去年艾滋病发病数是新冠约4倍！中国首款抗艾创新药仅需每周打1针，已进医疗保险
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/CFF20LXzkOyx0mFUW6nq3IA9zuy2PqicQ6KJGuAIhIWstvBBeXzQ26TGzdeAHo9HKPkYwOf2libaHKfZUxYdkDhQ/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/2eic4iblTAWEXoxLgR9V3ZE60HfuAPI1sK3yrTI3yDhvDHTAxXbgHVa7r7qNJE4escYAwugwweHLKfD03H0XbY9g/640?wx_fmt=jpeg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;"><strong style="color: blue;">■ <span style="color: black;">关联</span><span style="color: black;">机构</span>：</strong>前沿生物</span><span style="color: black;">（<span style="color: black;">SH</span>688221，股价14.95元，市值54亿元）</span><span style="color: black;"><strong style="color: blue;">■ 核心</strong></span><span style="color: black;"><strong style="color: blue;">竞争力</strong></span><strong style="color: blue;"><span style="color: black;">：</span></strong><span style="color: black;"><span style="color: black;">机构</span>前身为2002年成立的重庆前沿，<span style="color: black;">拥有</span>20年<span style="color: black;">开发</span>经验，在HIV长效治疗<span style="color: black;">行业</span><span style="color: black;">拥有</span>国际竞争力，在研<span style="color: black;">制品</span>FB1002拟探索艾滋病免疫疗法，实现功能性治愈；<span style="color: black;">持有</span>抗HIV创新药艾可宁（通用名：艾博韦泰）；抗新冠病毒在研<span style="color: black;">制品</span>注射用FB2001；有成熟的抗病毒<span style="color: black;">行业</span>技术<span style="color: black;">累积</span>和丰富的<span style="color: black;">制品</span>管线等</span><span style="color: black;"><strong style="color: blue;">■ <span style="color: black;">公司</span>眼中的</strong></span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">机构</span>：</strong></span><span style="color: black;">FB2001静脉注</span><span style="color: black;">射3CL蛋白酶<span style="color: black;">控制</span>剂正在</span><span style="color: black;">开展国际多中心II/III期临床<span style="color: black;">实验</span>，拟治疗<span style="color: black;">全世界</span>新冠肺炎住院<span style="color: black;">病人</span>；疫情波动常态化，新冠治疗及预防<span style="color: black;">药品</span>成刚需品种，国内仍有市场空间</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">■ 所属</span></strong></span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">概念：</span></strong></span><span style="color: black;">生物医</span><span style="color: black;">药、新冠<span style="color: black;">药品</span>、HIV药物、创新药</span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZsoV0JLs3o0l2bPFGhibeib07GeYy4Ur9c1iaRH02dKg54tIgasS99o7xZg/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;">艾滋病，又<span style="color: black;">叫作</span><span style="color: black;">得到</span>性免疫缺陷<span style="color: black;">综合症</span>（AIDS），与其它病毒性感染<span style="color: black;">疾患</span>相比，<strong style="color: blue;">艾滋病最大的区别在于其几乎<span style="color: black;">无</span>自愈性，并且<span style="color: black;">截止</span><span style="color: black;">日前</span>还<span style="color: black;">无</span>能够彻底治愈艾滋病的<span style="color: black;">药品</span>和疫苗，大<span style="color: black;">都数</span><span style="color: black;">病人</span><span style="color: black;">必须</span>终生服药以<span style="color: black;">控制</span>病毒。</strong></span><span style="color: black;"><span style="color: black;">全世界</span>每年艾滋病新增感染者数百万，<span style="color: black;">日前</span><span style="color: black;">重点</span>采用的鸡尾酒疗法虽<span style="color: black;">能够</span>减少单一用药产生的抗药性，其<span style="color: black;">坏处</span>端除了给药频率较高以外，<span style="color: black;">长时间</span>治疗不可避免地会<span style="color: black;">显现</span>毒副<span style="color: black;">功效</span>，病患产生耐药病毒，依从性变差等问题，在历经几十年的科学<span style="color: black;">科研</span>中，<span style="color: black;">海量</span>数据<span style="color: black;">显示</span>，<strong style="color: blue;">长效<span style="color: black;">药品</span>或缓释制剂<span style="color: black;">能够</span>为艾滋病的治疗和预防<span style="color: black;">供给</span>新的<span style="color: black;">选取</span>，<span style="color: black;">能够</span>有效<span style="color: black;">处理</span>因<span style="color: black;">长时间</span>接受抗病毒治疗所产生的问题</strong>。