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赛立奇单抗注射液(金立希)
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重庆智翔金泰生物制药股份有限公司 自愿披露关于赛立奇单抗注射液纳入2025年国家医保目录的公告
药品分类:白介素抑制剂 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。 根据国家医保局、人力资源社会保障部《关于印发〈国家基本医疗保险、生育保险和工伤保险药品目 录〉以及〈商业健康保险创新药品目录〉(2025年)的通知》,重庆智翔金泰生物制药股份有限公司(以 下简称"公司")自主研发的赛立奇单抗注射液(金立希)成功纳入《国家基本医疗保险、生育保险和工 伤保险药品目录》(以下简称"国家医保目录")。新版国家医保目录将自2026年1月1日起正式实施。现 将相关信息公告如下: 一、产品纳入国家医保目录的情况 药品名称:赛立奇单抗注射液 商品名:金立希 注册类别:治疗用生物制品Ⅰ类 本次赛立奇单抗注射液被纳入国家医保目录,体现了国家医疗保障局对临床价值高、患者获益大的创新 药品的支持和认可,也将有利于进一步推动赛立奇单抗注射液的市场推广及未来销售,对公司长期经营 业绩产生积极影响。 新版国家医保目录将于2026年1月1日起正式执行,医保支付标准、医保报销细则等相关信息,需以国家 医保局等相关政府部门公示信息为准。此外,公司产品销售将受 ...
智翔金泰:自主研发赛立奇单抗纳入2025年国家医保目录
12月7日,智翔金泰(688443)发布公告称,公司自主研发的赛立奇单抗注射液(金立希)成功纳入《国 家基本医疗保险、生育保险和工伤保险药品目录》,新版目录将于2026年1月1日起正式实施。 报告显示,赛立奇单抗注射液是智翔金泰基于独有的双载体噬菌体呈现技术平台研发的重组全人源抗 IL-17A单克隆抗体。该药物通过特异性结合血清中的IL-17A细胞因子,阻断IL-17A与IL-17RA的结合, 抑制炎症的发生和疾病的发展。 智翔金泰表示,赛立奇单抗被纳入国家医保目录,是公司践行"创新惠民"初心的重要里程碑。未来,公 司将继续以患者需求为导向,持续推进更多具有国际竞争力的创新药物研发,推动国产创新药从"跟 跑"向"领跑",并积极配合医保政策落地实施,让优质治疗药物惠及更多中国患者与家庭。(郑渝川) 在纳入国家医保目录前,赛立奇单抗已通过多渠道提升患者用药可及性。上市一年以来,赛立奇单抗已 实现30个省份的市场覆盖,累计惠及超万名的中国患者。随着赛立奇单抗被纳入医保目录,将进一步降 低患者自付比例,提升药品可及性,助力更多患者用上可信赖和可负担的国产创新药。 三季报显示,公司多项在研项目取得积极进展。第三季度单季 ...
晚间公告|12月7日这些公告有看头
Di Yi Cai Jing· 2025-12-07 10:46
Corporate Announcements - China Pacific Insurance announced that Vice President Yu Ze is under investigation for serious violations of discipline and law, but this will not affect the company's management [2] - Guanglian Aviation reported that its controlling shareholder and chairman Wang Zengduo has had his detention lifted, allowing him to resume his duties, with normal operations continuing [3] - China Communications Construction Company clarified that it bears no repayment or guarantee obligations related to overdue financial products linked to its controlling shareholder, and its operations remain normal [4] - Annie Co. is planning a change in control, with stock trading resuming on December 8, 2025, after a share transfer agreement is signed [5] - Guoao Technology announced that its actual controller is planning a change in control, leading to a temporary suspension of its stock [6] - ST Tianrui terminated its planned change in control due to a lack of consensus, with stock resuming trading on December 8, 2025 [7] Industry Developments - Double Star New Materials noted that leading companies in the BOPET industry have reached a consensus on production cuts to balance supply and demand, although the sustainability of long-term price increases remains uncertain [8] - First Venture received a notice of administrative penalty for failing to diligently supervise a bond project, resulting in fines and warnings, but this will not significantly impact its operations [12] - China Chemical announced that its nylon new materials project has reached full production capacity, enhancing efficiency and market competitiveness [14] Pharmaceutical Sector Updates - Hengrui Medicine reported that nine of its drugs have been included in the national medical insurance directory, with a total expected sales of approximately 8.66 billion yuan for 2024 [15] - Junshi Biosciences announced that its products have received new indications