Grace Zheng
再鼎医药
前大分子药学副总裁
Grace Zheng has more than 35 years of experience in R&D, Process Development, and GMP Production of Biopharmaceuticals for clinical and commercial supplies. She held various leadership roles in biotech / biopharma companies such as Glycotech, HGSI, Red Cross, Macrogenics, Teva in the US since early 1990s. In the recent decade, she led multiple biopharmaceutical projects in CMC Project Management, Process Scale-up, Pilot, Clinical and Commercial Manufacturing, GMP management and operational training with WuXi Biologics and ZaiLab in China. She has played key roles of leadership in the development and commercialization of multiple projects of monoclonal antibodies, fusion proteins, bi/tri-specific antibodies, ADCs, vaccines, and recombinant proteins in her career. She has rich experiences in Process Development, Process Scale-up, Tech Transfer, Clinical and Commercial Manufacturing, and Regulatory Documentation Writing and Review for US/China filings. Her expertise covers Upstream and Downstream Process Development, cGMP manufacturing, as well as the application of disposable / membrane technologies in large-scale production. Grace has served as a reviewer for BioPlan Associates, Inc. of International Bioprocess Conference in the US. She is also members of various professional organizations in biopharmaceuticals such as Globe's Bioprocess, ASME, ISPE, etc., playing a highly influential role in the industry.
GLP-1类生物制品临床申报与BLA的中美双报的规范与要点
1）对GLP-1的介绍
2）药学中美双报的思路
3）如何准备申报及面对可能监管关注的问题。
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GLP-1类药物的研发和应用前景广阔，相关产业链的市场价值及容量巨大。目前全球已有多款GLP-1多肽类药物上市，包括诺和诺德的Ozempic及礼来的Tirzepatide。受益于降糖与减重市场的扩展，GLP-1类药物近年来在国内的销售规模不断突破新高。2021年，中国GLP-1市场规模首次突破20亿元人民币，达到24.6亿元。到2023年上半年市场规模已达到46亿元。全球市场也呈现类似的增长趋势，随着司美格鲁肽和替尔泊肽等药物上市后的商业化放量，全球市场规模不断扩展。总体来看，GLP-1类药物在降糖与减重市场的应用推动了其快速增长，并有望进一步扩展到其他疾病领域。
于是，国内诸多药企也将GLP-1生物类似药作为开发重点，也带动了从药品开发到下游制剂生产、高值耗材、药用包材及冷链运输全产业链的发展。从而使GLP-1类药物及其全产业链成为了生物药目前的热点领域。
因此，11月19日（周二）和21日（周四），德特威勒医药包装(Datwyler Healthcare)、斯蒂瓦那托集团(Stevanato Group)联合佰傲谷BioValley，举办GLP-1城市巡回活动，以期为GLP-1受体激动剂这一“明星药物”创造出更多的技术创新和合作机会。
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