</span><span style="color: black;">在治疗手段上，仿制药和进口<span style="color: black;">药品</span>此前<span style="color: black;">始终</span>是国内市场的主角，本土<span style="color: black;">公司</span>的创新<span style="color: black;">药品</span>则屈指可数。前沿生物注射用艾可宁（通用名：艾博韦泰）的上市打破了国外药企在抗艾滋病<span style="color: black;">药品</span><span style="color: black;">行业</span>的垄断，<span style="color: black;">创立</span>起了中国在该<span style="color: black;">行业</span>的创新壁垒。</span><span style="color: black;"><span style="color: black;">做为</span>艾可宁<span style="color: black;">暗地里</span>的<span style="color: black;">开发</span><span style="color: black;">公司</span>，前沿生物<span style="color: black;">亦</span>于2020年10月在科创板挂牌上市。在科创板开市三周年之际，<strong style="color: blue;">《每日经济<span style="color: black;">资讯</span>》记者专访了前沿生物董事长、首席<span style="color: black;">专家</span>谢东</strong>。</span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">面对市场需求</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">我国首款艾滋病原创新药应运而生</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;">当前我国在抗艾滋病毒<span style="color: black;">行业</span>的形势非常严峻，艾滋病的发病率及死亡率逐年呈<span style="color: black;">提升</span>趋势。<span style="color: black;">按照</span>国家<span style="color: black;">疾患</span>预防<span style="color: black;">掌控</span>局披露的数据，2021年，全国共报告传<span style="color: black;">患病</span>6233537例，死亡22198人；其中，</span><span style="color: black;">艾滋病报告发病60154例，死亡19623例，发病率为4.2669 /10万，死亡率高达1.3919/10万，死亡人数居全国甲乙类传<span style="color: black;">患病</span>的首位。<span style="color: black;">做为</span>对比，2021年新冠肺炎报告发病15243例，死亡2例。</span><span style="color: black;">据<span style="color: black;">认识</span>，<span style="color: black;">日前</span>针对艾滋病的治疗应用最为广泛的是“鸡尾酒疗法”，该疗法最先由美国华裔<span style="color: black;">专家</span>何大一提出，<span style="color: black;">指的是</span><span style="color: black;">运用</span>三种<span style="color: black;">或</span>三种以上<span style="color: black;">区别</span><span style="color: black;">功效</span>机制的抗逆转录病毒<span style="color: black;">药品</span>进行治疗，除了有效<span style="color: black;">控制</span>艾滋病毒在<span style="color: black;">病人</span><span style="color: black;">身体</span>的复制，该疗法还<span style="color: black;">能够</span>减轻单一<span style="color: black;">药品</span>的抗药性。<span style="color: black;">由于</span>该疗法的<span style="color: black;">明显</span>特点是多种<span style="color: black;">药品</span>混合<span style="color: black;">运用</span>，类似鸡尾酒的调配，<span style="color: black;">亦</span><span style="color: black;">因此呢</span>被人们<span style="color: black;">叫作</span>之为鸡尾酒疗法。</span><span style="color: black;">世界卫生组织（ WHO） 和中国艾滋病诊疗指南均<span style="color: black;">意见</span>，一旦确诊艾滋病，应立即<span style="color: black;">起始</span>联合抗逆转录病毒治疗并终生维持，且当初治<span style="color: black;">方法</span>对<span style="color: black;">病人</span><span style="color: black;">没</span>效或不耐受时，即需进行换药。<span style="color: black;">全世界</span>每年HIV新增感染者数百万，<span style="color: black;">因此呢</span>临床上亟需<span style="color: black;">更加多</span><span style="color: black;">方便</span>、安全、<span style="color: black;">有效</span>的抗病毒<span style="color: black;">药品</span>。<span style="color: black;">然则</span>，国内艾滋病用药水平却相对落后，临床用药<span style="color: black;">选取</span>较少且以国家免费仿制药、老药为主，缺乏长效<span style="color: black;">药品</span>。</span><span style="color: black;">谢东于1993年在美国约翰霍普金斯大学取得博士学位，并先后担任约翰霍普金斯大学生物量热中心执行<span style="color: black;">专家</span>、美国国家肿瘤<span style="color: black;">科研</span>所（NCI）生物<span style="color: black;">理学</span>实验室<span style="color: black;">专家</span>等职务，<span style="color: black;">这里</span><span style="color: black;">时期</span>，谢东领导和参与了多个艾滋病新药<span style="color: black;">全世界</span><span style="color: black;">研发</span>与上市工作。