and have been included in the national medical insurance directory, enhancing market accessibility [16] - Huadong Medicine's subsidiary has had its products included in the national medical insurance and commercial insurance innovation drug directories, aiding market promotion [17] - Aidi Pharmaceutical's two innovative HIV drugs have been renewed for inclusion in the national medical insurance directory, with specific pricing established [18] - ZhiXiang JinTai's monoclonal antibody has been included in the national medical insurance directory, which is expected to positively impact future sales [19] - Fosun Pharma announced multiple products have been newly included in the national medical insurance directory, which is anticipated to positively influence future performance [20] - Zejing Pharmaceutical's drug has been included in the national medical insurance directory, which will enhance affordability and market promotion [21] - Micron Biologics' product has been included in the national medical insurance directory, with no significant impact on current performance expected [22] Shareholder Commitments - Tianci Materials' controlling shareholder has committed not to reduce his shareholding in the company for six months, reflecting confidence in the company's future [23] Major Contracts - Guangqi Technology's subsidiary signed contracts worth 696 million yuan for the mass production of metamaterials, expected to impact the company's performance in 2026 [24]
智翔金泰:赛立奇单抗注射液被纳入2025年国家医保目录
人民财讯12月7日电,智翔金泰(688443)12月7日公告,公司自主研发的赛立奇单抗注射液(金立希)成 功纳入《国家基本医疗保险、生育保险和工伤保险药品目录(2025年)》。新版国家医保目录将自2026 年1月1日起正式实施。 (原标题:智翔金泰:赛立奇单抗注射液被纳入2025年国家医保目录) ...
智翔金泰:自主研发赛立奇单抗注射液纳入2025年国家医保目录
Xin Lang Cai Jing· 2025-12-07 08:25
Core Viewpoint - The company announced that its self-developed monoclonal antibody injection, Sairiqi (Jinlixi), has been successfully included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List, effective from January 1, 2026, with an agreement valid until December 31, 2027 [1] Group 1 - The drug is classified as a Class I biological product and a Class B prescription drug, intended for the treatment of moderate to severe plaque psoriasis and ankylosing spondylitis [1] - The corresponding indications for the drug are expected to receive market approval in August 2024 and January 2025, respectively [1] - Inclusion in the medical insurance list may facilitate the market promotion and sales of the product, although sales are subject to various influencing factors, leading to uncertainty [1]
智翔金泰(688443.SH):赛立奇单抗注射液纳入2025年国家医保目录
智通财经网· 2025-12-07 08:25
智通财经APP讯,智翔金泰(688443.SH)发布公告,公司自主研发的赛立奇单抗注射液(金立希)成功纳入 《国家基本医疗保险、生育保险和工伤保险药品目录》(以下简称"国家医保目录")。新版国家医保目录 将自2026年1月1日起正式实施。 赛立奇单抗注射液是一款由公司自主研发的重组全人源抗IL-17A单克隆抗体,注册分类为治疗用生物制 品Ⅰ类,作用靶点为IL-17A。该产品可特异性结合血清中的IL-17A蛋白,阻断IL-17A与IL-17RA的结 合,抑制炎症的发生和发展,从而对IL-17A过表达的斑块状银屑病、放射学阳性中轴型脊柱关节炎等自 身免疫性疾病达到治疗效果。 ...
智翔金泰:赛立奇单抗注射液纳入2025年国家医保目录
Mei Ri Jing Ji Xin Wen· 2025-12-07 07:57
每经AI快讯,12月7日,智翔金泰(688443.SH)公告称,公司自主研发的赛立奇单抗注射液(金立希)成功 纳入《国家基本医疗保险、生育保险和工伤保险药品目录》,新版目录将于2026年1月1日起正式实施。 该药品为治疗用生物制品Ⅰ类,适用于中度至重度斑块状银屑病成人患者及常规治疗疗效欠佳的强直性 脊柱炎成人患者。纳入医保目录将有利于推动药品市场推广及未来销售,对公司长期经营业绩产生积极 影响。但医保支付标准、报销细则等以国家医保局公示信息为准,且销售受多种因素影响,存在不确定 性。 ...
