欧洲最后一座青霉素工厂命悬一线：山德士称监管决定或成致命一击、中国原料药份额已达86%
奥地利昆德尔（Kundl）——瑞士制药公司山德士（Sandoz）位于奥地利阿尔卑斯山麓昆德尔镇的工厂，是欧洲最后一座从原料药到成品全程自产的青霉素工厂。山德士首席执行官理查德·塞诺尔（Richard Saynor）本周对彭博社表示，欧洲药品管理局打算把阿莫西林从关键药品清单中移除，这对这座工厂可能是「致命一击」。
「我们现在真的是到了午夜前一分钟，要决定是否继续留在欧洲生产青霉素，」塞诺尔说。消息传出当天，山德士股价一度下跌8.3%，创有记录以来最大单日跌幅。
这座工厂的困境是成本问题。据欧盟统计局数据，中国在欧盟青霉素及其原料药进口中的份额，已从2019年的44%升至去年的86%；注射用阿莫西林原料价格自去年1月以来暴跌56%，逼近历史低位。昆德尔工厂年产能为2.4亿包装，足以供应欧洲与北美的大部分需求，但塞诺尔说目前开工率只有一半多。
关键药品清单的地位，决定了工厂能否获得欧盟新《关键药品法案》下的资金支持与受保护的采购安排，从而与成本低得多的中国厂商竞争。这座工厂三年前刚完成2亿欧元扩建，其中5,000万欧元来自公共资金，背景是2022年底欧洲暴发阿莫西林短缺。今年3月，山德士已向欧盟委员会提交反倾销申诉，指控中国阿莫西林生产商以低于成本的价格扰乱市场。
昆德尔工厂负责人斯特凡妮·杰德纳（Stephanie Jedner）对路透社说，如果工厂关停，「欧洲将完全依赖中国」。该厂雇用2,000多名员工，耗电量约相当于附近有13万人口的因斯布鲁克市。
财务压力同时体现在业绩上：山德士第三季度净销售额为29.4亿美元，低于约30.1亿美元的市场预期，并把全年销售增长指引下调至5%至6%；公司称抗感染业务的批发端逆风使当季增长少了约两个百分点。
（来源：路透社）
Europe's Last Penicillin Plant on the Brink: Sandoz Warns a Regulatory Move Could Be a 'Death Blow' as China's Share Hits 86%
Kundl, Austria — The Sandoz plant in the Austrian Alpine town of Kundl is Europe's last fully integrated penicillin factory, making the antibiotic from raw active ingredients through to finished products. Sandoz chief executive Richard Saynor told Bloomberg this week that Europe's medicines regulator wants to drop amoxicillin from its list of critical medicines, a move he called a potential death blow to the plant.
"We're now literally at one minute to midnight to deciding whether we continue to stay in Europe making penicillin," Saynor said. Sandoz shares fell as much as 8.3 percent on the day, their worst drop on record.
The plant's problems are about cost. China's share of EU imports of penicillins and their ingredients rose from 44 percent in 2019 to 86 percent last year, according to Eurostat data, and injectable-amoxicillin raw-material prices have plunged 56 percent since January last year, close to an all-time low. The Kundl plant can make 240 million packages a year, enough for most of Europe and North America, but Saynor said it is running at just over half its capacity.
Placement on the critical medicines list is the door to funding and protected procurement under the EU's new Critical Medicines Act, support that could let a higher-cost European operation survive. The plant completed a 200-million-euro expansion three years ago, including 50 million euros in public funds, after an amoxicillin shortage that began in late 2022. In March, Sandoz filed an anti-dumping complaint with the European Commission, accusing Chinese amoxicillin makers of selling below production cost.
"If the plant closes, Europe will be completely dependent on China," Kundl site director Stephanie Jedner told Reuters. The site employs more than 2,000 people and uses roughly as much electricity as the nearby city of Innsbruck, home to over 130,000 people.
The pressure showed in the company's results: third-quarter net sales came in at $2.94 billion, short of the roughly $3.01 billion consensus, and Sandoz cut its full-year sales-growth guidance to 5 to 6 percent, saying an anti-infective wholesale headwind stripped about two percentage points off quarterly growth.
(Source: Reuters)
来源：路透社
发布：GSM·美国（发布链接）
图片来源：图：奥地利蒂罗尔州昆德尔镇（欧洲最后一座一体化青霉素工厂所在地，资料图）。CC BY-SA 3.0，经 Wikimedia Commons。 / Photo: Kundl, Tyrol, Austria, home to Europe's last fully integrated penicillin plant (file photo). CC BY-SA 3.0, via Wikimedia Commons.
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