</span><span style="color: black;">谢东告诉记者，<strong style="color: blue;"><span style="color: black;">日前</span><span style="color: black;">全世界</span>大<span style="color: black;">大概</span>三十多款针对艾滋病的<span style="color: black;">药品</span>，其中<span style="color: black;">都数</span>为口服药，尽管多款口服药在鸡尾酒疗法下临床效果<span style="color: black;">明显</span>，但<span style="color: black;">药品</span>的毒副<span style="color: black;">功效</span><span style="color: black;">亦</span>会给<span style="color: black;">病人</span>身体带来<span style="color: black;">极重</span><span style="color: black;">包袱</span>，并且<span style="color: black;">长时间</span><span style="color: black;">运用</span><span style="color: black;">亦</span>容易<span style="color: black;">引起</span><span style="color: black;">病人</span><span style="color: black;">显现</span>耐药现象</strong>。“<span style="color: black;">因此</span><span style="color: black;">咱们</span>当时设计艾可宁的<span style="color: black;">另一</span>一个特点，<span style="color: black;">便是</span>它<span style="color: black;">拥有</span>全新的<span style="color: black;">功效</span>机制，它不仅是长效注射，还对<span style="color: black;">日前</span>现有的耐药病毒<span style="color: black;">所有</span>有效，这一特性<span style="color: black;">亦</span>使得<span style="color: black;">病人</span>在<span style="color: black;">显现</span>多重耐药的<span style="color: black;">状况</span>下，艾可宁能够<span style="color: black;">作为</span>一个救命药。”</span><span style="color: black;"><span style="color: black;">这里</span>契机下，艾可宁孕育而生。<strong style="color: blue;">2018年6月5日，前沿生物自主<span style="color: black;">开发</span>的国家一类新药艾可宁<span style="color: black;">得到</span>国家<span style="color: black;">药物</span>监督管理局<span style="color: black;">准许</span>上市。<span style="color: black;">做为</span>我国首个治疗艾滋病的原创新药、<span style="color: black;">全世界</span>首个抗艾滋病病毒（HIV）长效融合<span style="color: black;">控制</span>剂，填补了国内抗艾滋病创新药的空白</strong>。</span><span style="color: black;">“艾可宁在分子结构、多肽序列及化学修饰、<span style="color: black;">功效</span>靶点以及在人<span style="color: black;">身体</span>的分布与代谢上均实现了技术突破。”谢东介绍，<span style="color: black;">首要</span>在<span style="color: black;">功效</span>机制上，艾可宁与靶点HIV膜蛋白gp41结合，<span style="color: black;">控制</span>病毒膜与人体CD4+T细胞膜融合，<span style="color: black;">功效</span>于HIV病毒感染的<span style="color: black;">第1</span>环节。<strong style="color: blue;"><span style="color: black;">因为</span><span style="color: black;">功效</span>靶点gp41存在于所有HIV-1病毒，<span style="color: black;">无</span>病毒嗜性等<span style="color: black;">选取</span>性，<span style="color: black;">因此呢</span>艾可宁对<span style="color: black;">重点</span>流行HIV病毒<span style="color: black;">包含</span>耐药病毒都有效</strong>。</span><span style="color: black;">第二个特点则是艾可宁长效注射的给药方式，<strong style="color: blue;">艾可宁在人<span style="color: black;">身体</span><span style="color: black;">拥有</span>11-12天长半衰期，大幅长于<span style="color: black;">通常</span>多肽<span style="color: black;">药品</span>2-3小时的<span style="color: black;">身体</span>半衰期，因而仅需每周注射一次，用药频率低</strong>，<span style="color: black;">提高</span>了用药依从性及便利性，更易被医患所接受。</span><span style="color: black;"><span style="color: black;">另外</span>，</span><span style="color: black;">艾可宁属于多肽<span style="color: black;">药品</span>，其在<span style="color: black;">身体</span>经水解变成氨基酸和水，不经过肝脏代谢，副<span style="color: black;">功效</span>低，安全性高；</span><span style="color: black;">而口服<span style="color: black;">药品</span>则<span style="color: black;">重点</span>是<span style="color: black;">经过</span>肝肾代谢，艾可宁独特的代谢路径使其<span style="color: black;">作为</span><span style="color: black;">日前</span><span style="color: black;">药品</span>相互<span style="color: black;">功效</span>最小的一类抗艾滋病<span style="color: black;">药品</span>，适用于<span style="color: black;">必须</span><span style="color: black;">同期</span>治疗多种并发症的<span style="color: black;">病人</span>。“正是<span style="color: black;">因为</span><span style="color: black;">药品</span>相互作用较小的特点，艾可宁在全国的住院市场推广效果比较好，可能是<span style="color: black;">日前</span><span style="color: black;">运用</span>最多的<span style="color: black;">药品</span>之一。” 