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1、大药的诞生,才是医药的未来大药的诞生,才是医药的未来Blockbuster Drug,the Future of Pharmaceutical Market孟科含孟科含 Kehan Meng,袁艺琳袁艺琳 Yilin Yuan,2023年年3月月10日日本研究报告由海通国际分销,海通国际是由海通国际研究有限公司,海通证券印度私人有限公司,海通国际株式会社和海通国际证券集团其他各成员单位的证券研究团队所组成的全球品牌,海通国际证券集团各成员分别在其许可的司法管辖区内从事证券活动。关于海通国际的分析师证明,重要披露声明和免责声明,请参阅附录。(Pleasesee appendix for Engl
2、ish translation of the disclaimer)Equity Asia Research2大药的诞生,才是医药的未来大药的诞生,才是医药的未来我们希望回答以下几个当前资本市场最关注的问题:我们希望回答以下几个当前资本市场最关注的问题:投资药品投资药品、疫苗股的核心逻辑是什么疫苗股的核心逻辑是什么?创新药创新药、仿制药长期控费下仿制药长期控费下,药品板块见底了吗药品板块见底了吗?几款重磅国产新药出海突破几款重磅国产新药出海突破,中国创新的海外空间如何预期中国创新的海外空间如何预期?下一个下一个PD1、HPV疫苗在哪里疫苗在哪里?投资建议投资建议For full disclos
3、ure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 8X8XeUdX9WfYaYbZ6MaO9PmOnNmOnOjMpPpMlOoPpN8OsQmPNZtQnQwMrNpP3目录目录短期趋势:诊疗复苏,板块对流动性负面因素脱敏短期趋势:诊疗复苏,板块对流动性负面因素脱敏长期空间:不断寻找大品种的成长周期投资药品、疫苗的核心逻辑是什么?过去的历史证明:从来都是寻
4、找大品种带来的成长周期全球潜在重磅产品梳理寻找下一个“PD1”审评、支付、出海出现拐点,关注国内制药行业“新常态”For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 医院诊疗在后疫情时代迎来修复医院诊疗在后疫情时代迎来修复医院诊疗在2020年受疫情影响,就诊人次下滑,下滑幅度住院门诊:医院诊疗人次同比-13.5%,住院人数同比-
5、33.3%,综合医院门急诊同比-14.3%,住院病人手术人次同比-28.6%。2021年,伴随疫情影响减弱、社会秩序逐步恢复,医院诊疗修复至2019年疫情前水平4For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:HTI医院诊疗在后疫情时代迎来修复医院诊疗在后疫情时代迎来修复医院门诊及住院收入同样在2020年受疫情影响
6、,并在2021年迎来修复。门诊收入较住院收入受疫情影响更小,疫后回弹幅度高:2020年门诊收入同比-4.2%,住院收入同比-6.9%;2021年,门诊收入较2019年+12.7%,住院收入较2019年+5.6%。5For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:HTI参考香港经验:参考香港经验:刚性医疗需求复苏稳健
7、,麻醉药及处方药业绩修复刚性医疗需求复苏稳健,麻醉药及处方药业绩修复刚性医疗需求复苏稳健:精神科刚性医疗需求复苏稳健:精神科内科内科外科外科骨科骨科眼科眼科耳鼻喉科耳鼻喉科妇科妇科儿科儿科。刚需修复程度好刚需修复程度好,但回弹程度小但回弹程度小,慢病或长期疾病回弹迟滞慢病或长期疾病回弹迟滞。22财年是回弹的主要财年,慢病和长期疾病疫情期间受创程度可控,因此修复程度好,直接进入增量区间,如精神科和内科。回弹更多的主要解决紧急的医疗需求,如耳鼻喉科、儿科、外科及骨科。我们认为我们认为,内科修复以及外科内科修复以及外科+骨科回弹将分别带动肿瘤及处方药骨科回弹将分别带动肿瘤及处方药、麻醉药的业绩修复麻
8、醉药的业绩修复。6For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:香港医院管理局统计数字,HTI-15%-10%-5%0%5%10%15%20%FY18FY19FY20FY21FY22耳鼻喉科妇科內科眼科骨科儿科精神科外科107%105%102%102%99%96%94%86%4%6%9%10%8%16%6%10%
9、0%20%40%60%80%100%120%0 500 0001 000 0001 500 0002 000 0002 500 0003 000 0002022较2019年修复,%较2021年增长,%2019FY22较较FY19年门诊水平修复情况,按较疫前修复程度排序,年门诊水平修复情况,按较疫前修复程度排序,%FY18-22香港香港44家公立医院专科门诊量增速,家公立医院专科门诊量增速,%注释:香港财年为第二年3月。如2022财年对应2021-Q2至2022-Q1。For full disclosure of risks,valuation methodologies and target
10、price formation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:Wind,政府网援引新华社,HTI注:A股制药板块选取SW化学制剂板块和其他生物制品板块(2021版)剔除ST个股-2%0%2%4%6%8%10%12%14%-50%-45%-40%-35%-30%-25%-20%-15%-10%-5%0%5%2022/1/42022/2/42022/3/42022/4/42022/5/42022/6/42022/7/42022/8/42022/9/42022
11、/10/42022/11/4名义美元指数变化(右轴)联邦基金目标利率(右轴)A股制药板块涨跌幅(左轴)XBI指数涨跌幅(左轴)A股制药板块走势逐渐摆脱宏观负面因素影响股制药板块走势逐渐摆脱宏观负面因素影响制药板块估值与宏观负面因素逐渐脱敏制药板块估值与宏观负面因素逐渐脱敏A股制药板块年初至今仍为负收益,但经历两轮强劲反弹。我们认为药品(特别是生物科技公司)具有“高投入、高回报”的属性,因此盈利模型和估值对宏观因素的剧烈波动较为敏感。截止2023年3月3日收盘,A股制药板块和XBI指数与2021年底比仍为负收益,分别为-11%、-28%。我们认为板块的跌幅可能与美国联邦基金目标利率从2022年3
