编辑丨王多鱼 这是一个为 "真正有突破意义的研究"而设的征稿项目 ： 重点征稿方向一：肿瘤与创新治疗机制 聚焦生命科学前沿 ：肿瘤生物学、免疫机制、新型药物与技术平台 国际期刊平台 ：多本 SCI 收录期刊，全球传播 高效出版支持 ：部分专题提供 APC 优惠 精准主题匹配 ：由 国际 期刊主编或专家团队领衔征稿 关注 靶点发现、作用机制、治疗耐药与新型治疗模式 扫码查看征稿详情 排版丨水成文 哪些研究，正在真正推动生命科学与医学的下一次跃迁？ 从 CAR-T、ADC、免疫检查点抑制剂 ，到 mRNA 递送系统、AI 驱动的耐药预测、精准医疗与罕见病研究 ，一批能够改变疾病认知与治疗路径的研究方向，正在走向临床与真实世界。 Taylor & Francis 及其旗下 Dove Medical Press 正式推出 Game Changer Series （破局者系列） 征稿 ，面向全球生命科学与医学研究者，集中开放一系列 聚焦机制突破、技术创新与转化价值 的专题征稿。 为什么是 Game Changer Series？ 扫码查看征稿详情 重点征稿方向四：前沿技术与精准医学 重点征稿方向二：感染、耐药与疫苗研究 ...

21世纪经济报道记者 季媛媛 韩利明 肿瘤领域始终是医药创新的热土，PD-1/PD-L1抑制剂、细胞和基因疗法、双特异性/多特异性抗体等新 型疗法迭代涌现，推动肿瘤治疗范式革新。其中，兼具单抗药物"精准识别"和小分子毒素"强效杀伤"双 重优势的抗体偶联药物（ADC），已成为当前肿瘤治疗领域最具潜力的热门赛道之一。 依托成本控制与研发效率等显著优势，中国创新药企（Biotech）已跻身全球ADC创新的核心阵营。数 据显示，我国ADC新药管线数量占全球总量的50%以上，且在部分细分领域已构建技术优势。2023年 底，百利天恒与百时美施贵宝（BMS）达成的ADC领域重磅战略合作，刷新了全球ADC类药物单品交 易总价的纪录，更将行业创新热度推向高峰。 进入2025年，ADC领域的BD（商务拓展）热潮持续延续。《2025年中国创新药出海正当时》统计，前8 个月，ADC药物以14项交易成为最热门的出海技术赛道之一，信诺维医药、石药集团、映恩生物、信 达生物等多笔ADC授权总金额超10亿美元。此外，企业不再局限于HER2、TROP2等成熟但拥挤的靶 点，而是向CDH6、CDH17、DLL3等"蓝海"靶点拓展，寻求更宽的治疗 ...

抗体偶联药物（ADC）凭借将细胞毒性药物精准递送至癌细胞的能力，正成为推动肿瘤领域新药研发的重点方向之一。公开资料显示，全球范围内有数百 款ADC疗法处于积极的临床研究阶段，其中包含了数十款双抗ADC，靶点涵盖了EGFR、HER2、HER3、c-Met 、ROR1、PD-L1、B7-H4、B7-H3等等，临 床开发适应症涉及一系列实体瘤和血液系统恶性肿瘤。 2025年以来，ADC新药研发管线迎来一系列新进展。其中，多款创新ADC获监管机构批准上市，为不同类型的乳腺癌、非小细胞肺癌等患者带来了新的治 疗选择。 比如，12月，美国FDA批准由阿斯利康和第一三共联合开发的靶向HER2的ADC疗法Enhertu联合帕妥珠单抗，用于一线治疗经FDA批准检测确定为不可切除 或转移性HER2阳性（IHC 3+或ISH+）乳腺癌的成人患者。 再如，10月，FDA批准葛兰素史克（GSK）靶向BCMA的ADC药物Blenrep，联合硼替佐米和地塞米松，用于治疗至少接受过两种既往疗法的复发或难治性 多发性骨髓瘤成年患者。5月，FDA批准艾伯维（AbbVie）靶向c-Met的ADC药物Emrelis上市，用于治疗c-Met蛋白高度表 ...

