中国上海，2022年7月7日——药明康德子公司合全药业今日宣布，其位于常州原料药研发及生产基地的又一全新寡核苷酸及多肽生产大楼正式投入运营，进一步提升大规模生产能力，将更好地满足全球合作伙伴在寡核苷酸及多肽药物开发方面日益增长的需求，为广大患者带来更多创新疗法。 此次新投产的生产大楼包括面积为2,840平方米的寡核苷酸生产车间，以及2,068平方米的多肽生产车间。投产后，合全药业将拥有4条公斤级大规模寡核苷酸生产线，以及20余条小规模和中等规模生产线，单次寡核苷酸合成的最大总规模将从1.9摩尔上升至6.0摩尔，进一步巩固了公司在寡核苷酸研发和生产领域的领先地位。多肽生产车间配备了3条全新生产线，配备的最大的多肽固相合成釜达1,000升。启用后，合全药业多肽固相合成釜总体积将跃升至6,490升。凭借强大的产能以及超过850人的专业技术团队，合全药业寡核苷酸和多肽CRDMO平台将为合作伙伴的后期及商业化项目提供更有力的支持。 全新投产的生产大楼是合全药业一体化新型分子药物CRDMO(合同研究、开发及生产组织)平台的重要组成部分。该平台覆盖寡核苷酸和多肽的从早期发现到工艺开发最后到商业化生产的全生命周期，并包括寡核苷酸新型单体、非天然氨基酸、连接子以及各种复杂化学偶联物在内的全方位服务。此外，合全药业注射剂平台能够为新分子CRDMO平台提供从研发到生产的一站式制剂服务，加上先进的脂质纳米颗粒(Lipid Nano Particles, LNP)药物递送技术，全面的分析化学能力及全球新药申报资料撰写服务，能与新型分子原料药平台相结合充分发挥CMC(化学、生产和控制)一体化协同效应，加速寡核苷酸及多肽创新药的上市进程。 “我们很荣幸能赋能合作伙伴为广大患者开发新型分子药物，解决未满足的临床需求。”药明康德联席首席执行官、合全药业首席执行官陈民章博士表示：“未来，合全药业将持续不断地强化新型分子CRDMO平台的能力和产能，助力合作伙伴加速推进更多突破性疗法问世，造福全球病患。” 目前，合全药业已在全球设有多个研发及生产基地，分别位于亚洲、北美及欧洲地区，其中在美国特拉华州米德尔顿设立的生产基地，预计将于2024年投入运营。 关于合全药业合全药业是药明康德子公司，在亚洲、北美及欧洲地区均设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合同研究、开发与生产领域（CRDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：www.stapharma.com.cn WuXi STA Opens New Large-scale Oligonucleotide and Peptide Manufacturing Facility
Site Enhances New Modality CRDMO Platform Capacity for Customers Shanghai, China, July 6, 2022 - WuXi STA, a subsidiary of WuXi AppTec, today announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. The new facility underscores WuXi STA’s ongoing commitment to enhance its capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide, making more innovative therapies accessible to the patients. With the opening of the new 30,570 sq.ft. oligonucleotide plant, WuXi STA extends its leadership in oligonucleotide development and manufacturing worldwide, with four large-scale oligonucleotide production lines and more than 20 small- to mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol. The new 22,260 sq.ft. peptide plant features three new production lines with reactors that can accommodate up to 1,000 L, increasing WuXi STA’s overall Solid Phase Peptide Synthesis (SPPS) total reactor volume to 6,490 L. The new facility is an essential part of WuXi STA’s comprehensive end-to-end Contract Research, Development, and Manufacturing Organization (CRDMO) platform for new modalities. The platform supports oligonucleotides and peptides, including novel monomers and linkers, and complex conjugates, from early discovery to development and commercial production at any scale. With this enhanced manufacturing capacity and over 850 dedicated scientists, WuXi STA’s new modality CRDMO platform can better enable global partners as their projects progress to late and commercial stages. In addition, WuXi STA offers injectable formulation development and manufacturing services, including Lipid NanoParticle technology (LNP), as well as comprehensive analytical and Chemical, Manufacturing, and Controls (CMC) dossier preparation services, which further accelerate the development of new oligonucleotide and peptide therapeutics for the market. “We are pleased to support our global partners in their efforts to develop new modality therapies for patients in need,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA. “WuXi STA is committed to enabling partners by enhancing our new modality CRDMO platform’s capacity and capability to expedite the development and commercialization of more innovative therapies to benefit patients worldwide.” WuXi STA has a global network of multiple R&D and manufacturing sites across Asia, North America and Europe, including a new pharmaceutical manufacturing campus in Middletown, Delaware that is scheduled to open in 2024. About WuXi STAWuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry with operations across Asia, North America and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial uses. For more information, please visit http://www.STApharma.com