9月29日，由北京市委网信办主办、新京报贝壳财经承办的"京彩不设限·经济热力站"月度主题走访活动 在北京举办，本期主题为"创新策源 健康领航"。 在蔡宝川的讲解中，媒体调研团了解到，立贝韦塔单抗（HH-003）是全球首个靶向乙肝病毒表面大包 膜蛋白PreS1区的中和抗体，华辉安健拥有完全自主知识产权。立贝韦塔单抗（HH-003）已分别获得中 国CDE和美国FDA"突破性疗法"认定，2024年12月新药上市申请（NDA）已正式获得中国国家药监局 受理并获得优先审评资格，预计2025年年底或2026年年初有望获得附条件批准上市。 据悉，立贝韦塔是在病毒性肝炎领域，获得FDA突破性疗法认定的首个完全由中国企业研发的全球创新 性的候选药物。 在走访过程中，华辉安健高级研发技术总监陈建和带着媒体调研团参观了公司的细胞间、早研开放实验 室等区域。 人才和资本"双轮驱动" 华辉安健于2015年在北京成立，致力于开发"first-in-class"或"best-in-class"新药。 据华辉安健运营副总裁蔡宝川介绍，公司专注于病毒学、肝病学和相关肿瘤学领域，致力于研发全球范 围内具有竞争力的创新药物，拥有6款具有潜在"Fi ...

Core Viewpoint - The collaboration between Maiwei Biotech and Calico is noteworthy as it marks a significant shift in the innovation drug landscape, leading to a substantial increase in Maiwei's stock price and market capitalization [2][3]. Company Overview - Maiwei Biotech, established 8 years ago, has gained prominence in the innovative drug sector, with its stock price increasing over 140% this year, reaching a market cap close to 240 billion yuan [2]. - The company has a focus on First-in-Class products, emphasizing deep understanding of biological mechanisms and disease relationships as the foundation for innovation [2][8]. Business Development (BD) Strategy - The partnership with Calico, a leader in anti-aging research, was formed after a swift negotiation process of just five months, highlighting the efficiency of the BD project [3]. - Maiwei's previous BD project involved a collaboration with DISC for a monoclonal antibody targeting TMPRSS6, also a First-in-Class product, indicating a trend of proactive interest from potential partners [4]. Clinical Development and Product Pipeline - Maiwei Biotech has multiple ADCs (Antibody-Drug Conjugates) in clinical trials, with 2025 designated as a key year for BD activities, further fueling market enthusiasm [5]. - The company has maintained a steady pace of product approvals since its listing on the STAR Market in 2022, with significant sales growth reported for its biosimilar products [6]. Market Position and Future Outlook - The company aims to build a comprehensive innovation ecosystem, focusing on First-in-Class and Best-in-Class products, while also exploring unique ADC development strategies [7][9]. - Maiwei's approach to BD emphasizes the importance of understanding target mechanisms and disease relationships, setting it apart from many biotech firms that focus solely on technical iterations [8]. Innovative Sales Strategies - The company is considering a "shared sales" model to enhance efficiency and reduce costs by collaborating with other biotech firms to form a unified sales team [11]. - This strategy reflects a flexible approach to navigating the competitive landscape of the Chinese pharmaceutical market, which is characterized by intense competition and a predominance of generic drugs [10].

Core Viewpoint - The collaboration between Maiwei Biotech and Calico is noteworthy as it marks a significant shift in the innovation drug landscape in China, leading to a substantial increase in Maiwei's stock price and market capitalization [1][2]. Company Overview - Maiwei Biotech, established 8 years ago, has gained prominence in the innovative drug sector, particularly with its IL-11 antibody project, which has First-in-Class potential [1][3]. - The company has experienced a stock price increase of over 140% this year, with its market value reaching nearly 240 billion yuan at one point [1]. Business Development (BD) Strategy - The partnership with Calico, which had not acquired external products for a decade, highlights Maiwei's strategic choice to prioritize collaboration with established players in the anti-aging field [2][3]. - Maiwei's previous BD project involved a collaboration with DISC for a monoclonal antibody targeting TMPRSS6, also a First-in-Class product, indicating a consistent strategy of pursuing innovative drug development [3][6]. Financial Performance - Maiwei's sales revenue has shown significant growth, with a 243.53% increase in sales from its three biosimilar products last year, and a 53.50% increase in sales revenue in the first half of this year [5][6]. - The company anticipates further market penetration for its products, particularly in the context of expanding indications for its drugs [5]. Innovation and Research Focus - Maiwei emphasizes deep research into target mechanisms and disease relationships, which differentiates its approach from many biotech firms that focus on technical iterations [7][8]. - The company is developing multiple ADCs (antibody-drug conjugates) with a focus on tailoring Linkers and Payloads to specific tumor characteristics, aiming for Best-in-Class potential [8][9]. Market Position and Future Outlook - The Chinese pharmaceutical market is characterized by a predominance of generic drugs, which poses challenges for biotech firms; however, Maiwei's strategy includes flexible routes to market through licensing and partnerships [10]. - The company is exploring a "shared sales" model to enhance efficiency and reduce costs by collaborating with other biotech firms to form a unified sales team [10].