Remetinostat

On October 31, 2025, Pfizer announced a significant licensing agreement with SBio for the exclusive development, manufacturing, and commercialization of SSGJ, an advanced bispecific antibody targeting PD-1 and VEGF, across markets in Asia, excluding China. This collaboration marks a strategic milestone in the expansion of immuno-oncology therapies throughout the Asian pharmaceutical landscape. 2025年10月31日，辉瑞宣布与SBio达成重要许可协议，获得SSGJ在亚洲市场（不包括中国）的独家开发、生产和商业化权利。SSGJ是一种先进的双特异性抗体，靶向PD-1和VEGF。此次合作标志着免疫肿瘤治疗在整个亚洲制药领域扩展的战略性里程碑。As the demand for combination and next-generation biologic treatments escalates, both companies have positioned this partnership to specifically address the rapidly evolving regulatory landscape, local R&D synergies, and manufacturing infrastructure needed for successful commercialization and patient access in diverse Asian economies.. 随着对联合治疗和下一代生物治疗的需求不断攀升，两家公司都已将此合作定位为专门应对快速演变的监管环境、本地研发协同效应以及在不同亚洲经济体中成功实现商业化和患者获取所需的制造基础设施。The agreement assigns Pfizer exclusive rights to utilize SBio’s scientific and IP portfolio leveraged around SSGJ, with clinical development plans tailored to the regulations and market dynamics of priority Asian nations. This transaction not only consolidates Pfizer’s immuno-oncology pipeline for the region but also expedites SBio’s ambition to bring innovative antibody therapeutics beyond its home market. 该协议赋予辉瑞公司独家权利，以利用SBio围绕SSGJ建立的科学和知识产权组合，临床开发计划则根据优先亚洲国家的法规和市场动态量身定制。此项交易不仅巩固了辉瑞在该地区的免疫肿瘤学产品线，还加速了SBio将其创新抗体疗法推广至本土市场之外的雄心。SSGJ, which engages both PD-1 (programmed death protein 1) and VEGF (vascular endothelial growth factor) at the molecular level, is among a new generation of immunotherapies designed to enhance anti-tumor efficacy through dual-pathway inhibition. Bispecific antibodies, capable of simultaneously engaging multiple immune checkpoints and angiogenic factors, represent a fast-growing segment in biopharma R&D, particularly in Asian markets where new regulatory frameworks support accelerated review pathways.. SSGJ是一种在分子水平上同时作用于PD-1（程序性死亡蛋白1）和VEGF（血管内皮生长因子）的新一代免疫疗法，旨在通过双通路抑制来增强抗肿瘤效果。双特异性抗体能够同时靶向多个免疫检查点和血管生成因子，是生物制药研发中增长最快的领域之一，尤其是在亚洲市场，新的监管框架支持加速审评路径。Under the agreement, SBio will retain the rights to the Chinese market, while Pfizer will undertake regulatory filings, clinical development, and manufacturing for the rest of Asia. The collaboration’s structure addresses a recent trend: the strategic exclusion of China from certain multi-nation biopharma deals, reflecting ongoing complexities in Chinese IP, regulatory, and market environments. 根据协议，SBio将保留对中国市场的权利，而辉瑞将负责亚洲其他地区的监管申报、临床开发和生产。该合作的结构应对了一个近期的趋势：在某些多国生物制药交易中战略性地将中国排除在外，这反映了中国在知识产权、监管和市场环境方面的持续复杂性。Both partners anticipate the opportunity to leverage real-world data and clinical network resources to support regional Phase II/III trials, including Japan, South Korea, Taiwan, Southeast Asia, and India, reflecting the need for robust pan-Asian efficacy and safety evidence for approval and reimbursement.. 双方都期待利用真实世界数据和临床网络资源，支持包括日本、韩国、台湾、东南亚和印度等区域的II/III期试验，这反映出获得批准和报销所需的强有力的泛亚疗效和安全性证据的需求。