谢东<span style="color: black;">暗示</span>。</span><span style="color: black;">但不容<span style="color: black;">忽略</span>的是，多肽<span style="color: black;">药品</span>的特性<span style="color: black;">亦</span>决定了艾可宁在生产工艺上的<span style="color: black;">繁杂</span>。在艾可宁的生产供应方面，前沿生物确定了自建产能与外包合作“两条腿走路”的方式，“尤其是<span style="color: black;">针对</span>艾滋病<span style="color: black;">这般</span>的慢性病，<span style="color: black;">病人</span><span style="color: black;">必须</span><span style="color: black;">长时间</span>服药，一旦停药就可能<span style="color: black;">显现</span>病情加重<span style="color: black;">乃至</span>传染给他人的<span style="color: black;">危害</span>，<span style="color: black;">因此</span>为了<span style="color: black;">保准</span><span style="color: black;">药物</span>供应链的稳定性和安全性，<span style="color: black;">咱们</span>采取的策略是一方面自主生产，另一方面与合作伙伴来<span style="color: black;">一起</span><span style="color: black;">保准</span>（供应）。”<span style="color: black;">日前</span>，<strong style="color: blue;">前沿生物还在着力扩大自建产能，南京江宁的制剂生产基地已进入设备调试<span style="color: black;">周期</span>、四川金堂的原料药生产基地的生产线<span style="color: black;">已然</span>竣工验收，为艾可宁的生产<span style="color: black;">供给</span>充足产能</strong>。</span><span style="color: black;">在谢东看来，艾滋病<span style="color: black;">药品</span>在上市的<span style="color: black;">全部</span>流程中要<span style="color: black;">尤其</span><span style="color: black;">重视</span>与产能的匹配。“<span style="color: black;">针对</span>艾滋病<span style="color: black;">这般</span>的慢性病，<span style="color: black;">按照</span><span style="color: black;">咱们</span>过去的经验，<span style="color: black;">营销</span>要达到峰值大约<span style="color: black;">必须</span>5到7年的时间，艾宁是在2018年上市的，<span style="color: black;">咱们</span><span style="color: black;">亦</span><span style="color: black;">根据</span>这个时间点进行了相应的产能匹配。”</span><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZs1URHXW8Uo1IFayxpUL7T0uUQnicQVArUhj4OymjficN0tcuEjKpkUVIg/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">前沿生物办公楼 <span style="color: black;">照片</span><span style="color: black;">源自</span>：受访者供图</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">纳入<span style="color: black;">医疗保险</span>后尚未实现“以量换价”</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">将来</span>怎么做好<span style="color: black;">商场</span>化？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;"><span style="color: black;">按照</span>灼识咨询报告，2018年，北美、中西欧等发达地区抗艾滋病病毒<span style="color: black;">药品</span>市场规模达到309.7亿美元，占据<span style="color: black;">全世界</span>整体市场规模的91.2%。发展中国家市场占据整体<span style="color: black;">药品</span>市场的4.12%，市场规模约为14.0亿美元。其中，<strong style="color: blue;">中国的抗艾滋病病毒<span style="color: black;">药品</span>市场从2013年的7.9亿元人民币<span style="color: black;">增多</span>到2018年的20.2亿元人民币，年均复合增长率20.7%</strong>。预计至2023年，中国的抗艾滋病病毒<span style="color: black;">药品</span>市场将达49.6亿元人民币。</span><span style="color: black;">随着市场规模的扩大，国内抗艾<span style="color: black;">药品</span><span style="color: black;">亦</span>面临着支付方式上的变革。方正证券在研报中指出，<strong style="color: blue;"><span style="color: black;">日前</span>国家集中采购免费治疗方式正在向“政府免费治疗+<span style="color: black;">医疗保险</span>支付+自费市场”相结合的支付方式转变，其中<span style="color: black;">医疗保险</span>及自费<span style="color: black;">药品</span>市场规模有望进一步扩大</strong>。预计到2027年，国内抗艾滋病<span style="color: black;">药品</span>格局中，<span style="color: black;">医疗保险</span>支付<span style="color: black;">途径</span>可占六成<span style="color: black;">上下</span>，政府免费治疗<span style="color: black;">途径</span>和高端自费市场<span style="color: black;">途径</span>各自约占两成。</span><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZs65pI56MNMC0dKRJgFPPCWRXgibLwl2tnzYZ7cNwsiaYUImI4k3bgOQdw/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">图表<span style="color: black;">源自</span>：方正证券研报</span><strong style="color: blue;"><span style="color: black;">2021年年报<span style="color: black;">表示</span>，前沿生物全年共实现营业收入4050.29万元，<span style="color: black;">重点</span>由艾可宁在国内的<span style="color: black;">营销</span>收入<span style="color: black;">形成</span>。