截至 2025 年 8 月，该集团(即公司及控股子公司/单位，下同)现阶段针对该产品的累计研发投入约为人 民币 1.83 亿元(未经审计)。 智通财经APP讯，复星医药(02196)公布，近日，公司控股子公司复星凯瑞(上海)生物科技有限公司(以下 简称"复星凯瑞")就布瑞基奥仑赛注射液(项目代号：FKC889，申请注册分类：治疗用生物制品 3.2 类; 以下简称"该产品")的药品注册申请获国家药品监督管理局受理，本次申报适应症为用于治疗复发或难 治性前体 B 细胞急性淋巴细胞白血病(ALL)成人患者。 该产品系复星凯瑞基于自 Kite Pharma,Inc.(系 Gilead Sciences, Inc.的控股子公司)引进的 Tecartus 经技术 转移并获授权于中国(包括香港、澳门)进行开发及本地化生产的靶向 CD19 的 CAR-T 细胞治疗产品。 Tecartus 已于 2020 年 7 月及 12 月先后于美国、欧洲获批上市。 截至本公告日期(即 2025 年 9 月 24 日，下同)，该产品的另一适应症(即用于治疗既往接受过二线及以上 治疗后复发或难治性套细胞淋巴瘤(r/r MCL)成人患者)于中 ...

Group 1: Company Overview and Investor Relations - The investor relations activity involved a telephone conference with over 130 participants from various financial institutions [2][3]. - Key personnel included the Chairman and Senior Vice President of the company, who addressed investor inquiries [3]. Group 2: Product Development and Clinical Trials - The "AK1012 project" for treating respiratory syncytial virus infections has completed Phase I clinical trials [3]. - "AK2017 injection" has successfully completed Phase II clinical trial enrollment, with discussions for Phase III trials underway [3]. - "HuA21 injection," targeting HER2, has completed Phase Ib/II clinical trials and is preparing for Phase III based on interim analysis [3][10]. - "AK2024 injection," another HER2-targeted drug, has received clinical approval and shows promising preclinical results [3]. - "HK010 injection," a dual-target PD-L1*4-1BB antibody, is progressing well in Phase I trials [3]. Group 3: Collaborations and Innovations - Collaboration with Afana Company on "AFN0328 injection" for HPV precancerous lesions is in Phase I trials, with plans for further mRNA drug development [4]. - The company’s affiliate, Boshengji, has developed the first CAR-T cell therapy targeting CD7, which has been included in a list of breakthrough therapies by the CDE [4][9]. - The "recombinant L-IFN adenovirus injection" developed by Yuansong Bio has received clinical trial approvals from both CDE and FDA for advanced solid tumors [4]. Group 4: Market Potential and Strategic Partnerships - The long-acting growth hormone "Transcon" is expected to outperform existing products, with a significant market opportunity projected at over 4 billion CNY in 2025 for follicle-stimulating hormone [8]. - The partnership with Baoyi Pharmaceutical for "SJ02," a long-acting follicle-stimulating hormone, aims to enhance treatment options in assisted reproductive technology [8]. - The PA3-17 injection has shown an objective response rate (ORR) of 84.6% and a complete remission rate of 95% in clinical trials [9]. Group 5: Future Plans and Regulatory Compliance - The company is actively building production lines compliant with FDA and EU standards, aiming for international market commercialization [11]. - Future clinical plans include launching Phase II trials for PA3-17 and exploring international registration based on Chinese clinical data [9].