Heavyweight deals from Hengrui, Abo, and others: How can CMC protect commercial success? 2026BPD Chengdu session breaks it down.

At the end of 9, innovative drugs going global made headlines one after another. On 9/29,Hengrui MedicineandNovo NordiskSecured a licensing agreement to grant the exclusive global rights (excluding Greater China) for HRS-1, an oral GLP-1596/GIP dual receptor agonist with potential for once-weekly dosing, to the buyer. The deal is valued at up to $26 billion, consisting of an upfront payment of $3 billion plus up to $23 billion in development, regulatory, and commercialization milestones. Although clinical trials have not yet begun, the buyer has already secured the global market. The industry is excited not only by the deal size but also by the strategic focus: oral GLP-1 represents one of the most challenging formulation technologies globally.

Covering multiple directions including going global and internationalization, pre-production for formulation development, innovative therapies and CMC, quality and production management, with special guestsAstraZenecaAnnounce a strategic investment of $0 billion in Summit Therapeutics and lead the initiative.AkesoClinical study of Ivonescimab combined with its CLDN18.2 ADC (Sone-Ve) for multiple gastrointestinal tumors. This is not a simple financial subscription; multinational giants are betting on the conjugation technology, comparability, and global commercial synergy behind the "immunotherapy 2.0+ADC" combination."

10 2,AbbVie and NovartisSecures $0 billion deal: Novartis pays $1 upfront to lock in global exclusive rights to ABO2, an mRNA-encoded T-cell engager from Aibo, and gains exclusive option to develop other potential projects based on its RNA platform.

Three transactions spanMetabolism、Tumor Immunology、mRNAThree distinct tracks, each with its own shape, yet all pointing to the same question:The molecule has been signed off. Can the process keep up?

Data from the National Medical Products Administration shows that this year, total deal values for licensed innovative drugs have surpassed $0 billion, up by 1% year over year. Deals are becoming increasingly frequent, yet industry attention is shifting to a more practical issue:Once signed, can the drug be manufactured on time, to quality standards, and in compliance with overseas regulatory requirements?

Molecules are easy to source; processes are hard to perfect.

Molecules are easy to find; processes are hard to perfect. From once-weekly oral GLP-1 and ADC conjugation with comparability, to scalable CGT manufacturing—every step hinges on process excellence.For overseas buyers, CMC and production capacity are now standard requirements in due diligence checklists.The fact that down payments exceed $10 billion and major deals are frequently closing also shows that buyers are willing to pay a premium for process certainty.

At the same time, domestic regulators are elevating process oversight: Order No. 818/828 took effect in 5, solidifying a dual-track approach for CGT where "technology follows 818" and "drugs follow 828". In 7, the CDE released guidance on classifying cell and gene therapy drugs to clearly delineate boundaries between standardized pharmaceuticals and personalized technologies. In 9, the National Health Commission further emphasized that in-house testing capability is a key indicator of an institution's technical strength and quality assurance.The faster the clinical progress, the heavier the burden on process and quality control.

On-site CMC Dissection and Commercialization Pathway

This is precisely2026BPD Chengdu Biopharmaceutical Process Development Conferencekey highlights. The conference will be held at11 5-6InHyatt Place Chengdu Bio-CityGrandly hosted with special guests invited on-site2000+Audience,70+Speaker. Forum agenda coversCore pain points and bottlenecks on the path to global expansionFrom ADC comparability and quality control, large-scale production of GLP-1 peptides, and CGT process development to technology transfer and segmented outsourcing, FDA inspections, dual submissions in the U.S. and China, and AI-driven commercial manufacturing—each topic is dissected by process leaders and battle-tested experts from top companies. These are precisely the items on your delivery checklist for the next phase of global expansion.

2026BPD Chengdu-related forum agenda

Schedule updated through 9/29

Masterclass

Report: Contamination Control Strategy for Biological Products and Inspection Deficiencies

Guest: Hongyu Tan, a senior domestic pharmaceutical GMP expert and former core inspector at CFDI.

