【40+大咖阵容揭晓，议程揭幕】绿色、智能、创新、国际化！—APM第三届亚洲制药产业大会（11月24-25日·上海）

肇 晖，副秘书长，上海医药行业协会

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创新驱动 · 转型升级 · 高质量发展

——《 “十四五”医药工业发展规划》解读

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产业升级加速:后疫情时代中国原料药行业发展思考

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传统大药企的转型创新之路

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 超限制造赋能智能制药

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后疫情时代中国创新药企全球化新思考

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“ 创新+国际化”战略布局下的药企全球发展路径

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 医药产业变革下药企数字化转型探索与实践

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智能制造在制药企业运营管理中的应用

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生物制药企业数字化转型的思考

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智能制造与药片的连续化生产

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Sanofi与数字化

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产业格局重构：药企的数字化转型的路径与价值

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生物药上游工艺开发与技术应用案例分享

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生物药品生命周期中技术转移的关键与实践

【主题讲演-保留席位】

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创新引领，生态化优势

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如何应对生物医药的商业化生产的关键挑战？

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案例分享：药品生产过程中的风险管控

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Continuous Manufacturing of Biopharmaceuticals

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关于使用国产物料开发全球化抗体生产工艺的探讨

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上下游协同：医药生产服务企业的合作模式创新

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原料药与制剂双轮驱动下的产业链一体化布局

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最终灭菌注射剂的参数放行探索

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高质量发展：原料药企的转型策略与发展布局

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出海进程加快：高端制剂开发国际化

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绿色生产：药厂生产技术开发与应用案例

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化学药生产过程中的质量控制和风险管理关键

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产品竞争优势和生命周期管理探讨

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新环境下的药企内部建设和持续改进

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 构建新格局：产业链上下游整合与协同

菲特公司是全球知名的提供压片生产综合解决方案的供应商。公司专注于为制药、营养品和化工行业提供高性能的机械设备。业务范围包括压片机、压片模具、过程设备以及专业的售后维护、培训和咨询服务。菲特公司提出的全设备生命周期概念的框架致力于为客户提供产品的全生命周期综合性技术支持。

菲特公司是制药行业知名的国际压片机供应商，全球设备保有量超过5000台。核心的研发领域包括密闭防护、连续化生产和口服固体制剂数字化解决方案。其中，口服固体制剂数字化解决方案属于菲特OSDi业务单元。

菲特公司的战略与固体制剂生产商的要求一致，即为日益增长的世界人口生产高质量和安全的药物以及营养补充品。公司重点关注可持续解决方案的开发，进一步减少生产中的资源消耗，同时尽可能对操作人员与环境进行有效保护。

公司位于德国汉堡附近的施瓦岑贝克，拥有140多项与压片生产相关的核心技术与工艺专利，展现了菲特在技术上的领先地位。菲特公司在中国南京拥有第二家结合能力中心和生产力的工厂。菲特公司是一家拥有自己全球网络的压片机制造商，在德国（施瓦岑贝克）、巴西（坎皮纳斯）、中国（南京）、印度（果阿）和美国（新泽西州洛克威）设有五个设备齐全的可支持数字化连接的能力中心。公司拥有超过100名高度专业化的服务和应用技术人员，向全球的客户提供专业知识以及与压机生产相关的服务。

此外，菲特公司在阿尔及利亚、比利时、英国、法国、墨西哥、新加坡、西班牙、阿联酋和其他50多个国家拥有子公司，子公司的专业人员也为公司客户提供本地支持。

菲特公司是LMT集团成员之一，LMT集团是一家中型家族企业。集团还包括领先的工业加工精密工具制造商- 利美特金属加工技术有限公司。LMT集团在全球20多个地方拥有1,800名员工，在2021财年实现销售额3.9亿欧元。

Fette Compacting is the world’s leading provider of integrated solutions for industrial tablet production. The company specializes in high-performance machines for the pharmaceutical, nutraceutical, and chemical industry. Its range includes tablet presses, tableting tools, process equipment, and the respective maintenance, training and consulting services. Within the framework of the Lifetime Efficiency concept developed by Fette Compacting, these are aligned toward providing customers with comprehensive support along the entire product life cycle.

With more than 5,000 installed machines, Fette Compacting is the leading global provider for tablet presses in the pharmaceutical industry. Key research and development areas include production under containment conditions, continuous manufacturing, and digital solutions for solida production. The latter are bundled in the OSDi business unit.

The company's strategy is aligned toward the requirements of producers of solid formulations who manufacture high-quality and safe medication as well as nutritional supplements for a growing world population. One key focus is the development of sustainable solutions which further reduce the consumption of resources in production while ensuring optimal protection for operators and the environment. 

More than 140 patents on core technologies and processes associated with tablet production underscore the leading technical role held by the company based in Schwarzenbek near Hamburg. Fette Compacting operates a second technology and production facility in Nanjing, China.