Core Viewpoint - Newway, the world's largest caffeine producer, is facing transformation anxiety as it seeks external financing through an IPO on the Hong Kong Stock Exchange to address performance challenges and transition pressures [1] Group 1: Financial Performance - Newway's overall performance has been declining, with revenue shrinking year by year. The company's revenue for 2022, 2023, and 2024 was 2.838 billion, 2.539 billion, and 1.981 billion respectively, reflecting year-on-year declines of 10.55% and 21.98% in 2023 and 2024 [2] - The net profit has also worsened, with figures of 294 million and 126 million for 2022 and 2023, and a projected net loss of 304 million for 2024 [2] - In the first seven months of 2025, revenue showed a slight increase of 8.74%, but losses expanded to 226 million compared to 38.79 million in the same period of 2024 [2] Group 2: Traditional Business Challenges - The core reason for the performance pressure is the sluggish growth of traditional business, which includes functional raw materials and health foods, contributing over 90% of revenue [2] - Revenue from functional raw materials and health foods was 2.571 billion in 2022, declining by 4.7% in 2023 and further by 24.9% in 2024, with a corresponding drop in gross margin to 39.6% [3] Group 3: Innovation Drug Transition - Newway's transition to innovative drugs has not yet yielded significant results, with the biopharmaceutical segment contributing less than 5% of revenue in 2024 [5] - The company invested 1.871 billion to acquire a 51% stake in Giant Bio, gaining access to antibody drugs and mRNA vaccines, but the revenue contribution from this segment remains low [5] - R&D expenses surged to 843 million in 2024, accounting for 42.5% of revenue, exacerbating losses [6] Group 4: Future Outlook - The success of Newway's IPO and its ability to alleviate financial pressure during the transition will depend on the efficiency of R&D conversion and commercialization capabilities post-funding [7] - If the core pipeline can progress smoothly through clinical trials and gain approval, it may open up revenue growth opportunities; otherwise, the challenges may intensify [7]

【文/观察者网 王一】在上海郊区，工程师们正检查一排巨大的不锈钢发酵罐，里面源自仓鼠卵巢细胞 的生物药即将进入量产阶段，每个罐体的容量足以生产5万升这种药物。得益于当地政府快速的审批流 程和"保姆式"支持，生产这些药物的工厂自今年2月动工至今已提前一个月进入投产准备阶段。 麦肯锡报告显示，中国药企在新药研发各环节的时间与成本均具有明显的优势——从锁定靶点到推进候 选药物进入早期临床试验，中国的速度可以比全球平均水平快两到三倍。药物进入临床后，中国庞大的 患者群体让试验入组速度比全球快两到五倍。 "过去三四年，中国的发展速度非常迅猛，已成为全球最重要的创新源泉之一。"上海碧博生物医药科技 有限公司创始人兼首席执行官焦鹏说，中国的基础研究已相当成熟，但还需要通过大量实验来确定合适 的制剂配方。 他补充说："这更像是一个谜题，需要的是工程思维而非科学思维。这类工作需要一支高效的团队，能 够迅速行动，找出可行的解决方案。" 碧博生物的新工厂距离特斯拉上海超级工厂不远，坐落于一个专为生物科技初创企业打造的产业园区， 里面的企业可以获得补贴、优惠的租金以及来自地方政府的全程支持。工厂建设方案获批仅用了9天， 而在欧洲，同 ...

【文/观察者网 王一】在上海郊区，工程师们正检查一排巨大的不锈钢发酵罐，里面源自仓鼠卵巢细胞 的生物药即将进入量产阶段，每个罐体的容量足以生产5万升这种药物。得益于当地政府快速的审批流 程和"保姆式"支持，生产这些药物的工厂自今年2月动工至今已提前一个月进入投产准备阶段。 "这是中国生物医药产业蓬勃发展的其中一个例证。"英国《金融时报》12月2日发文称，全球制药业正 经历一场权力交接，西方药企可能在他们曾引以为傲的新药创新领域失去领先地位，而中国凭借惊人的 研发速度、庞大的人才体系与产业链效率，正在快速逼近甚至反超。 报道注意到，近年来，中国生物医药产业迅速崛起，密集的交易活动吸引外国药企涌入，寻求有前景的 新药来补充其日益萎缩的研发线。多家国际药企高管和投资者甚至私下发出警告称，若不加速创新，西 方可能会在新药研发上被中国赶超。 他们认为，推动中国生物医药跃升的核心在于速度与效率，这不仅为药物研发提速，也显著压低了研发 成本。中国的优势来自于庞大而成熟的人才体系，从实验室研究人员到仪器制造工程师，再到在药厂中 安装生产线的技术工人，这些人才部分有海外科研背景，但主力都是中国本土工程师。 "如今中国团队的效率 ...

