Glaxo Wellcome UK Ltd.

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course offers a comprehensive overview of critical components necessary for obtaining and preserving successful marketing authorization within the region. It will delve into the recent regulatory reforms and the drug regulatory systems that impact this process. Participants will gain insights into both import and local manufacture registration procedures, alongside detailed coverage of clinical product development, including Chemistry, Manufacturing, and Controls (CMC) regulatory requirements. The course also provides a practical interpretation of these topics, aiming to equip attendees with applicable knowledge. Additionally, it offers a valuable platform for delegates to exchange experiences, enhancing learning through shared insights and discussions. Who Should Attend: This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Benefits of attending: Gain an overview of the regulatory procedures in the region Understand and assess the impact of recent regulatory reforms Discuss clinical product development and Chinese-specific approaches Understand requirements for import and local manufacturing registration Discuss product registration strategies Certifications: CPD: 12 hours for your records Certificate of completion Agenda: Day 1 General introduction to the PRC and the pharmaceutical market Commercial and cultural background P.R. China - Drug Regulatory Systems Regulatory authorities Recent regulatory changes Regulations and guidelines Drug classification systems Import and local manufacture registration Data requirements Registration requirements Labelling requirements P.R. China - Clinical Product Development Regulatory aspects of clinical development Recent regulatory changes Documentation needs including CMC Regulatory requirements including GCP aspects Chinese-specific approaches Multinational clinical trials Hong Kong SAR Background overview Regulatory authorities Regulatory requirements and procedures Specific market aspects Macau SAR Brief overview of regulatory aspects Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) Cultural background Regulatory authorities Regulations and guidelines Drug classification systems Data requirements Country-specific matters P.R China - Recent Developments Speakers: Mónica Dressler-Meyer DRA Manager Management Forum Mónica is DRA Manager based in Switzerland with several years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for development activities in other regions. Prior to this, she worked at F. Hoffmann-La Roche in Switzerland where she gained several years' experience in industry basics and pre-clinical research. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs. He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia. Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices. He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs. For more information about this conference visit https://www.researchandmarkets.com/r/smaxv9 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

月初第一周狂增四次BD，12月是属于葛兰素史克（GSK）的。 在管线拓展上，不仅以超10亿美元协议金额与映恩生物达成独家授权协议获取其临床前阶段的ADC新药DB-1324大中华区外全球权益，还分别与Rgenta、Muna两家公司达成了多靶点RNA小分子剪接调节剂与阿尔茨海默病药物靶点的研究合作。 此外，更是在商业化方面与重庆智飞达成协议修订，修订后的协议将原定的带状疱疹疫苗Shingrix商业化3年期限（2024-2026 年）延长8年至2034年，并修订了预期数量至约216亿采购额（2024-2029年）。并将与智飞达成初始期限为10年的独家合作，在中国大陆实现呼吸道合胞病毒（RSV）疫苗的商业化。 近乎疯狂的BD速度下，是GSK想要重回全球药企霸主的决心。 1 快乐拼图 随着药剂师 Silvanus Bevan 于1715年在伦敦开设了Allen & Hanburys有限公司的前身Plough Court药房，属于葛兰素史克的历史正式拉开了帷幕。（Allen & Hanburys公司后于1958年并入葛兰素公司） 巨头葛兰素史克的历史太久远，不可能每一天都是顺利的。但当我们以宏观的视角来熨平那些历史的细微波动，在成立的前300年间葛兰素史克的发展可以说是顺利且幸福的。 旗下的几大基石公司如Glaxo Laboratories、SmithKline和Burroughs Wellcome、Allen & Hanburys，都在其应有的故事线里逐渐发展壮大并相继合并，并最终在2000年迎来了葛兰素史克快乐拼图的巅峰时刻。 图一：葛兰素史克“拼图”史 来源：参考来源1 2000年1月，葛兰素威康和史克必成宣布合并意向。合并于当年12月27日完成，成立了葛兰素史克公司(GSK)。 彼时的葛兰素史克风光无量，旗下拥有包括阿莫西林/克拉维酸（Augmentin）、帕罗西汀（Paxil）、氟替卡松（Flovent）等多款“重磅炸弹药物”，一跃成为了全球制药TOP 2的企业。（注：PharmExec全球药企排行榜，仅以处方药品+疫苗核算） 图2: 2009年PharmExec全球药企排行榜TOP 10 来源：参考来源2 但随着专利到期影响，这几款重磅药物销售额至2005年已大幅下挫，其中Paxil（帕罗西汀）的降幅更是高达60%，自15.5亿英镑下降至6.15亿英镑。 令人费解的是，在多个重磅炸弹药物销售额下降的情况下，葛兰素史克仍然能够持续维持制药全球TOP 2霸主之位至2009年，原因为何？ 其实，有时候改变一切的一款超级重磅炸弹药物的产生，真的就来源于平淡无奇的“1+1”。 先把时间拉回1969年，在Glaxo Laboratories Ltd.收购Allen & Hanburys Ltd.后，新的研发团队迅速推出了属于GSK的第一种哮喘药物Ventolin，而这正式拉开了葛兰素史克哮喘类研发药物的序幕。 由于在Ventolin尝到了甜头，GSK分别在1990年与1993年于英国上市了‌沙美特罗（Serevent）与氟替卡松（Flovent）。 沙美特罗是一种长效β2肾上腺素受体激动剂（LABA），用于哮喘和COPD的长期管理。它的作用持续时间长，通常一天服用一次，帮助控制夜间症状和减少急性发作的频率。 氟替卡松是一种吸入性类固醇（ICS），用于长期控制和预防哮喘症状。它通过减少气道炎症，帮助哮喘患者控制症状并减少急性发作的频率。 由于哮喘的时候还会发生炎症，GSK干脆结合两种药物的不同机制，推出了沙美物罗和氟替卡松的复方制剂舒利迭（Seretide/Advair）。 舒利迭是世界上第一个将类固醇与长效β2受体激动剂组合在一起的复方制剂，用于治疗哮喘和COPD。其机制是通过两种药物的协同作用，既能够缓解气道收缩，也能控制气道炎症。 至此，简单的“1+1”得到了一款超级重磅炸弹药物。 图3：舒利迭销售额 来源：参考来源3 舒利迭最早于1999年3月在英国上市,2000年8月获美国FDA批准。由于其极强的药效与首创的复方作用机制，上市后放量极快，一跃成为了GSK的当家花旦，巅峰销售额按当年汇率计算超80亿美元。 也正是其在GSK多款重磅药物陷入专利悬崖后，以一己之力扛起了一片天。 2 花无百日红 自成立之日起，昂扬向上的近300年匆匆而过，GSK来到了转折点。 2013年对GSK来说是不顺的一年。 2013年7月，公安部首次向社会公开葛兰素史克(中国)投资有限公司的部分高管涉嫌严重经济犯罪，被湖南长沙、上海和河南郑州等地公安机关依法立案侦查的消息。2014年，GSK因行贿受贿案被判处罚金30亿元，这是当时中国开出的最大罚单，马克锐等被告人被判处有期徒刑二到三年。 不仅如此，舒利迭的巅峰销售额也在2013年划上了句号，开始步入下行通道。 图4：2014年GSK药物品种销售额分别（不含疫苗） 来源：参考来源3 并且此时GSK可以依靠的药物却举目皆空（2014年，舒利迭占据了药品销售额约50%），除舒利迭外没有任何一款药物销售额超过10亿英镑。 一系列的不顺，再加上当时根本没有其他重磅药物可以依靠，一度让GSK的销售额陷入泥泞之中，其制药部分销售额（药品+疫苗）2015年仅270亿美元。（注：在考虑汇率的情况下巅峰期GSK销售额高达430亿美元，2013年为330亿美元） 2015-2017年三年，GSK的制药销售额均在270亿美元左右，而GSK的全球排名也一路下坠至第8名。