Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate

– World-renowned leaders in cell therapy, drug discovery and development join Kelonia as it moves toward early clinical development of in vivo CAR-T cell therapies – BOSTON--(BUSINESS WIRE)-- Kelonia Therapeutics, a biotech company revolutionizing in vivo gene delivery, today announced the appointments of global leaders in cell therapy and drug development, Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to its board of directors. “Kristen and Mathai are joining during an exciting time as we continue to shepherd our lead in vivo anti-BCMA CAR program into the clinic and expand our pipeline into additional therapeutic areas to reach even more patients in need,” said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. “Their insight and expertise in developing numerous impactful medicines will be invaluable as we unlock the full potential of our potent and tissue-specific iGPS gene delivery platform, starting in multiple myeloma.” Dr. Hege stated, “The first wave of CAR-T cell therapies have been unquestionable breakthroughs in treating blood cancer. However, challenges posed by the complexity and time requirements for ex vivo manufacturing of autologous CAR-T cell products may limit patient access to these breakthrough therapies. Furthermore, some patients never receive their autologous CAR-T products due to disease progression or clinical deterioration during the manufacturing window. Kelonia’s iGPS technology holds tremendous potential to overcome these barriers and help deliver on the promise of CAR-T cell therapies for a much larger segment of patients who need them. I am particularly encouraged by Kelonia’s use of a next-generation targeted lentivirus platform, that enables in vivo CAR delivery specifically to T cells, along with amplification of one CAR modified T cell into an exponential number of CAR modified daughter cells. In addition, the field of cell and gene therapy has gained tremendous expertise and insight into the manufacturing of lentiviral vectors at commercial scale. I look forward to working with the Kelonia team to apply this compelling, potentially transformative science to create significant change for patients.” Dr. Mammen added, “The field of CAR-T immunotherapy is at a critically important juncture: Its impacts, as I’ve seen firsthand, can be transformational, but we must find ways to expand its benefits to more people with cancer, in more geographies around the world. Kelonia’s in vivo CAR-T technology holds exciting promise to upend today’s model for CAR-T delivery, and the company’s team has demonstrated a phenomenal level of execution that lays the groundwork for significant impact to come. I am excited to join Kelonia’s board of directors to support its continued progress and contribute to the success of its important therapeutic mission.” Dr. Hege has nearly three decades of hematology, oncology and cell therapy translational and clinical research experience. Previously, she held leadership roles in early clinical and translational development in hematology/oncology and cell therapy at Bristol Myers Squibb (BMS) and Celgene. In these roles, she was responsible for global early clinical development and oversight of their internal pipeline and partnered assets, in all hematologic and solid tumor indications from first-in-human studies through human proof-of-concept. In particular, she led the bluebird bio (now 2seventy bio) partnered BCMA CAR-T cell (Abecma) product development from target identification to FDA approval. Dr. Hege also spent nearly three decades as a part-time clinical faculty member in the division of hematology at the University California, San Francisco (UCSF), most recently as clinical professor of medicine. Prior to BMS and Celgene, she was a senior medical advisor and chief medical officer to development-stage biotech companies, including Aragon, Cellerant and Theraclone. A pioneer in immuno-oncology, Dr. Hege began her career at Cell Genesys Inc., where she spent 14 years in various roles of increasing responsibility, culminating in an executive officer role leading clinical development. While there she focused on cell and gene therapy development, including oversight of pioneering clinical studies of CAR-T cells in HIV infection and cancer. Dr. Hege holds a M.D. from the UCSF School of Medicine and a B.A. in biochemistry from Dartmouth College. She completed her residency in Internal Medicine at Brigham and Women’s Hospital, Harvard Medical School, and completed a subspecialty fellowship in hematology and oncology at UCSF. Dr. Mammen is currently the chief executive officer, president and chairman at FogPharma. Previously, he was a member of the executive committee at Johnson & Johnson, where he served as executive vice president of pharmaceuticals, R&D and spearheaded a significant evolution of Janssen’s R&D – one of the largest R&D organizations in the world. Dr. Mammen was a key leader in Johnson & Johnson’s COVID vaccines development, and under his leadership, Janssen R&D executed 40+ acquisitions and licenses and 350+ strategic partnerships and collaborations and created one of the top portfolios in the industry. He led his team to global approvals of eight new medicines, including Tremfya™, Darzalex Faspro™, Balversa™, Carvykti™, Rybrevant™, Ponvory™, Spravato™ and Tecvayli™, with many additional global approvals for expanded indications of marketed products. Prior to his role at Johnson & Johnson, Dr. Mammen served as senior vice president at Merck, where he was responsible for multiple research areas, including cardiovascular, metabolic and renal diseases, immunology, oncology and immuno-oncology. Before Merck, he led R&D at Theravance, Inc., a company he co-founded out of graduate school based on his work at Harvard University with Dr. George Whitesides. Under his leadership, Theravance advanced a robust pipeline of multiple development-stage compounds resulting in five approved pharmaceutical products including Breo™, Anoro™, Trelegy™, Yupelri™ and Vibativ™, and separated into two companies: Theravance Biopharma, Inc. and Innoviva, Inc. Dr. Mammen holds an M.D. from the Harvard Medical School and Massachusetts Institute of Technology (HST) and a Ph.D. in chemistry from Harvard University. About Kelonia Therapeutics Kelonia is pioneering a new wave of genetic medicines using its in vivo gene placement system (iGPS®). The company’s elegant, cutting-edge in vivo gene delivery technology uses an advanced lentiviral vector particle harboring envelope modifications to improve in vivo gene transfer efficiency and tropism molecules to facilitate tissue-specific delivery. Initially focused on developing transformational in vivo CAR-T therapies for hematologic cancers, Kelonia is building a pipeline of genetic medicines for a range of diseases, with the bold goal of making genetic medicines accessible to every patient in need, when and where they need them. Learn more about Kelonia at and follow us on LinkedIn and Twitter.