This agreement is indicative of the overall trend in Asian pharma strategy, where leading multinational corporations seek to deepen their regional portfolios by accessing advanced development-stage biologics through licensing. For Pfizer, the addition of SSGJ aligns with its goal of becoming a central innovator in targeted immunotherapies in Asia, supplementing its extensive presence in vaccines, rare diseases, and existing oncology therapies. 该协议体现了亚洲制药战略的总体趋势，即领先的跨国公司寻求通过许可方式获取处于开发阶段的先进生物制品，以加深其区域产品组合。对辉瑞而言，SSGJ的加入符合其成为亚洲靶向免疫疗法核心创新者的战略目标，补充了其在疫苗、罕见病和现有肿瘤治疗领域的广泛布局。For SBio, partnering with a global powerhouse provides the financial resources, regulatory savvy, and commercial scale needed to optimize SSGJ’s reach and impact outside China, further validating its antibody engineering platform’s value proposition.. 对于SBio来说，与全球巨头合作提供了优化SSGJ在中国以外的覆盖范围和影响力所需的财务资源、监管智慧和商业规模，进一步验证了其抗体工程平台的价值主张。From a manufacturing perspective, the deal encompasses technology transfer, scale-up of cell lines, process validation, and compliance with the latest cGMP standards in Pfizer’s established Asian facilities. Special attention is being paid to supply chain resilience, quality control, and region-specific requirements for cold chain logistics and QA documentation. 从制造的角度来看，该协议涵盖了技术转让、细胞系的规模化、工艺验证以及在辉瑞成熟的亚洲设施中遵守最新的cGMP标准。特别关注供应链弹性、质量控制以及针对特定地区的冷链物流和质量保证文件的要求。Regulatory teams from both parties have signaled intent to work closely with local authorities—such as Japan’s PMDA, South Korea’s MFDS, and India’s CDSCO—to align the clinical trial and regulatory submissions with each country’s specific guidelines for innovative biologics. Post-approval, Pfizer expects to initiate broad regional commercialization within two years of filing, prioritizing cancer indications with the highest unmet medical needs and leveraging digital health partnerships to accelerate provider and patient uptake.. 双方的监管团队都表示有意与当地监管机构——如日本的PMDA、韩国的MFDS和印度的CDSCO——密切合作，使临床试验和监管申报符合各国针对创新生物制品的具体指导方针。在获批后，辉瑞预计将在递交申请的两年内启动广泛的区域性商业化，优先考虑医疗需求未得到满足的癌症适应症，并利用数字健康合作伙伴关系加快医生和患者的采用速度。Industry analysts view the Pfizer-SBio licensing deal as exemplary of a larger wave of Asia-centric B2B collaborations in bio pharma, as companies seek to capitalize on regional scientific capacity, accelerating regulatory harmonization, and unmet need in oncology. With billions invested in Asian clinical trial infrastructure and local manufacturing, such partnerships are increasingly necessary to deliver cutting-edge therapies at scale. 行业分析师认为，辉瑞与SBio的许可协议是生物制药领域以亚洲为中心的B2B合作浪潮的典范，因为企业希望利用区域科学能力、加速的监管协调以及肿瘤学中未满足的需求。随着数十亿美元投资于亚洲临床试验基础设施和本地制造，此类合作伙伴关系对于大规模提供前沿治疗变得越来越必要。As Asian pharmaceutical markets grow ever more critical to global revenue strategies, agreements like this are poised to shape the next decade of biopharma innovation and patient impact.. 随着亚洲医药市场对全球收入战略变得越来越重要，像这样的协议将塑造生物制药创新和患者影响的下一个十年。