</span></strong><span style="color: black;">2020年12月，</span><span style="color: black;"><strong style="color: blue;">艾可宁<span style="color: black;">经过</span>谈判被纳入国家<span style="color: black;">医疗保险</span>，2021年3月，<span style="color: black;">医疗保险</span>目录正式执行。</strong></span><span style="color: black;">尽管艾可宁在2021年的销量从2020年的7万支升至11.18万支，同比增长59.75%；但<span style="color: black;">因为</span>纳入<span style="color: black;">医疗保险</span>后<span style="color: black;">营销</span>价格大幅下调，艾可宁全年<span style="color: black;">营销</span>收入反而有所下滑。</span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZsQU2TnqY1eJyIcfRCy4XSCqiazSOibeiaRErIu1UAwuQKE081ib4cUG5cHg/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></span><span style="color: black;">前沿生物解释<span style="color: black;">叫作</span>，国内市场方面，2021年下半年<span style="color: black;">因为</span>受疫情影响，全国多省、市地区的传<span style="color: black;">患病</span>专科<span style="color: black;">选定</span>医院及公共卫生中心<span style="color: black;">显现</span>停诊或封院<span style="color: black;">状况</span>，人员通行、物流运输<span style="color: black;">也</span>受到阻碍，艾可宁的<span style="color: black;">制品</span><span style="color: black;">营销</span>受到<span style="color: black;">很强</span>程度的影响。</span><span style="color: black;">“<span style="color: black;">咱们</span>的市场医学团队<span style="color: black;">亦</span>在积极筹划，在受疫情影响的<span style="color: black;">状况</span>下，<span style="color: black;">怎样</span>能够让<span style="color: black;">病人</span>得到有效的治疗。”谢东说，<span style="color: black;">详细</span>而言，<span style="color: black;">机构</span>将双管齐下改善<span style="color: black;">日前</span>艾可宁营收增长乏力的困境，“一个是继续扩大<span style="color: black;">咱们</span>的营销团队，以期覆盖<span style="color: black;">更加多</span>医院和<span style="color: black;">病人</span>。第二，<span style="color: black;">咱们</span><span style="color: black;">亦</span>在探索一种新的营销模式，在<span style="color: black;">咱们</span>历经三四年的医学推广下来，艾可宁的特点以及品牌影响力<span style="color: black;">已然</span>在<span style="color: black;">大夫</span>和<span style="color: black;">病人</span>群体里有了<span style="color: black;">基本</span>，之后<span style="color: black;">咱们</span>还会和区域性的经销商合作，让伙伴们替<span style="color: black;">咱们</span>覆盖<span style="color: black;">更加多</span>的医院和<span style="color: black;">行业</span>。”</span><span style="color: black;"><span style="color: black;">不外</span>，人工<span style="color: black;">花费</span>、市场推广费等<span style="color: black;">营销</span><span style="color: black;">花费</span><span style="color: black;">亦</span>水涨船高。<strong style="color: blue;">在过去的一年中，前沿生物<span style="color: black;">连续</span>扩充<span style="color: black;">商场</span>化团队，<span style="color: black;">营销</span><span style="color: black;">花费</span>由上年同期的3706.85万元增长到6018.45万元，同比增长62.36%。</strong><span style="color: black;">截止</span>2021年底，<span style="color: black;">机构</span>已搭建国内HIV防治<span style="color: black;">行业</span>覆盖医疗<span style="color: black;">公司</span>最广的营销体系，<strong style="color: blue;">艾可宁共计进入全国200余家HIV<span style="color: black;">选定</span>治疗医院及100余家DTP<span style="color: black;">药店</span>，<span style="color: black;">机构</span>计划到2023年实现覆盖300家<span style="color: black;">选定</span>医院及DTP<span style="color: black;">药店</span></strong>。</span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZscvRoEk73Xyx1fdp8vvOZmCTFk33uGlKoAcu5nKjXEYgc76vZ0Qv37g/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></span><span style="color: black;">创新药的<span style="color: black;">开发</span>成本极高，加上国内集采和<span style="color: black;">医疗保险</span>谈判等政策的实施，国产创新药已很难仅靠国内市场收回<span style="color: black;">开发</span>成本，“出海”<span style="color: black;">研发</span>国际市场<span style="color: black;">亦</span>就<span style="color: black;">成为了</span>行业共识。