Core Viewpoint - Tian Tan Biological has withdrawn its application for a hemophilia drug after 10 months of acceptance, citing the need for additional clinical trial data for children under 12 years old as per the CDE's review [1][4]. Group 1: Company Developments - Tian Tan Biological's drug, "Recombinant Human Coagulation Factor VIIa," had an investment of 266 million yuan in R&D and was expected to treat bleeding in patients aged 12 and older [1][3]. - The company’s product was designed to be similar to the imported drug Novoseven, which has been in the market for over 20 years without any domestic alternatives until recently [2][3]. - The recent announcement did not specify age groups for the drug's indications, aligning it closely with the imported product [4]. Group 2: Market Context - The hemophilia drug market is predominantly controlled by foreign companies, with over 90% market share, highlighting the challenges faced by domestic firms [7]. - The approval of the first domestic recombinant factor VIIa by Zhengda Tianqing in July 2023 marked a significant milestone, although its indications are limited compared to Novoseven [2][6]. - The domestic market for rare disease drugs is evolving, with 21 rare disease drugs approved in the first half of 2025, indicating a shift towards addressing previously unmet needs [7][8]. Group 3: Regulatory and Industry Trends - Regulatory bodies are increasingly focused on ensuring that new drugs address comprehensive patient needs, particularly for children, as seen in the requirement for additional pediatric data for Tian Tan's drug [6]. - The Chinese government has initiated programs to support the development of pediatric drugs and streamline approval processes, which may enhance the availability of treatments for rare diseases [7]. - The competitive landscape is changing, with domestic companies pushing for market share, leading to price reductions in existing treatments, thereby improving accessibility for patients [8].

Core Viewpoint - Tian Tan Bio's application for a hemophilia drug was withdrawn after 10 months of acceptance due to the need for additional clinical trial data for children under 12 years old, highlighting regulatory scrutiny in the rare disease market [2][11]. Company Summary - Tian Tan Bio's subsidiary Chengdu Rongsheng Pharmaceutical withdrew the registration application for "Recombinant Human Coagulation Factor VIIa Injection," which had a research investment of 266 million yuan [2][5]. - The drug's indication was aligned with that of imported products, focusing on adult and adolescent patients, but lacked data for younger patients, which is now a regulatory requirement [4][11]. - The company had previously completed a Phase III clinical trial, but the latest announcement did not specify age groups for the patient population [4][5]. Industry Summary - The hemophilia drug market in China is dominated by foreign companies, with over 90% market share, and there is a growing demand for domestic alternatives [12][13]. - The recent approval of a similar drug by Zhengda Tianqing, which does not cover children under 12, indicates a gap in the market that domestic companies are trying to fill [8][11]. - Regulatory bodies are pushing for comprehensive data that includes pediatric populations, reflecting a shift towards more inclusive treatment options for rare diseases [11][12]. - The domestic pharmaceutical industry is accelerating its efforts in rare disease drug development, with 21 rare disease drugs approved in the first half of 2025, indicating a positive trend towards addressing unmet medical needs [12][13].

Core Viewpoint - Tian Tan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa" by its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. due to the need for additional clinical trial data for pediatric patients under 12 years old [1] Group 1: Company Actions - The product's market authorization application was submitted to the National Medical Products Administration (NMPA) on January 2025 and received an acceptance notice [1] - Following the NMPA's review comments, Chengdu Rongsheng decided to withdraw the drug registration application to supplement the required clinical data [1] - The company plans to resubmit the drug registration application after completing the necessary clinical trials [1] Group 2: Impact on Business - The announcement states that the withdrawal of the drug registration application will not have a significant impact on the company's operating performance [1] - The company must complete the clinical trial data and pass the review and approval processes to achieve production and market sales [1] Group 3: Industry Considerations - The announcement highlights the long-term and uncertain nature of drug development, indicating potential risks for investors [1]

Group 1 - The announcement details that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has withdrawn its drug registration application for "Recombinant Human Coagulation Factor VIIa for Injection" due to the need for additional clinical trial data for pediatric patients under 12 years old [1][2] - The product's registration application was initially submitted to the National Medical Products Administration (NMPA) on January 2025 and received an acceptance notice [1] - The company plans to supplement the required clinical data and will resubmit the drug registration application after completing this work [1][2] Group 2 - The withdrawal of the drug registration application is not expected to have a significant impact on the company's operating performance [2] - The drug development process is described as a long-term endeavor that involves various internal and external uncertainties [2]

Core Viewpoint - TianTan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa Injection" due to the need for additional clinical trial data for pediatric patients under 12 years old [1][3]. Group 1 - TianTan Biological's subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., submitted the drug registration application to the National Medical Products Administration (NMPA) in January and received an acceptance notice [3]. - Since receiving the acceptance notice, Chengdu Rongsheng has been actively cooperating with the review process [3]. - The company plans to resubmit the drug registration application after completing the necessary clinical data for the pediatric population [1].

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]

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]

Core Viewpoint - TianTan Bio announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. received a GMP compliance inspection notice from the Sichuan Provincial Drug Administration, indicating that the production facility meets national GMP requirements [1] Group 1: Regulatory Compliance - The certificate number for the GMP compliance inspection is 川许2025169, with the inspection conducted from June 16 to June 19, 2025 [1] - The inspection concluded that the facility complies with the "Drug Production Quality Management Standards (2010 Revision)" and related appendices [1] Group 2: Product Development - The receipt of the notice signifies that Chengdu Rongsheng's production workshop for recombinant products is compliant with national standards [1] - The company is awaiting the registration certificate and final production license for "Recombinant Human Coagulation Factor VIIa for Injection" to commence production [1]