Meeting Agenda

Forum Agenda

Empower Innovative Oncology Pipelines, Unlock Global Core Value of Early-Stage Clinical Assets

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Meeting time: morning of July 22nd

 

Session 1: Accelerating Global Value Realization of Novel Therapy Pipelines in Early-Phase Clinical Trials

 

Paradigm Shift in R&D: Early-phase oncology R&D has moved beyond traditional cytotoxic agents and entered the era of complex innovative therapies, including next-generation ADCs, T-cell engagers, trispecific antibodies, and cell and gene therapies (CGT).

 

Regulatory and Design Evolution: Global regulatory frameworks, exemplified by FDA's Project Optimus, are continuously raising the bar for first-in-human (FIH) trial standards. Conventional, rigid Phase I trial designs are increasingly inadequate for novel therapeutic modalities, exposing pipelines to unnecessary R&D risks and potentially undermining early-stage asset valuation.

 

Innovative Clinical Development Systems: Leveraging adaptive, biology-driven dose-finding models such as BOIN and mTPI to replace the traditional MTD-based approach. Combined with platform or umbrella master protocols to rapidly generate early efficacy signals across multiple tumor types, and biomarker-driven strategies to bridge preclinical data with patient selection.

 

Refined Medical Risk Management: Targeted medical monitoring to address modality-specific toxicities including CRS, ICANS, and on-target/off-tumor effects. Partnering with globally recognized investigators and specialized Phase I clinical centers to ensure trial safety and data quality.

 

Global Asset Value Enablement: Supporting Chinese biopharma companies in conducting multi-regional clinical trials (MRCT) to generate compliant, high-quality global clinical data, thereby facilitating out-licensing, M&A transactions, and other commercial pathways. An open Q&A session will be available to address company-specific development and protocol challenges.

 

Session 2: Unlocking Global Commercial Value of Early-Stage Oncology Pipeline Assets

 

R&D Challenges and Value Construction: An in-depth analysis of the core challenges in early-phase clinical development of novel anti-tumor drugs, identifying key value-shaping factors tailored to different innovative therapeutic modalities. Grounded in the global regulatory landscape, this session provides actionable guidance for early-stage R&D decision-making.

 

Market and Valuation Positioning: Assessing the core value drivers of early-stage oncology assets in the context of the global biopharmaceutical competitive landscape, with a focus on aligning with globalization-driven commercial strategies.

 

Practical Development Strategies: Deconstructing real-world case studies—both monotherapy and combination therapy—to extract validated methodologies and key learnings that can accelerate clinical development and enhance asset valuation.

 

Regional Innovation, Global Upgrade: Focusing on early-stage assets originating from the Asia-Pacific region, this session outlines critical optimization measures to help biotech companies strengthen their global clinical data packages and comprehensively enhance the international competitiveness and worldwide value of their assets.

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