Fette Compacting is the only manufacturer of tablet presses to operate its own global network with five fully-equipped and digitally-connected Competence Centers in Germany (Schwarzenbek), Brazil (Campinas), China (Nanjing), India (Goa), and the US (Rockaway, New Jersey). More than 100 highly-specialized service and application technicians make their entire expertise and all services associated with tablet production available to customers all over the world at each location within this network. 

In addition, Fette Compacting specialists at further subsidiaries in Algeria, Belgium, England, France, Mexico, Singapore, Spain, UAE, and in more than 50 other countries, also offer the company's customers local support.

Fette Compacting is a member of the LMT Group – a medium-sized, family-owned group of companies. The Group also includes LMT Tools, a leading manufacturer of precision tools for industrial processing of construction materials. 1,800 people work for LMT Group companies at over 20 locations worldwide. The Group achieved sales of 375 million euros in fiscal 2021.

上海海昕防静电产品有限公司成立于1999年，是一家专业生产和销售防静电服，洁净服，洁净鞋及一系列洁净产品（帽、口罩、手套、鞋套、无尘抹布等）的生产制造商。拥有先进的生产数码裁剪设备，并开发了洁净服智能电子监控系统。生产的洁净防护产品广泛应用于生物医药，食品化工，电子通信，航天航空等领域。致力于为国内外客户提供全套洁净室穿戴解决方案。

ShangHai HaiXin Antistatic Production Co,.LTD, was founded in 1999. Company is specialized in producing and selling antistatic clothes, clean clothes, clean shoes and a series of cleaning products( such as hats, masks, gloves, shoe-cover, clean-wiper, etc.). Company had introduced advanced  digital cutting machine tool. And developed clean-suit intelligent electronic monitoring system. Products are widely used in biological medicine, food, chemical industry, electronic communications, aerospace and other fields. Company provides professional solutions for cleanroom wearing.

北京诺禾致源科技股份有限公司（股票代码：688315）于2011年3月在北京中关村生命科学园注册成立，专注于开拓前沿分子生物学技术和高性能计算在生命科学研究和人类健康领域的应用，致力于成为全球领先的基因科技产品和服务提供者。企业总部位于北京，在天津、南京、美国、英国和新加坡设有实验室或实验基地，并在中国香港、美国、英国、新加坡、荷兰、日本和泰国设有子公司，办公面积逾40,000m2。

目前，诺禾致源现已建立一支来自海内外顶级名校、多学科交叉型的高素质综合团队，其中硕士及以上学历占比约52%。公司建立了高通量大规模的基因测序平台和高性能计算平台，有效地支撑着生命科学研究和医疗健康两大领域对大数据分析和存储的需求。

公司业务覆盖全球6大洲约70个国家和地区，服务客户超过6,100家。诺禾致源在全球范围内与众多学术机构建立了广泛的合作关系，完成多项具有国际先进水平的基因组学研究工作，截止2022年6月，诺禾致源与项目伙伴合作发表SCI文章950余篇，累积影响因子大于7970；目前已取得软件著作权274项，专利45项；合作伙伴遍布全球，包括近3300家科研院所和高校、600余家医院、2200余家医药和农业企业等。

作为目前国内基因测序领域的佼佼者，诺禾致源的业务覆盖生命科学基础科研服务、医学研究与技术服务、建库测序平台服务，为全球研究型大学、科研院所、医院、医药研发企业、农业企业等提供基因测序、质谱分析和生物信息技术支持等服务。

Registered to be established in Zhongguancun Life Science Park in March 2011, Novogene is specialized in the application of advanced molecular biotechnology and the high-performance computing in the life science research and human health fields. It strives to become a global leading provider of genetic science and technology product and service. Headquartered in Beijing, the Company has established labs or experimental bases in Tianjin, Nanjing, UK and Singapore, and set up branches in Hong Kong China, US, UK, Singapore, Netherlands, Japan and Thailand, with the office area exceeding 40,000m2.

At present, Novogene has set up a high-quality comprehensive interdisciplinary team composed of members from top universities in China and overseas, nearly 52% of which had master degree or above. The Company has established the high-flux large-scale gene sequencing and the high-performance computing platforms, which effectively support the demands of the life science research and medical health for big data analysis and storage.

Novogene served over 6,100 customers all over the world, covering about 70 countries and regions in Six Continents. Novogene has established extensive cooperation with many academic institutions all over the world, and completed several genomics research projects with internationally advanced level. By June 2022, Novogene published more than 950 SCI articles in cooperation with project partners，accumulating impact factors over 7970. Currently, it has obtained 274 software copyrights and 45 patents. It has partners all over the world, including nearly 3,300 scientific research institutions and universities, over 600 hospitals, over 2,200 pharmaceutical and agricultural enterprises.

As the leader in the gene sequencing field, Novogene’s business covers the fundamental scientific research service of life science, medical research and technology service, storage-building sequencing platform service, providing gene sequencing, mass spectrometry and bio-information technology support for global research universities, scientific research institutions, hospitals, pharmaceutical R&D enterprises and agricultural enterprises. 

