Shen Lian Biomedical(688098)
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申联生物:创新药UB-221注射液II期临床研究已完成全部受试者入组
Xin Lang Cai Jing· 2025-08-31 09:55
Core Viewpoint - The company announced the completion of participant enrollment for the Phase II clinical trial of the innovative drug UB-221, indicating significant progress in its development [1] Group 1: Clinical Trial Progress - The company received a notification from its associate company, Shizhi Yuan, regarding the progress of the Phase II clinical trial for UB-221 [1] - A total of 145 participants have been enrolled in the clinical trial as of the date of the announcement [1] Group 2: Product and Commercial Rights - Shizhi Yuan holds all commercialization rights, including marketing authorization, research, production, and sales for UB-221 in mainland China [1] - UB-221 is a humanized monoclonal antibody developed as a subcutaneous injection, representing a next-generation product from the inventor of the anti-IgE treatment method, Dr. Zhang Ziwen [1] - The drug was originally developed by United Biomedical, Inc. (UBI), the company's second-largest shareholder [1]
申联生物(688098) - 关于参股公司UB-221创新药II期临床研究进展的自愿性披露公告
2025-08-31 09:45
申联生物医药(上海)股份有限公司(以下简称"公司")近日收到参股公 司扬州世之源生物科技有限责任公司(以下简称"世之源")关于创新药 UB-221 注射液 II 期临床研究进展的《告知函》,截至本公告披露日,该项目已完成全部 145 例受试者入组。现将相关情况公告如下: 一、UB-221 基本情况介绍 世之源拥有 UB-221 在中国大陆的上市许可和研发、生产、销售等全部商业 化权益。UB-221 是由公司第二大股东美国联合生物医学公司(United Biomedical, Inc., UBI)原研研发,该项目由 anti-IgE 治疗法发明人张子文博士开发的次世代 产品,是皮下注射剂型的人源化原研单抗。 UB-221 不仅可同时中和引发过敏反应的游离 IgE,亦能透过结合至 B 细胞 表面的 CD23 受体结合的 IgE 而抑制 IgE 的合成。临床前资料充分证明 UB-221 具有比同类已上市的产品更加优越的药理学特征:UB-221 不仅可中和游离 IgE, 抑制 IgE 生成;UB-221 中和游离 IgE 的效果更好;UB-221 阻断 IgE 生成的效果 更优;在食蟹猴和人类 IgE(ε,κ)基因转 ...
申联生物(688098.SH):UB-221创新药II期临床研究完成全部受试者入组
智通财经网· 2025-08-31 07:51
Group 1 - The company received a notification regarding the progress of the Phase II clinical trial for the innovative drug UB-221, which has completed the enrollment of all 145 participants [1] - The clinical trial is a Phase II, multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of UB-221 in patients with chronic spontaneous urticaria (CSU) [1] - The trial planned to recruit 144 patients but ultimately enrolled 145, with participants randomly assigned to one of five treatment groups [1] Group 2 - The company is focused on building a world-class high-tech biopharmaceutical company, leveraging its diverse biopharmaceutical technology platform and talent pool to expand its business boundaries [2] - The company is actively developing three innovative drugs: UB-221, UB-421, and UB-621, while also exploring new indications for these drugs [2] - The company aims to transition from animal health to human pharmaceuticals by utilizing its technological expertise in synthetic peptides, genetic engineering, and mRNA, alongside its capabilities in innovative drug development management [2]
申联生物:UB-221创新药II期临床研究完成全部受试者入组
Guo Ji Jin Rong Bao· 2025-08-31 07:39
Core Viewpoint - The announcement from Shenglian Bio indicates significant progress in the clinical trial of the innovative drug UB-221, which is aimed at treating chronic spontaneous urticaria (CSU) [1] Group 1: Clinical Trial Details - The clinical trial for UB-221 is a Phase II, multi-center, randomized, double-blind, placebo-controlled, parallel-group study [1] - A total of 145 subjects have been enrolled, surpassing the initial target of 144 patients [1] - Patients are randomly assigned to one of five treatment groups, receiving either 4mg/kg UB-221, 2mg/kg UB-221, 1mg/kg UB-221, 300mg Xolair, or a placebo [1] Group 2: Study Objectives - The primary endpoint of the trial is the percentage of patients achieving HSS7=0 at week 12 [1] - UB-221 is developed as a next-generation product by Dr. Zhang Ziwen, the inventor of the anti-IgE treatment method [1] Group 3: Company Background - UB-221 is a humanized original monoclonal antibody in a subcutaneous injection form, developed by the second-largest shareholder, United Biomedical, Inc. [1]
申联生物(688098.SH)上半年净亏损1286.97万元
Ge Long Hui A P P· 2025-08-30 16:50
Summary of Key Points Core Viewpoint - Shenlian Bio (688098.SH) reported a decline in revenue for the first half of 2025, indicating challenges in its financial performance [1] Financial Performance - The company achieved total operating revenue of 122 million yuan in the first half of 2025, representing a year-on-year decrease of 3.68% [1] - The net profit attributable to shareholders of the parent company was -12.87 million yuan, which is an improvement of 21.64 million yuan compared to the same period last year [1] - The basic earnings per share stood at -0.03 yuan [1]
申联生物: 第四届董事会第四次会议决议公告
Zheng Quan Zhi Xing· 2025-08-29 12:17
Group 1 - The board of directors of Shenyuan Biopharmaceutical (Shanghai) Co., Ltd. held its fourth meeting on August 29, 2025, with all nine directors present, ensuring the legality and validity of the resolutions made [1][2] - The board approved the 2025 semi-annual report and its summary, confirming that the report accurately reflects the company's financial status and operational results for the first half of 2025, with no false records or misleading statements [1][2] - The board also approved the special report on the use of raised funds from January to June 2025, stating that the use of funds complies with relevant regulations and that all projects funded by the initial public offering have been completed [2][3] Group 2 - The board agreed to disclose the semi-annual evaluation report of the "Quality Improvement and Efficiency Enhancement Action Plan" for 2025, with unanimous approval from all directors [3] - The board proposed to cancel the supervisory board and amend the company's articles of association, which is aimed at improving the corporate governance structure and aligning with the latest legal requirements [4][5] - The board decided to convene the second extraordinary general meeting of shareholders for 2025 on September 25, 2024, to discuss the cancellation of the supervisory board and other operational regulations [5][6]
