迄今，公司已成功完成依坦生长激素α的技术转移和工艺优化，地产化生产能力全面就绪，进口与地产 产品的生物等效性临床试验已获得国家药品监督管理局药品审评中心批准（受理号：CXSL2500596） 并已启动。鉴于上述多方面考量，公司主动撤回此前递交的依坦进口生物制品上市申请（受理号： JXSS2400105），聚焦快速递交地产化依坦的上市申请。 12月30日，天境生物与济川药业（600566）联合宣布，基于对中国生长激素市场发展趋势的战略判断， 响应国家新药地产化政策，也基于地产依坦商业优势及超预期的地产化推进时间表，双方决定全面实施 依坦重组人生长激素注射液（以下简称通用名"依坦生长激素a"或"依坦"）的地产化战略。 ...

Core Insights - Tianjing Biopharma has signed a collaboration agreement with Zhijiang Laboratory Technology Holdings to develop next-generation long-acting innovative biologics, including growth hormones, aimed at providing more convenient treatment options for patients [1][5]. Company Overview: Tianjing Biopharma - Tianjing Biopharma focuses on innovative therapies for autoimmune diseases, tumor immunology, and metabolic diseases, with a differentiated dual-tier innovative drug pipeline [6]. - The first tier includes three products (Fizetuzumab, Eitan Growth Hormone α, and Idaglutide α) that have entered the product listing acceptance stage, while four additional innovative products are in the registration clinical stage or about to start Phase III clinical trials [6]. - The second tier consists of First-in-Class innovative drug projects based on the AntibodyPLUS platform, which are about to enter Phase I clinical trials or initiate clinical applications [6][7]. - The company is accelerating the internationalization of its innovative drug pipeline and integrating R&D, production, and product listing processes in China through collaborations with partners like Jichuan Pharmaceutical, Shiyao Group, and Sanofi [7]. Company Overview: Zhijiang Laboratory Technology Holdings - Zhijiang Laboratory Technology Holdings was established on September 27, 2020, to accelerate the application of technological achievements in the field of intelligent computing and to serve the development of the digital economy and emerging industries [8]. - The company has a registered capital of 100 million yuan and is located in the Future Technology City AI Town in Yuhang District, Hangzhou [8]. - Zhijiang Holdings is dedicated to providing high-quality full-chain services for the transformation and industrialization of technological achievements, including basic services like policy promotion and project due diligence, as well as value-added services such as concept verification and financing [8]. Collaboration Insights - The collaboration will leverage Zhijiang Laboratory's AI-driven research discovery platform, BioDeepDiscovery (BDD), while Tianjing Biopharma will contribute its extensive R&D experience, biological data, and preclinical research capabilities [2][6]. - The partnership aims to combine the strengths of both companies to accelerate drug development processes, particularly in exploring long-acting innovative biologics across multiple therapeutic areas [2][6].

Core Insights - Tianjing Biotech successfully completed nearly 600 million RMB in C+ round financing, aimed at advancing phase III clinical trials and market applications for first-tier products, while accelerating the development of second-tier global innovative drug candidates [1] - The financing reflects recognition of Tianjing Biotech's innovative capabilities and growth potential, as well as the strong appeal of the biomedical industry in Hangzhou Qiantang [1] Company Overview - Tianjing Biotech focuses on autoimmune diseases, tumors, and metabolic diseases, and has shown rapid growth since its strategic restructuring in early 2024 [1] - The company has established a diversified revenue model combining commercialization of near-market products, external licensing of innovative products, and CDMO services, effectively balancing high investment and risk in innovation [1] - Key milestones achieved include a strategic cooperation with Sanofi valued at approximately 1.7 billion RMB for the rights of Ureliximab in Greater China, and the breakthrough therapy designation for Punalizumab by the National Medical Products Administration [1] Product Pipeline - The innovative drug pipeline is entering a "harvest period" with a clear "dual-tier" layout, where the first tier includes six major products in late clinical stages, with new drug applications nearing completion [2] - The second tier consists of globally innovative projects and next-generation drugs expected to enter clinical trials between 2025 and 2026 [2] - The production base in Hangzhou plays a crucial role in supporting the entire industry chain, having fully operated its first phase and complied with GMP standards [2] Industry Context - The financing news for Tianjing Biotech is part of a broader trend, as multiple biopharmaceutical companies in Qiantang have also secured funding in the third quarter, indicating a vibrant development ecosystem in the region [3] - Companies like Zhejiang Ganaiwei Medical Technology and Hangzhou Derui Zhiyao Technology have also completed significant financing rounds, showcasing the robust vitality of the Qiantang biomedical industry [3]

Core Viewpoint - Tianjing Biopharma has successfully transformed into a comprehensive, innovative, and commercially broad platform-based biotechnology company, achieving significant milestones since its strategic restructuring in early 2024 [1][2]. Financing and Strategic Partnerships - Tianjing Biopharma completed a C2 round financing of nearly 600 million RMB, led by CICC Capital, with participation from various investment institutions [1]. - The company has established a strategic partnership with Sanofi for the rights to Ureliximab in Greater China, valued at approximately 1.7 billion RMB [1]. - Collaborations with other global and local leaders, such as Boehringer Ingelheim and Shijiazhuang Pharmaceutical, have been initiated to accelerate product development [3]. Product Pipeline and Clinical Development - The company has submitted applications for two products, including Eitan Growth Hormone α and Fizezomab for multiple myeloma indications [1]. - Fizezomab has been recognized as a breakthrough therapy by the National Medical Products Administration and has entered Phase III clinical trials [2]. - The product pipeline is divided into two tiers: the first tier includes six key products nearing commercialization, while the second tier focuses on globally innovative projects with first-in-class potential [2]. Business Model and Revenue Generation - Tianjing Biopharma's diversified revenue model includes commercialization of near-market products, external licensing of innovative products, and CDMO services, effectively balancing R&D investment and risk [1][2]. - The funds raised in the latest financing round will primarily support the Phase III clinical trials and market applications of first-tier products, as well as accelerate the development of second-tier global innovative candidates [2]. Industry Position and Future Outlook - The company is seen as a model of growth potential in the biopharmaceutical industry, particularly in the context of current market challenges and geopolitical changes [2]. - Investors express confidence in Tianjing Biopharma's ability to deliver innovative therapies that meet clinical needs, with a strong focus on autoimmune diseases, metabolic disorders, and oncology [2][3].