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派林生物静注人免疫球蛋白补充申请获受理
Bei Jing Shang Bao· 2026-02-03 10:43
北京商报讯(记者王寅浩宋雨盈)2月3日,派林生物(000403)发布公告称,公司全资子公司广东双林生 物制药有限公司收到国家药品监督管理局核准签发的静注人免疫球蛋白药品补充申请《受理通知书》, 2.5g/瓶、5g/瓶和10g/瓶的静注人免疫球蛋白的境内生产药品补充申请获受理。 根据公告,静注人免疫球蛋白主要适应症包括原发性免疫球蛋白缺乏症、继发性免疫球蛋白缺陷病以及 自身免疫性疾病。目前国内拥有静注人免疫球蛋白(5g/瓶,10%,50ml)上市批件的企业包括成都蓉生药 业有限责任公司、贵州泰邦生物制品有限公司以及华润博雅生物(300294)制药集团股份有限公司。 ...
2月3日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-03 10:11
Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]
派林生物(000403.SZ):全资子公司获得药品补充申请受理通知书
Ge Long Hui A P P· 2026-02-03 09:23
1、原发性免疫球蛋白缺乏症,如X联锁低免疫球蛋白血症,常见变异性免疫缺陷病,免疫球蛋白G亚型 缺陷病等。 格隆汇2月3日丨派林生物(000403.SZ)公布,近日,公司之全资子公司广东双林生物制药有限公司收到 国家药品监督管理局核准签发的静注人免疫球蛋白药品补充申请《受理通知书》。 静注人免疫球蛋白主要适应症包括: 经查询,目前国内拥有静注人免疫球蛋白(5g/瓶,10%,50ml)上市批件的企业包括成都蓉生药业有限责 任公司、贵州泰邦生物制品有限公司以及华润博雅生物制药集团股份有限公司。 2024年5月,广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意广东双 林开展静注人免疫球蛋白(10%)适应症为原发免疫性血小板减少症(ITP)的临床试验;2025年4月,广东 双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意广东双林开展静注人免疫 球蛋白(10%)新增适应症为治疗慢性炎性脱髓鞘性多发性神经根神经病(CIDP)的临床试验;2025年12 月,广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意广东双林开展静 注人免疫球蛋白(pH4)生产工艺变更后 ...
派林生物:全资子公司获得药品补充申请受理通知书
Ge Long Hui· 2026-02-03 09:22
格隆汇2月3日丨派林生物(000403.SZ)公布,近日,公司之全资子公司广东双林生物制药有限公司收到 国家药品监督管理局核准签发的静注人免疫球蛋白药品补充申请《受理通知书》。 2、继发性免疫球蛋白缺陷病,如重症感染、新生儿败血症等。3、自身免疫性疾病,如原发性血小板减 少性紫癜、川崎病等。静注人免疫球蛋白(10%)采用国际主流的辛酸沉淀及多步层析精制纯化工艺,在 产品质量、病毒安全性等方面,特别是产品收率方面有显著的优势,将有助于提升临床用药安全性及便 捷性,使国内产品工艺水平与国际接轨。 经查询,目前国内拥有静注人免疫球蛋白(5g/瓶,10%,50ml)上市批件的企业包括成都蓉生药业有限责 任公司、贵州泰邦生物制品有限公司以及华润博雅生物制药集团股份有限公司。 2024年5月,广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意广东双 林开展静注人免疫球蛋白(10%)适应症为原发免疫性血小板减少症(ITP)的临床试验;2025年4月,广东 双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,同意广东双林开展静注人免疫 球蛋白(10%)新增适应症为治疗慢性炎性脱髓鞘性多发性神 ...
