Core Viewpoint - TianTan Bio (600161.SH) has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, but has since withdrawn the application to supplement clinical trial data for pediatric patients under 12 years old [1] Group 1 - TianTan Bio's subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., is responsible for the development of the product [1] - The application received an acceptance notice from the Center for Drug Evaluation (CDE) with acceptance number CXSS2500005 [1] - The CDE has requested additional clinical trial data specifically for the pediatric patient group, leading to the withdrawal of the marketing authorization application [1]

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, and has received the acceptance notice [1] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [1] - Chengdu Rongsheng is actively conducting work to support the review process since the acceptance of the application [1] - The NMPA has requested additional clinical trial data for the pediatric population (under 12 years old), leading Chengdu Rongsheng to withdraw the drug registration application [1] Group 2 - Chengdu Rongsheng plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, receiving an acceptance notice [1] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [1] - Chengdu Rongsheng is actively conducting work to support the review process since the acceptance of the application [1] - Recent feedback from the NMPA indicates that additional clinical trial data for pediatric patients (under 12 years old) is required [1] Group 2 - In response to the NMPA's request, Chengdu Rongsheng has submitted a withdrawal application for the drug registration [1] - The company plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]

证券日报网讯天坛生物11月18日在互动平台回答投资者提问时表示，血液制品产品从血浆采集到实现销 售收入需要经过检疫、生产、检验、批签发等相关工作，需要一定的时间周期，2024年，公司全年实现 采集血浆约2781吨，同比增长15.15%。公司持续深化生产精细化管理，严格执行生产计划，确保血浆 应投尽投，产品应交尽交，保障产品市场供应；同时，通过加强市场拓展，提高产品终端覆盖率、提高 产品销量。 （文章来源：证券日报） ...

Group 1 - The company is closely monitoring market dynamics and is analyzing and assessing them in a timely manner [2] - The company is adjusting its sales strategies as needed based on market conditions [2]

Group 1 - The core transaction on November 17 involved a block trade of 1.5 million shares of Tiantan Biological, with a transaction value of 27.51 million yuan and a price of 18.34 yuan per share [2][3] - The buyer was Guotai Junan Securities Co., Ltd. headquarters, while the seller was China International Capital Corporation Shanghai branch [2] - Over the past three months, there have been two block trades for this stock, totaling 49.61 million yuan [3] Group 2 - The closing price of Tiantan Biological on the day of the transaction was 18.34 yuan, reflecting a decrease of 1.34% [3] - The stock had a turnover rate of 0.54% for the day, with a total trading volume of 198 million yuan and a net outflow of 63.53 million yuan in main funds [3] - The latest margin financing balance for the stock is 1.463 billion yuan, with a decrease of 13.56 million yuan over the past five days, representing a decline of 0.92% [4]

11月17日，天坛生物大宗交易成交150万股，成交额2751万元，占当日总成交额的12.2%，成交价18.34 元，较市场收盘价18.34元持平。 | 股票委宣信省 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 成交价(元) 成交金额(万元) 成交量( *) 买入营业部 | 交易日期 | 证券商除 | 证券代码 | 卖出营业部 | 是否为专场 | | | | | 国泰港湾区委股份 | 安國因寫主婦努奴 | 025-11-17 | 2751 | 天坛生物 | 600161 | 18.34 | 150 | ко | ...

Group 1 - The core point of the article is that TianTan Biological Products (600161.SH) has confirmed that its products are not exported to EU countries [1] Group 2 - The company has engaged with investors through an interactive platform to clarify its export status [1]

Group 1 - Tian Tan Biological Products Co., Ltd. executed a block trade on November 7, with a transaction volume of 1.2 million shares and a transaction amount of 22.104 million yuan, at a price of 18.42 yuan per share [2][3] - The buyer of the block trade was Guotai Junan Securities Co., Ltd. headquarters, while the seller was China International Capital Corporation Shanghai branch [2][3] - The closing price of Tian Tan Biological on the same day was 18.42 yuan, reflecting a slight increase of 0.11%, with a trading volume of 124 million yuan and a net outflow of main funds amounting to 14.058 million yuan [2][3] Group 2 - The latest margin financing balance for Tian Tan Biological is 1.484 billion yuan, showing a decrease of 11.2132 million yuan over the past five days, which is a decline of 0.75% [3] - Tian Tan Biological was established on June 8, 1998, with a registered capital of 1.977371446 billion yuan [3]

Group 1 - Tian Tan Biological's stock closed at 18.42 yuan on November 7, with a slight increase of 0.11% [1] - A block trade occurred involving 1.2 million shares, totaling a transaction value of 22.104 million yuan, with a premium rate of 0.00% [1] - The buyer was Guotai Junan Securities Co., Ltd. headquarters, and the seller was China International Capital Corporation Shanghai branch [1] Group 2 - In the last three months, there has been one block trade for this stock, with a total transaction value of 22.104 million yuan [1] - Over the past five trading days, the stock has seen a cumulative decline of 0.05%, with a net outflow of 29.2361 million yuan in principal funds [1]