免疫治疗2.0时代

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君实生物: 开启免疫治疗2.0时代
Bei Jing Shang Bao· 2025-08-05 10:36
当国产PD-1抑制剂将癌症治疗费用大幅拉低,曾被高价药阻隔的消费需求正不断释放。 2025年,迎来创新药发展的十年节点。我国创新药企通过持续研发创新,让更多新药"飞入寻常百姓 家"。同时,国产创新药凭借硬实力开始常态化"出海",在国际市场的知名度越来越高。 手握国产首个PD-1单抗的君实生物,正是蓬勃发展的本土创新药企的典型代表。中国创新药企从"仿制 跟随"到"源头创新",在特定疾病领域已实现并跑乃至领跑的跨越。 "PD-1四小龙"竞速 君实生物见证并参与了中国创新药发展的黄金时代。 2012年,君实生物成立。那时对于中国医药界来说,自主研发的创新生物药还遥不可及。欧美巨头垄断 了全球创新药市场,高昂的药价让患者望而兴叹。 从公司成立到核心产品特瑞普利单抗注射液(商品名:拓益)上市,君实生物用了六年。 2018年底,拓益作为我国首个以PD-1为靶点的国产单抗药物获批上市,拓益的上市,填补了国产PD-1 单抗的空白,君实生物也由此一战成名。 随后,信达生物的信迪利单抗、恒瑞医药(600276)的卡瑞利珠单抗、百济神州的替雷利珠单抗先后获 批,"PD-1四小龙"的竞争格局形成,PD-1也成为国内外最热门的创新赛道 ...
创新消费力| 君实生物: 开启免疫治疗2.0时代
Bei Jing Shang Bao· 2025-08-05 10:16
Core Viewpoint - The article highlights the significant advancements and competitive landscape of China's innovative drug industry, particularly focusing on the development and commercialization of PD-1 inhibitors, with Junshi Biosciences as a key player in this transformation [3][4][5]. Group 1: Industry Development - The Chinese innovative drug sector is experiencing a pivotal decade, with local companies transitioning from imitation to original innovation, particularly in the field of cancer treatment [3]. - The approval of the first domestic PD-1 monoclonal antibody, Tuoyi (Tremelimumab), marked a significant milestone, leading to the emergence of a competitive landscape known as the "PD-1 Four Dragons" [7][8]. - As of now, Tuoyi has received approval for 12 indications, with 10 included in the national medical insurance catalog, significantly reducing treatment costs for patients [7][11]. Group 2: R&D and Innovation - Junshi Biosciences is focusing on the development of next-generation immunotherapy drugs to address unmet clinical needs, including PD-1/VEGF dual antibodies and other innovative targets [9][10]. - The company has raised over 1 billion HKD through equity financing, with a significant portion allocated to R&D for innovative drugs [9]. - The competitive landscape is becoming increasingly crowded, necessitating a focus on original innovation and differentiated product development strategies [10]. Group 3: Market Accessibility and Policy - Junshi's pricing strategy for Tuoyi was significantly lower than imported counterparts, making it one of the most affordable PD-1 drugs globally, which has been crucial for patient access [11]. - The Chinese government is reforming the medical insurance system to balance commercial viability with the need to reflect the value of innovation, aiming for a sustainable ecosystem for innovative drugs [11][12]. - Recent policy changes, including a dual-track payment system for innovative drugs, are expected to enhance market flexibility and accessibility [12]. Group 4: Global Expansion - The global market is becoming a new battleground for innovative drugs, with Junshi exploring various international strategies, including licensing and joint ventures [14][15]. - The company has established a global commercialization network covering over 80 countries and regions, actively pursuing international clinical trials for its pipeline products [16]. - The trend of licensing out has become a primary funding source for unprofitable innovative drug companies, with significant growth in transaction volumes reported [17]. Group 5: Future Outlook - The innovative drug industry is transitioning from a focus on urgent medical needs to long-term health management services, driven by an aging population and increased health awareness [19]. - Junshi aims to redefine the consumer value of innovative drugs by enhancing clinical efficacy, affordability, and patient adherence [19]. - The industry is expected to see increased interest from multinational pharmaceutical companies, providing opportunities for domestic firms to secure funding and expand internationally [21].