<span style="color: black;">始终</span><span style="color: black;">败兴</span>，美国市场凭借庞大市场份额以及FDA认证所赋予的认可度，<span style="color: black;">常常</span>是创新药企“出海”的<span style="color: black;">第1</span>站。<span style="color: black;">不外</span>，<span style="color: black;">此刻</span><span style="color: black;">亦</span>有越来越多的<span style="color: black;">公司</span>将新兴市场国家视为国际化发展的突破口。</span><span style="color: black;"><span style="color: black;">日前</span>，艾可宁已在厄瓜多尔、柬埔寨、阿塞拜疆等国<span style="color: black;">获准</span>上市，向哈萨克斯坦及白俄罗斯提交了注册申请，<span style="color: black;">截止</span>2021年末已累计向8个国家提交注册申请。<span style="color: black;">机构</span><span style="color: black;">亦</span>同步在布局其他发展中国家的市场，其中相对比<span style="color: black;">很强</span>的是俄罗斯和南非市场，注册<span style="color: black;">需求</span>会更高，注册周期<span style="color: black;">亦</span>相应更长。</span><span style="color: black;">谢东在谈到艾可宁的出海之路时<span style="color: black;">说到</span>，<strong style="color: blue;">在海外进行市场推广时，首要<span style="color: black;">思虑</span>的<span style="color: black;">便是</span>定价问题</strong>，<span style="color: black;">机构</span>要先做好<span style="color: black;">病人</span>人群的分析，<span style="color: black;">评定</span>在当地与同<span style="color: black;">行业</span><span style="color: black;">药品</span>竞争时<span style="color: black;">制品</span><span style="color: black;">是不是</span>具备竞争力；其次则要紧密结合当地<span style="color: black;">药物</span>的支付体系，<span style="color: black;">非常多</span>抗病毒<span style="color: black;">药品</span><span style="color: black;">是由于</span>国际组织<span style="color: black;">或</span>政府统一采购的，<span style="color: black;">亦</span>有一部分是自费或<span style="color: black;">是由于</span>保险<span style="color: black;">公司</span>支付。</span><span style="color: black;">“以艾可宁为例，<span style="color: black;">咱们</span>当时选了60多个国家，将近1800万的感染者，其中900万人在进行<span style="color: black;">药品</span>治疗，而适合艾可宁的<span style="color: black;">病人</span>大<span style="color: black;">大概</span>130多万人，综合<span style="color: black;">思虑</span>到<span style="color: black;">制品</span>的上市周期、成本、竞争<span style="color: black;">优良</span>等<span style="color: black;">原因</span>，<span style="color: black;">咱们</span>制定了分步的<span style="color: black;">制品</span>推广策略。<span style="color: black;">商场</span>化推广上，<span style="color: black;">咱们</span>还是要在当地找到艾滋病治疗<span style="color: black;">行业</span>中最领先的<span style="color: black;">机构</span>进行合作，<span style="color: black;">咱们</span><span style="color: black;">经过</span>授权，给<span style="color: black;">她们</span><span style="color: black;">供给</span>医疗和医学事务信息上的支持，<span style="color: black;">她们</span>则在当地<span style="color: black;">帮忙</span><span style="color: black;">咱们</span>进行推广。<span style="color: black;">同期</span>，<span style="color: black;">咱们</span><span style="color: black;">亦</span>在探索新模式，例如在欧洲等地实现<span style="color: black;">药品</span>的特殊进口，<span style="color: black;">期盼</span>多样化形式实现‘出海’”。</span><strong style="color: blue;"><span style="color: black;">谢东<span style="color: black;">针对</span>艾可宁<span style="color: black;">将来</span>在海外市场的拓展抱有<span style="color: black;">阳光</span>预期，在不远的将来，国际市场有望进一步扩大<span style="color: black;">机构</span>的营收</span></strong><span style="color: black;">。“<span style="color: black;">另外</span>，<span style="color: black;">咱们</span>还在拓展多元化的营收模式，重点布局与HIV治疗<span style="color: black;">关联</span>的新型<span style="color: black;">药品</span>、HIV病载及耐药检测<span style="color: black;">制品</span>，实现多元化营收，<span style="color: black;">提高</span>市场推广团队人均<span style="color: black;">营销</span>金额。对<span style="color: black;">处在</span><span style="color: black;">开发</span>中后期<span style="color: black;">周期</span>的在研<span style="color: black;">制品</span>，寻找意向合作方，实现<span style="color: black;">制品</span><span style="color: black;">商场</span>化授权收入。”