GR1803注射液
Search documents
1月9日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-09 10:19
Group 1 - China Shipbuilding Defense expects a net profit of 940 million to 1.12 billion yuan for 2025, an increase of 149.61% to 196.88% year-on-year [1] - China First Heavy Industries has only undertaken a small number of related accessory projects and has not generated revenue from them [2] - Huanyu Electronics plans to invest 30 million yuan in a private equity fund focused on AI and emerging industries [3] Group 2 - Zhixiang Jintai's GR1803 injection has been included in the priority review list by the National Medical Products Administration [4] - JianKai Technology's shareholder plans to reduce holdings by up to 3% of the company's shares [5] - Debon Holdings will continue to suspend trading from January 12 due to significant matters being planned [6] Group 3 - South Network Technology's shareholder intends to transfer 847.05 million shares, accounting for 1.50% of the total share capital [7] - Hengrui Medicine has received approval for clinical trials of four drugs [8] - Daotong Technology expects a net profit of 900 million to 930 million yuan for 2025, a year-on-year increase of 40.42% to 45.10% [10] Group 4 - Betta Pharmaceuticals has invested 50 million yuan to acquire a 20% stake in Hangzhou Zhixing Pharmaceutical [11] - Tianyu Biology reported a 10.38% year-on-year decline in cumulative sales revenue for 2025 [12] - Lifang Pharmaceutical's subsidiary has obtained a drug registration certificate for a pain relief product [13] Group 5 - R&F Properties reported a total sales revenue of approximately 14.21 billion yuan for 2025 [14] - Wanfu Biology expects a net profit decline of 87.71% to 91.81% for 2025 [15] - Dazhi expects a negative net profit for 2025 [16] Group 6 - Dongzhu Ecology is negotiating to terminate the acquisition of control over a satellite communication company [17] - Baotai has received a milestone payment of 10 million USD from Hikma Pharmaceuticals [18] - Huace Navigation expects a net profit of 670 million to 690 million yuan for 2025, a year-on-year increase of 14.84% to 18.27% [19] Group 7 - Shenzhen Gas reported a net profit decline of 3.45% for 2025 [20] - Baogang Co. plans to adjust the price of rare earth concentrate for Q1 2026 to 26,834 yuan per ton [21] - Jiuding Investment expects to report a loss for 2025 [22] Group 8 - Shanghai Pharmaceuticals has received a drug registration certificate for a treatment for myasthenia gravis [23] - Hualan Biological plans to acquire a 35% stake in Guangfeng Capsule [24] - Ruina Intelligent plans to invest 169.9 million yuan in a new R&D production base for heat pumps [25] Group 9 - Wantong Development expects to report a loss for 2025 [26] - Xianghe Industrial has completed the purchase of a 5% stake in Hezhixiang Technology [27] - Guangkang Biochemical received a warning letter from the Guangdong Securities Regulatory Commission [28] Group 10 - Xiaoming Co. reported a 37.07% year-on-year decline in chicken product sales revenue for December 2025 [29] - Luokai Co. won a procurement project from State Grid Fujian Power worth approximately 48.2 million yuan [30] - Minhe Co. reported a 65.22% year-on-year increase in the sales of commodity chick seedlings for December 2025 [31] Group 11 - Zhenghai Biological has obtained a registration certificate for calcium silicate bio-ceramic materials [32] - Three Gorges Energy reported a 5.99% year-on-year increase in cumulative total power generation for 2025 [33] - Huisheng Biological expects a net profit of 235 million to 271 million yuan for 2025 [34] Group 12 - Maihe Co. announced the release of the detention measures against its chairman [35] - Wandong's Alzheimer's project has been included in a national major special project for innovative drug development [36] - Kangxin New Materials plans to transfer forest land assets with a book value of 1.203 billion yuan [37] Group 13 - Greenland Holdings expects a net loss of 16 billion to 19 billion yuan for 2025 [39] - Zhongxin Fluorine Materials has obtained a pesticide production license [40]
智翔金泰(688443.SH):GR1803注射液纳入优先审评品种名单
智通财经网· 2026-01-09 10:15
智通财经APP讯,智翔金泰(688443.SH)发布公告,近日,公司产品GR1803注射液被国家药品监督管理 局药品审评中心纳入优先审评品种名单。拟定适应症(或功能主治):本品适用于既往至少接受过三线治 疗(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发性骨髓 瘤成人患者。 ...
智翔金泰:GR1803注射液被纳入优先审评品种名单
Mei Ri Jing Ji Xin Wen· 2026-01-09 09:25
每经AI快讯,1月9日,智翔金泰公告称,公司产品GR1803注射液被国家药品监督管理局药品审评中心 纳入优先审评品种名单,拟定适应症为既往至少接受过三线治疗的复发或难治性多发性骨髓瘤成人患 者。GR1803注射液是一款由公司自主研发的双特异性抗体药物,注册分类为治疗用生物制品1类。新药 上市申请尚需经过多个环节,产品能否成功上市及上市时间存在不确定性。 ...
智翔金泰:GR1803注射液纳入优先审评品种名单
Xin Lang Cai Jing· 2026-01-09 09:20
智翔金泰公告,近日,公司产品GR1803注射液被国家药品监督管理局药品审评中心纳入优先审评品种 名单。GR1803注射液是一款由公司自主研发的双特异性抗体药物,作用靶点为BCMA和CD3,注册分 类为治疗用生物制品1类。 ...