编者按：本文来自米内网，作者未晞；赛柏蓝授权转载，编辑相宜数据显示，在重点省市公立医院终端化学药吸入剂市场，4大新品种崛起，TOP20品牌已不见跨国巨头勃林格殷格翰的身影，恒瑞继续稳坐销冠。第十批国采或将迎来新突破。01吸入剂市场跌宕起伏4大新品种崛地而起图1：化学药吸入剂的销售情况（单位：万元）2021年在重点省市公立医院终端化学药吸入剂的销售规模达到了近十年的峰值47亿元，2022年微降9.38%，2023年Q1-Q3止跌回升14.17%，市场潜力依然可期。吸入剂TOP20品种门槛逐年上涨，2020年为1000万元左右，2021年为3200万元，2022年达到了3300万元，2023年Q1-Q3涨至3500万元。表1：2020年及2023年Q1-Q3吸入剂品种排名变化情况对比2020年及2023年Q1-Q3吸入剂TOP20品种，有16个品种顶住了压力留在榜单内。其中，布地奈德、七氟烷、乙酰半胱氨酸、布地奈德福莫特罗牢牢占据前4位，布地奈德的市场份额有下滑态势，其余3个品种的市场份额变化不大。4大新上榜品种备受市场瞩目，左沙丁胺醇、布地奈德格隆铵福莫特罗(布地格福)、氟替美维、氨溴索均为2019年获批的新品种。图2：左沙丁胺醇吸入剂的销售情况（单位：万元）2019年9月，健康元药业集团的盐酸左沙丁胺醇雾化吸入溶液获批首仿，成为了左沙丁胺醇吸入剂首款上市产品，目前已获批企业数量（进口+国产）达12家。2020年医保谈判中，盐酸左沙丁胺醇雾化吸入溶液顺利“入保”，在2022年转入国家医保常规目录。在医保助力下，左沙丁胺醇吸入剂在重点省市公立医院终端的销售额持续暴涨，2022年突破1亿元关口，2023年Q1-Q3已超过2亿元。图3：布地格福吸入剂的销售情况（单位：万元）2019年12月，阿斯利康的布地格福吸入气雾剂获批进口，目前为独家产品，2020年起进入国家医保谈判目录，限慢性阻塞性肺疾病。在重点省市公立医院终端，布地格福吸入剂的销售额持续暴涨，2022年突破1亿元，2023年Q1-Q3已超过1.5亿元。2019年11月，葛兰素史克的氟替美维吸入粉雾剂获批进口，目前为独家产品，2020年起进入国家医保谈判目录，限中重度慢性阻塞性肺病。在重点省市公立医院终端，氟替美维吸入剂的销售额持续暴涨，2023年Q1-Q3涨至6000万元以上。2019年韩美药品的吸入用盐酸氨溴索溶液获批进口，成为了氨溴索吸入剂首款上市产品，截至目前吸入用盐酸氨溴索溶液已获批企业数量（进口+国产）达4家，2023年进入国家医保谈判目录；2021年罗欣药业的盐酸氨溴索喷雾剂获批，目前为独家产品。在重点省市公立医院终端，氨溴索吸入剂的销售额持续暴涨，2023年Q1-Q3也涨至6000万元以上。新品种的爆发力过于强劲，TOP20品种门槛逐年提升，乌美溴铵维兰特罗和缩宫素从2021年起被挤出了TOP20品种榜单。此外，两大畅销品种“陨落”，异丙托溴铵/沙丁胺醇吸入剂在重点省市公立医院终端的销售额在2018-2019年均有9000万元左右，2023年Q1-Q3仅剩2300万元左右；氮卓斯汀吸入剂的销售额在2014-2019年均达到4000万元以上，2023年Q1-Q3仅剩1800万元左右。02跨国巨头跌落神坛，销冠易主9个新上榜品牌亮眼2020年在重点省市公立医院终端化学药吸入剂TOP20品牌中，跨国药企勃林格殷格翰占了4个席位，涉及吸入用异丙托溴铵溶液、噻托溴铵吸入粉雾剂、噻托溴铵吸入喷雾剂和吸入用复方异丙托溴铵溶液，到了2022年仅有噻托溴铵吸入粉雾剂和噻托溴铵吸入喷雾剂上榜，2023年Q1-Q3则“全军覆没”，TOP20品牌中已无勃林格殷格翰的身影。从企业的角度来看，勃林格殷格翰的吸入剂2019年在重点省市公立医院终端的销售规模超过了4.5亿元，到了2023年Q1-Q3仅剩9000万元左右，一代巨头“跌落神坛”。