Iobitridol

12月27日，据CDE官网显示，重庆圣华曦药业递交的4类仿制化药碘佛醇注射液上市申请获受理。今年6月份，倍特药业也提交了该品种的上市申请。数据显示，除原研，目前仅2家国产企业拥有该品种的批文，若重庆圣华曦药业和倍特药业能顺利获批，有望斩获国产第3家。截图来源：CDE官网碘佛醇注射液最早由美国万灵科(Mallinckrodt)公司研制，于1988年获得FDA批准在美国上市，1999年进入国内市场，2000年进入医保乙类，2009年进入医保甲类。它是一种血管造影剂，用于各种血管造影、CT增强检查等。主要为经血管用药的非离子、低渗透、水溶性、不透射线造影剂，作用机制为经血管注入后，造影剂流经的血管将变成不透光状态，从而可在X线下显影。0126亿+“销冠”造影剂恒瑞占据九成市场数据显示，碘佛醇注射液自上市以来，在全国院内销售市场规模持续增长。该产品2022年在全国院内销售额超26亿元，同比增长近20%。其中，恒瑞医药占据了91.93%的市场份额。2022年全国院内销售市场有16个造影剂销售额超过1亿元，其中碘佛醇注射液以超26亿元的销售额首次荣登“销冠”王者宝座，其次碘克沙醇注射液、碘普罗胺注射液、碘海醇注射液3个品种销售额超12亿。2022年全国院内销售市场，国内企业在造影剂领域已经超越了外国企业，成为市场的领跑者。在前10名企业中，本土药企占据8席，分别有恒瑞医药、博莱科国际有限公司、通用电气、扬子江药业、北京北陆药业、中国生物制药、上海司太立制药、广州康臣药业，其余2家企业均为外企。02恒瑞率先拿下首仿圣华曦、倍特抢国产第3家恒瑞医药率先于2006年拿下碘佛醇注射液国内首仿，并在2021年8月夺得了首家过评。数据显示，除原研，国内仅有恒瑞医药和上海司太立制药2家国产企业拥有该品种的批文。目前碘佛醇注射液仅有重庆圣华曦药业和倍特药业提交了仿制上市申请，均在审评审批中，若重庆圣华曦药业和倍特药业能顺利获批，有望斩获国产第3家。重庆圣华曦药业已有多款产品获批并视同通过一致性评价，包含甲磺酸伊马替尼片、非布司他片、依折麦布片、左乙拉西坦口服溶液、左乙拉西坦注射液、瑞巴派特片、磷酸奥司他韦胶囊7款品种。除此次提交的碘佛醇注射液，还提交了20款产品的仿制申请，均在审评审批中。除了碘佛醇注射液，其在造影剂布局还有碘比醇注射液、碘美普尔注射液、碘普罗胺注射液3款。截至2023年10月，倍特药业累计有94个药品过评，涉及全身用抗感染药、呼吸系统用药、神经系统用药、消化系统及代谢药等多个领域。其中，在造影剂领域，其碘普罗胺注射液于2022年8月获批并成为国内首仿，碘帕醇注射液、碘克沙醇注射液于今年5月相继获批上市。此外，倍特药业还有7款造影剂处于待获批状态。END作者 | 药融云来源 | 药融云赛柏蓝药械交流群扫描下方二维码加入医药代理商转型交流群扫描下方二维码加入

Revenue at 30 September 2023 Activity 9-month revenue: €573.9 million, up 2.7% at CER1 Third-quarter sales remained very strong in Asia (+15.2% at CER), were stable in EMEA (+0.6%) and showed a smaller decline in the Americas (-5.2%)Expecting double-digit activity growth in the fourth quarter of 2023 thanks to the surge in sales of EluciremTM and strong momentum in Interventional Imaging Financial targets confirmed 2023 revenue up by more than 5% like-for-like and at CERRestated EBITDA margin2 of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%) Villepinte, 19 October 2023: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the period to 30 September 2023. Over the first nine months of the year, Group sales came to €573.9 million, up 0.8% on the same period in 2022. Business activity reflected a negative forex effect of €10.4 million. At CER1, revenue for the first nine months grew by 2.7%. Sales in the third quarter of 2023 came to €195.2 million, up 2.3% at CER, after rising by 2.8% during the first half of the financial year. Taking into account the expected ramp-up in EluciremTM sales in the fourth quarter, this scenario supports Guerbet’s financial targets for the full year and for next year. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeSales in EMEA245.2258.5+5.4%258.6+5.5%Sales in the Americas182.5160.9-11.8%161.5-11.5%Sales in Asia141.4154.4+9.2%164.2+16.1%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. In the EMEA region, the Group saw an increase in 9-month sales of 5.4% at current exchange rates and 5.5% at CER, driven by the increase in volumes and positive price effects. In the third quarter, revenue for the region came to €79.9 million, with moderate growth (+0.6% at CER) linked to a particularly high comparison base. In the Americas, sales for the period to end-September 2023 fell by 11.8% at current exchange rates and by 11.5% at CER. As expected, the decline in revenue slowed significantly in the third quarter to -5.2% at CER. After the complete normalisation of production rates during the first half of 2023, the Raleigh (North Carolina) site was again able to increase its production capacity with a view to increasing its sales - of EluciremTM in particular - in the fourth quarter. In Asia, sales growth over the 9-month period was +9.2%, incorporating a particularly substantial negative forex effect of -€9.8m (depreciation of Chinese, Japanese and Korean currencies) during the period; at CER, growth was +16.1%, a remarkable performance driven mainly by China (+39%), which continued to benefit from the introduction of direct distribution in 2022. In the third quarter alone, sales in Asia were up 15.2% at CER. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 September 20239 months 20229 months 2023At current exchange rates% change9 months 2023At CER1% changeDiagnostic Imaging 502.2506.4+0.8%515.3+2.6%MRI192.4187.3-2.7%189.4-1.6%X-ray309.8319.0+3.0%325.8+5.2%Interventional Imaging67.067.5+0.7%69.0+3.0%Total569.2573.9+0.8%584.3+2.7% 1Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year. Revenue from Diagnostic Imaging at CER was up 2.6% at 30 September 2023 (+0.8% at current exchange rates) and up 1.2% in the third quarter. Note that the X-ray division now includes the revenue of Intrasense, consolidated since 1 January 2023. In MRI, sales for the 9-month period were down 1.6% at CER due to a contraction in activity in the third quarter of 2023. This reflects: A negative price effect linked to the price pressure exerted by the generic product for Dotarem® on the US market.Sales of EluciremTM which slowed in the third quarter due to longer-than-expected approval times (formulary process) in US hospitals, with a strong catch-up effect expected from the fourth quarter of 2023. In the X-ray division, revenue rose by 5.2% over the first nine months at CER, marked by a sharp acceleration in growth in the third quarter (+8.7%), again due to a sharp increase in sales of Xenetix®. In Interventional Imaging, sales at CER were up 3.0% compared with the first nine months of 2022. After a negative comparison base effect in the Asia-Pacific region in the first half of 2023, revenue for the third quarter rose by a sharp 10.3%, driven by strong sales of Lipiodol®. Financial targets for 2023 and 2024 confirmed Activity continues to be underpinned by robust volumes and broadly positive price effects (with the exception of Dotarem®), reflecting the Group’s ability to pass on cost increases to its customers (iodine in particular). In the fourth quarter of 2023, Guerbet expects double-digit sales growth driven by a very strong rebound in activity in the United States, linked in particular to the ramp-up of EluciremTM sales once the current approval processes are completed, and to continued favourable trends in Interventional Imaging. For the full year, Guerbet confirms that it is targeting revenue growth of more than 5% like-for-like and at CER. It still expects a restated EBITDA2 to revenue ratio of around 11% in 2023, before returning in 2024 to a higher level than in 2021 (14.4%). As a reminder, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favourable opinion on the granting of marketing authorisation for Elucirem™ in the European Union for use in adults and children aged two and older for contrast-enhanced MRI. The European Commission is expected to make its decision by the end of 2023. Next event: Publication of full-year revenue8 February 2024 after market close About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €753 million in revenue in 2022. Forward-looking statements Certain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control.These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.23-0203 on March 31, 2023, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. 2 Excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts : Guerbet Jérôme Estampes, Chief Financial Officer +33.1.45.91.50.00 / jerome.estampes@guerbet.comClaire Lauvernier, Communications Director +33.6.79.52.11.88 / claire.lauvernier@guerbet.com Actifin Marianne Py, Financial Communications +33.1.80.48.25.31 / mpy@actifin.frJennifer Jullia, Press +33.1.56.88.11.19 / jjullia@actifin.fr Attachment 23 1019 Guerbet_ CP CA T3 VA Vdef