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三生国健(688336.SH):重组抗IL-4Rα人源化单克隆抗体注射液新药上市申请获受理
智通财经网· 2026-02-25 13:28
智通财经APP讯,三生国健(688336.SH)公告,公司收到国家药品监督管理局核准签发的《受理通知 书》,公司产品重组抗IL-4Rα人源化单克隆抗体注射液(研发代码:SSGJ-611)的新药上市申请(NDA)获 得受理。 公告显示,SSGJ-611是公司自主研发设计、筛选并人源化的抗IL-4Rα单克隆抗体,具有全新的氨基酸序 列。SSGJ-611能够通过特异性的结合IL-4Rα,阻断IL-4和IL-13的信号传导达到缓解特应性皮炎等疾病 的作用。 ...
三生国健重组抗IL-4Rα人源化单克隆抗体注射液新药上市申请获得受理
Bei Jing Shang Bao· 2026-02-25 11:57
三生国健表示,SSGJ-611是公司自主研发设计、筛选并人源化的抗IL-4Rα单克隆抗体,具有全新的氨基 酸序列。SSGJ-611能够通过特异性的结合IL-4Rα,阻断IL-4和IL-13的信号传导达到缓解特应性皮炎等 疾病的作用。 北京商报讯(记者 丁宁)2月25日晚间,三生国健(688336)发布公告称,公司收到国家药品监督管理 局核准签发的《受理通知书》,公司产品重组抗 IL-4Rα人源化单克隆抗体注射液(研发代码:SSGJ- 611)的新药上市申请获得受理。 ...
三生国健(688336) - 三生国健:关于自愿披露公司重组抗IL-4Rα人源化单克隆抗体注射液新药上市申请获得受理的公告
2026-02-25 11:45
证券代码:688336 证券简称:三生国健 公告编号:2026-005 | | 重组抗 IL-4Rα | | | | --- | --- | --- | --- | | 药品名称 | 人源化单克隆 | 申请事项 | 境内生产药品注册上市 | | | 抗体注射液 | | 许可 | | 剂型 | 注射剂 | 申请人 | 三生国健药业(上海) | 一、药品基本情况 1 三生国健药业(上海)股份有限公司 关于自愿披露公司重组抗 IL-4Rα人源化单克隆抗体 注射液新药上市申请获得受理的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: 近日,三生国健药业(上海)股份有限公司(以下简称"公司") 收到国家药品监督管理局核准签发的《受理通知书》,公司产品重组 抗 IL-4Rα人源化单克隆抗体注射液(研发代码:SSGJ-611)的新药 上市申请(NDA)获得受理。 由于药品在获得上市申请受理后,尚需通过国家药品监督管理局 相关审评程序并获批准后方可上市、销售。本次新药上市申请能否获 得批准存在不确定性。敬请广大投资者谨 ...
太平洋医药日报:Molbreevi获FDA授予优先审评资
2026 年 02 月 24 日 行业日报 看好/维持 医药 医药 太平洋医药日报(20260224):Molbreevi 获 FDA 授予优先审评资 格 ◼ 走势比较 (10%) (2%) 6% 14% 22% 30% 25/2/24 25/5/8 25/7/20 25/10/1 25/12/13 26/2/24 ◼ 子行业评级 | 化学制药 | 无评级 | | --- | --- | | 中药生产 | 无评级 | | 生物医药Ⅱ | 中性 | | 其 他 医 药 医 | 中性 | | 疗 | | 相关研究报告 <<太平洋医药日报(20260213):安进 Inebilizumab 获欧盟批准>>--2026- 02-15 <<太平洋医药日报(20260212):默沙 东 Keytruda 获 FDA 批准新适应症>>- -2026-02-15 <<太平洋医药日报(20260211):礼来 米吉珠单抗在华获批新适应症>>-- 2026-02-13 证券分析师:周豫 电话: E-MAIL:zhouyua@tpyzq.com 分析师登记编号:S1190523060002 证券分析师:张崴 电话: E-MAIL: ...
