Ulenistamab

Prestige Biopharma, a leading Singapore-based biopharmaceutical company specializing in antibody therapeutics, announced on November 26, 2025, a significant step in its international expansion strategy via an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina. 新加坡领先的生物制药公司 Prestige Biopharma 专注于抗体治疗，于2025年11月26日宣布通过与总部位于阿根廷布宜诺斯艾利斯的生物技术公司 Biosidus 达成独家许可和供应协议，在其国际扩展战略中迈出了重要一步。This agreement centers on the commercialization of Tuyznue® (trastuzumab), Prestige's flagship biosimilar product, across key Latin American markets—a collaboration poised to widen access to affordable therapies in oncology and highlight Asia's rising influence in global biopharma partnerships.. 该协议重点关注在主要拉丁美洲市场商业化推广 Prestige 的旗舰生物仿制药产品 Tuyznue®（曲妥珠单抗），这一合作旨在扩大肿瘤学领域可负担疗法的获取渠道，并彰显亚洲在全球生物制药合作中日益增长的影响力。Tuznue® is a biosimilar version of Herceptin® (trastuzumab), a well-established treatment for HER2-positive metastatic and early breast cancer, as well as metastatic gastric cancer. Having obtained European Commission (EC) marketing authorization in September 2024, Tuznue® stands at the forefront of Prestige Biopharma's biosimilars portfolio, aiming to offer cost-effective yet high-quality therapeutic alternatives for cancer patients globally. Tuznue® 是 Herceptin®（曲妥珠单抗）的生物类似药版本，Herceptin® 是一种已被广泛认可的用于治疗 HER2 阳性转移性及早期乳腺癌和转移性胃癌的药物。在 2024 年 9 月获得欧盟委员会 (EC) 的上市许可后，Tuznue® 成为 Prestige Biopharma 生物类似药产品组合中的前沿产品，旨在为全球癌症患者提供高性价比且高质量的治疗替代方案。This partnership enables Biosidus to exclusively market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, using its extensive regional commercial network and expertise in biosimilar adoption.. 该合作使 Biosidus 能够利用其广泛的区域商业网络和在生物仿制药采用方面的专业知识，独家在阿根廷、墨西哥、玻利维亚和巴拉圭营销和分销 Tuznue®。Under the agreement, while Prestige Biopharma will be responsible for the manufacture of the drug substance at its EU-GMP-certified and technologically advanced facility, Biosidus will localize the final drug product manufacturing in Buenos Aires. The product will not only address local demand but also serve as an export supply hub for broader Latin American markets, ensuring efficient and compliant distribution. 根据协议，虽然Prestige Biopharma将负责在其欧盟GMP认证且技术先进的设施中生产药物原料，但Biosidus将把最终药物产品的生产本地化在布宜诺斯艾利斯。该产品不仅将满足当地需求，还将作为更广泛的拉丁美洲市场的出口供应中心，确保高效且合规的分销。This partnership also demonstrates how Asian biopharma manufacturers are leveraging robust manufacturing capabilities and international regulatory experience to drive biosimilar access in emerging economies—a strategy that is increasingly relevant amid intensified global competition and regulatory complexity in the biosimilars segment.. 这种合作关系还展示了亚洲生物制药制造商如何利用强大的生产能力与国际监管经验，推动新兴市场中的生物类似药的普及——在生物类似药领域全球竞争加剧和监管复杂性增加的背景下，这一战略日益重要。The CEOs of both companies expressed confidence that this collaboration would enrich their biosimilars portfolios, boost regional market access, and ultimately expand healthcare choices for clinicians and health authorities. Lisa S. Park, CEO of Prestige Biopharma, highlighted Biosidus's proven track record and deep regional understanding as critical success factors, aiming for seamless product adoption and lifecycle management in new markets. 两家公司的首席执行官均表示，相信此次合作将丰富他们的生物仿制药产品组合，提升区域市场准入，并最终为临床医生和卫生当局扩大医疗选择。 Prestige Biopharma首席执行官Lisa S. Park强调了Biosidus经过验证的业绩记录和深厚的区域理解是关键的成功因素，旨在新市场中实现无缝的产品应用和生命周期管理。Similarly, Mariano Elizalde, CEO of Biosidus, noted that the agreement strengthens the company’s commitment to quality and affordability.. 