并且，随着舒利迭的销售额持续下降，如果GSK还不能即刻提升自己的销售额，跌出前十，乃至前二十都仅仅是时间的事儿。 好在危机时刻，新生代力量终于到场。 自2018年起，GSK在COPD、哮喘、HIV等领域，逐渐出现了7款年销售额超过10亿英镑的重磅药物，如全再乐（Trelegy Ellipta）、多伟托（Dovato）、美泊利单抗（Nucala）、绥美凯（Triumeq）等，详见下表。 图5：新型重磅药物 来源：参考来源3 多款十亿药物分子的出现，挽住了GSK的颓势。 但在全球MNC们的TOP 10药物动辄百亿美元，默沙东K药甚至超250亿美元的销售额面前，GSK的这几款药物仍然力不从心。 据PharmExec数据，2022-24年，GSK制药销售额均堪堪排名全球第十位，岌岌可危。 也许，GSK就将在这样的慢水煮青蛙里面慢慢损失自己的影响力。 3 峰回路转，跌跌绊绊 300多年历史的老江湖，自然不愿承认自己廉颇老矣。老牌药企想破局，只能通过快速外延并购+基于创新突破的内生生长。 2022年似乎是GSK奋勇开拓的转折点。 2022年8月8日，GSK与Mersana Therapeutics达成协议，GSK获得共同开发和商业化XMT-2056的独家选择权。根据协议条款，Mersana将获得1亿美元的预付款。如果GSK行使其选择权，Mersana也有资格获得高达13.6亿美元的里程碑付款，使得该交易成为迄今为止临床前ADC资产规模最大的交易之一。 自此，GSK开启了其在ADC药物、免疫疗法、双抗、mRNA领域完成了多起大额BD交易布局。 最令人称道的事件有两件，一是GSK分别于2023年10月20日和12月20日，两个月内与翰森旗下两款临床阶段ADC（分别靶向B7-H3和B7-H4）药物达成合作，合计首付款高达1.7亿美元，里程碑超30亿美元。 此外，即是在2024年12月一周内，GSK分别：1）以超10亿美元协议金额与映恩生物达成独家授权协议，获取其临床前阶段的ADC新药DB-1324大中华区外全球权益；2）以协议金额超5亿美元与Rgenta达成多年期战略研究联盟，推动多靶点RNA小分子剪接调节剂的发现与开发；3）以高达1.8亿欧元与Muna达成研究合作，利用MiND-MAP平台推进阿尔茨海默病药物靶点的发现。 图6：GSK 2022-24年重磅BD交易 来源：参考来源3 多种新药物的BD引入，不仅能够带来的新的管线希望，还能通过药品间的联用（如ADC药物、mRNA药物与GSK旗下的PD-1抑制剂Jemperli）带来新的可能性。 除开BD交易，GSK在内部研发上除了上文提到的那几款10亿分子外，真正开拓性的来源来自两款重磅疫苗的诞生，Shingrix和Arexvy。Shingrix 是一种用于预防带状疱疹的重组疫苗，2017年获FDA批准，保护效果超过90%，特别适用于50岁以上成人，需接种两剂。上市即放量，该疫苗在2023年的全球销售额达到了43.6亿美元，距离50亿美元“超级重磅药物炸弹”只差临门一脚‌。 而Arexvy 是GSK研发的首款呼吸道合胞病毒（RSV）疫苗，也是全球首款获批的RSV疫苗。2023年5月获FDA批准，适用于60岁以上成人，单剂接种，疗效超过80%。 Arexvy 2023年仅仅入市半年时间销售额破14亿美元（12.38亿英镑）。此前，根据行业顾问灼识咨询预测,预计到2030年,RSV疫苗在全球的市场规模将达到约167亿美元,市场空间极其广阔，引发人们的无限期待。 并且基于这两款药物的商业开发也在全球各个区域快速进行着，比如在中国大陆，GSK已在12月5日宣布，已与重庆智飞达成协议修订，修订后的协议将原定的带状疱疹疫苗 Shingrix 商业化3年期限（2024-2026 年）延长8年至2034年，并修订了预期数量至约216亿采购额（2024-2029年）。且与智飞达成了Arexvy的10年大陆独家权益。 在大幅的BD加持与疫苗重磅药物诞生下，似乎GSK即将迎来逆袭的大结局。 但几件”黑天鹅”的出现，让结局蒙上了一层扑朔迷离的迷雾。 首先是在2023年3月13日，GSK宣布于Mersana 引入的XMT-2056的I期临床试验出现治疗相关的5级（致命）严重不良事件（SAE）暂停临床试验。这不由得引发对GSK引进的其他前期ADC药物的风险思考。 此外，今年下半年GSK抱有极强期待的RSV疫苗也突遭滑铁卢，美国疾控中心（CDC）于今年6月调整了推荐接种的人群，从60岁上调至75岁，60-74岁年龄段限定在高风险人群。蝴蝶效应立刻在商业端显现，GSK的Arexvy第3季度销售额同比下降74%。 不仅如此，近期，FDA披露因出现“不平衡的严重RSV感染”，暂停了Moderna两款mRNA疫苗的婴幼儿研究。谨慎起见，FDA还部分搁置了其他非减毒活疫苗用于婴幼儿的研究。而老年人和婴幼儿正是RSV疫苗的主力接种人群。 这意味着本来对GSK来说起到决定性助力的RSV疫苗的未来已经不再确定。 对GSK来说未来是不确定但仍然可以争取的。目前其专利保护下的10亿分子药物数量多，距离专利悬崖尚远，能够提供稳定的现金流。 图7：GSK 管线布局 来源：参考来源3 在充裕现金流支撑的多次BD与内生研发下，目前GSK管线有超过67个药物/疫苗的适应症正在进行中，其中18项进入Ⅲ期，29项进入Ⅱ期，依然有着极大的想象空间。 前景仍然有光明，但在当下强大的敌人面前，有时候又很容易令人丧气。为什么？ 今年2024年12月10日，Nature旗下的Nature reviews drug discovery子刊上发布了一份生物企业简报，对2025年TOP 10 药物销售额进行了预测。 图8：2025年TOP 10 药物销售额预测 来源：参考来源4 可以看到，现在全球TOP 10药物已经进入到了100-300亿美元级别的战争，未来的全球药企霸主麾下至少得有一款甚至多款TOP药品才能稳固其地位。 GSK想要重返药企之巅，似乎还需要花点儿时间寻觅/打造那一道属于自己的超级药物之光。能否成功？我们拭目以待。 参考文献： 1.全球顶级制药企业之葛兰素史克GSK，MedTrend医趋势 2.PharmExec官网 3.GSK历年财报、各企业官网公开资料整理 4.K药，危！Nature 预测下一个大药时代开启，Biotech一品塘 5.拨开RSV疫苗赛道的迷雾，医药魔方 同写意媒体矩阵，欢迎关注↓↓↓

