杭州生物医药产业活力迸发。日前，派格生物医药（杭州）股份有限公司自主研发的1类创新药"维 培那肽注射液"（药名"派达康"）获国家药品监督管理局批准上市，成为杭州今年获批上市的第五个1类 创新药。全市1类创新药上市申请量占全省75%，多项核心指标领跑全省。 维培那肽凭借创新的定点PEG化技术，可以有效抵御DPP-4酶的降解，并显著降低肾脏清除率。这 一技术既确保了药物与GLP-1受体的高效结合，发挥药物生物活性，使其能够快速达到较高的暴露浓 度，又可明显减少免疫应答和清除、降低胃肠道副作用、避免因分子量过大可能引发的体内蓄积的风 险，使其在临床治疗时能够达到更长久的暴露时间，最终实现疗效与安全的理想平衡。 "杭州市市场监管局的工作人员主动上门服务，帮我们预判并解决问题，节省了大量时间和精 力。"派格生物相关负责人对这种"想在企业前面"的"杭州服务"模式印象深刻。在破解企业实际难题 上，杭州市场监管部门在全省率先开展贵重仪器设备委托检验备案，为企业缓解资金压力；针对跨省委 托生产等共性难题，组织专题讨论，推动指导原则落地，使相关咨询量显著下降。此外，积极搭建资源 对接桥梁，协助企业申报产业专项资金，确保惠企政策精 ...

Core Insights - The GLP-1 market is experiencing intense competition with new entrants, particularly from domestic Chinese companies, following the success of drugs like semaglutide and tirzepatide [1][2][3] - The approval of Pegbio's GLP-1 receptor agonist "PidaKang" marks a significant milestone for local firms in the GLP-1 sector, providing more treatment options for type 2 diabetes patients [1] - Morgan Stanley reports that Novo Nordisk and Eli Lilly dominate the GLP-1 market with a combined market share of 84% [3] Market Performance - Novo Nordisk's Q3 report indicates that its core products, including Ozempic and Rybelsus, generated approximately $25.4 billion in sales for the first three quarters of the year [2] - Eli Lilly's tirzepatide saw a 109% year-over-year increase in sales for its diabetes version, reaching $6.515 billion in Q3, while its weight loss version generated $3.588 billion, up 185% [2] Competitive Landscape - The GLP-1 market is described as a "red ocean," with numerous companies, including domestic players like Hengrui Medicine and Innovent Biologics, entering the field [2][3] - Experts emphasize that future GLP-1 drug development will focus on improving patient adherence and minimizing side effects, rather than solely maximizing weight loss [3] Clinical Research and Development - The high discontinuation rates of GLP-1 medications, with 65% after one year and 84% after two years, highlight the need for improved drug formulations [3] - Silverno's product, Supaglutide, has received FDA approval for clinical research targeting non-alcoholic steatohepatitis (NASH), indicating a potential expansion of GLP-1 applications beyond diabetes and obesity [4] Economic Impact - The financial burden of obesity-related complications in the U.S. is significant, with direct medical costs estimated at $37 billion and indirect costs exceeding $1 trillion annually [5]