表2：2023年Q1-Q3吸入剂TOP20品牌注：销售额低于1亿元用*表示对比2020年及2023年Q1-Q3吸入剂TOP20品牌，有11个品牌顶住了压力留在榜单内。TOP1品牌曾长期被阿斯利康的吸入用布地奈德混悬液占领，到了2022年上海恒瑞医药的吸入用七氟烷夺冠并在2023年Q1-Q3继续保持领军优势，市场份额跃升至10%以上，是目前TOP20品牌中唯一一个达双位数份额的品牌。9个新上榜品牌涉及4个国产，健康元药业集团、成都倍特药业旗下四川普锐特药业、长风药业成绩亮眼。图4：健康元药业集团两个吸入剂的销售情况（单位：万元）健康元药业集团的盐酸左沙丁胺醇雾化吸入溶液、吸入用布地奈德混悬液分别在2019年、2020年获批上市，目前公司的盐酸左沙丁胺醇雾化吸入溶液已成长为亿元级别产品，吸入用布地奈德混悬液也在持续放量，数据显示，截至目前健康元药业集团已拥有8个吸入剂产品的生产批文，在业界名列前茅。5个新上榜的进口品牌中，布地格福吸入气雾剂、吸入用丙酸倍氯米松混悬液、氟替美维吸入粉雾剂、茚达特罗格隆溴铵吸入粉雾剂目前为独家产品，未来“国产替代原研”大有可为。03两大品种备战第十批国采中药龙头参战备受瞩目截至2024年3月12日，已过评/视同过评的吸入剂产品达16个，其中6个产品已纳入国采，均为阻塞性气管疾病用药。表3：已中标国采的吸入剂目前已过评且暂未纳入国采的吸入剂中，麻醉剂吸入用七氟烷以及祛痰药吸入用乙酰半胱氨酸溶液的竞争企业数量（原研+过评）已达到5家及以上。七氟烷是2023年Q1-Q3重点省市公立医院终端吸入剂TOP2品种，销售额超过6亿元。目前吸入用七氟烷由上海恒瑞医药以60%以上的份额领军市场，山东新时代药业等6家国内药企积极备战。乙酰半胱氨酸是2023年Q1-Q3重点省市公立医院终端吸入剂TOP3品种，销售额接近4亿元。目前吸入用乙酰半胱氨酸溶液由原研企业赞邦占据半壁江山，健康元药业集团、四川普锐特药业、江苏康缘药业等超10家国内药企积极备战。值得注意的是，中药创新龙头企业康缘药业在2022年正式进军化学药吸入剂市场，首款获批产品就是吸入用乙酰半胱氨酸溶液，2023年获批的吸入用异丙托溴铵溶液为第五批国采目录品种。若第十批国采最终纳入吸入用乙酰半胱氨酸溶液，康缘药业或将参与竞标，我们静待最终结果。045个重磅首仿蓄势待发健康元、普锐特出击表4：2023版国家医保目录新增的化学药吸入剂2023版国家医保目录新增了6个化学药吸入剂，均为近五年获批的新品，医保将助力新品放量，实现腾飞，也进一步激励了新品研发。表5：部分报产在审且暂未有国产仿制药获批的重磅吸入剂注：统计不含原研地产化产品葛兰素史克的沙美特罗替卡松吸入粉雾剂是2023年Q1-Q3重点省市公立医院终端化学药吸入剂TOP9品牌，吸引到了众多国内药企申报仿制上市，目前已累计有7家国内药企报产，正在审评审批中的仅有健康元药业集团、上海欧米尼医药、四川普锐特药业3家，国内首仿最终花落谁家，我们拭目以待。意大利凯西制药的吸入用丙酸倍氯米松混悬液是2023年Q1-Q3重点省市公立医院终端化学药吸入剂TOP11品牌，今年1月才有国内药企提交仿制上市申请。江西艾施特制药与河北创健药业均在2024年1月提交该产品的4类仿制上市申请，时间相隔6天，后续会否吸引到更多国内药企申报，有待继续观察。目前，国内化学药吸入剂市场正经历“脱胎换骨”式的结构重塑阶段。一方面，新品持续获批，在医保助力下，畅销产品矩阵不断更新；另一方面，国采助力国产品牌替代原研，逐步打破跨国药企称霸市场的局面，让患者能用上更优惠、质量更高的产品。资料来源：米内网数据库END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联