Core Viewpoint - Minghui Pharmaceutical has submitted its IPO application, focusing on its pipeline of nearly 10 antibody-drug conjugates (ADCs) in early development stages, including targets like TROP-2, B7-H3, B7-H4, c-Met, and PSMA, as well as a PD-1/VEGF bispecific antibody [1][4]. Group 1: Company Overview - Minghui Pharmaceutical was established in 2018 and is currently developing a range of ADCs, with a notable focus on innovative drug development [1]. - The company has no marketed products yet and is facing significant competition in the ADC space, particularly from companies like Hansoh Pharmaceutical [5][9]. - The founder and chairman, Cao Guoqing, previously held a senior position at Heng Rui Pharmaceutical, which adds credibility to the company [8]. Group 2: Financial Performance - The company reported losses of 137 million yuan in 2023 and 283 million yuan in 2024, with no revenue expected in these years [5][7]. - In the first half of 2025, the company generated revenue of 264 million yuan but incurred a loss of 167 million yuan [7]. - The company’s cash and cash equivalents were reported at 1.3 billion yuan in 2023 and 290 million yuan in 2024, indicating a potential liquidity issue [7]. Group 3: Product Pipeline and Market Potential - The ADC market is experiencing significant growth, with products like Enhertu generating sales of 1.976 billion USD in the first three quarters of the year, reflecting a 37% year-on-year increase [1]. - Minghui's B7-H3 ADC (MHB088C) has been licensed to Qilu Pharmaceutical for development in Greater China, with an initial payment of 280 million yuan and potential milestone payments exceeding 1 billion yuan [4]. - The company is also developing a topical JAK inhibitor for atopic dermatitis, which is closest to commercialization, with its application already accepted [5]. Group 4: Industry Trends - The ADC sector is evolving, with innovations in antibody, payload, linker, and conjugation technologies expected to enhance clinical differentiation and market potential [8]. - Chinese companies are moving from a fast-follow approach to becoming global leaders in ADC development, with a focus on innovative targets and combination therapies [8].

Core Viewpoint - The stock of HAPO Pharmaceutical-B (02142) has increased by over 4%, reaching HKD 14.22, with a trading volume of HKD 27.84 million, following the announcement of an updated global strategic collaboration with AstraZeneca [1] Group 1: Collaboration Details - HAPO Pharmaceutical announced an update to its global strategic collaboration with AstraZeneca, established in March 2025, focusing on the discovery and development of next-generation biotherapies, including antibody-drug conjugates (ADC) and T-cell engagers (TCE) [1] - Under the agreement, AstraZeneca will nominate R&D projects annually for the next four years, demonstrating the deepening of the partnership [1] - HAPO Pharmaceutical will be eligible to receive option fees, exercise fees, development and commercial milestone payments, as well as tiered royalties based on future net sales of the licensed projects, consistent with the financial framework established in March 2025 [1]

Core Viewpoint - The collaboration between AstraZeneca and Hengrui Medicine has been deepened through a revised agreement to jointly discover and develop next-generation biotherapies, including antibody-drug conjugates (ADC) and T-cell engagers (TCE) [2][3]. Group 1: Collaboration Details - AstraZeneca has previously engaged with Hengrui Medicine through multiple agreements, including a global license for Claudin18.2/CD3 bispecific antibody with a total deal value of $325 million, and a preclinical monoclonal antibody project with a total deal value of $575 million [3]. - The revised collaboration agreement expands the scope to include ADCs and TCEs, indicating a strong recognition of Hengrui's R&D platform by AstraZeneca [3][4]. Group 2: TCE Technology Advantages - TCE technology, developed by Hengrui, has shown significant advantages over traditional ADCs and CAR-T therapies, including lower preparation costs, better safety profiles, and ease of administration [8]. - TCEs are expected to achieve tumor clearance comparable to CAR-T therapies while expanding indications to autoimmune diseases, thus promoting accessible immunotherapy [8]. Group 3: Market Activity and Trends - The TCE technology has become a popular direction for business development (BD) in the industry, with a total of $4 billion in BD deals since the second half of 2024 [8]. - Hengrui has successfully completed several BD transactions involving TCEs, including a $470 million deal with Otsuka Pharmaceutical for HBM7020 [6].

Core Insights - The announcement highlights the deepening global strategic collaboration between Heptares Therapeutics and AstraZeneca established in March 2025 [1] - The partnership focuses on the discovery and development of next-generation biotherapies, including antibody-drug conjugates (ADCs) and T-cell engagers (TCEs) [1] Collaboration Details - AstraZeneca will nominate research projects to Heptares Therapeutics annually over the next four years, demonstrating the ongoing commitment to the partnership [1] - Heptares Therapeutics is eligible to receive option fees, exercise fees, development and commercial milestone payments, as well as tiered royalties based on future net sales of licensed projects [1]