Peptide Innovation Drug Developer

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http://gzw.sc.gov.cn/scsgzw/CU23020302/2025/8/13/8a9421fd3eba4db2bf1cffbd836220bc.shtml;
JIUDIAN PHARMACEUTICAL, etc.

In recent years, the global new drug research and development industry is undergoing unprecedented changes and opportunities. With the rapid rise of China's innovative pharmaceutical companies, "going global" has become a key term in the industry. Local enterprises are promoting their innovative pipelines to the global market through international cooperation, showcasing the international competitiveness of China's pharmaceutical innovation. Frontier fields such as ADCs, peptides, and GLP-1 drugs are booming, becoming hotspots for capital and R&D focus. However, the industry still faces many challenges: How to optimize clinical trial designs to meet FDA review standards? How to overcome bottlenecks in CMC (Chemistry, Manufacturing, and Control) processes? How to build a differentiated innovative pipeline amidst fierce international competition?
Themed with "Decoding the Innovation Map of Pharmaceuticals for the Next Decade," this conference gathers top experts, business leaders, and regulatory representatives from both within and outside China. Focusing on core fields such as ADCs, peptides and GLP-1, and small molecule drugs, it provides an in-depth analysis of industry trends and practical experiences, spanning from target discovery, clinical design, process development to regulatory strategies.
◈Main Forum:Looking Forward to the Global Development Path of China's Innovative Drugs;
◈Clinical and Regulatory Session:In-depth Analysis of FDA Review Logic: How to Gain Market Advantage with Differentiated Clinical Data
◈Process and CMC Challenges:Sharing Practical Solutions for Cost Reduction and Efficiency Improvement in CMC Challenges of Small Molecules, Peptides, and ADCs
◈Face to Face with Experts:Sincerely invite field experts to explore multi-dimensional cooperation opportunities.

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Proposed Agenda
- DAY1 -
ADC Global :
Decoding the Map of Drug Innovation for the Next Decade
·XDC 2.0 Era: The Technological Leap from ADC to Multimodal Conjugated Drugs
· XDC+AI: The Synergy and Boundaries of Disruptive Technologies
· China's Innovative Drug "Going Global 2.0 Era"
· ADC and Bispecific Antibodies: The New Golden Track of Global Drug R&D
· 2025 BD Major Events Review and the Next BD Trend
· NewCo and BD Going Global for ADC Drugs
· Preclinical Research of ADC Drugs
· Indications Selection for Next-Generation ADC Drugs
· Application of Organoids in XDC Development
· Emerging Targets in Tumor/Non-tumor Fields
· Challenges in Scaling Up Conjugation Processes
· Case Sharing of Early Clinical Trial Design for ADC Drugs
· Design and Implementation Strategies for Global Multicenter Clinical Trials
· Regulatory Requirements and Differences for Clinical Trials in Different Regions
· FDA Expert Explains How to Efficiently Advance Global Clinical Trials
· Multicenter Clinical Trial Monitoring and Coordination Strategy
· Key Focus Points in Clinical Trial Data
· Panel: How to Improve FDA's Acceptance and Trust in Clinical Data from China?
· Trends in Peptide and GLP-1 Drug Development: Multi-targeting and Indication Expansion
· Expansion of Non-Oncology Indications for PDC Peptide-Drug Conjugates
· Next-Generation GLP-1 and Weight Loss Drug Innovation and Development
· Development of Novel Peptide-Conjugated Drugs
······
· Innovative Technology-Driven Development of Next-Generation Small Nucleic Acid Drugs
·Small Nucleic Acid Drug Delivery Systems and Clinical Progress
·Research and Development of Small Nucleic Acid Drugs for Nervous System Diseases
·Research and Development of New Drugs Targeting Higher-Order Nucleic Acid Structures
·siRNA Patent Breakthrough and Global Layout Strategy
- DAY 2-
· FDA's Review Standards and Expectations for China's Innovative Drugs
· Successes and Lessons Learned from Chinese Pharmaceutical Companies in FDA Submissions
· Development Potential of ADC Drugs Produced in China from the FDA's Perspective
· Sharing of Failed Clinical Cases
· New Trends in Regulatory Policies and Response Strategies of Chinese Pharmaceutical Enterprises
· Development and Global Collaboration of Small Molecule Innovative Drugs
· Frontier New Technologies Empower Small Molecule Innovative Drug Development
· Discovery of Innovative Small Molecule Drugs
· Differentiated Small Molecule Innovative Drug Project Selection
· Small Molecule Kinase Inhibitor New Drug Development
· Small Molecule CNS Drug Development
· Application of High-Throughput Screening Technology in Small Molecule Drug Discovery
· Frontier Drug Design, Evaluation, and New Target Exploration
· Research on the Discovery and Drug-Likeness Evaluation of Small Molecule Agonists
· Key Points of Preclinical Pharmacological Research for Small Molecule Drugs
· CNS Drug Multi-Indication Development Strategy
· Trends in CNS Drug Development
· Preclinical Research, Clinical Development Strategies and Progress of CNS Drugs
· Key Points in CNS Drug Development: Preclinical Animal Models of Neurological Diseases
· High-Throughput Screening and CNS Drug Development
· Application of AI in the Efficient Discovery of CNS Candidate Drugs
· Current Status and Future Prospects of the Nuclear Medicine Industry
· Mechanism of Action and Structural Design of Radiopharmaceuticals
· Key Technologies for Original Nuclear Medicine Development
· Radiation Dosimetry-Based Dosing Regimen Design
· Prospects for the Development of Terbium-161 Radionuclide Research
Process Development and CMC Challenges
(Small molecules, Peptides, ADC)
· Emerging Technologies and Future Trends
· Next-Generation Linker and Payload Technology
· Challenges in ADC Drug Development and CMC Regulatory Considerations
· Solutions to the Challenges of ADC Process Scale-Up
· Development of Analytical Methods for ADC Drugs
· CMC Development of ADC Biosimilar Drugs
· Synthesis and Process Safety Control of Highly Toxic Small Molecule Payloads
· Formulation Development of XDC
· Characterization Methods of XDC
· From Clinical Samples to Commercial Production
· CMC Development Strategy from IND to BLA Stage
· Case Analysis: CMC Experience of Marketed XDCs (e.g., Enhertu, Trodelvy)
· CMC Challenges of Bispecific ADCs
· GMP Radiopharmaceutical Production
· Stability Challenges: Radiation Autolysis and Formulation Optimization
· Thoughts on the Full Life Cycle Management of Small Molecule Innovative Drugs CMC
· Peptide Drug Substances and Formulation Processes


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