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July 18, 2025, Chengdu – The “Innovative Drug Development Closed-Door Seminar” hosted by SDM Bioservices was successfully held at the Chengdu Frontier Medical Center. The event focused on accelerating drug approval pathways, innovative oncology drug development, and global registration strategies.
Distinguished speakers included Dr. Zou Limin, Associate Researcher at Westlake University School of Medicine; Professor Niu Ting, Director of Hematology at West China Hospital, Sichuan University; and Professor Chen Lijuan, Founder and Chairman of Zenitar Bio. They were joined by SDM executive team: Chairman Cao Tiejun; Dr. Howard Yuwen, SVP of Global Regulatory affairs & CBO; Dr. Dong Qinsheng, VP of Medical & Pharmacovigilance; and Dr. Gao Chao, VP of Biostatistics and Data Management, for in-depth discussions on cutting-edge industry topics.
During the event, Liang Rui, Head of Clinical Medicine at Zenitar Bio, and Yu Hongna, VP of Clinical Operations at SDM, signed a cooperation agreement on behalf of their organizations for an innovative hematologic oncology drug project. They also announced the successful enrollment of the first subject in the Phase 3 clinical trial, marking a critical milestone in the project’s advancement.
Experts Discuss Challenges and Opportunities in Accelerating Drug Approval
As a highlight of the seminar, Dr. Zou Limin delivered a presentation titled “Implications and Challenges of Expedited Drug Registration Pathways.” Using case studies from both Chinese and the US regulatory reviews, she provided a systematic interpretation of the three major expedited pathways-Breakthrough Therapy, Conditional Approval, and Priority Revies- as outlined in the Drug Registration Regulation. She elaborated on the drafting intent, key focuses, benefits, and challenges of relevant regulatory guidelines. Dr. Zou emphasized, “While policy incentives provide a “fast track” for innovative drug, companies must develop scientifically sound clinical development strategies tailored to their product characteristics, ensuring a balance between data quality and clinical value.”
Professor Chen Lijuan presented exciting R&D achievements and share breakthroughs in the development of two innovative targeted drugs for hematologic tumors:
Puyisita Mesylate (PM): A highly selective HDAC subtype inhibitor for relapsed or refractory diffuse large B-cell lymphoma, which has been approved for Phase 3 pivotal clinical trials.
Malic Acid Fluonotinib (FM): The world’s first JAK2/CDK6/FLT3 triple-target inhibitor. Its Phase 2b data in treating intermediate-to-high-risk myelofibrosis demonstrated significant superiority over ruxolitinib.
From an international perspective, Dr Howard Yuwen shared SDM’s exploratory efforts in serving innovation and its successful experience in global registration. Through recent case examples involving vaccines, drugs for autoimmune diseases, and declarations for biological excipients, he detailed registration strategies and technical essentials for different products and regional markets, offering valuable insights for local companies looking to expand globally.
Zenitar Bio and SDM Bioservices Sign Agreement to Advance Phase 2 Pivotal Clinical Trial
The signing between Zentiar and SDM, a highlight of the seminar, was witnessed by attending experts and R&D representatives from various companies.
As the Co-leading Principal Investigator (PI) for the project, Professor Niu Ting shared the encouraging progress and clinical value of the study, commending SDM professional expertise and contributions as a CRO. He stated, “the rapid progression of this innovative hematologic oncology drug from Phase 1 to Phase 3 exemplifies a clinical demand-driven R&D strategy.”
Professor Chen Lijuan expressed great delight at the signing ceremony, stating: “Today marks not only the enrollment of the first subject in the Phase 3 trial, but also the anniversary of multiple major milestones in the industrialization of our team’s years of scientific research achievements.”
Mr. Cao Tiejun first expressed gratitude to Zentiar Bio and Professor Niu Ting’s team for their trust in SDM. He reaffirmed the company’s commitment to maintaining high-quality and high-efficiency standards to advance the project and facilitate the early market launch of the innovative drug for the benefit of patients.
Pannel Discussion: Aligning Drug Discovery, R&D, Clinical, and Regulatory Needs
During the panel discussion, experts engaged in an in-depth dialogue on how to anchor clinical value and optimize R&D strategies. Key topics included improving R&D efficiency through early communication with regulatory agencies, defining clinical value positioning during the drug discover state, and specific statistical considerations in oncology drug development.
The seminar attracted representatives from nearly 30 pharmaceutical companies in the Sichuan-Chongqing region, injecting new momentum into the regional biopharmaceutical innovation ecosystem. SDM will continue to foster exchange platforms to advance the internationalization of China’s innovative drugs.
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
Beijing Shouyan Lab is certified by NGSP in the United States.
Provide diverse and better treatment options for patients worldwide.
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
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Dr. Wang delivered a keynote presentation titled "The Power of Quantitative Pharmacology: Critical Insights from Landmark Clinical Development and Regulatory Cases," providing an in-depth analysis of the central role of quantitative pharmacology across the entire clinical development lifecycle of investigational drugs.
The seminar attracted representatives from nearly 30 pharmaceutical companies in the Sichuan-Chongqing region, injecting new momentum into the regional biopharmaceutical innovation ecosystem.
As BaoPharm's strategic regulatory partner, SDM Bioservices' global registration team delivered comprehensive support for this project, including gap analysis, technical dossier compilation, and submission management services.
As a clinical development pioneer with twenty years of China-focused expertise, SDM Bioservices provides comprehensive clinical research solutions to pharmaceutical partners worldwide. Our integrated capabilities include proven regulatory submission experience across China, U.S. and EU markets, innovative early-phase development approaches, reliable bioanalytical services, and demonstrated expertise in managing large-scale clinical trials for therapeutic drugs, and specialized knowledge in vaccines and medical aesthetics.
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