派林生物(000403) - 关于全资子公司获得药品补充申请受理通知书的公告
2026-02-03 09:15
证券代码:000403 证券简称:派林生物 公告编号:2026-001 派斯双林生物制药股份有限公司 关于全资子公司获得药品补充申请受理通知书的公告 本公司及董事会全体成员保证信息披露的内容的真实、准确和完整,没有虚假 记载、误导性陈述或者重大遗漏。 近日,派斯双林生物制药股份有限公司(以下简称"公司")之全资子公司广东双 林生物制药有限公司(以下简称"广东双林")收到国家药品监督管理局核准签发的静 注人免疫球蛋白药品补充申请《受理通知书》,现将有关情况公告如下: 一、药品基本情况 1、受理通知书(受理号:CYSB2600049) 药物名称:静注人免疫球蛋白 剂型:注射剂 规格:2.5g/瓶(10%,25ml) 申请事项:境内生产药品补充申请 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。 2、受理通知书(受理号:CYSB2600050) 药物名称:静注人免疫球蛋白 剂型:注射剂 规格:5g/瓶(10%,50ml) 申请事项:境内生产药品补充申请 申请人:广东双林生物制药有限公司 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。 申请人 ...
派林生物:子公司获静注人免疫球蛋白药品补充申请受理通知书
Xin Lang Cai Jing· 2026-02-03 09:08
派林生物公告,近日,全资子公司广东双林生物制药有限公司收到国家药品监督管理局核准签发的静注 人免疫球蛋白药品补充申请《受理通知书》。此次申请涉及三种规格的静注人免疫球蛋白药品:2.5g/ 瓶(10%,25ml)、5g/瓶(10%,50ml)和10g/瓶(10%,100ml)。药品主要适应症包括原发性免疫 球蛋白缺乏症、继发性免疫球蛋白缺陷病和自身免疫性疾病。此次受理有助于提升临床用药安全性及便 捷性,使国内产品工艺水平与国际接轨。 ...
生物制品板块1月29日跌1.3%,华兰疫苗领跌,主力资金净流出8.66亿元
Zheng Xing Xing Ye Ri Bao· 2026-01-29 09:03
Market Overview - The biopharmaceutical sector experienced a decline of 1.3% on January 29, with Hualan Vaccine leading the drop [1] - The Shanghai Composite Index closed at 4157.98, up 0.16%, while the Shenzhen Component Index closed at 14300.08, down 0.3% [1] Individual Stock Performance - Weigao Bio (002880) saw a closing price of 30.07, with an increase of 4.59% and a trading volume of 88,100 shares, totaling a transaction value of 266 million yuan [1] - Changchun High-tech (000661) closed at 98.30, up 0.92%, with a trading volume of 64,700 shares and a transaction value of 629 million yuan [1] - Other notable performers include Boya Bio (300294) and Zhifei Biological (300122), both with a closing price increase of 0.92% and 0.73% respectively [1] Declining Stocks - Hualan Bio (301207) reported a significant decline of 9.05%, closing at 22.62, with a trading volume of 300,600 shares and a transaction value of 689 million yuan [2] - Junshi Biosciences (688180) fell by 6.02%, closing at 36.82, with a trading volume of 266,100 shares and a transaction value of 1 billion yuan [2] - Other stocks such as Jinkang (688670) and Bohui Innovation (300318) also experienced declines of 5.81% and 4.95% respectively [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 866 million yuan from institutional investors, while retail investors contributed a net inflow of 682 million yuan [2] - Notable net inflows from retail investors were observed in stocks like Shanghai Laishi (002252) and Weigao Bio (002880) [3] - Conversely, stocks such as Zhixiang Quantai (688443) and Weigao Bio (002880) experienced significant net outflows from institutional and speculative investors [3]
为什么和晶泰合作的企业都能大涨?揭开“晶泰赋能方程式”
Ge Long Hui· 2026-01-23 10:41
近日,马斯克透露,SpaceX与特斯拉正联合推进太阳能储能项目,目标三年内在美国实现每年100吉瓦 的太阳能电力制造产能,同时探索太空太阳能利用。 值得关注的是,光伏巨头晶科能源宣布与晶泰共同推进AI钙钛矿叠层Topcon电池用于太空光伏后,股 价直封涨停,单日涨幅高达20%,彻底点燃市场情绪。 一次又一次,晶泰仿佛掌握了激活市值的"密码"。这背后,究竟是怎样一套系统化的商业逻辑在支撑? 解码"晶泰效应":技术、资本与战略的协同共振 资本市场的反应迅速且直接,近期两起标志性合作更是将"晶泰效应"体现得淋漓尽致。其背后,是市场 对一套系统性赋能模型的高度认同。 晶科能源:AI+光伏,开启太空能源想象 2026年1月9日,全球光伏组件出货量第一的晶科能源宣布,与晶泰控股合作研发AI钙钛矿叠层Topcon 太阳能电池,用于太空光伏领域。公告当日,股价涨停,涨幅11.65%。 这一合作完美呼应了马斯克描绘的能源未来。他曾指出,中国太阳能年产能已达1500吉瓦,年部署量超 1000吉瓦,并测算在美国特定区域铺设约160公里×160公里的太阳能电池板即可满足全国用电。而"太 空光伏"进一步突破地表限制,理论上可实现近乎无 ...