烟台万润药业有限公司成立于2012年，是由中节能万润股份有限公司（股票代码：002643）投资的全资子公司，是一家专业从事原料药和口服固体制剂及保健食品的研制、生产与销售的综合型制药企业。

Yantai Valiant Pharmaceutical Co., Ltd, founded in 2012, is a wholly owned subsidiary of CECEP Valiant Co., Ltd.(Stock code:002643)and a pharmaceutical enterprise specializing in development, manufacture and marketing of API, oral solid preparation and the health care products.

现有的原料药合成车间按照2010年新版GMP标准建成的，占地面积约1700平方米，建筑面积约7200平方米，内建有符合GMP生产要求的百公斤级生产线三条，公斤级和克级生产线各一条，可满足不同批量产品的生产需要。另建有洁净度为D级的洁净区四个，满足产品精制、烘干、包装在洁净环境下的需要，原料药年生产能力可达100吨。公司于2010年向FDA提交了第一个DMF，注册号为24019；公司已取得日本政府颁发的医药品外国制造者认定证书，认定号为AG10500451。

The current chemical synthesis workshop was built as per the GMP standard (2010 vision) covering an area of 1700 square meters, and its construction area is 7200 square meters. The workshop has separated three hundred-kilogram level production suites, one kilogram-level and one gram-level production lines based on GMP requirements to manufacture various scales of APIs and intermediates. In addition, four Grade D clean areas are in place to satisfy the needs of products purification, drying and packaging in clean environments. Our API production capacity could reach 100 tons annually. In 2010, we submitted the first DMF to FDA with the registration number 24019. We have acquired Accreditation Certificate of Foreign Drug Manufacturer issued by Japanese government with the number AG10500451.

新GMP合成车间于今年正式开始启用，原料药年产能预计超过200吨。

The new GMP synthesis workshop will be officially launched in 2021, and the annual capacity of API is expected to exceed 200 tons.

公司具有一流的药品研发和质量管理团队，现已有多个原料药品种顺利通过日本及国内的官方审计，与欧美客户合作开发的新品种也计划通过WHO、EMA认证。公司始终秉承“质量第一”“客户至上”的原则与理念，充分利用高端研发和硬件技术的优势，打造高标准的医药产品服务平台。

The company has a  top-ranking R&D and quality management team. As of now, several APIs have successfully passed inspections of PMDA and NMPA, and new varieties developed in cooperation with European and American clients are also planned to apply for WHO and EMA certification. The company always adheres to the principles and concepts of "Quality First" and "Customer First", with the advantages of high-end R&D and hardware technology to create a high-standard pharmaceutical service platform.

凌凯医药·LinkChem于2011年成立，是一家致力于全合成化学技术、流体化学工程技术的领先的研发、产业化高新技术企业。总部及研发中心位于上海，旗下设立三座控股子公司作为研发中试项目孵化基地、商业化生产基地。公司拥有卓越的研发能力、完善的产业化基地配套和国际化的质量管理体系，致力于为国内外知名药企、新材料新能源企业等提供专业的小分子医药原料药、特色小分子中间体、特种材料单体产品等的技术服务与商业化生产。凌凯秉承不断为生命健康和绿色能源革新事业作出贡献的精神，将持续把新产品研发与产业化作为一项全局性长久发展的事业！

Found in 2011, LinkChem has grown into a leading R&D and industrialized high-tech enterprise focused on total synthesis and flow chemistry technology. The headquarters and R&D center are located in Shanghai, and its three holding subsidiaries serve as incubation bases for R&D pilot projects and commercial production bases. With excellent R&D capabilities, a complete set of complementary industrialization support, and an international quality management system, LinkChem is committed to providing professional technical services and commercialization of small molecule APIs, specialty intermediates, special material monomer products for domestic and overseas well-known pharmaceutical companies, advanced materials and new energy companies. LinkChem will continue to take the research, development, and industrialization as the company's overall and long-term development strategy, aimed at actively contributing to the cause of life, health, and green energy innovation.

圆壹智慧是一家拥有快速、自主进化的AI药物设计平台的新一代生物技术公司。其第三代AI系统为小分子、抗体和其他复杂治疗方式提供极速虚拟筛选和多目标药理学优化的解决方案。该平台能在几小时内计算筛选多达10的十次方个蛋白质序列或化合物，最终筛选出的候选化合物，其实验验证率显著高于传统方法所得，极大缩短了发现周期和成本。详情请访问ainnocence.cn。

Ainnocence is a next-generation biotech company with a fast, self-evolving AI drug design platform. The company's third-generation AI system delivers lightning-fast virtual screening and multi-objective pharmacological profile optimization for small-molecule, antibody, and other complex therapeutic modalities. This platform provides a computational screening capacity of up to 10^10 protein sequences or chemical compounds within hours. The end results are a shortlist of candidates with a very high wet-lab hit rate, and a dramatically reduced discovery time and cost. To learn more, visit ainnocence.com.