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BWXT Medical Submits Tc-99m Generator New Drug Application To FDA
BWXT Medical Submits Tc-99m Generator New Drug Application To FDA
BWX Technologies, Inc. (NYSE:BWXT) announced today that subsidiary BWXT Medical Ltd. has submitted a new drug application to the U.S. Food and Drug Administration (FDA) to request approval of its technetium-99m (Tc-99m) generator for diagnostic imaging.
Once approved for commercial production by regulatory bodies, BWXT Medical's new proprietary manufacturing technology will be used to irradiate molybdenum targets at an Ontario Power Generation reactor, process Mo-99 (the parent isotope of Tc-99m) and subsequently incorporate material into Tc-99m generators at BWXT Medical's Kanata, Ontario facility for delivery to radiopharmacies and hospitals across the United States and Canada.
Tc-99m is used in over 40 million diagnostic procedures annually, and is the daughter isotope of molybdenum-99 (Mo-99). Historically Mo-99 has been produced within research reactors using uranium as a starting material. Alternatively, the BWXT Tc-99m generator will be produced from natural molybdenum targets irradiated at a commercial power reactor, greatly reducing complex waste by-products. These targets are processed into the finished active pharmaceutical ingredient and then loaded into generators that have the function and form of generators already used at radiopharmacies and hospitals today.
"We are excited to reach this key milestone for BWXT Medical, putting us one step closer toward our aspiration of global leadership in nuclear medicine manufacturing," said Rex D. Geveden, BWXT's president and chief executive officer. "Our Tc-99m generator product is a lower cost, more reliable, drop-in replacement to current generators, and we see it as a key component of our medical portfolio."
"BWXT's multi-year, comprehensive R&D campaign is resulting in not only a foundational product line for the business, but also in the delivery of a crucial diagnostic drug product that supports the health of millions of people," said Dr. Jonathan Cirtain, president and chief executive officer of BWXT Medical. "Beyond Tc-99m, I am excited to lead BWXT Medical through a compelling set of growth opportunities including early success indications driven by breakthroughs in therapeutic nuclear medicine."
"Our multi-faceted growth strategy is focused on commercializing our Tc-99m generator, expanding our base business of cGMP-quality isotopes and finished drug products, and providing new therapeutic radioisotopes and sterile drug products to address significant growing demand for these innovative therapies," said Dr. Cirtain.
BWXT has published a presentation on the Investor Relations section of its website about BWXT Medical. The presentation highlights the subsidiary's Tc-99m generator strategy, its growing nuclear medicine product portfolio and exciting future opportunities in therapeutic radioisotopes. The presentation can be found here.
BWX Technologies, Inc. (NYSE:BWXT) announced today that subsidiary BWXT Medical Ltd. has submitted a new drug application to the U.S. Food and Drug Administration (FDA) to request approval of its technetium-99m (Tc-99m) generator for diagnostic imaging.
BWX Technologies,Inc.(纽约证券交易所代码:BWXT)今天宣布,其子公司BWXT Medical Ltd.已向美国食品和药物管理局(FDA)提交了一份新药申请,以请求批准其用于诊断成像的~(99m)Tc(Tc-99m)发生器。
Once approved for commercial production by regulatory bodies, BWXT Medical's new proprietary manufacturing technology will be used to irradiate molybdenum targets at an Ontario Power Generation reactor, process Mo-99 (the parent isotope of Tc-99m) and subsequently incorporate material into Tc-99m generators at BWXT Medical's Kanata, Ontario facility for delivery to radiopharmacies and hospitals across the United States and Canada.
一旦获得监管机构的商业生产批准,BWXT Medical的新专有制造技术将用于照射安大略省发电反应堆的钼靶,加工Mo-99(Tc-99m的母体同位素),然后将材料整合到BWXT Medical位于安大略省卡纳塔的工厂的Tc-99m发电机中,交付给美国和加拿大的放射性药物和医院。
Tc-99m is used in over 40 million diagnostic procedures annually, and is the daughter isotope of molybdenum-99 (Mo-99). Historically Mo-99 has been produced within research reactors using uranium as a starting material. Alternatively, the BWXT Tc-99m generator will be produced from natural molybdenum targets irradiated at a commercial power reactor, greatly reducing complex waste by-products. These targets are processed into the finished active pharmaceutical ingredient and then loaded into generators that have the function and form of generators already used at radiopharmacies and hospitals today.
TC-99m每年用于4000多万次诊断程序,是钼-99(Mo-99)的子体同位素。从历史上看,钼-99一直是在以铀为原料的研究反应堆中生产的。或者,BWXT TC-99m发生器将由商业电力反应堆照射的天然钼靶生产,大大减少复杂的废物副产品。这些靶子被加工成最终的活性药物成分,然后装载到发电机中,这些发电机具有今天已经在放射性制药和医院中使用的发电机的功能和形式。
"We are excited to reach this key milestone for BWXT Medical, putting us one step closer toward our aspiration of global leadership in nuclear medicine manufacturing," said Rex D. Geveden, BWXT's president and chief executive officer. "Our Tc-99m generator product is a lower cost, more reliable, drop-in replacement to current generators, and we see it as a key component of our medical portfolio."
宝华XT医疗集团首席执行官兼首席执行官雷克斯·D·格维登表示:“我们很高兴能达到宝华XT医疗集团的这一重要里程碑,这让我们离在核医学制造领域保持全球领先的目标又近了一步。”我们的Tc-99m发电机产品是当前发电机的低成本、更可靠的替代产品,我们将其视为我们医疗产品组合的关键组成部分。“
"BWXT's multi-year, comprehensive R&D campaign is resulting in not only a foundational product line for the business, but also in the delivery of a crucial diagnostic drug product that supports the health of millions of people," said Dr. Jonathan Cirtain, president and chief executive officer of BWXT Medical. "Beyond Tc-99m, I am excited to lead BWXT Medical through a compelling set of growth opportunities including early success indications driven by breakthroughs in therapeutic nuclear medicine."
保卫通医疗集团首席执行官兼首席执行官乔纳森·西尔坦博士说:“保卫通多年的全面研发活动不仅为该业务打造了一条基础性的产品线,而且还推出了一种支持数百万人健康的关键诊断药物产品。除了Tc-99m,我很高兴能够领导BWXT医疗公司通过一系列令人信服的增长机会,其中包括治疗性核医学突破所推动的早期成功迹象。“
"Our multi-faceted growth strategy is focused on commercializing our Tc-99m generator, expanding our base business of cGMP-quality isotopes and finished drug products, and providing new therapeutic radioisotopes and sterile drug products to address significant growing demand for these innovative therapies," said Dr. Cirtain.
Cirtain博士说:“我们的多方面增长战略侧重于将我们的Tc-99m发生器商业化,扩大我们cGMP质量的同位素和成品药物的基本业务,并提供新的治疗性放射性同位素和无菌药物产品,以满足对这些创新疗法的巨大增长需求。”
BWXT has published a presentation on the Investor Relations section of its website about BWXT Medical. The presentation highlights the subsidiary's Tc-99m generator strategy, its growing nuclear medicine product portfolio and exciting future opportunities in therapeutic radioisotopes. The presentation can be found here.
BWXT在其网站的投资者关系部分发布了一篇关于BWXT Medical的演示文稿。报告重点介绍了该子公司的Tc-99m发生器战略、不断增长的核医学产品组合以及令人兴奋的治疗性放射性同位素的未来机会。演示文稿可在此处找到。
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