12、月开始加息有关。78目录目录短期趋势:诊疗复苏,板块对流动性负面因素脱敏长期空间:不断寻找大品种的成长周期长期空间:不断寻找大品种的成长周期投资药品、疫苗的核心逻辑是什么?投资药品、疫苗的核心逻辑是什么?过去的历史证明:从来都是寻找大品种带来的成长周期全球潜在重磅产品梳理寻找下一个“PD1”审评、支付、出海出现拐点,关注国内制药行业“新常态”For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the late
13、st full report on our website at 投药企就是投成长,而大品种的持续成长往往驱动公司的阶段性业绩增长。恒瑞医药2014年收入75亿、市值564亿,随着阿帕替尼、19K、吡咯替尼及PD1等重磅创新药陆续上市销售,公司达到2020年收入277亿、市值5943亿,后又因2021年PD1医保续约大幅降价,第5批、第7批带量采购涉及大量公司注射剂业务,市值回落至2022年的2458亿。智飞生物2016年收入4亿、市值264亿,与默沙东合作的HPV疫苗获批后,2021年收入达到307亿(包含新冠业务),市值达到1994亿。长春高新2015年收入24亿、市值158亿,随着消费级
14、产品生长激素逐步放量,2021年收入107亿,市值1098亿。429420040060080000020406080100120收入(亿元,左轴)市值(亿元,右轴)7688874070500025000500300350收入(亿元,左轴)市值(亿元,右轴)37465462759332772590040005000600070000500300收入(亿元,左轴)市值(亿元,右轴)
15、智飞生物自代理智飞生物自代理HPV疫苗后出现戴维斯双击疫苗后出现戴维斯双击生长激素大单品驱动长春高新股价上涨生长激素大单品驱动长春高新股价上涨恒瑞自恒瑞自2014年阿帕替尼上市进入创新药收获期年阿帕替尼上市进入创新药收获期投资药品、疫苗的核心逻辑是什么?投资药品、疫苗的核心逻辑是什么?9For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our websit
16、e at 资料来源:Wind,各公司年报,HTI10目录目录短期趋势:诊疗复苏,板块对流动性负面因素脱敏长期空间:不断寻找大品种的成长周期长期空间:不断寻找大品种的成长周期投资药品、疫苗的核心逻辑是什么?过去的历史证明:从来都是寻找大品种带来的成长周期过去的历史证明:从来都是寻找大品种带来的成长周期全球潜在重磅产品梳理寻找下一个“PD1”审评、支付、出海出现拐点,关注国内制药行业“新常态”For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,
17、please refer to the latest full report on our website at 回顾既往回顾既往3年年MNC公司的发展公司的发展,大药诞生支撑大药诞生支撑MNC市值不断突破市值不断突破,全球药品研发和技术路径已经出现方向性的改变全球药品研发和技术路径已经出现方向性的改变。现阶段市场空间大的品种已经逐步兑现,增速高涨,如礼来和诺和诺德在GLP-1及双靶点产品上的追逐,肿瘤免疫治疗中抑制剂、细胞疗法等产品近年接连涌现,我们认为中国也会经历类似的过程,创新研发不断积累产生大药,大药诞生铸造具有国际竞争力的药企。通过对临床最前端成果的跟踪和市场空间研判,我们认为未来在
18、神经系统疾病如阿尔茨海默病(AD)、代谢类疾病非酒精性脂肪性肝炎如NASH、乙肝药物、带状疱疹疫苗、RSV疫苗等领域有望诞生大单品。资料来源:公司年报,Wind,HTI;市值数据截至2022/12/31,USDEUR=0.92355,USDGBP=0.829566,USDCHF=0.926044,USDDKK=6.8951;注:GSK尚未披露22年度收入,21年收入为USD411亿。度普利尤单抗为赛诺菲与再生元合作研发及商业化。全球视角的大药逻辑:核心单品成长驱动市值阶段性成长全球视角的大药逻辑:核心单品成长驱动市值阶段性成长11For full disclosure of risks,val
19、uation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 38625200200025003000202072005720152003辉瑞新冠mRNA疫苗EPO沙美特罗替卡松利妥昔单抗来那度胺英夫利昔单抗依那西普阿托伐他汀帕博利珠单抗阿达木单抗预计产品至预计产品至20
20、26年累计销售额(亿美元)年累计销售额(亿美元)产品产品企业企业上市时上市时间间达峰时间达峰时间销售峰值销售峰值(亿美元)亿美元)达峰当年总营收达峰当年总营收(亿美元)亿美元)占总营收比例占总营收比例立普妥辉瑞1996年2006年12948329%修美乐艾伯维2002年2018年19932861%丙肝治疗组合吉利德2013年2015年19132259%帕博利珠单抗默沙东2014年2021年(仍在增长)17248735%Comirnaty辉瑞/BioNTech 2020年2022年378100338%SPIKEVAXModerna2020年2021年(2022FY数据暂缺)17718596%从全
21、球制药行业看,仍然是重磅产品驱动企业和行业的发展:小分子药时代的立普妥(辉瑞)在2006年达到销售峰值129亿;2002年上市的自免领域重磅生物制剂修美乐(艾伯维)在过去20年间年销售额攀升至200亿;丙肝治疗组合(吉利德)上市约2年后于2015年迅速达到191亿销售峰值;肿瘤免疫治疗K药(默沙东)上市以来不断拓展适应症和联合疗法、2022年销售额突破200亿;新冠大流行+mRNA技术促成新冠疫苗Comirnaty(辉瑞/BioNTech)、Spikevax(Moderna)这些重磅品种都是企业阶段性市值成长的重要推动力。药企市值成长的最好阶段往往在新药加速放量阶段,再生元2016年开始阿柏西
