Porton Webinar｜小核酸药物：从 IND、FIH 到 NDA 全链条开发优化

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小核酸药物逐步从小众细分领域跻身产业主流，Alnylam、Ionis等先行者落地产品印证商业化价值，诺华、罗氏等跨国药企相继加码布局。在药物从IND、FIH直至NDA申报的全研发周期中，研发企业普遍遭遇各类共性难题，结合各国监管规范与产业实际，探寻务实可行的解决方案已是行业刚需。

北京时间6月30日（周二）上午8:00-10:00，三位行业专家将共同相会ZOOM云端，以“小核酸药物从IND、FIH至NDA全流程开发：非临床、临床与 CMC环节的关键挑战及应对策略”为主题展开一场深度对话（英文），分享小核酸药物前沿经验与实战案例。

本次研讨会从非临床评价、临床转化及CMC开发三大维度，结合真实案例，系统拆解小核酸药物在IND至FIH阶段的关键决策节点：包括药理毒理与CMC的闭环联动、临床前到临床的CMC桥接策略，以及全球申报中的常见“非临床—临床”脱节陷阱，旨在为小核酸药物研发团队提供一套可操作的风险预判框架，真正提升从实验室到首次人体试验的转化成功率。扫描下方海报二维码即可报名，Zoom支持浏览器观看。

嘉宾简介

徐天祺 博士

博腾股份

小分子新药研发中心

新分子研发总监

2016年于香港中文大学取得化学博士学位。修读博士期间研究课题包括多肽类似物的合成及其分子间相互作用的研究。

博士毕业后的10年间先后从事多肽仿制药上下游工艺研发及GMP生产、创新药IND阶段到早期临床阶段的工艺研究，有丰富的与国内外客户合作的经验。对于复杂多肽的工艺开发方面亦具备相当丰富的经验，包括50个氨基酸以上的直链肽、大环肽、多环肽及订书肽，以及低稳定性肽类等。

刘健 博士

益诺思

海外销售总监

在生物制药行业拥有20余年从业经验，兼具深厚的科研背景和商业管理能力。在RNA治疗、小核酸（siRNA）-LNP递送平台、GLP毒理学研究及IND支持策略等领域拥有丰富经验，主导并推动多个项目从药物发现阶段向临床前开发阶段转化。其负责全球客户合作拓展及科学服务组合战略规划；曾担任Nitto BioPharma毒理学总监，负责多个创新药项目的非临床安全性评价工作，并成功支持多项IND申报。

刘健博士在国际同行评审期刊发表多篇学术论文，并长期担任南加州生物医药促进协会（SABPA）执行副会长及董事会成员，负责协会赞助合作与发展战略工作，积极推动产业界与学术界交流合作。

魏晓雄 博士

益诺思转化医学中心负责人

益临思首席医学顾问

美国爱达荷州立大学博士，美国华盛顿大学UW、美国癌症研究所（NCI/NIH）博士后。美国Milestone Biopharm管理合伙人、汉都医药联合创始人，美国临床药理学与治疗学会成员。

曾任FDA临床药理学高级审评员10年，具有丰富的Pre-IND、IND、NDA审评经验，累计参与超百项IND/NDA/BLA案例，获FDA杰出贡献奖、药物安全奖等10余项行业荣誉。

曾负责美国临床CRO Medpace早期临床10年，深耕临床药理学与临床药物开发30年，主导完成百余项全球新药早期临床开发项目。受邀于国际学术会议发表主题报告20余次，参编《药物代谢与药物相互作用研究》等权威著作。

核心要点

国际视角同台：三位专家分别基于海外与国内的实战经验，对标国际监管趋势，输出可借鉴的策略。

全流程痛点洞察：从非临床评价、临床转化到CMC，覆盖IND→FIH→NDA各阶段的关键痛点。

实时跨洋互动：每场演讲后设问答环节，您的问题可同时由中美专家实时回应。

直播时间

北京时间：6月30日（周二）08:00-10:00

美东时间：6月29日（周一）20:00-22:00

美西时间：6月29日（周一）17:00-19:00

报名链接

Zoom：https://zoom.us/webinar/register/WN_WEEElJzsTg2UxXVFCWbR_A

期待与您云端相会，畅谈小核酸前沿发展！

博腾股份成立于2005年，为全球药企、生物科技公司及科研机构等提供从临床前研究到药品上市全生命周期的端到端CDMO服务，涵盖小分子药物、多肽与寡核苷酸药物、蛋白与偶联药物以及细胞与基因治疗药物的原料药到制剂全流程。截至2025年末，公司拥有全球员工4300余人，累计服务客户1400余家，成功交付项目超5000个。我们始终坚持以客户为中心，致力于提供创新可靠的全球化CDMO解决方案，让好药更早惠及大众。

Oligonucleotide therapeutics are rapidly evolving from a niche modality into a mainstream segment of the biopharmaceutical industry. The commercial success of pioneers such as Alnylam and Ionis has validated the value of RNA-based medicines, while global pharmaceutical companies including Novartis and Roche continue to expand their investments in this field.

