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被学长抱进小树林C个爽作文:带你走进前所未有的互动体验与分享盛宴
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  来源:国际金融报

  兴齐眼药还能凭借“近视神药”走多久?

  4月21日盘后,兴齐眼药发布2024年财报:全年实现营收19.43亿元,同比增长32.42%;归母净利润3.38亿元,同比增长40.84%。

  受此消息影响,4月22日,兴齐眼药微涨0.31%,报收71.9元/股。

  值得注意的是,随着年报的披露,兴齐眼药旗下“近视神药”硫酸阿托品滴眼液也交出了成绩单。从公司滴眼剂产品的销售情况来看,硫酸阿托品滴眼液并未达到此前市场机构预计的15亿元。同时,硫酸阿托品滴眼液竞品的上市许可申请已在今年获得国家药品监督管理局受理。

  “近视神药”销售不及市场预期

  硫酸阿托品滴眼液是兴齐眼药近年来最受市场关注的核心产品,该滴眼液主要用于延缓球镜度数为-1.00D至-4.00D(散光≤1.50D、屈光参差≤1.50D)的6至12岁儿童的近视进展。

  据弗罗斯特沙利文数据,近年来我国20岁以下近视患者人数持续增长,预测2025年将达到1.87亿人。另据国家疾控局监测数据,2022年我国现阶段儿童青少年总体近视率高达51.9%。因此,近年来近视相关产品市场持续扩大。

  兴齐眼药的硫酸阿托品滴眼液被不少家长奉为“近视神药”。该药在正式获批前已通过院内制剂的方式进行出售。最初,患者不仅可以在兴齐眼科医院进行线下购买,也可以通过兴齐眼科互联网医院上传病历、检查单和处方,再加上医生审核的方式进行远程购买。

  但在2022年7月,硫酸阿托品滴眼液受到互联网禁售监管,兴齐眼科也发布公告称,互联网医院暂停处方院内制剂0.01%硫酸阿托品滴眼液销售。

  直到2024年3月,兴齐眼药的硫酸阿托品滴眼液才正式获得国家药品监督管理局批准上市,成为我国首款获批的用于延缓儿童近视进展的低浓度硫酸阿托品滴眼液。

  据了解,该产品已被列入《2024近视防控指南》《近视防控白皮书》《低浓度阿托品滴眼液临床应用中国专家共识2024版》多项指南,并被推荐为我国儿童青少年近视长期管理的基础用药。

  硫酸阿托品滴眼液上市后,券商机构对该产品保持着乐观的态度。其中,国盛证券研报预计,兴齐眼药的阿托品滴眼液2024年收入有望达到约15亿元,在渗透率逐步提升的情况下,该产品在2030年收入有望达到约68亿元。

  德邦证券预测中性情况下,兴齐眼药的阿托品滴眼液能在上市的第三个完整年(即2027年),达到101.8亿元的销售峰值。

  但根据年报,硫酸阿托品滴眼液的销售情况显然未达预期。兴齐眼药去年的滴眼剂系列(包括硫酸阿托品滴眼液在内)产品的整体销售额都未能达到15亿元,仅为13.66亿元。

  市值坐上过山车

  兴齐眼药硫酸阿托品滴眼液在市场上备受关注的程度,在公司的股价上也能够充分反应。

  2024年硫酸阿托品滴眼液获批后,兴齐眼药股价屡创新高,最高曾在去年5月13日达到巅峰的299.99元,当日收盘价为291元,公司总市值突破360亿元。

  随着兴齐眼药2024年半年报的发布,以及硫酸阿托品滴眼液销售情况的揭晓。公司去年下半年股价持续下滑,跌落至去年9月24日盘中的最低值64.88元,随后又略有起色。

  截至4月22日,兴齐眼药报收71.9元,市值126亿元,较此前的历史高位已蒸发超200亿元。

  目前来看,兴齐眼药硫酸阿托品滴眼液的市场前景仍存在一定的不确定性。特别是在今年2月,恒瑞医药的硫酸阿托品滴眼液(HR19034滴眼液)的药品上市许可申请已获国家药品监督管理局受理。

  今年1月,兆科眼科曾公告称,国家药品监督管理局已受理NVK002(低剂量阿托品0.01%)的简化新药申请。并且,相较于恒瑞医药和兴齐眼药,兆科眼科这款药物的目标患者组别更为广泛,为3至17岁的儿童及青少年。

  另针对硫酸阿托品滴眼液市场独占期的问题,兴齐眼药方面表示,2022年国家药监局综合司公开征求《中华人民共和国药品管理法实施条例(修订草案征求意见稿)》意见中提到,儿童用药给予最长不超过12个月的市场独占期。

  2018年国家药品监督管理局关于公开征求《药品试验数据保护实施办法(暂行)》意见中提到:对儿童专用药,自该适应症首次在中国获批之日起给予6年数据保护期。

  “但目前上述文件仅为征求意见稿,并未落地实施。”兴齐眼药指出。

  目前,除硫酸阿托品滴眼液外,兴齐眼药旗下还有一款核心滴眼剂产品环孢素滴眼液(Ⅱ),该产品主要用于干眼症患者。兴齐眼药曾披露这款产品在2024年前三季度保持良好增长,目前在干眼治疗领域处于优势地位。

  研发方面,兴齐眼药2024全年投入2.21亿元,同比增长31.9%。其中硫酸阿托品滴眼液(0.02%/0.04%)和硫酸阿托品滴眼液(0.01%)已进入临床末期。

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