智翔金泰:赛立奇单抗注射液(金立希)的两项适应症已经获批上市
Mei Ri Jing Ji Xin Wen· 2025-10-31 11:13
Core Viewpoint - The company is focusing on innovative drug development in the fields of autoimmune diseases, infectious diseases, and tumors, with a strong emphasis on monoclonal antibodies and bispecific antibodies [2]. Group 1: Drug Development Focus - The company is actively developing monoclonal antibody drugs and bispecific antibody drugs [2]. - The company has received market approval for two indications of its monoclonal antibody injection, named Jinlixi® [2]. - Several other monoclonal antibody injections, including Silevimi, Weikangduta, and Tailiqibai, have had their New Drug Applications (NDA) accepted [2]. Group 2: Clinical Trials - Multiple products in the company's pipeline are currently undergoing clinical trials [2].
智翔金泰前三季度净利亏损3.33亿元,同比减亏
Bei Jing Shang Bao· 2025-10-30 14:17
Core Viewpoint - Zhixiang Jintai (688443) reported a significant increase in revenue for the first three quarters of 2025, with a total revenue of 208 million yuan, reflecting a year-on-year increase of 1562.05%. However, the company recorded a net profit loss of 333 million yuan, indicating a reduction in losses compared to the previous year [1]. Financial Performance - The company's revenue for the first three quarters reached 208 million yuan, marking a substantial increase of 1562.05% year-on-year [1]. - The net profit attributable to shareholders was -333 million yuan, showing a reduction in losses compared to the same period last year [1]. Revenue Drivers - The increase in revenue was attributed to the recognition of licensing income from the GR1803 injection authorization and commercialization agreement, as well as sales growth from the company's first commercial product, the Selqi monoclonal antibody injection (Jinlixi) [1]. - The absence of share-based payment expenses in the reporting period, due to the completion of the company's 2022 equity incentive plan service period, also contributed to the narrowing of net losses [1].
智翔金泰旗下两款注射液签独家协议 推进产品商业化将获付款至高超5亿元
Core Insights - Zhixiang Jintai (688443) has made substantial progress in the commercialization of its products through exclusive cooperation agreements with Xizang Kangzhe Pharmaceutical Development Co., Ltd. and RXILIENT MEDICAL PTE. LTD. for two monoclonal antibody injections [1][4] - The agreements include upfront payments and milestone payments totaling approximately 260 million yuan and 250 million yuan for the two products, with Zhixiang Jintai also set to pay promotional service fees based on sales revenue in mainland China [1][4] Company Overview - Zhixiang Jintai is an innovation-driven biopharmaceutical company focusing on autoimmune diseases, infectious diseases, and oncology, possessing full industry chain capabilities from molecular discovery to commercialization [2] - As of mid-2025, Zhixiang Jintai has 14 products under research, with two indications of its monoclonal antibody injection, Sailiqi, already approved for market, and two other injections, GR2001 and GR1801, having their New Drug Applications (NDA) accepted [2][3] Product Details - The Weikang Duta monoclonal antibody injection is a recombinant humanized monoclonal antibody targeting tetanus toxin, classified as a Class 1 therapeutic biological product, and has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) [3] - The Sileweimi monoclonal antibody injection is a recombinant fully human bispecific antibody for rabies virus, also classified as a Class 1 therapeutic biological product, and is the first globally to be used for passive immunity against rabies [3] Partnership Insights - Kangzhe Pharmaceutical is focused on linking pharmaceutical innovation with commercialization, managing the entire product lifecycle, and is engaged in the development and commercialization of innovative products [4] - The cooperation agreements are effective upon signing and have an initial term of ten years after the products are approved for market in mainland China, with automatic ten-year extensions unless terminated [4] - Zhixiang Jintai aims to enhance patient accessibility and long-term development in its infectious disease pipeline through this collaboration, while continuing to build its own sales team for product promotion [4]