生物医药异动,长春高新涨停,新药获批临床!生物医药ETF汇添富涨超1%,获净申购1200万份!CXO或迎复苏拐点,恒生生物科技ETF汇添富受关注
Sou Hu Cai Jing· 2026-02-25 08:15
Group 1: Market Performance - The A-share biopharmaceutical ETF Huatai Fuhua (159839) rose by 1.1%, with a total trading volume exceeding 22 million yuan, marking the fourth consecutive day of inflows totaling over 20 million yuan [2] - The Hong Kong biopharmaceutical ETF Huatai Fuhua (513280) fluctuated and closed flat, with a trading volume exceeding 42 million yuan, and a net inflow of over 17 million yuan in the last 60 days [3] - The majority of the popular component stocks in the biopharmaceutical ETF Huatai Fuhua (159839) showed positive performance, with Changchun High-tech hitting the daily limit and its subsidiary GenSci141 ointment receiving clinical trial approval [5] Group 2: Company Performance - WuXi AppTec (药明康德) reported a significant performance increase, with a projected net profit growth of 41.3% in 2025, driven by the TIDES business, which saw revenue growth exceeding 90% [8] - WuXi Biologics (药明生物) achieved a record total of 945 projects, with a 30% growth in dual monoclonal antibodies and ADC projects, indicating strong future revenue potential [8] - The domestic clinical CRO market is expected to return to a growth trajectory in 2025, benefiting companies like Tigermed (泰格医药) from improved order prices and increased clinical pipeline numbers [8] Group 3: Industry Trends - The global CXO industry is expected to continue its strong recovery, with significant investment and transaction demand in the biotech and pharmaceutical sectors anticipated to rebound in 2025 [7] - The Chinese innovative drug market is showing robust activity, with a 19% year-on-year increase in IND numbers and a substantial rise in BD transaction amounts, indicating a vibrant domestic market [7] - The Chinese innovative drug sector is transitioning from pipeline expectations to revenue realization, with over 70% of companies projected to achieve positive revenue growth in 2025 [11]
AI医疗与脑机接口持续活跃,医疗创新ETF(516820)红盘上扬
Xin Lang Cai Jing· 2026-02-25 06:07
截至2026年2月25日 13:49,中证医药及医疗器械创新指数(931484)上涨0.71%,成分股三生国健上涨 8.16%,浙江医药上涨4.83%,南微医学上涨3.45%,新和成上涨2.80%,康龙化成上涨2.16%。医疗创新 ETF(516820)上涨0.55%,最新价报0.36元。 医药板块结构性机会持续深化,AI医疗与脑机接口成为短期主线。消息面上,常州市第一人民医院门 诊大厅内,两个人形机器人"智能导诊员"正式上岗。它们不仅具备预检分诊、信息查询等功能,还能与 患者握手互动,让就医更高效、更有温度。 中信建投证券认为,春节前后A股脑机接口板块部分个股大幅上涨,港股手术机器人公司亦因中标进展 获正面催化;叠加恒瑞医药IL-15疗法启动NMIBC三期、亚盛医药BTK PROTAC进入美国一期临床、和 铂医药新一代CTLA-4抗体通过NewCo出海等密集管线进展,创新药械"从0到1"逻辑正从前端研发向临 床验证与商业化环节传导,AI驱动的靶点发现、药物设计及智能诊疗设备有望成为中长期核心赛道。 医疗创新ETF紧密跟踪中证医药及医疗器械创新指数,中证医药及医疗器械创新指数从医药卫生行业的 上市公司中,选取 ...
ETF盘中资讯|医械迎政策利好,规模最大医疗ETF(512170)延续高频溢价!FDA审评政策松绑,药ETF(562050)止跌企稳
Sou Hu Cai Jing· 2026-02-25 04:12
Group 1 - The A-share pharmaceutical sector rebounded, with medical device stocks and AI healthcare concepts leading the gains, including Meinian Health and Lepu Medical rising over 3% [1] - The largest medical ETF in the market (512170) saw a near 1% increase, with a net subscription of 77.77 million yuan on the previous day [1][5] - A new policy from the Beijing-Tianjin-Hebei region aims to enhance clinical trial efficiency and reduce compliance costs for CXO and medical device companies, set to take effect on March 1, 2026 [3] Group 2 - The pharmaceutical sector stabilized, with innovative drug concepts showing mixed results; Sanofi's stock rose over 3%, while Dizhe Pharmaceutical fell over 4% [3] - The only ETF tracking the pharmaceutical index (562050) turned positive during trading [3] - The FDA's recent announcement to establish a single pivotal clinical trial as the default standard for new drug approvals is expected to shorten development cycles and lower capital costs, benefiting innovative drug companies [4]