每一座城市都能成为创新的土壤。从长江之滨到莱茵河畔，从太平洋岸到日内瓦湖边——药明康德的足迹，正与世界的城市一同成长。 在10月31日世界城市日这一天，我们不仅庆祝城市的繁荣与多样，更希望讲述一段关于“全球连接”的故事。2000年，药明康德从一间实验室起步，如今在亚洲、欧洲和北美拥有20多个研发和生产基地，覆盖新药研究（R）、开发（D）和生产（M）的各个环节。我们为当地和全球客户提供灵活、高效和高质量的服务，赋能每个创新梦想转化为切实有效的疗法。 25年来，药明康德的发展跨越国界，跨越时区与文化，却始终恪守同样的高质量标准；如今的我们，仍在以CRDMO业务模式和极致运营，驱动自身的长期发展，也不断为客户、为创新生态圈、为全球患者创造价值。 从亚洲、北美、到欧洲，夯实CRDMO全球网络 在全球生命科学产业合作日益紧密的今天，创新的脚步从未停歇，药明康德也步履不停。 中国泰兴基地——药明康德5个原料药生产基地中最新及最大的基地，覆盖了所有合成分子类型，包括小分子、多肽、寡核苷酸及相关偶联药物。今年3月，泰兴原料药基地顺利通过美国FDA针对1款多肽创新药商业化生产进行的上市前检查（Pre-Approval Inspection），检查过程中未发现任何不符合项，标志着泰兴基地已具备面向全球市场提供原料药商业化供应的能力。 正在建设中的美国米德尔顿基地，于2022年破土动工，目前已完成建筑主体，进入内部安装阶段，预计将于2026年底前投入运营。 米德尔顿基地占地77万平方米，旨在为全球客户提供从临床前到商业化阶段的制剂开发与生产服务。一期工程将具有口服和注射制剂的研发、生产、包装、贴标和分发在内的能力，能够更好地赋能美国及全球客户。 位于瑞士库威的生产基地也在持续扩建，其中口服剂型包装产能已于2024年翻倍，喷雾干燥车间正在建设中，预计将于2026年四季度竣工，后续还将增加肠外制剂等方面的能力建设。 与此同时，在新加坡，面向未来的原料药生产基地正在加速建设，以高效与可持续为核心理念，连接亚洲与世界，为区域产业生态注入新动能。该基地于2024年初正式开工建设，计划于2027年起陆续投入运营，为小分子、寡核苷酸、多肽及复杂偶联药物提供服务。 足迹的每一次延伸，都是药明康德与城市共生共长的新篇章。近日，公司与沙特新未来城（NEOM）及沙特卫生部分别签署战略合作备忘录。药明康德将与NEOM携手合作，探索在沙特开展新药研发与生产服务的本地化进程。 此次合作为公司未来在NEOM的先进、清洁制造城市Oxagon或沙特其他地区建立世界一流的CRDMO研发及生产基地奠定了基础。药明康德将凭借其独特的专业能力与全球网络，持续推动医药创新，助力当地生物技术产业的加速发展。 此次合作汇聚了药明康德服务全球生物医药行业二十多年的深厚经验，以及NEOM在创新与可持续领域的宏伟愿景。双方将共同推动医药创新生态在中东地区的成长，并助力当地生物技术产业的加速发展。 同时，药明康德与沙特卫生部的合作将重点聚焦医药产业价值链本地化、医药人才培养及吸引外商直接投资，为区域医疗健康体系注入新动能。 精益运营，质量为基 值得一提的是，历经多年，药明康德一直承接着大量客户需求，建能力、扩规模的效率也在不断提升。 在不久前的投资者开放日活动上，公司披露，常州基地从2016年第一个车间投入使用，一期和二期共计9个车间，耗时5年完成全部建设，并投入使用。而到了三期，6个车间仅用两年时间，便投入使用。在一江之隔的泰兴基地，一期的6个车间、二期的4个车间，分别都只用了一年时间就投入使用，产能爬坡的速度越来越快。 2017年，药明康德从投入使用一个新车间，到达到满产，大约需要2年时间，而在2024年，这一数字已经缩短为两个月。“药明速度”的背后，有规模效应带来的资源调配便利、标准化培训的机制方法，也体现出药明康德文化中对极致的追求。 今年9月，泰兴基地已经提前完成多肽产能建设。公司多肽固相合成反应釜总体积目前已提升至超过10万升。 而不可忽视的是，快速建设和投产离不开以完善的质量体系作为基石。坚实的质量才能承托起卓越的运营。 今年3月，美国FDA对药明康德常州原料药基地开展了未预先通知的GMP符合性检查（又称“飞行检查”），涵盖六大GMP系统和21款已获FDA批准的产品。其结果是，FDA检查官提前一天完成所有核查，未发现任何不符合项，证明了药明康德所恪守的高质量体系，经得起随时随地的检验。 2009年以来，仅前述基地所在的药明康德化学业务平台，就成功通过了全球监管机构的审计超过140次，所支持的创新药在全球105个国家获批。得益于出色的质量记录，化学业务平台已有25次新药审批前审计得到美国FDA和欧洲EMA的豁免。 结束语 不同城市承载了药明康德不同的成长印记，他们也都是公司全球发展的缩影。广泛的布局让药明康德更贴近全球各地的客户，也让创新成果更快抵达患者。通过统一的质量体系、精益运营与极致执行，药明康德正在让科学的力量跨越地理与语言的边界，让创新真正“无界”。 从城市网络到实验室里的每一个细节，从新药发现、开发、生产，到真正惠及患者，25年来，我们不断推动创新成果快速转化，为全球客户提供全方位支持。未来，药明康德将继续聚焦一体化CRDMO业务模式，以开放合作的姿态，与城市共生，与产业共进，与各方携手，共同实现“让天下没有难做的药，难治的病”的愿景。 Connected by Science, United for Health — WuXi AppTec’s Global Footprint Innovation thrives wherever people and ideas connect. From the banks of the Yangtze to the shores of the Rhine, from the Pacific Coast to Lake Geneva, WuXi AppTec has grown alongside the world’s most vibrant cities — linking science, talent, and opportunity across continents. On World Cities Day, October 31, we not only celebrate the prosperity and diversity of cities but also share a story about global connection. Founded in 2000 with a single laboratory, WuXi AppTec now operates more than 20 R&D and manufacturing sites across Asia, Europe, and North America, covering the full spectrum of new drug Research (R), Development (D) and Manufacturing (M). Our global network enables us to provide flexible, efficient, and high-quality services to customers worldwide — helping every innovative idea transform into effective therapies. Over the past 25 years, WuXi AppTec’s growth has crossed borders, time zones, and cultures — yet we have always adhered to the same high-quality standards. Today, through our CRDMO business model and relentless