22、普增速放缓,公司股价迎来调整期。005006007002009-06-052010-07-302011-09-232012-11-162014-01-102015-03-062016-04-292017-06-232018-08-172019-10-112020-12-04再生元股价(美元、前复权)605.9328.831)PD-1相继在欧美获批;2)跟Analymn合作新冠中和抗体593亿市值664.64IRR=84%IRR=37%0.258.3814.0917.36 26.76 33.23 37.02 40.77 46.44 68.1%23.2%54.1%24.2%1
23、1.4%10.1%13.9%00.20.40.60.8020406020001720182019Eylea销售额(亿美元)Eylea增速再生元股价随着阿柏西普放量快速增长;阿柏西普增速放缓,股价回撤再生元股价随着阿柏西普放量快速增长;阿柏西普增速放缓,股价回撤重磅新药决定药企的成长空间重磅新药决定药企的成长空间过去的历史证明:从来都是寻找大品种带来的成长周期过去的历史证明:从来都是寻找大品种带来的成长周期12For full disclosure of risks,valuation methodologies and target price fo
24、rmation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:Wind,各公司年报,HTI中国历年首次中国历年首次IND创新药数量创新药数量2015年药政改革、“722”事件大大加速新药审评速度港股18A规则修订,创新药公司退出通道打开国家医保局成立科创板开板、首个国产抗癌新药泽布替尼美国上市传奇生物best-in-class细胞治疗药物西达基奥仑赛美国上市首个国产抗体药物君实生物JS016美国上市过尽千帆,中国药品行业进入创新新常态过尽千帆,中国药品行业进入创新新常态
25、从中国制药行业过去十年来看:2015年药政改革之前,几乎没有创新药行业。2015-2020年,宏观环境上的宽松周期,中观维度上的CDE的改革、医保的创新药价格谈判纳入医保目录,催生了PD-1、HPV疫苗为代表的50亿以上单品,也使得行业一路高歌猛进,几乎所有人都能融资做创新药。2021年7月开始,宏观环境上美联储持续加息,中观环境上CDE肿瘤药物新规单臂试验、医保持续3年的创新药谈判杀价,微观环境上的大量重复靶点竞争,持续杀估值,创新药被市场放弃。然而,产业的进步并没有停滞,源于这是一个供给创造需求的行业,只要有未被满足的临床需求,总有新的药物诞生,就有机会。然而,产业的进步并没有停滞,源于这
26、是一个供给创造需求的行业,只要有未被满足的临床需求,总有新的药物诞生,就有机会。资料来源:Wind,各公司年报,HTI13For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 中国市场足够大且统一,创新药具有结构成长机遇中国市场足够大且统一,创新药具有结构成长机遇中国拥有全球难得的规模较大中国拥有全球难得的规模较大、增速较快的统一
27、药品市场增速较快的统一药品市场。2021年全球药品市场规模11860亿美元,同比增长7.7%。2021年成熟药品市场平均增速6.4%,而新兴市场增速高达11.9%。全球五大药品市场分别为美国、日本、中国、德国、法国。中国药品市场中创新药销售额占比仍有较大提升空间中国药品市场中创新药销售额占比仍有较大提升空间。2021年中国创新药销售额仅占医院药品销售的25%,创新药的市场占比较少。2025年中国药品市场规模预计年中国药品市场规模预计1970亿美元,体量全球前亿美元,体量全球前4资料来源:阿斯利康2021年年报,医药魔方IPM数据库,HTI70602960263074050
28、0370310240180-2%0%2%4%6%8%10%12%14%00400050006000700080002025年市场规模(亿美元,左轴)年增速(%,右轴)2021年中国创新药医院销售额占比仍较低年中国创新药医院销售额占比仍较低14For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 药品和医保总量
29、最终归结于经济增长药品和医保总量最终归结于经济增长卫生投入占比仍有提升空间卫生投入占比仍有提升空间2020年中国药品费用年中国药品费用2.1万亿,占卫生总费用万亿,占卫生总费用31%资料来源:中国政府网,中国卫生健康统计年鉴,2020年中国卫生总费用核算结果与分析,国家医保局官网,HTIFor full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our websit
30、e at 15序号序号公司公司FY21收入(亿元)收入(亿元)增幅增幅1复星医药390 29%2华东医药346 3%3智飞生物307 102%4石药集团280 12%5中国生物制药270 14%6恒瑞医药259-7%7人福医药205-1%8科伦药业173 5%9丽珠集团121 15%10翰森制药99 14%截至截至FY21已有已有18家披露国内收入过百亿的中国药企家披露国内收入过百亿的中国药企序号序号公司公司最新市值(亿元,截至最新市值(亿元,截至2023/3/2)FY21收入(亿元)收入(亿元)FY21增速增速1恒瑞医药2755259-7%2百济神州-U173576258%3智飞生物1416
31、307102%4万泰生物113858144%5石药集团91328012%6复星医药82939029%7翰森制药7809914%8华东医药8193463%9中国生物制药68927014%10沃森生物6153518%11君实生物-U46140152%12信达生物5474311%13传奇生物515119%14金斯瑞生物科技4153331%15荣昌生物3571446753%16人福医药422205-1%17华兰生物40644-12%18康泰生物3833762%19信立泰3963112%20科伦药业4151735%市值前市值前20的药企仍有较大成长空间的药企仍有较大成长空间序号序号公司公司中国收入中国收
