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丽珠医药集团股份有限公司关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告
Group 1 - The core announcement is about the acceptance of the marketing authorization application for "Lai Kang Qi Ta" monoclonal antibody injection by the National Medical Products Administration [1][2] - The drug is a first-in-class, self-developed innovative IL-17A/F dual-target inhibitor for moderate to severe plaque psoriasis in adults [3][4] - The clinical trials showed that the drug achieved superior efficacy compared to the control group, with faster onset and better long-term effects [3] Group 2 - The total research and development expenses incurred for the drug amount to approximately RMB 204.03 million [5] - Currently, there are no approved products for psoriasis indications targeting IL-17A/F dual targets in China, while there are five products targeting IL-17A and IL-17RA [7] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [7] Group 3 - The company has completed a share repurchase program, acquiring 16,193,259 A-shares, which is 1.79% of the total share capital [9][10] - The repurchase was conducted at a total cost of approximately RMB 600.22 million, with a maximum price of RMB 41.99 per share and a minimum price of RMB 33.21 per share [9][10] - All repurchased shares will be canceled, leading to a reduction in registered capital [11][13]
12月24日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-24 10:12
Group 1 - Jizhi Co., Ltd. plans to acquire at least 51% equity in Pumai Technology through cash payment, aiming to gain control over the company, which is a leading enterprise in the field of robot performance testing and calibration in China [1] - Yaxing Chemical's subsidiary intends to transfer 7.14% equity for 60 million yuan to another fund under the same control, indicating strategic investment movements within the same management group [2] - Weigao Bio's application for clinical trials of subcutaneous human immunoglobulin has been accepted by the National Medical Products Administration, targeting primary immunodeficiency diseases [3] Group 2 - Sentai Co., Ltd.'s controlling shareholder plans to increase shareholding by at least 100 million yuan within 12 months, aiming to enhance confidence in the company's future [4] - Health元's subsidiary has received acceptance for the marketing authorization application of Lecanemab injection, which is intended for moderate to severe plaque psoriasis patients [5][11] - Sunshine Nuohuo has signed a technical development contract for the STC008 injection project, with a total payment of 500 million yuan, indicating significant investment in cancer treatment [6] Group 3 - Hunan YN has been designated as a delivery warehouse for lithium carbonate by the Guangzhou Futures Exchange, enhancing its position in the lithium market [7] - Tianji Co., Ltd. is pushing for the industrialization of lithium sulfide material preparation, although it faces risks in commercialization [8] - Yuandong Bio has received FDA approval for Methylene Blue injection, expanding its product portfolio in the U.S. market [10] Group 4 - Nanshan Aluminum has established a wholly-owned subsidiary in Hainan with an investment of 5 million yuan, focusing on high-end aluminum products [13] - ST Xifa plans to acquire 50% equity in Lhasa Beer, aiming for full ownership, with the transaction currently in the planning stage [14] - Hengrui Medicine's SHR-A1904 injection has been included in the list of breakthrough therapy products, indicating its potential in treating advanced gastric cancer [12] Group 5 - Chengdu Gas is planning to merge three subsidiaries, streamlining operations and enhancing efficiency [26] - Baoli Electric intends to invest 50 million yuan to establish a wholly-owned subsidiary focused on key equipment and solutions in energy storage [27] - Huadian International has successfully put the second unit of its Longkou Phase IV project into commercial operation, marking a significant milestone in its energy production capacity [34]
丽珠医药(01513.HK):莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理
Jin Rong Jie· 2025-12-24 09:29
Core Viewpoint - Lijun Pharmaceutical (01513.HK) announced that its subsidiary, Zhuhai Lijun Monoclonal Antibody Biotechnology Co., Ltd., received the acceptance notice from the National Medical Products Administration for the registration application of the monoclonal antibody injection, Laikangqita, developed in collaboration with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] Group 1 - The acceptance notice is identified by the acceptance number CXSS2500144 [1] - The drug registration application is for domestic production [1] - The collaboration involves Lijun Monoclonal Antibody and Beijing Xinkanghe [1]
丽珠医药(01513.HK):康奇塔单抗注射液上市许可申请获国家药监局受理
Ge Long Hui· 2025-12-24 09:24
Core Viewpoint - Lijun Pharmaceutical's subsidiary, Zhuhai Lijun Monoclonal Antibody Biotechnology Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the registration application of the monoclonal antibody injection, Laikangqita, developed in collaboration with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] Group 1 - The acceptance notice was issued under the acceptance number CXSS2500144 [1]
丽珠医药(01513):莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理
智通财经网· 2025-12-24 09:23
智通财经APP讯,丽珠医药(01513)公布,公司控股子公司珠海市丽珠单抗生物技术有限公司(丽珠单抗) 收到国家药品监督管理局核准签发的《受理通知书》(受理号:CXSS2500144),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境内生产药品注册上市许可申请获国家药监局受 理。 ...
