When it comes to expanding radiotherapy manufacturing capacity for Lutathera and Pluvicto, Novartis is putting its money where its mouth is.

在扩大Lutathera和Pluvicto的放射治疗制造能力方面，诺华正在把钱放在嘴里。

The Swiss pharma is building a new radiotherapy production facility in China with an investment of more than 600 million Chinese yuan ($84.6 million), the company said (Chinese) Friday.

该公司周五表示，瑞士制药正在中国建造一家新的放射治疗生产设施，投资超过6亿元（合8460万美元）。

The new plant is located in Haiyan in the Zhejiang province about 60 miles from Shanghai. Pending regulatory approvals, the plant is expected to be operational in 2026.

新工厂位于距离上海约60英里的浙江省海燕市。在获得监管部门批准之前，该工厂预计将于2026年投入运营。

Radioligand therapy requires sophisticated technology to ensure that the medication can reach patients within hours of production, Novartis’ operations president Steffen Lang, Ph.D., said in a Chinese statement. The Haiyan facility will make sure that patients in need of these therapies receive a consistent and reliable treatment experience, he added..

诺华公司运营总裁Steffen Lang博士在一份中国声明中说，放射性配体治疗需要复杂的技术，以确保药物能够在生产后数小时内到达患者。他补充说，海燕设施将确保需要这些治疗的患者获得一致可靠的治疗经验。。

The Chinese project adds to Novartis’ existing radioligand therapy manufacturing facilities in Ivrea, Italy; Zaragoza, Spain; Millburn, New Jersey; and Indianapolis, Indiana, which is pending FDA approval to supply commercial doses. Novartis is aiming to have a combined annual capacity of at least 250,000 doses from existing facilities by around 2024..

中国项目增加了诺华在意大利伊夫雷亚现有的放射性配体治疗生产设施；萨拉戈萨，西班牙；Millburn，新泽西州；和印第安纳州的印第安纳波利斯，正在等待FDA批准提供商业剂量。诺华的目标是到2024年左右从现有设施中获得至少250000剂的年总产能。。

Further, the company is evaluating the possibility of establishing more production base in other key markets.

此外，该公司正在评估在其他关键市场建立更多生产基地的可能性。

The volume of production capacity at the new Haiyan site remains unclear, and Novartis didn’t say  whether the site will supply to markets other than China. The copmany didn’t immediately reply to a Fierce Pharma inquriy by publication time.

新海燕网站的生产能力尚不清楚，诺华没有说该网站是否会供应到中国以外的市场。在出版时，copmany没有立即回复激烈的制药公司。

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Amid Pluvicto shortage, FDA quickly clears Novartis manufacturing facility

在Pluvicto短缺的情况下，FDA迅速清除诺华制造工厂

The expansion comes as Novartis grapples with surging demand for its PSMA-targeted radiotherapy Pluvicto in prostate cancer. In fact, demand was so high that the drug earlier this year went into a temporary shortage, which was resolved in fall.

随着诺华公司应对前列腺癌PSMA靶向放射治疗加VICTO需求激增，扩张。事实上，需求如此之高，今年早些时候该药物暂时短缺，并在秋季得到解决。

Meanwhile, the company is preparing to move Pluvicto into earlier lines of treatment, which would significantly increase the therapy’s patient base. But Novartis recently postponed a potential FDA filing for Pluvicto as a pre-chemo treatment as it awaits a longer-term overall survival readout from the phase 3 PSMAfore trial..

与此同时，公司正在准备将Pluvicto转移到早期的治疗方案中，这将显着增加治疗的患者基础。但诺华最近推迟了FDA提交Pluvicto作为化疗前治疗的潜在申请，因为它正在等待第3阶段PSMAfore试验的长期总生存期读数。。

In China, Novartis in May kicked off a phase 2 trial for Pluvicto in Chinese patients with progressive PSMA-positive metastatic castration-resistant prostate cancer. The global phase 3 PSMAdditioin trial that’s testing Pluvicto in metastatic hormone-sensitive disease includes multiple sites in China..

在中国，诺华5月开始对中国进行性PSMA阳性转移性去势抵抗性前列腺癌患者进行Pluvicto的2期临床试验。正在测试Pluvicto治疗转移性激素敏感性疾病的全球3期PSMAdditioin试验包括中国的多个地点。。

In its Friday press release, Novartis highlighted recent guidance on reviewing radiotherapies from China’s National Medical Products Administration. The agency encourages innovative radiotherapies that are already approved abroad to seek registration in China and offers expedited reviews for those therapies that meet urgent medical need.

诺华在周五的新闻稿中强调了最近关于审查中国国家医疗产品管理局放射治疗的指导。该机构鼓励已获得国外批准的创新放射疗法在中国寻求注册，并为满足紧急医疗需求的疗法提供快速审查。

Novartis hopes the new facility will accelerate the introduction of its radioligand therapy into the country..

诺华希望新设施能够加速将其放射性配体治疗引入该国。。

China is an important market for Novartis, and the new Haiyan facility will further expand the reach of Novartis’ innovative medicines, Lang said in his statement.

郎在声明中说，中国是诺华的重要市场，新海燕工厂将进一步扩大诺华创新药物的覆盖面。

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Novartis brings radiotherapy production back online, touts expansion plans

诺华将放射治疗生产带回网上，吹捧扩张计划

China, alongside the U.S., Germany and Japan, is a priority geography for Novartis. Back in September 2022, Novartis laid out a goal to be a top-three pharma player in China, up from fifth. And the radioligand field is one of three novel technology platforms that the company is focused on besides the traditional chemistry and biologics.

中国与美国，德国和日本一起，是诺华的优先地理位置。早在2022年9月，诺华就制定了成为中国三大制药企业的目标，从第五位上升。放射性配体领域是该公司除传统化学和生物制剂之外关注的三大新技术平台之一。

The other two platforms are xRNA and cell & gene therapy..

另外两个平台是xRNA和细胞与基因治疗。。

After a pandemic-related lull, China has lately been delivering double-digit sales growth for Novartis. In the third quarter, the Swiss pharma booked a 14% revenue growth in the country at constant currencies to $848 million.

在大流行相关的平静之后，中国最近为诺华提供了两位数的销售增长。在第三季度，瑞士制药以恒定货币预定该国14%的收入增长至8.48亿美元。

Besides the new radiotherapy plant, Novartis owns a large facility in Beijing. That oral drug production plant occupies 6.9 acres of land and can make up to 3 billion tablets per year. Back in 2019, Novartis sold a drug ingredient plant in the Shanghai-neighboring city of Suzhou to local firm Zhejiang Jiuzhou for about $110.5 million..

除了新的放射治疗工厂外，诺华还在北京拥有一家大型设施。该口服药物生产工厂占用6.9英亩的土地，每年可构成30亿片。早在2019年，诺华就在上海邻近城市苏州向当地公司浙江九州出售了一家原料药工厂，价格约为1.155亿美元。。