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。