32、入(亿元)(亿元)增幅增幅总收入总收入(亿(亿美元)美元)增幅增幅占公司占公司收入比收入比1罗氏415-2%683 1%9%2阿斯利康396-4%44418%13%3默沙东348 20%59322%9%4赛诺菲228 1%46014%7%5诺华214 2%505-2%6%6诺和诺德155 1%24825%9%7礼来99-13%285 1%5%截至截至FY22已有已有7家披露国内收入百亿的跨国药企家披露国内收入百亿的跨国药企中国市场足够孵化多个百亿级别药企中国市场足够孵化多个百亿级别药企18家药企披露家药企披露2021年中国区营收超百亿:年中国区营收超百亿:截至2021年末,中国药企中复星医药、
33、华东医药、智飞生物、石药集团、恒瑞医药等7家企业收入均已超200亿元,科伦药业、丽珠集团、翰森制药等3家企业收入超100亿元。截至2022年末已有7家跨国药企披露中国区收入达100亿元,其中阿斯利康、默沙东、罗氏等跨国药企巨头已超过350亿元。资料来源:Wind,各公司年报,HTIFor full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website a
34、t 1617目录目录短期趋势:诊疗复苏,板块对流动性负面因素脱敏长期空间:不断寻找大品种的成长周期长期空间:不断寻找大品种的成长周期投资药品、疫苗的核心逻辑是什么?过去的历史证明:从来都是寻找大品种带来的成长周期全球潜在重磅产品梳理全球潜在重磅产品梳理寻找下一个“寻找下一个“PD1”审评、支付、出海出现拐点,关注国内制药行业“新常态”For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest f
35、ull report on our website at 适应症治疗靶点全球潜在市场规模(美元)核心产品(全球)研发企业(全球)研发进度(全球)国内主要企业及进度NASHTHR300-400亿ResmetiromMadrigalIII期临床歌礼(II期)、拓臻(II期)LanifibranorInventiva/中国生物制药III期临床中国生物制药(III期)、微芯生物(II期)、拓臻(II期)PPAR糖尿病/肥胖GIP/GLP-1400-500亿替尔泊肽礼来BLA信达(III期,GLP1/GCGR)等阿尔茨海默病A100-200亿LecanemabEisai/Biogen获批上市恒瑞医药(I
36、期)、先声药业(I期)HER2+恶性肿瘤HER2(ADC)50-100亿DS-8201第一三共获批上市恒瑞(III期)、荣昌(III期)、浙江医药(III期)、康宁杰瑞(I期)多发性骨髓瘤CD3*BCMA(BsAb)200-300亿TeclistamabGenmab/强生获批上市康诺亚(I/II期)、岸迈生物(I/II期)、智翔(I期)肺癌等实体瘤EGFR*c-MET(BsAb)50-100亿AmivantamabGenmab/强生获批上市贝达(I/II期)、岸迈生物(I/II期)乙肝100-200亿bepirovirsenGSK/IonisIII期临床特宝生物(干扰素III期)、凯因科技(干
37、扰素III期)、歌礼制药(PDL1+ASO II期)、腾盛博药(II期)RSV疫苗50-100亿多个产品多家企业BLA重组带状疱疹疫苗50-100亿GSK1437173A第一三共/GSK获批上市百克(减毒,上市)、北京绿竹(II期)、江苏中慧元通(I/II期)、成都迈科康(I期)、瑞科生物(IND)新冠疫苗200-300亿万泰(上市)、康希诺(上市)、神州细胞(上市)、智飞(上市)、康泰生物(上市)等资料来源:各公司官网,医药魔方,HTI重磅新药始终需要解决未满足的临床需求,重磅新药始终需要解决未满足的临床需求,2022年多个新药领域迎来突破。年多个新药领域迎来突破。研发端:研发端:从全球药物
38、从全球药物 2022 年研发进展找寻下一个年研发进展找寻下一个“PD-1”18For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 阿尔茨海默病(AD)是一种导致痴呆的进行性神经退行性疾病。受预期寿命不断延长影响,衰老相关的AD成为迄今为止最常见的老年痴呆症。据估计,全球痴呆症患者人数将从2019年的5740万例增加到2050年的
39、1.5亿例;目前中国有超过700万的AD患者。在过去的15年里,尽管AD的诊断由基于症状和体征的综合征,转变为基于疾病病理特征的生物标志物构建(淀粉样蛋白沉积、病理性tau蛋白和神经变性等)。然而,AD药物的研发仍具有许多难点药物的研发仍具有许多难点,使得其失败率很高:使得其失败率很高:99%的试验显示药物的试验显示药物-安慰剂没有差异安慰剂没有差异。阿尔茨海默症新药阿尔茨海默症新药III期成功并获批期成功并获批,为靶向为靶向A的的AD疾病调修药物的研发注入疾病调修药物的研发注入“强心针强心针”。Lecanemab(Eisai/Biogen)的III期临床达到主要终点及所有关键次要终点、显著延
40、缓认知症状恶化进程,并于2023年1月在FDA获批。资料来源:各公司官网,Cummings J,et al.Alzheimers Dement(N Y).2022,HTILecanemab的的AD III期临床提示延缓认知症状恶化(期临床提示延缓认知症状恶化(MCI至轻度)至轻度)A靶向治疗是靶向治疗是AD药物研发的重要方向药物研发的重要方向研发端:研发端:阿尔茨海默病的阿尔茨海默病的A靶向药靶向药Lecanemab III期临床显示认知改善期临床显示认知改善Aducanumab/AduhelmAducanumab/AduhelmLecanemab研发机构Biogen/EisaiBiogen/
41、EisaiBiogen/Eisai临床试验ENGAGEEMERGEClarity AD方案高剂量低剂量安慰剂高剂量低剂量安慰剂治疗组治疗组安慰剂安慰剂样本量555547545547543548859875CDR-SB,较安慰剂组-0.03-0.18-0.39*-0.26-0.45*GantenerumabGantenerumabDonanemab研发机构RocheRoche研发机构Eli Lilly临床试验GRADUATE IGRADUATE II临床试验TRAILBLAZER-ALZ 4(早期症状性AD)方案治疗组安慰剂治疗组安慰剂方案治疗组Aduhelm样本量499485477498样本量
