Group 1 - The announcement states that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1][2] - The inspection was conducted from June 16 to June 19, 2025, and concluded that the production facility complies with the Drug Production Quality Management Standards (2010 revision) [2] - The inspected facility is focused on the production of therapeutic biological products, specifically the injection of recombinant human coagulation factor VIIa [1][2] Group 2 - The product "Injection of Recombinant Human Coagulation Factor VIIa" has completed Phase III clinical trials and has submitted a marketing authorization application, which is currently under review [3] - The receipt of the GMP Compliance Inspection Notice indicates that the production facility meets national GMP requirements, allowing for potential production upon obtaining the registration certificate and final production license for the product [3] - Future production of the product may be influenced by national policies and market conditions, indicating a level of uncertainty [3]

北京天坛生物制品股份有限公司 关于下属企业获得《药品GMP符合性检查告知书》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、准确性和完整性承担法律责任。 证券代码：600161 证券简称：天坛生物 编号：2025-045 近日，北京天坛生物制品股份有限公司下属成都蓉生药业有限责任公司（以 下简称"成都蓉生"）收到四川省药品监督管理局颁发的《药品 GMP 符合性检查 告知书》。现就相关情况公告如下： 一、 药品 GMP 符合性检查告知书相关信息 证书编号：川许 2025169 企业名称：成都蓉生药业有限责任公司 | 序号 | 产品名称 | | 同类产品市场情况 | | --- | --- | --- | --- | | 1 | 注射用重组人凝血因子Ⅶa | N01 | 正大天晴药业集团南京顺欣制药有限公司 | *注：以上资料来自国家药品监督管理局网站（https://www.nmpa.gov.cn/）。 四、 对公司的影响及风险提示 目前，成都蓉生"注射用重组人凝血因子Ⅶa"已完成Ⅲ期临床试验，递交 上市许可申请并获得受理，处于药品审评阶段。本次成都 ...

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. received a "Drug GMP Compliance Inspection Notification" from the Sichuan Provincial Drug Administration, specifically concerning the production workshop for recombinant products [1] Group 1 - The notification indicates compliance with Good Manufacturing Practice (GMP) standards, which is crucial for the production of pharmaceutical products [1] - The involved workshop is dedicated to the production of recombinant products, highlighting the company's focus on advanced biopharmaceutical manufacturing [1]

智通财经APP讯，天坛生物(600161.SH)公告，公司下属成都蓉生药业有限责任公司(简称"成都蓉生")收 到四川省药品监督管理局颁发的《药品GMP符合性检查告知书》，涉及车间为：重组产品生产车间。 ...

天坛生物公告，下属企业成都蓉生药业有限责任公司收到四川省药品监督管理局颁发的《药品GMP符 合性检查告知书》。证书编号为川许2025169，检查时间为2025年6月16日至6月19日，检查结论为符合 《药品生产质量管理规范（2010年修订）》及相关附录规定。此次获得告知书意味着成都蓉生的重组产 品生产车间符合国家GMP要求，待取得"注射用重组人凝血因子Ⅶa"注册证书和最终生产许可后，即可 实现该产品的生产。 ...

Group 1: Changshan Pharmaceutical - The company is preparing for clinical trials of Aibennate peptide for weight loss, with no current plans for oral formulation development [1] - Aibennate peptide is a long-acting GLP-1 receptor agonist, developed through chemical modification of exenatide [1] - The marketing preparation includes team building, product knowledge training, and marketing strategy formulation [1] Group 2: Fosun Pharma - Four innovative drugs approved in the first half of the year are expected to gradually increase sales in the coming months [2] - Innovative drug revenue exceeded 4.3 billion yuan, a year-on-year increase of 14.26%, accounting for over 30% of total drug revenue [2] - The company is actively participating in negotiations for the inclusion of its innovative drugs in insurance and national basic medical insurance directories [2] Group 3: Tiantan Biological Products - The company has established an international cooperation department to enhance its global market presence [3] - Products such as tetanus immunoglobulin and rabies immunoglobulin have already been exported [3] - The company is focused on international certification and registration of key products [3] Group 4: Kangtuo Medical - The US-based subsidiary BIOPLATE has launched a local production line for PEEK plates [4] - The company has completed market access in nearly 40 countries and regions [4] - The marketing of "4D bioactive plates" and PEEK fixation systems is underway in the US [4] Group 5: Tailong Pharmaceutical - The company is focusing on the development of modified new drugs across various therapeutic areas including respiratory, digestive, and oncology [5] - Projects in progress include treatments for Alzheimer's disease and schizophrenia [5] Group 6: Heng Rui Pharmaceutical - The HRS-5635 injection has been included in the list of proposed breakthrough therapies [6][7] - Chronic hepatitis B infection affects approximately 257 million people globally, with a significant mortality rate [7] - There is a pressing need for more effective treatments to achieve functional cure for chronic hepatitis B [7]