同样，Biosidus首席执行官马里亚诺·埃利萨尔德指出，该协议加强了公司对质量和可负担性的承诺。Tuznue® has undergone rigorous regulatory review to demonstrate equivalence in safety, efficacy, and immunogenicity to the original reference product. Its inclusion in national cancer treatment programs is expected to accelerate as health systems in Latin America seek to optimize budgets while maintaining care standards. Tuznue® 已经过严格的监管审查，证明其在安全性、有效性和免疫原性方面与原始参比产品具有等效性。随着拉丁美洲的卫生系统寻求在保持护理标准的同时优化预算，Tuznue® 有望加速被纳入国家癌症治疗计划。The agreement's framework combines Prestige Biopharma's experience in biologics manufacturing with Biosidus’s market access infrastructure, exemplifying cross-border collaboration and knowledge transfer, increasingly characteristic of Asia-LATAM biopharma expansion efforts. This model offers valuable insights for pharma executives seeking to address both regulatory and commercial challenges in emerging markets, emphasizing the necessity for partnerships grounded in technology sharing, regional compliance, and end-to-end supply chain management.. 该协议的框架结合了Prestige Biopharma在生物制品制造方面的经验与Biosidus的市场准入基础设施，体现了跨境合作和知识转移，这是亚洲-拉丁美洲生物制药扩张行动中日益显著的特征。这一模式为制药业高管提供了宝贵的见解，帮助他们应对新兴市场的监管和商业挑战，同时强调了基于技术共享、区域合规及端到端供应链管理的合作的必要性。Established in 2015, Prestige Biopharma continues to advance a diversified pipeline, including first-in-class antibodies and biosimilars targeting blockbuster drugs. Its PAUF-based antibody drug, ulenistamab, has received orphan drug and fast-track designations from the U.S. FDA, EMA, and Korean MFDS, with clinical trials spanning the United States, Europe, and Asia. 成立于2015年的Prestige Biopharma不断推进多样化的研发管线，包括首创抗体和针对重磅药物的生物类似药。其基于PAUF的抗体药物乌勒尼司他单抗（ulenistamab）已获得美国FDA、欧洲EMA和韩国MFDS的孤儿药和快速通道资格，临床试验覆盖美国、欧洲和亚洲。Biosidus, with over 42 years of experience, has built a reputation in Latin America and other emerging markets for developing and producing high-quality, affordable biopharmaceuticals—a background that complements Prestige Biopharma’s ambitions for biosimilar leadership.. 拥有超过42年经验的Biosidus在拉丁美洲和其他新兴市场建立了声誉，致力于开发和生产高质量、价格合理的生物制药——这一背景与Prestige Biopharma在生物仿制药领域的领导抱负相辅相成。This alliance signals the growing trend of Asia-headquartered biopharma companies forming strategic ties with international partners, leveraging scientific innovation and manufacturing excellence from Asia to support emerging markets worldwide. As more Asian biosimilars achieve regulatory milestones and roll out through local partnerships, the broader business lesson centers on the importance of global reach, agility in regulatory navigation, and alignment with regional partners who possess nuanced market intelligence and established supply chains.. 这一联盟标志着总部位于亚洲的生物制药公司与国际合作伙伴建立战略联系的趋势日益增强，利用亚洲的科学创新和制造优势来支持全球新兴市场。随着越来越多的亚洲生物类似药通过本地合作实现监管里程碑并推出上市，更广泛的商业经验集中在了全球化覆盖的重要性、在监管导航中的敏捷性，以及与拥有细致市场情报和成熟供应链的区域伙伴保持一致。For the B2B audience—including pharma executives, drug manufacturers, and R&D strategists—this development underscores how cross-regional licensing deals and technology transfer agreements remain pivotal tools for expanding biosimilar access and driving growth outside core Asian territories. It also illustrates how next-generation biosimilars can be commercialized through collaborations that balance rigorous quality controls and regionally attuned market approaches, setting a template for future Asia-led biopharma expansion.. 对于包括制药企业高管、药物制造商和研发战略家在内的B2B受众，这一进展凸显了跨区域许可协议和技术转让协议在扩大生物类似药的可及性以及推动核心亚洲地区以外的增长方面仍然是关键工具。同时，这也展示了下一代生物类似药如何通过协作实现商业化，这些协作在严格的质控与因地制宜的市场策略之间取得平衡，为未来亚洲主导的生物制药扩张树立了模板。