Archives: Agenda

• How to build a “Predict and Prevent” Supply Mindset
• Dynamic Re-supply Models for a Dynamic Clinical Reality
• A Step-by-Step Guide to Smoother Cross-Border Movements
• Rapid Response Protocols and Effective Contingency Planning
• Integrating Partners into a Single, Seamless Team

• 如何建立“预测并预防”的供应思维。
• 面向动态临床现实的动态补货模型。
• 更顺畅跨境运输的分步指南。
• 快速响应流程与有效的应急规划。
• 将合作伙伴整合为一个无缝协作团队。

Moderator: Jae-Young Ha, CBO, AriBio

下午茶歇及交流

下午茶歇及交流

• Leveraging China’s integrated research, healthcare, and technology networks to accelerate development
• How scale, speed, and digital innovation are reshaping global clinical trial execution
• Translating local operational excellence into global study success
• Less on drug supplys multinational sponsors can apply from China’s evolving clinical ecosystem

• 借助中国一体化的科研、医疗和技术网络加速开发。
• 规模、速度与数字化创新如何重塑全球临床试验执行。
• 将本土运营卓越转化为全球研究成功。
• 跨国申办方可从中国不断演进的临床生态中借鉴的经验。

Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient’s bedside.
抗体偶联药物（ADC）和双特异性抗体（BsAb）代表了靶向肿瘤治疗的前沿。ADC 结构（连接子、抗体、载荷）的精密平衡，以及 BsAb（两个不同结合结构域）的复杂组装，对从产线到病床的每一个物流环节都提出了前所未有的挑战。

• Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
• Strategies from Point-of-Manufacture to Global Distribution
• How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
• Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
• Leveraging China’s Mature Biologics Supply Chain Ecosystem

• 识别 ADC 与 BsAb 供应链中的关键节点
• 从生产端到全球配送的策略
• 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
• 剂量递增与生物标志物驱动患者分层的动态策略
• 借力中国成熟的生物制品供应链生态

• AI as Digital Workforce: Automating Clinical Operations and Intelligent Data Quality Control under ICH E6(R3)
• From Pain Points to Solutions: DCT Application & Landing Practice

• AI 作为数字化劳动力：在 ICH E6(R3) 框架下实现临床运营自动化与智能数据质量控制。
• 从痛点到解决方案：DCT 应用与落地实践

Moderator: Suqin Xia, Founder, DCT Academy

• Proof of concept established: 2.5-year follow-up data for OTOF gene therapy demonstrate that inner-ear gene therapy is safe, effective, and delivers predictable therapeutic outcomes.
• The target-to-IND pathway is mature: parallel workflows + a dense CRO/CDMO ecosystem + an integrated CRDMO model enable China to move from discovery to IND 50–70% faster than the global norm.
• Supply chain readiness determines successful delivery: cold-chain logistics, potency testing, and end-to-end regulatory compliance systems (NMPA/QMS) are critical to the scaled delivery of cell and gene therapies (CGT).
• Structural advantage: national strategic tailwinds + partners’ end-to-end delivery capabilities help Chinese companies such as Euhearing Therapeutics accelerate CGT implementation.

• 概念验证已成立: OTOF 基因治疗 2.5 年随访数据证明内耳基因治疗安全、有效且疗效可预测。
• 从靶点到 IND 已成熟: 并行化工作流 + 密集 CRO/CDMO 生态 + CRDMO 一体化,使中国「发现→IND」周期比全球快 50–70%。
• 供应链就绪决定落地: 细胞与基因治疗(CGT)的冷链、效价与全程监管链(NMPA/QMS)是规模化交付的关键。
• 结构性优势:国家战略红利 + 合作伙伴端到端交付，有助于以佑音医药等为代表的中国企业加速 CGT 落地。

Chinese biotech is moving faster than ever from innovation to global ambition — but the challenge now goes beyond developing a differentiated asset. It’s proving that asset’s value early, generating globally credible clinical data, and reaching the right international partners before momentum fades. Drawing on real-world case studies, this session examines how delays at proof-of-concept erode value, how regulatory and operational efficiency compress development timelines, and how Chinese biotechs can expand globally without slowing execution. Attendees will gain practical insight into how faster PoC, stronger patient access, efficient global trial deployment, and high-quality international data strengthen partnering discussions and make assets more attractive to global pharma.

中国生物医药产业正以前所未有的速度从“本土创新”迈向“全球雄心”。然而，企业如今面临的挑战已不仅限于研发具有差异化的资产，更在于如何在早期证明资产价值、生成具备全球公信力的临床数据，并在市场热度消退前精准对接国际合作伙伴。本议程将结合真实世界案例研究，深入探讨概念验证（PoC）阶段的延迟如何侵蚀资产价值、如何通过提升监管与运营效率来压缩研发周期，以及中国药企如何在不牺牲执行速度的前提下实现全球化扩展。参会者将获得极具实用价值的行业洞察，明确如何通过加速PoC进程、强化患者招募、高效部署全球临床试验以及获取高质量国际数据，来增加商务谈判筹码，从而让管线资产对跨国药企（Global Pharma）更具吸引力。