42、6664CDR-SB,较安慰剂组-0.31-0.19脑淀粉样蛋白斑块清除37.9%*1.6%19For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 非酒精性脂肪肝炎(Nonalcoholic Steatohepatitis,NASH)是一种由非酒精性脂肪肝进展而来的严重慢性肝脏疾病。根据流行病学调查,全球的NAFLD患病率约为2
43、5%,其中10%-30%最终会发展为NASH,即全球全球NASH患者在患者在1.9亿至亿至5.8亿之间亿之间。尽管尽管NASH药物治疗需求极大药物治疗需求极大,但目前尚未有真正可改善肝代谢但目前尚未有真正可改善肝代谢、改善炎症和逆转纤维化的改善炎症和逆转纤维化的NASH治疗药物批准上市治疗药物批准上市。目前全球临床III期20项,靶点布局主要集中在已有药物获批上市的FXR激动剂、GLP-1R激动剂等。例如获批用于胆汁性肝硬化的FXR激动剂奥贝胆酸GLP-1R激动剂索马鲁肽获批糖尿病和肥胖症,PPAR激动剂吡格列酮和SGLT2抑制剂恩格列净亦为上市药物。semaglutide已获批二型糖尿病和肥
44、胖症;同样的还有糖尿病药PPAR激动剂吡格列酮和SGLT2抑制剂恩格列净等,Madrigal的的THR激动剂激动剂Resmetirom以以NASH为主要适应症为主要适应症,目前该款药物尚未上目前该款药物尚未上市市。2022年年12月宣布月宣布III期临床成功期临床成功。NASH新药中,新药中,Resmetirom达到达到III期临床主要终点期临床主要终点研发端:研发端:NASH领域领域III期临床首次成功期临床首次成功资料来源:各公司官网,医药魔方,HTI20For full disclosure of risks,valuation methodologies and target pric
45、e formation on all HTI rated stocks,please refer to the latest full report on our website at 研发药物研发药物ResmetiromLanifibranorArmachol奥贝胆酸(获批)奥贝胆酸(获批)研发机构MadrigalInventiva/中国生物制药Galmed/SamilIntercept/Advanz靶点THRPan-PPARSCD1FXR临床试验Phase III,F2-3Phase IIb,F4除外Phase IIbPhase III,stage 2-3方案80mg100mg安慰剂安慰剂
46、1200mg800mg安慰剂600mg400mg安慰剂25mg10mg安慰剂样本量338312311NASH改善,纤维化无恶化26%*30%*10%49%*39%*22%16.7%7.5%5.0%22.4%*14.1%9.6%纤维化改善,NASH无恶化24%*26%*14%48%*34%29%29.5%21.3%17.5%6.5%6.5%3.5%IBI362(GLP-1R/GCGR),ph2,CNTirzepatide(GLP-1R/GIP),ph3,美国等Semaglutide(GLP-1R),ph3,美国等信达生物礼来诺和诺德NCT0496550
47、6NCT03987919NCT02648204至少3个月生活方式干预,伴或不伴稳定剂量二甲双胍治疗后HbA1C不达标(7.0%10.5%),T2DM二甲双胍1500mg治疗血糖控制不佳(7.0%10.5%),T2DM二甲双胍1500mg治疗血糖控制不佳(7.0%10.5%),T2DM设计随机,双盲,安慰剂/度拉糖肽(GLP-1R)对照开放标签,随机,索马鲁肽对照开放标签,随机,度拉糖肽对照No.Pts252470469470469301299300299治疗剂量治疗剂量3.0mg4.5mg6.0mg安慰剂安慰剂度拉糖肽度拉糖肽1.5mg5mg10mg15mg索马鲁肽索马鲁肽1mg0.5mg度拉
48、糖肽度拉糖肽0.75mg1.0mg度拉糖肽度拉糖肽1.5mg治疗周期20周(含滴定期)40周(含滴定期)40周(含滴定期)T2DM病史4.05.7年9.18.48.78.37.77.07.37.6基线HbA1C7.94%8.16%8.3%8.3%8.3%8.3%8.3%8.2%8.2%8.2%HbA1C变化绝对值-1.4%-1.7%-1.5%0.0%-1.4%-2.0%-2.2%-2.3%-1.9%-1.5%-1.1%-1.8%-1.4%HbA1C7.0%62.8%74.4%78.3%20.0%69.8%82.0%86.0%86.0%79.0%68.0%52.0%67.0%47.0%较基线体重
49、改变较基线体重改变-7.14%-1.38%-2.69%-7.6(8.2%)-9.3(9.8%)-11.2(11.9%)-5.7(6.1%)-4.6(4.8%)-2.3(2.4%)-6.5(6.8%)-3.0(3.2%)资料来源:信达生物微信公众号(0719)NEJM(SURPASS-2研究)Lancet(SUSTAIN-7研究)GLP-1R激动剂适用广泛。2015年,全球约19亿肥胖患者,约占总人口的39%;2021年,全球约5.4亿糖尿病患者,其中超过90%为2型糖尿病。GLP-1R激动剂是一类多肽类药物,代表药物索马鲁肽获FDA批准用于2型糖尿病及肥胖症治疗。替尔泊肽(礼来)糖尿病替尔泊肽
50、(礼来)糖尿病III期临床数据优于司美格鲁肽期临床数据优于司美格鲁肽:替尔泊肽15mg剂量组治疗40周,HbA1c7.0%比例达86.0%,高于司美格鲁肽1mg剂量组的79.0%;替尔泊肽vs 索马鲁肽体重较基线下降11.9%vs 6.1%。Tirzepatide(GLP-1R/GIP),ph3,美国等Semaglutide(GLP-1R),ph3,美国等Dulaglutide(GLP-1R),ph3,美国等礼来诺和诺德礼来NCT03954834NCT02054897NCT01126580生活方式干预后血糖控制不佳(7.0%9.5%),未用药,T2DM生活方式干预后血糖控制不佳(7.0%10.