</span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">开辟新冠<span style="color: black;">药品</span>管线</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">聚焦中、重度住院<span style="color: black;">病人</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/2eic4iblTAWEU5TYwjSRFV3UV8PPicicetVKeiaNmFUMSV5mOsKjYdIia5ndrYjLGUHSSY5hIYMACdwMcvvK8SVTEWmg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;">新冠疫苗的接种构筑了疫情防控的<span style="color: black;">第1</span>道防线，然而奥密克戎等变异毒株的<span style="color: black;">显现</span>，使<span style="color: black;">全世界</span>疫情又<span style="color: black;">显现</span>局部波动和扩散。在突破性感染<span style="color: black;">危害</span>加剧的背景下，针对新冠疫情<span style="color: black;">区别</span><span style="color: black;">周期</span>的治疗和预防需求，一个涵盖疫苗、抗病毒<span style="color: black;">药品</span>、中和抗体等的多层次防治体系亟待构建。</span><span style="color: black;">在7月11日举行的第三届中国抗病毒<span style="color: black;">药品</span><span style="color: black;">开发</span>大会上，谢东在主题演讲中<span style="color: black;">说到</span>：变异病毒株的流行，带来<span style="color: black;">全世界</span>住院<span style="color: black;">病人</span>数<span style="color: black;">连续</span>攀升，累计已超千万人。<span style="color: black;">日前</span><span style="color: black;">全世界</span>潜在着<span style="color: black;">包含</span>老龄、<span style="color: black;">身患</span><span style="color: black;">基本</span>病、未接种疫苗以及免疫缺陷的庞<span style="color: black;">成人</span>口基数的高危群体，<span style="color: black;">她们</span>和新冠住院<span style="color: black;">病人</span><span style="color: black;">同样</span>，<span style="color: black;">长时间</span>面临高危风险，而<span style="color: black;">全世界</span><span style="color: black;">日前</span>仅有一款吉利德的瑞德西韦用于新冠住院<span style="color: black;">病人</span>的治疗用药，<strong style="color: blue;"><span style="color: black;">全世界</span>中、重度住院<span style="color: black;">病人</span>高危人群对抗新冠病毒<span style="color: black;">药品</span>有<span style="color: black;">长时间</span>、刚性的需求</strong>。</span><span style="color: black;">前沿生物正在<span style="color: black;">研发</span>一款抗新冠病毒3CL蛋白酶<span style="color: black;">控制</span>剂FB2001。FB2001的I期临床<span style="color: black;">实验</span>已在中、美两国完成，<span style="color: black;">科研</span>结果<span style="color: black;">表示</span>FB2001对<span style="color: black;">重点</span>流行的SARS-CoV-2变异病毒株阿尔法、贝塔、德尔塔、奥密克戎等变异毒株均<span style="color: black;">拥有</span><span style="color: black;">有效</span>广谱<span style="color: black;">控制</span>活性，<span style="color: black;">同期</span><span style="color: black;">拥有</span>良好的临床安全性和耐受性。FB2001拟适用人群为<span style="color: black;">全世界</span>新冠住院<span style="color: black;">病人</span>，这类<span style="color: black;">病人</span><span style="color: black;">重点</span><span style="color: black;">包含</span>高龄、<span style="color: black;">身患</span><span style="color: black;">基本</span><span style="color: black;">疾患</span>、低免疫力及未接种疫苗的高<span style="color: black;">危害</span>人群，该类群体在新冠疫情下面临的<span style="color: black;">危害</span>远高于青壮年群体，并且大多都有进行<span style="color: black;">关联</span><span style="color: black;">基本</span><span style="color: black;">疾患</span>的<span style="color: black;">药品</span>治疗。</span><span style="color: black;">据记者<span style="color: black;">认识</span>，<strong style="color: blue;">当下新冠<span style="color: black;">药品</span>的<span style="color: black;">开发</span><span style="color: black;">重点</span>集中在两个靶点，一个是核苷类RdRp<span style="color: black;">控制</span>剂，另一个是3CL蛋白酶</strong>。“在过去的四十年中，最成功的抗病毒<span style="color: black;">药品</span><span style="color: black;">重点</span><span style="color: black;">便是</span>针对艾滋病以及丙肝、乙肝的<span style="color: black;">药品</span>，这三类<span style="color: black;">药品</span><span style="color: black;">重点</span><span style="color: black;">亦</span><span style="color: black;">是由于</span>核苷类<span style="color: black;">药品</span>和蛋白酶<span style="color: black;">控制</span>剂所<span style="color: black;">构成</span>的。