However, throughout the development journey—from IND submission and First-in-Human (FIH) studies to eventual NDA filing—developers often encounter a range of common scientific, technical, and regulatory challenges. Identifying practical solutions that align with both regulatory expectations and industry realities has become increasingly important for successful development.

Covering three key areas—nonclinical evaluation, clinical translation, and CMC development—this webinar will examine critical decision points throughout the IND-to-FIH development process. Through practical examples and industry experience, speakers will discuss integrated strategies across pharmacology, toxicology, and CMC development, approaches to bridging preclinical and clinical development, and common pitfalls that can lead to disconnects between nonclinical and clinical programs during global regulatory submissions.

The session is designed to provide oligonucleotide development teams with a practical framework for risk assessment and decision-making, helping improve translational success from the laboratory to first-in-human studies.

Featured Speakers

Tianqi Xu, Ph.D.

Director of New MoleculeR&D Dept., Porton

Dr. Tianqi Xu received his Ph.D. in Chemistry from The Chinese University of Hong Kong in 2016. His doctoral research focused on the synthesis of peptide analogs and the investigation of intermolecular interactions.Over the past decade, Dr. Xu has accumulated extensive experience in peptide and oligonucleotide development, covering process development, GMP manufacturing, and CMC activities from IND-enabling studies through early clinical development. He has worked closely with both domestic and international clients and has significant expertise in the development of complex peptide therapeutics.Dr. Xu joined Porton in May 2025 and is currently responsible for the company’s peptide and oligonucleotide business.

Jian Liu, Ph.D.

Head of Business Development, InnoStar

Dr. Jian Liu has over 20 years of experience in the biopharmaceutical industry, combining scientific expertise with extensive business and leadership experience. He has led multiple projects in RNA therapeutics, siRNA-LNP delivery platforms, GLP toxicology, and IND-enabling development, supporting the translation of innovative therapies from discovery to preclinical development.Prior to joining InnoStar, Dr. Liu served as Director of Toxicology at Nitto BioPharma, where he was responsible for nonclinical safety assessment and supported multiple IND submissions. He currently serves as Head of Business Development at InnoStar, driving global client partnerships and scientific service strategies.Dr. Liu has published multiple peer-reviewed scientific papers and serves as Executive Vice President and Board Member of the Southern California Association for Biomedical and Pharmaceutical Advancement (SABPA), promoting collaboration between industry and academia.

Jim Wei, Ph.D.

Head of Translational Medicine,InnoStar

Chief Medical Advisor, InnoClinic

Dr. Jim Wei is Head of Translational Medicine at InnoStar and Chief Medical Advisor at InnoClinic. He brings more than 30 years of experience in clinical pharmacology and drug development.Dr. Wei previously served as a Senior Clinical Pharmacology Reviewer at the U.S. FDA for 10 years, where he participated in more than 100 IND, NDA, and BLA submissions and received multiple honors, including the FDA Outstanding Contribution Award and Drug Safety Award. He also spent 10 years leading early clinical development programs at Medpace and has successfully supported over 100 global early-stage drug development projects.Dr. Wei received his Ph.D. from Idaho State University and completed postdoctoral training at the University of Washington and the National Cancer Institute (NCI/NIH). He is a Managing Partner at Milestone Biopharm, Co-founder of H&D Pharma, and a member of the American Society for Clinical Pharmacology and Therapeutics (ASCPT).

Registration Link

https://zoom.us/webinar/register/WN_WEEElJzsTg2UxXVFCWbR_A

Founded in 2005, Porton Pharma Solutions provides end-to-end CDMO services from pre-clinical to commercial stages. Our capabilities span Small Molecules, TIDES, Biologics and Conjugates (ADCs, AOCs, DACs, PDCs, RDCs, etc.), and Advanced Therapy Medicinal Products, from drug substance to drug product. As of 2025, Porton has over 4,300 employees globally, served more than 1,400 customers, and delivered over 5,000 projects. We are committed to a customer-centric approach, delivering innovative and reliable global CDMO solutions, enabling earlier access to good medicines.