申联生物: 第四届监事会第四次会议决议公告
Zheng Quan Zhi Xing· 2025-08-29 12:17
Group 1 - The core viewpoint of the announcement is that the Supervisory Board of the company has reviewed and approved the 2025 semi-annual report and its summary, confirming that the report accurately reflects the company's financial status and operational results for the first half of 2025 [1][2] - The Supervisory Board unanimously agreed that the preparation and review procedures of the semi-annual report comply with relevant laws and regulations, and there are no false records or misleading statements [2] - The company has completed the investment projects funded by the initial public offering, and the special account for raised funds has been closed, ensuring compliance with regulations regarding the use of raised funds [2][3] Group 2 - The Supervisory Board has proposed to cancel the Supervisory Board as part of a decision to enhance the company's governance structure, which aligns with the latest legal requirements and the company's operational needs [3][4] - The cancellation of the Supervisory Board will not harm the interests of shareholders, particularly minority shareholders, and the responsibilities of the Supervisory Board will be transferred to the Audit Committee of the Board of Directors [3][4] - This proposal is subject to approval at the company's shareholders' meeting, and until then, the current Supervisory Board will continue to fulfill its supervisory duties diligently [4]
申联生物: 申联生物医药(上海)股份有限公司2025年第二次临时股东大会会议资料
Zheng Quan Zhi Xing· 2025-08-29 12:17
Core Viewpoint - The company is holding its second extraordinary general meeting of shareholders in 2025 to discuss significant governance changes, including the cancellation of the supervisory board and amendments to the company's articles of association [1][5][7]. Meeting Procedures - The meeting will confirm the identity of attendees and ensure that only registered shareholders or their proxies can participate in voting [2][3]. - The agenda includes the announcement of the number of shareholders present and their voting rights, followed by the reading of meeting guidelines and the election of vote counters [5]. - Shareholders have the right to speak, inquire, and vote, but must register in advance and adhere to time limits during discussions [2][3][5]. Agenda Items - **Proposal 1**: The company proposes to cancel the supervisory board and amend the articles of association accordingly, transferring the supervisory functions to the audit committee of the board [6][7]. - **Proposal 2**: The company aims to revise and establish other operational regulations to align with the updated articles of association and improve governance [7][8]. Voting Process - Voting will be conducted through both on-site and online methods, with specific time frames for participation [4][5]. - The results of the votes will be announced after a break for counting, followed by the reading of the legal opinion by the witnessing lawyer [5][6].
申联生物: 关于召开2025年第二次临时股东大会的通知
Zheng Quan Zhi Xing· 2025-08-29 12:17
Meeting Overview - The shareholder meeting of Shenlian Biopharmaceutical (Shanghai) Co., Ltd. is scheduled for September 25, 2025 [1] - The meeting will utilize a combination of on-site and online voting methods [1][2] - The on-site meeting will take place at the company's office in Shanghai at 14:30 [1] Voting Procedures - Shareholders can vote through the Shanghai Stock Exchange's online voting system, with voting available from 9:15 to 15:00 on the day of the meeting [1][2] - Specific voting procedures apply to margin trading, transfer, and other related accounts as per the regulations [2] Agenda Items - The main agenda item for the meeting is the proposal to cancel the supervisory board and amend the company's articles of association, which has already been approved by the board and supervisory board [2] - There are no related shareholders that need to abstain from voting on this proposal [2] Attendance Requirements - Only shareholders registered by the close of trading on September 22, 2025, are eligible to attend the meeting [4] - Shareholders must complete registration procedures and present valid identification to participate [4][5] Additional Information - Shareholders are responsible for their own travel and accommodation arrangements for attending the meeting [5] - Contact information for the company is provided for any inquiries related to the meeting [5]
申联生物(688098) - 关于召开2025年第二次临时股东大会的通知
2025-08-29 12:14
证券代码:688098 证券简称:申联生物 公告编号:2025-032 申联生物医药(上海)股份有限公司 关于召开2025年第二次临时股东大会的通知 本公司董事会及全体董事保证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: 股东大会召开日期:2025年9月25日 本次股东大会采用的网络投票系统:上海证券交易所股东会网络投票系 统 一、 召开会议的基本情况 (一) 股东大会类型和届次 2025年第二次临时股东大会 (二) 股东大会召集人:董事会 (三) 投票方式:本次股东大会所采用的表决方式是现场投票和网络投票 相结合的方式 (四) 现场会议召开的日期、时间和地点 召开日期时间:2025 年 9 月 25 日14 点 30 分 召开地点:上海市闵行区江川东路 48 号公司综合楼一楼会议室 (五) 网络投票的系统、起止日期和投票时间。 网络投票系统:上海证券交易所股东会网络投票系统 网络投票起止时间:自2025 年 9 月 25 日 至2025 年 9 月 25 日 采用上海证券交易所网络投票系统,通过交易系统投票平台的投票时间为股 东大 ...