Nanjing Vazyme Biotech Co., Ltd.

NANJING, China, May 31, 2023 /PRNewswire/ -- Vazyme (688105.SH), China's leading biotechnology company, has officially signed a global strategic cooperation agreement with Azenta Life Sciences ("Azenta", Nasdaq: AZTA), which will promote to establish "one-stop" service process for both companies in the fields of next-generation sequencing, automated library preparation, raw material supply, experimental consumables, sample storage and more. Dr. Nie Junwei, General Manager of Life Science Division, Vazyme, and Mr. George Ge, General Manager of Azenta China, witnessed by Dr. Cao Lin, Chairman and Founder of Vazyme, and Mr. Stephen S. Schwartz, Global President and CEO of Azenta, signed the agreement on behalf of both parties. Vazyme, a global supplier specializing in design, manufacture and application of bioactive compounds, is committed to expanding the application fields of core technologies in life science, in vitro diagnostics, bio-medicine, and others. Leveraging its expertise in bioactive compounds, Vazyme is developing innovative biosolutions to bolster the research and development in life science. Headquartered in the U.S., Azenta is a global leader in life science solutions, providing innovative and reliable solutions for sample research and management. Azenta sample exploration and management solutions will accelerate impactful breakthroughs and therapies to market with greater speed and precision, and the company has established long-term partnerships with many multinational corporations and higher education institutions. "We are very pleased to achieve this global strategic cooperation, as partners with a solid foundation for cooperation - Vazyme had established deep collaboration with GENEWIZ (Azenta's genomics service) in 2016, we believe the new cooperation initiative will further expand and deepen Vazyme and Azenta's cooperation," said Dr. Nie, General Manager of Life Science Division, Vazyme. Vazyme: accelerating global roadmap with controllable upstream technology development and end product manufacturing capabilities Vazyme reported strong financial performance in 2022. The company's operating revenue reached USD 517.25 million, a 90.99 percent growth year-on-year, and its regular business revenue of USD146.96 million increased by 41.03 percent year-on-year. Life science, in vitro diagnostics, and bio-medicine were business sectors with top three growth and performance. Vazyme's strong financial performance in 2022 can be attributed to its focus on innovation and investment in cutting-edge technologies. To meet the varying needs of customers and partners, Vazyme invested a total of USD57.39 million in R&D in 2022, which was a 71.98 percent increase year-on-year, and its R&D team now has 1,196 researchers. By the end of 2022, Vazyme has obtained 109 patents, including 53 patents for invention, and it has built state-of-the-art R&D and production facilities that will meet various product needs. Vazyme thrives to deliver comprehensive solutions tailored to the diverse needs of the customers leveraging its core technologies, and aims to steadfastly enhance public health together with its partners towards a healthier, safer, and greener future. Looking forward, Vazyme and Azenta will carry out global cooperation in the fields of automated sample solutions, oligo synthesis, molecular biology services, and GLP standard specification services, fully integrating the resources and advantages of both companies to lead innovative breakthroughs, jointly developing international markets, and contributing to the life and health of all people. About Vazyme Established in 2012, Vazyme (688105.SH) is a global enzyme-based biosolution supplier with more than 200 types of genetically engineered recombinant enzymes, over 1,000 types of high-performance materials and over 1,000 end products. It was public listed on the Shanghai Stock Exchange in 2021. With a mission to create value for customers by pursuing the highest standards in product and service quality, the company is now serving customers in more than 60 countries and regions worldwide. Company Codes: Shanghai:688105

1月9日至11日，国家药监局党组成员、副局长徐景和在安徽、江苏调研新冠疫情防控药品医疗器械监管工作。调研组深入安徽智飞龙科马生物制药有限公司、国药控股安徽医药公司、南京诺唯赞生物科技股份有限公司、南京中山制药有限公司等新冠病毒疫苗、新冠病毒治疗药物、新冠抗原检测试剂企业，了解防疫药械产品质量安全管理情况；听取两省药品监管部门加强疫情防控药械质量监管情况。调研组充分肯定两省前一阶段全面加强疫情防控药械质量监管工作付出的努力和取得的成绩。 徐景和指出，疫情防控药械质量安全责任重大。生产经营企业和监管部门要认真落实党中央国务院要求，严格执行《药品管理法》《疫苗管理法》《医疗器械监督管理条例》，按照市场监管总局涉疫药械稳价保质有关要求和国家药监局的一系列部署，以对人民群众高度负责的态度，慎终如始，再接再厉，坚持问题导向，强化底线思维，切实落实企业主体责任和监管责任，聚焦风险隐患，保障质量管理体系持续有效运行，全力保障防疫药械质量安全。 徐景和强调，企业作为防疫药械质量安全的第一责任人，要严格执行《药品上市许可持有人落实药品安全主体责任监督管理规定》和《企业落实医疗器械质量安全主体责任监督管理规定》，加强全过程质量管理，确保防疫药械质量安全。药品监管部门要按照2023年全国药品监管工作会议要求，根据疫情防控工作新形势新任务，及时调整监管重点，加大对委托生产和扩大产能企业的监管力度。省局要监督指导市、县药品监管部门加强防疫药械经营使用环节的监督检查；要加强网络销售药械的监测处置工作，推动落实第三方平台和网络销售企业主体责任。要按照药品安全专项整治的工作要求，严查违法违规，严控安全风险，完善治理机制，提升监管能力，以更加坚决的态度和更加有力的措施确保防疫产品质量安全。 国家药监局器械监管司、安徽和江苏省药监局主要负责同志参加调研。