医械迎政策利好,规模最大医疗ETF(512170)延续高频溢价!FDA审评政策松绑,药ETF(562050)止跌企稳
Xin Lang Cai Jing· 2026-02-25 03:01
Group 1 - The A-share pharmaceutical sector has rebounded, with medical device stocks and AI healthcare concepts leading the gains, including significant increases in companies like Meinian Health and Lepu Medical [1][8] - The largest medical ETF in the market (512170) saw a nearly 1% increase, with a net subscription of 77.77 million yuan the previous day [1][8] - A new policy from the Beijing-Tianjin-Hebei region is expected to benefit CXO and medical device companies by improving clinical trial efficiency and reducing compliance costs [2][5][10] Group 2 - The FDA has announced a new default standard for drug approvals, allowing for a single key clinical trial plus confirmatory evidence, which is projected to shorten development cycles and reduce capital costs significantly [4][12] - The cost of a single key trial is estimated to range from 30 million to 150 million USD, which will enhance the research efficiency of innovative drug companies [4][12] - The medical ETF (512170) has over 50% weight in medical devices and more than 25% in CXO, covering 12 AI medical and brain-computer interface concept stocks [4][12] Group 3 - The pharmaceutical sector is stabilizing, with mixed performance among innovative drug concepts; companies like Sanofi and Dizhiyuan have shown notable fluctuations [2][10] - Traditional Chinese medicine stocks have generally risen, with companies like Darentang and Jilin Aodong seeing increases of over 2% [2][10] - The only ETF tracking the pharmaceutical index (562050) turned positive during trading, indicating a recovery in the sector [2][10]
医疗创新ETF(516820)红盘向上,2026中国创新药BD加速升温
Xin Lang Cai Jing· 2026-02-25 02:49
数据显示,截至2026年1月30日,中证医药及医疗器械创新指数(931484)前十大权重股分别为药明康 德、迈瑞医疗、恒瑞医药、爱尔眼科、片仔癀、新和成、华东医药、康龙化成、艾力斯、甘李药业,前 十大权重股合计占比63.9%。 截至2026年2月25日 10:27,中证医药及医疗器械创新指数(931484)上涨0.25%,成分股三生国健上涨 3.33%,新和成上涨2.33%,爱博医疗上涨1.73%,特宝生物上涨1.71%,浙江医药上涨1.08%。医疗创新 ETF(516820)上涨0.55%,最新价报0.36元。 从估值层面来看,医疗创新ETF跟踪的中证医药及医疗器械创新指数最新市盈率(PE-TTM)仅27.28 倍,处于近1年18.88%的分位,即估值低于近1年81.12%以上的时间,处于历史低位。 医疗创新ETF紧密跟踪中证医药及医疗器械创新指数,中证医药及医疗器械创新指数从医药卫生行业的 上市公司中,选取30只盈利能力较好且具备一定成长性和研发创新能力的上市公司证券作为指数样本, 以反映兼具盈利性与成长性的医药及医疗器械上市公司证券的整体表现。 消息面上,普华永道(PwC)称,和Anthropic宣布达 ...
A股开盘:沪指微涨0.15%、深成指涨0.21%,磷化工板块、小金属概念股活跃,影视院线板块继续调整
Jin Rong Jie· 2026-02-25 01:38
2月25日,A股三大股指小幅高开,其中沪指涨0.15%,报4123.78点,深成指涨0.21%,报14322.24点, 创业板指涨0.15%,报3313.09点,科创50指数涨0.21%,报1468.51点。磷化工、小金属概念股涨幅居 前,磷化工板块延续昨日强势,澄星股份2连板,和邦生物、金正大、六国化工、川金诺、云天化跟 涨;影视院线板块盘初走低,博纳影业、横店影视开盘跌停,中国电影、光线传媒、幸福蓝海跌幅居 前。昨日A股市场冲高回落,创业板指盘中一度涨超2%,沪深两市成交额达2.2万亿,全市场超4000只 个股上涨,其中109只个股涨停,市场活跃度较高。 盘面上,市场焦点股豫能控股(4板)高开4.69%,化工板块美邦股份(4板)竞价涨停、金牛化工(7 天4板)高开3.59%,AI应用端的风语筑(6天4板)低开3.27%、罗曼股份(2板)高开1.27%,商业航天 概念股顶固集创(创业板6天3板)高开4.71%,并购重组的韩建河山(9天5板)低开0.54%,光伏板块 协鑫集成(9天5板)高开2.74%,电网设备板块汉缆股份(3板)高开5.10%,玻纤概念股宏和科技(4 天3板)高开4.74%、山东玻纤(4天3 ...