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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]
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]
玉柴取得发动机扭矩传感器校正工装专利
Jin Rong Jie· 2026-01-13 04:57
Group 1 - The core point of the article is that Guangxi Yuchai Machinery Co., Ltd. has obtained a patent for a "Calibration Tool for Engine Torque Sensors," with the authorization announcement number CN115077788B, and the application date was July 2022 [1] - Guangxi Yuchai Machinery Co., Ltd. was established in 1993 and is located in Yulin City, primarily engaged in the manufacturing of specialized equipment [1] - The company has a registered capital of 4,729.89346 million RMB and has made investments in 17 enterprises, participated in 947 bidding projects, and holds 15 trademark registrations and 5,000 patent registrations [1] - Additionally, the company possesses 1,195 administrative licenses [1]
1月4日6家公司获基金调研
Zheng Quan Shi Bao Wang· 2026-01-05 03:21
Group 1 - On January 4, a total of 7 companies were investigated by institutions, with 6 companies being surveyed by funds, highlighting a significant interest in certain firms [1] - Among the companies surveyed, Jingji Zhino (京基智农) attracted the most attention, with 23 funds participating in the investigation, followed by Tianyang Technology (天阳科技) with 21 funds and Yuxin Technology (宇信科技) with 14 funds [1] - The surveyed companies included 3 from the Shenzhen main board and 3 from the ChiNext board, indicating a diverse representation across different market segments [2] Group 2 - The total market capitalization of the surveyed A-share companies included 2 firms with a market value of less than 10 billion yuan, specifically Shanjiji Technology (熵基科技) and Jingji Zhino (京基智农) [3] - In terms of market performance, 5 out of the surveyed stocks increased in value over the past 5 days, with Jingji Zhino leading at a rise of 23.94%, followed by Shanjiji Technology at 13.77% and Jingbeifang (京北方) at 11.09% [3] - Notably, Jingbeifang experienced a net inflow of 216 million yuan in funds over the past 5 days, indicating strong investor interest, while Yuxin Technology and Jingji Zhino also saw significant net inflows of 103 million yuan and 67.98 million yuan, respectively [3]
派林生物:接受易方达基金等投资者调研
Mei Ri Jing Ji Xin Wen· 2026-01-04 10:57
Group 1 - Palin Bio announced that from December 25, 2025, to January 4, 2026, it will accept investor research from E Fund and other investors, with the company's board secretary Zhao Yulin participating in the reception and answering investor questions [1] Group 2 - The article discusses predictions for Wall Street and the tech industry in 2026, including topics such as the potential collapse of the AI bubble, a 20% drop in US stocks, quantum computing's impact on cryptocurrency, and gold prices exceeding $10,000 [1]
派林生物(000403) - 2025年12月31日投资者关系活动记录表
2026-01-04 10:32
Group 1: Industry Outlook - The blood products industry is expected to experience significant growth due to factors such as economic development, aging population, and increased clinical demand for blood products [1] - In 2023 and 2024, the industry is projected to see a supply-demand mismatch, with a 5% increase in plasma collection expected in the first half of 2025 [2] Group 2: Company Performance and Projections - The company anticipates a cash dividend of approximately CNY 256 million for 2024, representing 41.79% of the net profit attributable to shareholders for 2023 [5] - For 2025, the expected cash dividend remains at CNY 256 million, accounting for 34.33% of the net profit for 2024 [6] - In the first three quarters of 2025, the company's revenue and net profit attributable to shareholders decreased due to capacity expansion efforts [7] Group 3: Production and Capacity - The company expects to collect nearly 1,600 tons of plasma in 2025, with a projected output of over 1,400 tons [8] - The total production capacity has been expanded to over 3,000 tons following the completion of capacity upgrades in 2025 [7] Group 4: Research and Development - The company is advancing the development of the fourth generation of immunoglobulin, with expected regulatory approval for new indications by 2027 [9][10] - The company is also focusing on the development of human coagulation factors, with anticipated approvals for new products in 2027 [10] Group 5: Market Expansion and Control Transfer - The company is actively pursuing overseas market opportunities, with plans for regulatory registration and export sales [3] - The transfer of control to China National Biological is in progress, with significant steps taken towards finalizing the transaction by June 30, 2026 [4][12] Group 6: Infrastructure and Product Range - The company operates a total of 38 plasma collection stations, ranking third in the industry [11] - The product range includes 11 varieties across multiple specifications, also placing the company third in the industry [11]
玉柴取得发动机机油冷却器布置系统专利
Jin Rong Jie· 2026-01-03 01:56
Group 1 - The core point of the article is that Guangxi Yuchai Machinery Co., Ltd. has obtained a patent for an "engine oil cooler arrangement system," with the patent announcement number CN117552853B, applied for on December 2023 [1] - Guangxi Yuchai Machinery Co., Ltd. was established in 1993 and is located in Yulin City, primarily engaged in the manufacturing of specialized equipment [1] - The company has a registered capital of 4,729.89346 million RMB [1] - Guangxi Yuchai Machinery Co., Ltd. has invested in 17 enterprises and participated in 945 bidding projects [1] - The company holds 15 trademark registrations and has 5,000 patent records, along with 1,195 administrative licenses [1]