51、0%),未用药,T2DM生活方式干预,或口服降糖药最高剂量50%控制不佳(6.5%9.5%),T2DM设计随机、双盲、安慰剂对照随机、双盲、安慰剂对照随机,双盲,二甲双胍对照No.Pts39270268治疗剂量治疗剂量5mg10mg15mg安慰剂安慰剂0.5mg1.0mg安慰剂安慰剂1.5mg0.75mg二甲双胍二甲双胍治疗周期40周(含滴定期)30周(含滴定期)26周(含滴定期)T2DM病史4.64.94.84.54.83.64.1333基线HbA1C8.0%7.9%7.9%8.1%8.1%8.1%8.0%7.67.67.6HbA1C变化绝对值-1
52、.8%-1.7%-1.7%-0.1%-1.5%-1.6%0.0%-0.78%-0.71%-0.56%HbA1C7.0%82.0%85.0%78.0%23.0%74.0%72.0%25.0%62%63%54%较基线体重改变较基线体重改变-6.3(-7.2%)-7.0(-8.1%)-7.8(-9.1%)-1.0(-1.2%)-3.73(4.1%)-4.53(4.6%)-0.98(1.1%)资料来源:Lancet(SURPASS-1研究)Lancet(SUSTAIN-1研究)Diabetes Care(AWARD-3研究)研发端:研发端:GLP-1双靶点药提升降糖、减重效果双靶点药提升降糖、减重效果
53、资料来源:Chooi YC et al.,Metabolism.2019,IDF Diabetes Atlas 2021 10th edition,各公司官网,医药魔方,HTI21For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at TTF通过低强度、中频率的交变电场来干扰肿瘤细胞的活动,为器械物理治疗,安全性极好,不影响健康细胞
54、,最常见的不良反应是轻度至中度皮肤刺激。我们认为TTF机制上和目前的临床试验结果可以看到抗肿瘤的广谱性和安全性,未来可能形成“N+1”的联用策略。Novocure在2003年启动TTF首次临床试验,至今肿瘤电场治疗已初步展现泛癌种治疗潜力。随着肿瘤电场治疗在非小细胞肺癌等大适应症上取得突破,国内市场空间天花板将进一步打开。研发端:研发端:肿瘤电场治疗:具备肿瘤电场治疗:具备PD-(L)1潜力的创新器械潜力的创新器械资料来源:公司公开推介材料,HTI22For full disclosure of risks,valuation methodologies and target price fo
55、rmation on all HTI rated stocks,please refer to the latest full report on our website at 呼吸道合胞病毒(呼吸道合胞病毒(RSV)是一种常见感染,其在老年人、婴儿和免疫力低下人群中可引起细支气管炎、肺炎甚至死亡。)是一种常见感染,其在老年人、婴儿和免疫力低下人群中可引起细支气管炎、肺炎甚至死亡。目前认为每个人3岁以前都已感染过RSV,而且一生都会每隔几年感染一次。尽管多数感染症状轻微,但多达2%3%的婴儿会在1岁以前因RSV感染住院,同时RSV也是导致体弱老年人死亡的主要原因,与季节性流感不相上下。RSV疫
56、苗研发从20世纪60年代已经开始,但当时的RSV灭活疫苗不仅未能预防RSV感染,还导致新发RSV感染的婴儿病情加重。2023年年3月月FDA的的ODAC会议,专家以会议,专家以7:4和和7:4的票数支持辉瑞的票数支持辉瑞RSV疫苗(老年)的有效性和安全性;以疫苗(老年)的有效性和安全性;以12:0和和10:2的票数支持的票数支持GSK RSV疫苗(老年)的有疫苗(老年)的有效性和安全性。效性和安全性。GSK RSVPreF3 OA有望成为第一款获批上市的有望成为第一款获批上市的RSV疫苗疫苗产品产品RSVPreF3 OARSVpreFmRNA-1345公司GSK辉瑞Moderna抗原preF/
57、单价/单次免疫preF/二价/单次免疫mRNA preF/单价/单次免疫佐剂AS01/技术路线蛋白疫苗蛋白疫苗mRNA疫苗剂量II期:30/60/120g120gII期:12.5/25/50/100/200gIII期临床AReSVi-00660岁以上,24960例RENOIR60岁以上,34284例ConquerRSV60岁以上,37000例主要终点RSV-LRTDRSV-LRTDRSV-LRTD疗效1种以上症状82.6%2种以上症状94.1%2种以上症状66.7%3种以上症状85.7%2种以上症状83.7%3种以上症状82.4%FDA投票有效性:12:0安全性:10:2有效性:7:4安全性:
58、7:4/PDUFA日May-23Aug-23/研发端:研发端:RSV疫苗获疫苗获FDA投票支持,首款产品有望在投票支持,首款产品有望在23年获批上市年获批上市资料来源:各公司官网,NEJM,HTI23For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 双抗、ADC等新型药物模式上榜。2019-21年全球药品销售额TOP100中,
59、双抗(Hemlibra,血友病)及ADC(Kadcyla,HER2+BC)在2020年首次上榜。K药2022年销售额首次突破200亿美元,除新冠相关产品外,全球排名第2。GSK带状疱疹疫苗全球放量,22年营收36亿美元。其中美国地区稳定增长,德国及中国贡献海外市场增长。GSK目标2026年实现营收翻倍。药品药品企业企业疾病领域疾病领域销售额销售额(亿美元)(亿美元)Comirnaty辉瑞/BioNTechCOVID-19378阿达木单抗AbbVie自免212帕博丽珠单抗默沙东实体瘤209Paxlovid辉瑞COVID-19189mRNA-1273ModernaCOVID-19184阿哌沙班BM