（文章来源：证券日报） 证券日报网讯 9月18日晚间，天坛生物发布公告称，2025年半年度利润分配方案为A股每股现金红利 0.15元（含税），股权登记日为2025年9月24日，除权（息）日为2025年9月25日，现金红利发放日同为 2025年9月25日。 ...

证券代码：600161 证券简称：天坛生物 公告编号：2025-044 北京天坛生物制品股份有限公司 2025年半年度权益分派实施公告 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、准确性和完整性承担法律责任。 重要内容提示： 每股分配比例 A 股每股现金红利0.15元 相关日期 1.发放年度：2025年半年度 2.分派对象： 截至股权登记日下午上海证券交易所收市后，在中国证券登记结算有限责任公司上海分公司 （以下简称"中国结算上海分公司"）登记在册的本公司全体股东。 3.分配方案： 本次利润分配以方案实施前的公司总股本1,977,371,446股为基数，每股派发现金红利0.15 元（含税），共计派发现金红利296,605,716.90元（含税）。 | 股份类别 | 股权登记日 | 最后交易日 | 除权（息）日 | 现金红利发放日 | | --- | --- | --- | --- | --- | | Ａ股 | 2025/9/24 | － | 2025/9/25 | 2025/9/25 | 差异化分红送转： 否 一、通过分配方案的股东会届次和日期 本次利 ...

北京天坛生物制品股份有限公司发布2025年半年度权益分派实施公告。本次利润分配经2025年8月20日 董事会审议通过，以总股本1,977,371,446股为基数，每股派发现金红利0.15元（含税），共计 296,605,716.90元（含税）。股权登记日为2025年9月24日，除权（息）日和现金红利发放日为9月25 日。分配实施方面，除部分自行发放对象外，委托中国结算上海分公司派发。不同类型股东扣税政策有 别，如自然人持股超1年暂免个税，QFII按10%扣税等。咨询可联系董事会办公室，电话010 - 65439720 。 ...

Core Viewpoint - The company is actively expanding its international market presence and enhancing its product offerings while addressing pricing strategies and production efficiency to meet annual targets [1][2]. Group 1: International Expansion and Product Development - The company has established an International Cooperation Department to focus on international market development and registration preparations, successfully exporting several immunoglobulin products [1]. - The company is advancing its key products towards international certification and registration, aiming to become a globally influential blood product enterprise [1]. Group 2: Pricing Strategy and Market Position - In response to investor concerns about declining gross margins due to falling prices of blood products, the management indicated that product prices have stabilized in 2025, although there was a decrease compared to the full year of 2024 [1]. - The company plans to implement multiple measures to achieve its annual goals, including increasing market share, boosting sales, and reducing inventory [1]. Group 3: Research and Development Progress - The company maintains a leading level of R&D investment in the industry, with over ten products under research, including blood products and gene-recombinant products [2]. - Two products have completed Phase III clinical trials and have submitted applications for marketing authorization, while others are progressing well in clinical trials [2]. Group 4: Production Capacity and Facility Development - The Yunnan project has completed key product registration inspections and is currently addressing inspection deficiencies, with plans to accelerate production site transfer for major products [2]. - The Yunnan facility is expected to commence production in 2026, focusing on human albumin, intravenous immunoglobulin, and prothrombin complex products [2].