当时在对新冠病毒做完初步分析后，<span style="color: black;">咱们</span><span style="color: black;">亦</span>觉得这两个应该<span style="color: black;">便是</span>最好的靶点。之后，<strong style="color: blue;">国内外<span style="color: black;">开发</span>新冠<span style="color: black;">药品</span>的<span style="color: black;">公司</span>中，<span style="color: black;">发展</span>最快、效果最好的<span style="color: black;">亦</span>基本都是在HIV和肝炎<span style="color: black;">行业</span>有<span style="color: black;">长时间</span>布局的这几个<span style="color: black;">公司</span></strong>。” 谢东告诉《每日经济<span style="color: black;">资讯</span>》记者。</span><span style="color: black;">谢东认为，基于这两类靶点所<span style="color: black;">开发</span>出的新冠<span style="color: black;">药品</span>各有优劣：“<span style="color: black;">例如</span>核苷类RdRp<span style="color: black;">控制</span>剂，它的制<span style="color: black;">导致</span>本与合成门槛都比较低，生物利用度（制剂中<span style="color: black;">药品</span>被吸收进入人体循环的速度与程度）比较高，但它可能存在的一个缺点是耐药屏障比较低，像是美国<span style="color: black;">已然</span>有报告在新冠<span style="color: black;">病人</span><span style="color: black;">身体</span><span style="color: black;">发掘</span>了瑞德西韦耐药变体，这一点<span style="color: black;">必须</span>高度关注。”</span><strong style="color: blue;"><span style="color: black;">3CL蛋白酶<span style="color: black;">已然</span>在艾滋病和肝炎上取得了临床成功，其优点在于药效和抗病毒活性<span style="color: black;">通常</span>都比较强，但<span style="color: black;">亦</span>有在HIV和肝炎的<span style="color: black;">药品</span>中<span style="color: black;">发掘</span>存在血脂<span style="color: black;">反常</span>、刺激肠胃等副<span style="color: black;">功效</span></span></strong><span style="color: black;">；<span style="color: black;">另外</span>，3CL蛋白酶的代谢速度较快，有时候就<span style="color: black;">必须</span>和药代动力学<span style="color: black;">加强</span>剂联用，就像辉瑞的Paxlovid等基于3CL蛋白酶研制的口服药，大多<span style="color: black;">必须</span>和利托那韦联用以延长单位剂量发挥抗病毒效果的时间。</span><span style="color: black;">谢东强调，FB2001能够很好地弥补3CL蛋白酶<span style="color: black;">药品</span>在这一点上的劣势，FB2001<span style="color: black;">没</span>需联合药代动力学<span style="color: black;">加强</span>剂，<span style="color: black;">能够</span>减少因<span style="color: black;">运用</span>药代动力学<span style="color: black;">加强</span>剂<span style="color: black;">显现</span>的潜在<span style="color: black;">药品</span>相互<span style="color: black;">功效</span><span style="color: black;">危害</span>，从而满足新冠肺炎住院<span style="color: black;">病人</span>对副<span style="color: black;">功效</span>低、<span style="color: black;">药品</span>相互<span style="color: black;">功效</span>小的抗新冠病毒<span style="color: black;">药品</span>的需求。</span><span style="color: black;">基于FB2001<span style="color: black;">知道</span>的<span style="color: black;">功效</span>机制，以及小分子<span style="color: black;">药品</span>易于雾化吸入的特点，<strong style="color: blue;">前沿生物<span style="color: black;">亦</span>开展了FB2001雾化吸入给药方式进行新冠感染暴露后预防的<span style="color: black;">关联</span><span style="color: black;">科研</span></strong>。“新冠病毒是一个经<span style="color: black;">呼气</span>道传染的病毒，其<span style="color: black;">重点</span>靶器官在<span style="color: black;">呼气</span>道和肺部，经雾化和滴鼻给药，可能<span style="color: black;">拥有</span>更好的预防和治疗效果。<span style="color: black;">经过</span>暴露后预防，阻断密接者的感染和传播，对新冠防疫<span style="color: black;">拥有</span>重大的<span style="color: black;">道理</span>。”谢东<span style="color: black;">暗示</span>。</span><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGuJtWRjq86RW4rBiaKUUyZsfHy04FXvmicMibdQRs1nOD9pTCyJqyBPdOPDYL6Lj4vkgJBWXKz28cOQ/640?wx_fmt=png&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><img src="https://mmbiz.qpic.cn/mmbiz_png/uLW17f0eLMGrU3ZdONSvIr6xDTFIKocroCyFT828b8LkgwnuFZ6icTFtibvgtWqHUCOxdIVmqQQ5PrqYTbtlibXwg/640?wx_fmt=png&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><strong style="color: blue;">记者|</strong></span><span style="color: black;">许立波</span></strong></span></p>
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