生物制品板块1月21日涨0.19%,近岸蛋白领涨,主力资金净流入7704.07万元
Zheng Xing Xing Ye Ri Bao· 2026-01-21 08:53
Group 1 - The biopharmaceutical sector increased by 0.19% on January 21, with Nearshore Protein leading the gains [1] - The Shanghai Composite Index closed at 4116.94, up 0.08%, while the Shenzhen Component Index closed at 14255.12, up 0.7% [1] - Key stocks in the biopharmaceutical sector showed significant price increases, with Nearshore Protein rising by 6.37% to a closing price of 48.76 [1] Group 2 - The biopharmaceutical sector experienced a net inflow of 77.04 million yuan from institutional investors, while retail investors saw a net outflow of 284 million yuan [2] - Major stocks like Watson Bio and Ganli Pharmaceutical attracted significant institutional investment, with net inflows of 64.45 million yuan and 55.25 million yuan, respectively [3] - Retail investors showed a negative trend in several stocks, with Watson Bio and Ganli Pharmaceutical experiencing net outflows of 33.30 million yuan and 39.14 million yuan, respectively [3]
天坛生物承压换帅 血制品业迎加速整合期
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-20 23:07
Group 1 - The core point of the article is the recent personnel changes at Tian Tan Biological Products, a subsidiary of China National Pharmaceutical Group, which aims to adapt to market changes and strengthen its position in the blood products industry [2][8] - Yang Huichuan resigned as chairman but remains as a board member and general manager, while Liang Hongjun has been elected as the new chairman [2][3] - Under Yang's leadership, the company saw steady revenue growth in 2023 and 2024, with revenues of 5.18 billion and 6.032 billion yuan respectively, and net profits of 1.11 billion and 1.549 billion yuan, marking increases of 25.99% and 39.58% [2][5] Group 2 - The blood products industry in China has experienced increasing performance differentiation and intensified market competition, prompting Tian Tan Biological's strategic personnel adjustments [2][6] - Liang Hongjun's appointment comes at a critical time as the company faces profit pressure, with a reported net profit decline of 22.16% in the first three quarters of 2025 [4][5] - The industry has seen a narrowing growth rate, with some companies like Hualan Biological and Boya Biological experiencing significant revenue declines, while others like Tian Tan Biological and Shanghai Lai Si have shown revenue growth [6][7] Group 3 - The blood products sector is undergoing consolidation, with fewer than 30 operational companies in China, making license resources scarce and acquisitions vital for enhancing competitive strength [7][8] - The industry is shifting from a low-competition, high-growth phase to a differentiated competition phase, necessitating continuous strategic adjustments from leading companies like Tian Tan Biological [8]