12月13日，国家药监局召开加强新冠病毒抗原检测试剂质量安全监管视频调度会，深入贯彻落实国务院联防联控机制近期关于疫情防控有关要求，强化注册人主体责任落实和属地监管责任落实，全力保障新冠病毒抗原检测试剂质量安全。国家药监局党组成员、副局长徐景和出席会议并讲话。 复星诊断科技(上海)有限公司、南京诺唯赞医疗科技有限公司、浙江东方基因生物制品股份有限公司、深圳市亚辉龙生物科技股份有限公司、重庆中元汇吉生物技术股份有限公司的主要负责人，汇报了企业落实主体责任、加强生产质量管理工作等有关情况。江苏省、福建省、重庆市药监局的负责同志汇报了加强新冠病毒抗原检测试剂生产经营环节质量安全监管工作情况。 会议指出，近期，疫情防控新十条优化措施、新冠病毒抗原检测应用方案相继出台，对新冠病毒抗原检测试剂质量安全提出新的要求，各新冠病毒抗原检测试剂注册人和监管部门要进一步提高政治站位，深刻认识加强抗原检测试剂质量监管的特殊重要性，以更加担当的精神和更加扎实的工作，确保抗原检测试剂的质量安全。 会议要求，各新冠病毒抗原检测试剂注册人、生产经营企业要全面落实《医疗器械监督管理条例》及其配套规章制度要求，坚持问题导向，强化底线思维，聚焦质量安全风险隐患，对标质量管理体系要求，全面开展排查治理。注册人作为产品质量安全的第一责任人，要严格执行生产质量管理规范要求，不得脱离质量管理体系进行生产，不得擅自变更或者增加生产地址，不得放行不合格产品出厂和上市，不得随意修改产品标签和说明书。经营企业要严格执行经营质量管理规范要求，不得脱离经营质量管理体系进行经营，不得无证或者无资质从事经营活动，不得经营或者进口不符合法定要求的产品，不得从非法渠道购进产品，不得擅自变更经营场所和库房地址，不得违规运输或者贮存产品，不得违法违规开展网络销售活动；网络交易服务第三方平台不得违法违规提供网络交易平台服务。各新冠病毒抗原检测试剂注册人、受托生产企业、经营企业、网络交易服务第三方平台，要认真排查是否全面履行各项主体责任，确保责任落实到位，体系运行到位，风险防控到位，质量管理到位。 会议强调，各级药品监管部门要认真贯彻落实党中央、国务院决策部署，始终牢记人民健康是“国之大者”，坚持人民至上、生命至上，慎终如始、再接再厉，全力保障抗原试剂质量安全。要强化质量管理体系检查，组织专业力量对本辖区新冠病毒抗原检测试剂注册人及其受托生产企业、网络交易服务第三方平台开展监督检查。发现存在违规行为，不能保证产品安全有效的，要责令企业立即暂停生产、召回问题产品并进行有效处置；违规情节严重的，要依法吊销医疗器械生产许可证，并对相关责任人依法进行处罚。要继续加强新冠病毒抗原检测试剂的质量监督抽检，对辖区内注册人、受托生产企业生产的新冠病毒检测试剂开展全覆盖抽检。对于监督抽检不合格产品，要立即采取处置措施，责令企业暂停生产、分析查找原因并开展整改，未经省级药品监管部门复查复检合格，不得恢复生产。对监督检查、监督抽检、投诉举报、网络监测、风险会商等工作中发现的问题和线索，要深挖细查，一查到底。对各类违法违规行为，要依法从严从重从快查处。涉嫌犯罪的，要及时移送公安机关。监管人员和其他公职人员涉嫌失职渎职的，要及时移送纪检监察机关。 各省、自治区、直辖市和新疆生产建设兵团药监局分管局领导及相关处室负责同志、各新冠病毒抗原检测试剂生产企业主要负责人在各自分会场参加会议。国家药监局有关司局和直属单位的有关负责同志参加会议。