operational excellence, we continue to drive sustainable growth and create value for customers, the innovation ecosystem, and patients around the world. From Asia to North America and Europe — Strengthening Our Global CRDMO Network In an era where global collaboration in life sciences grows ever closer, the pace of innovation never stops — and neither do we. At our Taixing site in China, the newest and largest among WuXi AppTec’s five API manufacturing facilities, we cover all types of synthetic molecules, including small molecules, peptides, oligonucleotides, and related conjugates. In March 2024, the site successfully passed a U.S. FDA Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic — with no observations — marking Taixing’s readiness to support commercial API supply for global markets. Across the Pacific, construction of our Middleton site in the United States — launched in 2022 — is progressing rapidly. The main structure has been completed, and interior installation is underway. Scheduled to start operation by the end of 2026, the 770,000 m² facility will provide formulation development and manufacturing services from preclinical to commercial stages. Phase I is designed for the development and manufacturing of oral and parenteral drug products, including packaging, labeling, and distribution — empowering customers in the U.S. and worldwide. In Couvet, Switzerland, expansion continues apace. Oral dosage packaging capacity has doubled in 2024, and a new spray drying workshop is under construction, expected to be completed in Q4 2026. Further investments are planned to add parenteral formulation capabilities in the future. Meanwhile, in Singapore, a next-generation API manufacturing site is taking shape — built on the principles of efficiency and sustainability to connect Asia with the world. Officially breaking ground in early 2024, the facility is expected to begin phased operations from 2027, serving small molecules, oligonucleotides, peptides, and complex conjugates. A new chapter unfolds in WuXi AppTec’s global journey of enabling innovation. Recently, WuXi AppTec has signed two strategic memoranda of understanding (MoUs) with NEOM, the sustainable region under development in northwest Saudi Arabia and the Ministry of Health of the Kingdom of Saudi Arabia (MOH). WuXi AppTec and NEOM have agreed to collaborate to explore the localization of pharmaceutical research, development and manufacturing in Saudi Arabia.  The agreement lays the groundwork for establishing world-class CRDMO facilities at Oxagon, NEOM’s advanced and clean manufacturing city, or other locations in Saudi Arabia. By leveraging WuXi AppTec’s unique expertise and global network, the initiative aims to drive innovation and accelerate the growth of the biotechnology sector in Saudi Arabia.  This partnership brings together WuXi AppTec’s decades of experience as a trusted partner to the global biopharmaceutical industry with NEOM’s commitment to fostering innovation and building a future-focused ecosystem.  