60、S/辉瑞抗凝血183比克恩丙诺吉利德HIV104来那度胺BMS免疫/血液瘤100乌司奴单抗强生自免97阿柏西普再生元/拜耳眼科9654266060小分子单抗重组蛋白疫苗双抗ADC201920202021双抗、双抗、ADC等新型药物模式上榜等新型药物模式上榜22年年GSK带状疱疹疫苗营收带状疱疹疫苗营收36亿美元亿美元10.223.125.723.736.53464%127%11%-8%54%-500%0%500%1000%1500%2000%2500%3000%3500%4000%0.05.010.015.020.025.030
61、.035.040.0200212022销售额(亿美元,左轴)yoy(亿美元,右轴)2022全球药品销售全球药品销售TOP10,K药营收突破药营收突破200亿美元亿美元销售端:销售端:双抗、双抗、ADC上榜上榜TOP100,K药突破药突破200亿,带状疱疹疫苗亿,带状疱疹疫苗36亿亿资料来源:医药魔方数据库,insight数据库,HTI24For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to
62、 the latest full report on our website at 资料来源:世界卫生组织,诺和诺德、礼来官网,HTI8%43%32%2%15%利拉鲁肽(短效)司美格鲁肽(长效)度拉糖肽(长效)替尔泊肽(双靶点)其他GLP-1Ra32343254992032440608000212022利拉鲁肽(短效)司美格鲁肽(长效)度拉糖肽(长效)替尔泊肽(双靶点)替尔泊肽上市半年销售强劲替尔泊肽上市半年销售强劲22年占年占GLP-1Ra市场份额市场份额2%GLP-1Ra药物的长效、多靶点替代成为趋势药
63、物的长效、多靶点替代成为趋势(全球销售额,单位:亿美元)(全球销售额,单位:亿美元)2022年诺和诺德年诺和诺德GLP-1Ra产品销售合计超产品销售合计超38亿元亿元5.18.910.215.715.80.13.022.10.05.010.015.020.025.0200212022利拉鲁肽司美格鲁肽销售端:销售端:22年年GLP-1Ra糖尿病治疗市场超糖尿病治疗市场超200亿,肥胖治疗想象空间巨大亿,肥胖治疗想象空间巨大GLP-1R激动剂自2005年艾塞那肽上市以来经历短效、长效、多靶点/口服的三个发展阶段;适应症由2型糖尿病的治疗向肥胖症、NASH等其他代谢相关疾病拓
64、展。2022年年GLP-1R激动剂糖尿病治疗市场超激动剂糖尿病治疗市场超200亿美元,双靶点激动剂销售强劲亿美元,双靶点激动剂销售强劲。22年司美格鲁肽(口服+注射,诺和诺德)合计销售额100亿美元(约占47%);度拉糖肽(礼来)销售额74亿美元(约占35%)。替尔泊肽(GLP-1R/GIP,礼来)2022Q2获批上市,全年销售额达到近5亿美元。根据诺和诺德,2022年中国地区GLP-1R激动剂合计销售38亿元;司美格鲁肽销售收入22亿元,利拉鲁肽销售收入16亿元。全球全球6.5亿肥胖增患者,市场潜力巨大亿肥胖增患者,市场潜力巨大。22年诺和诺德销售收入24亿美元,其中司美格鲁肽9亿美元,利拉
65、鲁肽15亿美元。25For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 26目录目录短期趋势:诊疗复苏,板块对流动性负面因素脱敏长期空间:不断寻找大品种的成长周期投资药品、疫苗的核心逻辑是什么?过去的历史证明:从来都是寻找大品种带来的成长周期全球潜在重磅产品梳理寻找下一个“PD1”审评、支付、出海出现拐点,关注国内制药行业“新常
66、态”审评、支付、出海出现拐点,关注国内制药行业“新常态”For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 资料来源:国家药监局,HTI监管端:监管端:临床需求导向更加明确,利好先发企业的竞争格局临床需求导向更加明确,利好先发企业的竞争格局2018-2022年中国共批准15款PD1(包括PDL1及相关双抗)、3款三代EGFR-T
67、KI,多款CAR-T处于临床阶段研发。扎堆式的药物研发导致企业投资回报率整体下降、临床资源浪费。2021年底国家药监局发布以临床价值为导向的抗肿瘤药物临床研发指导原则,要求随机对照研究中“尽量为受试者提供临床实践中最佳治疗方式/药物”,选择阳性药对照时应考虑“目标适应症患者最佳用药情况”,选择安慰剂或BSC对照时应确保“该适应症在临床中确无标准疗法”。我们认为随着过去几年肿瘤大适应症标准疗法快速提高,药监部门审评标准相对收紧,有临床意义的原创新药、解决可及性的先发我们认为随着过去几年肿瘤大适应症标准疗法快速提高,药监部门审评标准相对收紧,有临床意义的原创新药、解决可及性的先发fast-foll
68、ow药物格局药物格局将得到改善。将得到改善。27For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 带量采购边际影响有望减弱。带量采购边际影响有望减弱。“十四五”全民医疗保障规划预期2025年各省(自治区、直辖市)国家和省级药品集中带量采购品种达500个以上。根据2021年医疗保障事业发展统计快报,2018年至2021年底,国家
