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist aimed at treating neurological and psychiatric disorders, making it the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] - The clinical trial for the epilepsy indication of NS-041 was approved on December 27, 2023, and is currently undergoing Phase II clinical research [1] Group 2: Drug Mechanism and Efficacy - Research indicates that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, thereby improving symptoms related to depression [1] - In preclinical studies for the depression indication, NS-041 demonstrated significant antidepressant effects in classical acute and chronic depression models in mice [1] - The selectivity of NS-041 is higher than that of other drugs targeting the same pathway currently under investigation, and no potential ocular toxicity risks have been identified [1]
丽珠医药:NS-041 片新增治疗抑郁症适应症获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-12-21 10:35
Core Viewpoint - Lijun Pharmaceutical's subsidiary has received approval for clinical trials of NS-041 tablets for the treatment of depression, expanding its application beyond epilepsy [1][2] Group 1: Clinical Trial Approval - Lijun Pharmaceutical's subsidiary, Lijun Group, has been granted a clinical trial approval notice by the National Medical Products Administration for NS-041 tablets to treat depression [1] - NS-041 is a novel high-selectivity KCNQ2/3 agonist, currently the only KCNQ2/3 agonist in China approved for clinical research in both epilepsy and depression [1] Group 2: Clinical Research and Efficacy - The clinical trial for the depression indication follows the approval for epilepsy, with the latter currently in Phase II clinical research [1] - Preclinical studies indicate that KCNQ2/3 channel activators can modulate the excitability of dopamine neurons in the ventral tegmental area, improving symptoms of depression [1] - NS-041 has shown good antidepressant effects in classical acute and chronic depression models in mice, with higher target selectivity than other drugs in development and no potential ocular toxicity risks identified [1] Group 3: Financial Investment - As of the announcement date, the total direct investment in the research and development of NS-041 has reached approximately RMB 58.54 million [2]