The MoU offers a compelling opportunity to extend WuXi AppTec’s integrated capabilities into a market with ambitious national biotechnology goals. It also capitalizes on NEOM’s visionary approach to sustainability, innovation, and talent development.  Lean Operations, Quality as the Foundation Over the years, WuXi AppTec has continuously enhanced its capability-building and expansion efficiency — meeting a growing number of customer needs with speed and precision. At our recent Investor Day, we shared that construction of our Changzhou site has accelerated remarkably. Phase I and II — totaling nine workshops — were completed and put into operation in five years after the first plant launched in 2016. By Phase III, six plants were built and operational in just two years. Across the river at the Taixing site, Phase I (six plants) and Phase II (four plants) each took only one year to complete. In 2017, it took approximately two years for a new workshop to reach full capacity after startup; by 2024, this period has shortened to just two months. Behind this “WuXi Speed” are economies of scale, efficient resource allocation, standardized training, and a corporate culture that pursues excellence in every detail. In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule. WuXi AppTec's total reactor volume of Solid Phase Peptide Synthesizers has been increased to over 100,000L. But speed means little without quality. Robust quality systems remain the cornerstone of our world-class operations. In March 2024, the U.S. FDA conducted an unannounced GMP inspection at our Changzhou API site, following the FDA’s six-system inspection model while covering 21 FDA-approved products. The inspection concluded a day ahead of schedule, with no observations, demonstrating that WuXi AppTec’s rigorous quality system stands the test of any audit — anytime, anywhere. Since 2009, WuXi AppTec’s Chemical Business Platform alone has passed over 140 global regulatory inspections, supporting innovative drugs approved in 105 countries. Owing to this exceptional compliance record, the platform has received 25 FDA and EMA PAI waivers for new drug approvals. Conclusion Every city bears a unique mark of WuXi AppTec’s growth — each a reflection of our global journey. Our worldwide network brings us closer to customers and accelerates the delivery of innovation to patients. Through unified quality systems, lean operations, and excellent execution, WuXi AppTec is breaking the boundaries of geography and language — making innovation truly borderless. From our city network to every detail within our laboratories, from drug discovery and development to delivery to patients, we have spent 25 years enabling the fast translation of scientific breakthroughs into real-world therapies. Looking ahead, WuXi AppTec will continue to focus on our integrated CRDMO model, embracing open collaboration — co-growing with cities, advancing with industries, and working hand in hand with partners around the world to fulfill our vision:“ every drug can be made and every disease can be treated.” 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新