DUBLIN, April 20, 2023 /PRNewswire/ -- The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course will cover: All important aspects of gaining and maintaining a successful marketing authorisation in the region Recent regulatory reforms Drug regulatory systems An overview of import and local manufacture registration Clinical product development including CMC regulatory requirements An interpretation of practical aspects The opportunity to exchange experiences with other delegates Benefits of attending: Gain an overview of the regulatory procedures in the region Understand and assess the impact of recent regulatory reforms Discuss clinical product development and Chinese-specific approaches Understand requirements for import and local manufacture registration Discuss product registration strategies Who Should Attend: This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Key Topics Covered: Day 1 General introduction to the PRC and the pharmaceutical market Commercial and cultural background P.R. China - Drug Regulatory Systems Regulatory authorities Recent regulatory changes Regulations and guidelines Drug classification systems Import and local manufacture registration Data requirements Registration requirements Labelling requirements P.R. China - Clinical Product Development Regulatory aspects of clinical development Recent regulatory changes Documentation needs includingCMC Regulatory requirements includingGCPaspects Chinese-specific approaches Multinational clinical trials Hong Kong SAR Background overview Regulatory authorities Regulatory requirements and procedures Specific market aspects Macau SAR Brief overview of regulatory aspects Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) Cultural background Regulatory authorities Regulations and guidelines Drug classification systems Data requirements Country-specific matters P.R China - Recent Developments Speakers: Monica Dressler-Meyer DRA Manager Management Forum Mónica is DRA Manager based in Switzerland with several years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for development activities in other regions. Prior to this, she worked at F. Hoffmann-La Roche in Switzerland where she gained several years' experience in industry basics and pre-clinical research. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs. He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia. Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices. He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs. For more information about this conference visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets