里程碑｜博腾双载荷ADC IND成功交付，赋能下一代偶联药物研发

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双载荷ADC凭借双重杀伤机制成为下一代抗体偶联药物核心方向，但其偶联均一性、双毒素兼容性、工艺放大等环节存在极高产业化壁垒，对CDMO企业端到端的CMC能力提出严苛要求。近期，博腾一站式蛋白与偶联药物CDMO平台成功完成双载荷ADC工艺开发与GMP IND临床样品全流程交付，涵盖Payload-Linker、抗体、ADC研发、生产等核心环节，完整落地从工艺研发到注册样品放行全流程服务，全面验证了公司在蛋白与偶联药物领域成熟的产业化体系与能力。

技术攻坚，高效协同

此次双载荷ADC IND临床样品的成功交付，充分验证了博腾平台在复杂偶联药物领域的技术实力。

1. 项目执行过程中，技术团队攻克双载荷分子的定点偶联、载荷比例精准控制等核心技术难点，建立稳定的双载荷ADC制备工艺，顺利实现中试放大。

2. 依托同城一站式的服务平台，实现高效跨模块协作机制，Payload-Linker合成工艺开发与GMP生产提前对接后端偶联需求，工艺设计阶段即充分考虑后续步骤对物料质量属性的要求，抗体制备与小分子偶联无缝衔接，实现"研发-生产-后期应用"的一体化优化，有效提升开发效率与工艺稳健性。

董慧芳 博士

大分子新药研发生产中心

负责人

"我们已布局多载荷、双特异ADC等前沿偶联技术，不断迭代工艺、搭建专属产能配套，持续打造覆盖早期研发至商业化全流程服务体系。博腾大分子平台已在Payload-Linker研发生产、抗体中试放大、ADC双载荷工艺开发等方面形成技术积累，构建差异化竞争优势。"

全球布局，全流程服务

基于在蛋白偶联药物领域的持续投入与技术沉淀，博腾现已于上海闵行、上海奉贤、上海浦东、美国新泽西4处建成从研发到生产、从原料药到制剂的一站式研发生产基地，搭建覆盖单/双载荷ADC的一体化CMC服务平台，形成闭环式技术能力矩阵。平台现已积累丰富的ADC、AOC类药物、有效载荷-连接子、寡核苷酸等一站式研发生产项目经验，具备覆盖多类型偶联药物的全链条服务能力。

目前，博腾蛋白与偶联药物平台可提供全面的CMC解决方案，包含多肽与寡核苷酸，Payload-Linker的制备，偶联药物成药性研究、细胞株构建、上下游工艺开发、偶联工艺开发、制剂开发、分析方法开发、原液（DS）与制剂（DP）GMP生产、稳定性研究、临床试验用药生产，以及申报所需的药学资料支持等CMC服务，能适配国内外药品注册标准。

当前全球双载荷ADC研发管线持续扩容，市场需求稳步增长。博腾将持续深耕抗体和ADC领域，以成功项目经验，通过标准化技术体系降低客户CMC研发风险，缩短临床转化周期，赋能全球创新药企加速推进候选药物临床进程，让好药更早惠及大众。

博腾股份成立于2005年，为全球药企、生物科技公司及科研机构等提供从临床前研究到药品上市全生命周期的端到端CDMO服务，涵盖小分子药物、多肽与寡核苷酸药物、蛋白与偶联药物以及细胞与基因治疗药物的原料药到制剂全流程。截至2025年末，公司拥有全球员工4300余人，累计服务客户1400余家，成功交付项目超5000个。我们始终坚持以客户为中心，致力于提供创新可靠的全球化CDMO解决方案，让好药更早惠及大众。

Dual-payload ADCs, leveraging a dual-mechanism cytotoxic effect, have emerged as a core strategic direction for next-generation antibody-drug conjugates. However, significant industrialization barriers remain in terms of conjugation homogeneity, dual-toxin compatibility, and process scale-up, imposing stringent demands on CDMOs' end-to-end CMC capabilities. Recently, Porton One-stop Biologics and Conjugates CDMO Platform successfully completed the full-cycle delivery of process development and GMP IND clinical sample manufacturing for a dual-payload ADC. The scope encompassed all critical components, including payload-linker, antibody, and ADC R&D and manufacturing, and achieved seamless execution from process development through to regulatory lot release.

This milestone comprehensively validates the maturity and robustness of Porton’s platform for biologics and conjugate-based therapeutics.

Technical Innovation Meets Seamless Integration

The successful IND delivery of this dual-payload ADC underscores the technical strength of Porton’s platform in tackling complex conjugate drugs.

1. Throughout the project, the team cracked key challenges such as site-specific conjugation of two distinct payloads and fine-tuned control over payload stoichiometry. A robust and reproducible manufacturing process was established, and pilot-scale production was successfully achieved.

2. Backed by our co-located and integrated service platform, cross-module collaboration ran smoothly and efficiently. Process development and GMP manufacturing of the payload-linker were proactively aligned with downstream conjugation requirements, with quality attribute considerations for downstream steps incorporated at the process design stage. This enabled seamless integration of antibody production with small-molecule conjugation, creating a fully coordinated workflow from R&D through manufacturing to eventual application, translating into faster timelines and greater process robustness.

Huifang Dong, Ph.D

Head of Porton Large Molecule Platform

“We have been building our capabilities in next-generation conjugation technologies, including multi-payload and bispecific ADCs. Through ongoing process optimization and dedicated capacity expansions, we are building a service framework that spans early-stage development through commercial manufacturing. Our platform has developed strong capabilities in payload-linker R&D and manufacturing, antibody pilot-scale production, and dual-payload ADC process development, forming differentiated competitive advantages.”

One-stop Platform for End-to-end CMC Services

Through sustained investment and accumulated technical expertise in biologics and conjugates drug development, Porton has established four integrated R&D and manufacturing sites across Shanghai, China (Minhang, Fengxian, Pudong) and New Jersey, USA. These facilities cover the full spectrum from drug substance to drug product, and from early development through to commercial manufacturing, offering a unified CMC service platform for both single- and dual-payload ADCs. This creates a closed-loop technology matrix with comprehensive in-house capabilities. The platform has built an extensive track record in integrated R&D and manufacturing projects covering ADCs, AOC-type drugs, payload-linkers, and oligonucleotides, with end-to-end service capacity across multiple conjugate drug modalities.

Today, Porton Biologics and Conjugates Platform offers comprehensive CMC solutions spanning peptides and oligonucleotides, payload-linker synthesis, conjugate drug developability studies, cell line development, upstream and downstream process development, conjugation process development, formulation development, analytical method development, drug substance and drug product GMP manufacturing, stability studies, clinical trial material production, and regulatory CMC documentation compliant with global drug registration standards.

As the global pipeline of dual-payload ADCs continues to expand and market demand steadily grows, Porton remains committed to strengthening its antibody andADC capabilities. Leveraging its proven track record and standardized technical frameworks, Porton aims to reduce CMC-related development risks for its clients and shorten clinical translation timelines. Porton enables innovative biopharma and biotech companies worldwide to accelerate their drug candidates into the clinical phase, advancing the mission of enabling earlier access to good medicines.

Founded in 2005, Porton Pharma Solutions provides end-to-end CDMO services from pre-clinical to commercial stages. Our capabilities span Small Molecules, TIDES, Biologics and Conjugates (ADCs, AOCs, DACs, PDCs, RDCs, etc.), and Advanced Therapy Medicinal Products, from drug substance to drug product. As of 2025, Porton has over 4,300 employees globally, served more than 1,400 customers, and delivered over 5,000 projects. We are committed to a customer-centric approach, delivering innovative and reliable global CDMO solutions, enabling earlier access to good medicines.

(博腾股份 动态宝)