智翔金泰GR1803附条件上市申请获受理
Zhong Zheng Wang· 2026-01-09 05:59
作为智翔金泰自主研发的核心创新产品,GR1803注射液具有独特的技术优势。该药物为BCMA和CD3 双靶点双特异性抗体,基于共同轻链构建,结构与正常单抗分子高度类似,既便于制备工艺开发,又能 减少结构差异导致的免疫原性风险。其核心设计亮点在于非对称亲和力配置,结合BCMA的亲和力(10- 10M)较结合CD3的亲和力(10-8M)高两个数量级,可在有效募集并激活T细胞杀伤肿瘤细胞的同时,减 少T细胞非特异性激活引发的毒副作用,显著提升治疗安全性。此前,该产品已于2024年8月被纳入国 家药监局突破性治疗品种名单。 智翔金泰在公告中提示,GR1803注射液的上市申请尚需经过审评、药品临床试验现场检查、药品生产 现场检查和审批等多个环节,能否成功上市及上市时间存在不确定性。公司将按照相关规定及时披露后 续进展,投资者需谨慎决策、防范投资风险。 中证报中证网讯(王珞)1月9日,重庆智翔金泰生物制药股份有限公司(证券代码:688443,证券简称:智 翔金泰)发布公告称,公司自主研发的治疗用生物制品Ⅰ类创新药GR1803注射液,其境内生产药品注册 上市许可申请已获国家药品监督管理局受理(受理号:CXSS2600003) ...
重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1803注射液附条件上市申请获得受理的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-08 23:02
登录新浪财经APP 搜索【信披】查看更多考评等级 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,重庆智翔金泰生物制药股份有限公司(以下简称"公司")收到了国家药品监督管理局下发的关 于"GR1803注射液"境内生产药品注册上市许可申请的《受理通知书》,本次申请附条件批准上市的适 应症为:本品适用于既往至少接受过三线治疗(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者。现将有关情况公告如下: 一、药品基本信息 多发性骨髓瘤(multiple myeloma,MM)是一种克隆浆细胞异常增殖的恶性疾病,多发于老年。多发 性骨髓瘤的常见症状为骨髓瘤相关器官功能损伤,包括血钙升高、肾功能损害、贫血、骨科疾病等。多 发性骨髓瘤是血液系统第二大常见的恶性肿瘤,且发病率近年呈现总体上升趋势。高龄是多发性骨髓瘤 的重要危险因素,60岁以上人群发病率和死亡率明显更高。伴随我国老龄化程度的加深,多发性骨髓瘤 患病人数将不断提升。 GR1803注射液是一款由公司自主研发的双特异性抗体药物 ...
中无人机签订超1亿元无人机系统合同 天能股份拟以不超120亿元委托理财
Xin Lang Cai Jing· 2026-01-08 12:59
《科创板日报》1月8日讯 今日科创板晚报主要内容包括:工信部牵头警示锂电池产业非理性竞争;广 州:聚焦攻关可重复使用火箭技术;沪硅产业:大基金1月7日至1月8日期间累计减持0.2%股份。 【热点聚焦】 简讯: 工信部牵头警示锂电池产业非理性竞争 十余家头部企业参与 工信部官微发文称,工信部、国家发展改革委、市场监管总局、国家能源局于1月7日联合召开动力和储 能电池行业座谈会(下称座谈会),研究部署进一步规范动力和储能电池产业竞争秩序工作。据记者自知 情人士处获悉,本次会议召集了16家企业,包括13家动力电池与储能电池企业:宁德时代、比亚迪、中 创新航、国轩高科、亿纬锂能、欣旺达、蜂巢能源、瑞浦兰钧、鹏辉能源、海辰储能、正力新能、浙江 吉曜通行能源科技、楚能新能源。另有3家系统集成商:中车株洲所、海博思创、天合储能。此外,有 行业媒体报道称,中国汽车动力电池创新联盟、中国化学物理电源行业协会全程参与此次座谈会,对行 业自律进行倡导。 业内人士:市场监管总局约谈6家光伏龙头及行业协会 不得约定产能及销售价格等 日前有市场传闻称,市场监管总局约谈了中国光伏行业协会、通威集团、协鑫科技、大全能源、新特能 源、亚洲硅业 ...
智翔金泰GR1803注射液附条件上市申请获得受理
Bei Jing Shang Bao· 2026-01-08 11:05
公告显示,本次申请附条件批准上市的适应症为:本品适用于既往至少接受过三线治疗(包括一种蛋白 酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者。 北京商报讯(记者 丁宁)1月8日晚间,智翔金泰(688443)发布公告称,公司收到了国家药品监督管 理局下发的关于"GR1803注射液"境内生产药品注册上市许可申请的《受理通知书》。 ...
智翔金泰(688443.SH):GR1803注射液附条件上市申请获得受理
智通财经网· 2026-01-08 09:41
智通财经APP讯,智翔金泰(688443.SH)发布公告,近日,公司收到了国家药品监督管理局下发的关 于"GR1803注射液"境内生产药品注册上市许可申请的《受理通知书》,本次申请附条件批准上市的适 应症为:本品适用于既往至少接受过三线治疗(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者。 ...
智翔金泰:GR1803注射液附条件上市申请获得受理
Xin Lang Cai Jing· 2026-01-08 09:31
智翔金泰公告,近日,公司收到了国家药品监督管理局下发的关于"GR1803注射液"境内生产药品注册 上市许可申请的《受理通知书》,本次申请附条件批准上市的适应症为:本品适用于既往至少接受过三 线治疗(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发 性骨髓瘤成人患者。 ...