丽珠医药:莱康奇塔单抗注射液上市许可申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-12-24 09:18
Core Viewpoint - Lijun Pharmaceutical's subsidiary, Zhuhai Lijun Monoclonal Antibody Biotechnology Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the registration application of the monoclonal antibody injection, Laikangqita, developed in collaboration with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] Group 1 - The acceptance notice is identified with the registration number CXSS2500144 [1] - The drug registration application is for domestic production [1] - The collaboration involves a partnership with Beijing Xinkanghe [1]
丽珠集团:累计回购约1619万股
Mei Ri Jing Ji Xin Wen· 2025-12-24 09:17
每经AI快讯,丽珠集团(SZ 000513,收盘价:35.08元)12月24日晚间发布公告称,截至2025年12月23 日,公司本次回购期限已届满,回购方案已实施完毕,公司通过集中竞价交易方式回购了公司A股股份 共计约1619万股,占公司总股本的比例为1.79%,购买的最高价为人民币41.99元/股,最低价为人民币 33.21元/股,已使用的资金总额为人民币约6亿元。 截至发稿,丽珠集团市值为317亿元。 每经头条(nbdtoutiao)——左手"欠款"右手"豪购"!杨陵江收购"国内酒庄第一股",1919是否重启上 市?"吹太多牛都实现了,但千亿还没实现,我很着急" (记者 曾健辉) 2025年1至6月份,丽珠集团的营业收入构成为:医药制造业占比100.0%。 ...
丽珠集团(000513.SZ):莱康奇塔单抗注射液上市许可申请获受理
Ge Long Hui A P P· 2025-12-24 09:17
Core Viewpoint - LIZHU Group's subsidiary, Zhuhai Lizhu Antibody Biotechnology Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the domestic production registration application of "Lai Kangi Ta Monoclonal Antibody Injection" [1] Group 1 - The drug is a joint development with Beijing Xinkanghe Biological Pharmaceutical Technology Co., Ltd. [1] - "Lai Kangi Ta Monoclonal Antibody Injection" is the first domestically developed and the second globally progressing innovative IL-17A/F dual-target inhibitor [1] - The drug targets psoriasis, a chronic inflammatory skin disease affecting approximately 100 million patients worldwide [1]
丽珠集团(000513) - 关于A股股份回购结果暨股份变动公告
2025-12-24 09:17
证券代码:000513、01513 证券简称:丽珠集团、丽珠医药 公告编号:2025-080 丽珠医药集团股份有限公司 1、丽珠医药集团股份有限公司(以下简称"公司")于2024年12月24日召 开了公司2024年第四次临时股东大会、2024年第二次A股类别股东会及2024年第 二次H股类别股东会,审议通过了《关于回购公司部分A股股份方案的议案》, 于2025年5月29日召开了公司2024年度股东大会、2025年第一次A股类别股东会 及2025年第一次H股类别股东会,审议通过了《关于继续实施回购公司部分A股 股份方案的议案》,同意公司使用自有资金以集中竞价交易方式回购部分社会 公众A股股份,用于注销减少注册资本。回购总金额不低于人民币60,000.00万元 (含),不超过人民币100,000.00万元(含),回购价格不超过人民币45.00元/ 股(含),具体回购数量以回购期满时实际回购的股份数量为准,回购股份期 限为自2024年12月24日召开的股东大会审议通过回购股份方案之日起不超过12 个月。 2、截至2025年12月23日,公司本次回购期限已届满,回购方案已实施完毕, 公司通过集中竞价交易方式回购了公司 ...
丽珠集团(000513) - 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告
2025-12-24 09:15
一、药品基本情况 药物名称:莱康奇塔单抗注射液 剂型:注射剂 证券代码:000513、01513 证券简称:丽珠集团、丽珠医药 公告编号:2025-081 丽珠医药集团股份有限公司 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告 本公司及董事会全体成员保证信息披露内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 近日,丽珠医药集团股份有限公司(以下简称"本公司")控股子公司珠 海市丽珠单抗生物技术有限公司(以下简称"丽珠单抗")收到国家药品监督 管理局(以下简称"国家药监局")核准签发的《受理通知书》(受理号: CXSS2500144),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。 现将相关情况公告如下: 受理通知书审批结论:根据《中华人民共和国行政许可法》第三十二条的规 定,经审查,决定予以受理。 二、药品研发及相关情况 银屑病是一种由遗传、免疫和环境因素共同诱发的慢性炎症性皮肤病,全 球患者群体约1亿。莱康奇塔单抗注射液(以下简称"本品")作为国产首个、 全球范围内进度第二的自研创新IL-17A/F双靶点抑制剂 ...