ADC Manufacturing Process and Quality Control

Report: Comparative Study of ADC

Guest: Qu Yaocheng, Vice Director of Quality Control Department, Sinopharm Crosslink

Report: Key Considerations for ADC Special Quality Control Strategies, Hardware Facilities, and Workshop Layout (Draft)

Guest: Professor Park, former head of the Drug GMP Inspection Team at the National Medical Products Administration

Report: Iterative CMC Strategy Overcomes Scale-Up Challenges for Next-Generation Conjugate Drugs

Guest: Hongbin Song, Senior Director of ADC CMC at Innovent Biologics

Report: Quality Research and Control Strategy for XDC Drugs

Guest: Xu Ying,皓元医药 (Hao Yuan Pharmaceutical), Director / Head of ARD

Report: Analytical Characterization Challenges for Complex Molecules (ADCs, Bispecific Antibodies, and Fusion Proteins)

Guest: Mingze Sun, CMC Director at Tian Guangshi Biotech

Innovative R&D and Scalable Production of Peptide Drugs

Report: CR059: Long-acting Efficacy Study of Circular RNA Encoding GLP-1 Analog

Guest: Peiya, Chief Director of Early Drug R&D at PegBio

Report: Engineering of Metabolic Peptides

Guest: Nie Yunyu, Chief Scientist of Metabolic Peptide Engineering at Innovent Biologics

Report: Formulation Development Direction (Tentative)

Speaker: Yang Fengyun, Director of Formulation Development, Gansun Pharmaceutical

Report: Super-Scale Production of GLP-1 Class Peptide Drugs (Provisional)

Guest: Liu Hedong, Senior Manager of Microbial Process Development Platform & Hengqin Early Development Platform, Federal Biotech

Interview: CMC and Industrialization of Peptide Drugs: Scale-up, Quality Control, and Global Compliance

Guest: Fan Jun, Vice President of CMC R&D Center, MacroCap

Commercialization of Biologics Manufacturing

Report: Segmented Contract Manufacturing of Biological Products (Provisional)

Guest: He Yanchao, Simcere Pharmaceutical Group, Head of Quality/Qualified Person

Report: Key Success Factors for Technology Transfer (Provisional)

Guest: Li Hongcheng, Director of Upstream Process Development, Sinopharm Jinke

Report: Key Elements and Best Practices for Pre-Market Commercial Manufacturing in Biopharmaceuticals

Guest: Yang Shiming, Director of Production, Chubb Bio

Report: Mass Production Reshapes the Global Bio-Manufacturing Landscape

Guest: Biotree Biopharmaceuticals

Regulations and On-site Verification

Report: Scientific Oversight, Innovation-Driven Drug Development

Guest: Ran Zhang, Beihe Kangcheng, Chief Regulatory Advisor

Report: IND Strategy for Simultaneous Submission in China and the United States

Guest: Lei Juan, Registration Director, Hansi Aite

Report: New Drug Clinical Application Direction

Guest: Chen Yangqi, Chengdu Xuyuan Biology, COO

AI-Enabled CMC Development for Biopharmaceuticals

Report: Study on AI Digitalization, Compliance, and Business Impact

Guest: Ma Jun, former Vice President of Junshi Biosciences

Report: AI-Enabled Biopharmaceutical CMC and Regulatory Considerations

Guest: Dongqiang Lin, Zhejiang University, Professor

Interview: Building Smart Factories

Guest: Zhang Hong, Senior Director of Digital Development Center for Human Drug Formulations, Qilu Pharmaceutical

AI-Driven Commercial Biopharmaceutical Manufacturing

Report: Digital Transformation of Biopharmaceutical Manufacturing:

Henlius: Practices and Insights

Guest: Wei Gong, General Manager of ADC Development and Clinical Manufacturing at MacroGenics

Report: The Path and Practice of Digital Intelligence Advancement for Pharmaceutical Enterprises

Guest: Zhu Xiaofeng, Deputy General Manager of the Intelligent Data Department, China Resources Double Crane

Innovative CGT Therapy Process Development and Scalable Manufacturing

Report: Key Points for CGT Manufacturing Inspection

Guest: Teacher Tu, Regulatory Expert

Platform: The World's First Dual-Plasmid Gene Therapy Drug Development Platform

Guest: Chen Lijing, COO/VP of Jinweike Bio

Interview: Process Scale-Up Strategies and Quality Control Challenges for CGT Products Under a Dual-Track System

Guest: Tan Binghe, Bonyo Bio, CTO

Yao Shuyuan

Report: Best Practices for Quality Control Standards of Clinical Extracellular Vesicles

Guest: Yang Shuangshuang, Research and Development Manager, Qilu Cell Therapy

Report: Closed Automated Stem Cell Production

Guest: Wu Shouliang, Deputy Director of Production Technology at Sino-Union

Youth in Action

Interview: The Evolution of CMC Across Stages – From Technical Challenges to Commercial Success

Moderator: Tang Defang, Vice President of Jingze Bio

Guest: Ran Gugu, Salubris (Chengdu), Director of Project Management

Song Qingguo, Founder of Guanlan (Hong Kong) Medicine