69、医保局共开展6批国家药品集中带量采购,共采购234种药品,涉及金额占公立医疗机构化学药品年采购总额的30%,按集采前采购金额计算,累计节约费用2600亿元以上。截止第七批带量采购,药品数量已达截止第七批带量采购,药品数量已达319个,已过个,已过2025年预期值的一半,我们预计边际影响有望减弱。年预期值的一半,我们预计边际影响有望减弱。预计预计2023年底累计带量采购年底累计带量采购360个药品,过个药品,过2025年预期的一半年预期的一半支付端:支付端:仿制药带量采购进程过大半,药企存量业务下降压力减弱仿制药带量采购进程过大半,药企存量业务下降压力减弱200212022
70、20234+7全国扩围第二、第三批带量采购第四、第五批带量采购胰岛素专项采购第七批带量采购第八批带量采购平均降价幅度平均降价幅度52%59%53%54%48%48%覆盖品种数量(个)覆盖品种数量(个)25258710616 6041预计预计2023年底国家药品带量年底国家药品带量采购品种累计数量(个)采购品种累计数量(个)360至至2025年国家和省级累计年国家和省级累计需带量采购品种数量(个)需带量采购品种数量(个)500资料来源:中国政府网,国家医保局官网,HTI28For full disclosure of risks,valuation methodologies and targe
71、t price formation on all HTI rated stocks,please refer to the latest full report on our website at 我们认为医保准入对创新药放量至关重要我们认为医保准入对创新药放量至关重要,今年医保目录调整流程更加优化今年医保目录调整流程更加优化。本次调整优化了申报范围(向罕见病患者、儿童等特殊人群适当倾斜)、完善了准入方式(非独家药品准入时同步确定支付标准)、改进了续约规则(更利于稳定预期)、优化了工作流程(审评更加科学高效)。简易续约有利于稳定企业和社会各方面预期简易续约有利于稳定企业和社会各方面预期。简易续
72、约规则将非独家药品(无论协议是否到期),以及已经历过两个协议期(4年)但支付标准和支付范围均无变化的独家药品纳入常规目录管理;对今年调整医保支付范围但对基金影响预算不大(未超1倍)的药品也可以简易续约。新增非独家品种竞价规则新增非独家品种竞价规则,以医保支付意愿作为药品的准入门槛以医保支付意愿作为药品的准入门槛,首次明确“拟纳入药品目录的非独家药品采用竞价等方式同步确定医保支付标准“:第一步,医保方组织测算专家按程序进行测算,提出医保支付愿望作为该通用名药品的准入门槛;第二步,参与社保的企业按程序提交报价;第三步,药品通过竞价纳入医保目录的,取各企业报价中的最低者作为该通用名药品的支付标准。2
73、022年医保续约规则年医保续约规则资料来源:医保局官网,HTI29For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 支付端:支付端:创新药医保谈判更注重各方预期,调整后医保控费进入新常态创新药医保谈判更注重各方预期,调整后医保控费进入新常态出海加速出海加速中国创新走向前沿,海外授权拓展市场潜力中国创新走向前沿,海外授权拓展市场
74、潜力中国创新药中国创新药2020年开始加速授权海外,有望借助跨国企业的渠道打开产品市场空间,交易价格与全球市场规模、产品效果及竞争格局有关。年开始加速授权海外,有望借助跨国企业的渠道打开产品市场空间,交易价格与全球市场规模、产品效果及竞争格局有关。跨境交易金额较大的中国创新药主要包括:(跨境交易金额较大的中国创新药主要包括:(1)机制)机制/适应症突破:天境适应症突破:天境CD47(避免红细胞结合)、荣昌(避免红细胞结合)、荣昌HER2-ADC(HER2+胃癌胃癌/尿路上皮癌)、诺诚尿路上皮癌)、诺诚健华健华BTK(可透过血脑屏障,多发性硬化症)、加科思(可透过血脑屏障,多发性硬化症)、加科思
75、(SHP2全球进度领先);(全球进度领先);(2)进度较快的)进度较快的PD-1/PD-L1。中国创新药对外授权加速中国创新药对外授权加速资料来源:医药魔方,HTI30For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 多款中国创新药出海总交易金额超过多款中国创新药出海总交易金额超过10亿美元亿美元交易时间交易时间转让方转让方受
76、让方受让方产品(靶点,交易时研发阶段)产品(靶点,交易时研发阶段)权益范围权益范围专利分成(专利分成(净销售额百分比)净销售额百分比)总交易金额总交易金额首付款首付款里程碑付款里程碑付款2022/12/23科伦博泰MSD7个在研ADC(临床前)全球或大中华区以外94.751.7593.02022/12/6康方生物SummitAK112(PD-1/VEGF,III期临床)美国、加拿大、欧洲、日本低双位数50.05.045.02020/9/4天境生物AbbVie来佐利单抗(CD47,I/II期临床)大中华地区以外低至中双位数比例29.41.817.62021/12/20百济神州Novartis欧司
77、珀利单抗(TIGIT,III期临床)北美、欧洲、日本27.9528.953.018.95+6.07.0选择2021/8/9荣昌生物Seagen维迪西妥单抗(HER2-ADC,批准上市)亚洲外地区及日本、新加坡高个位数至中双位数26.02.024.02021/1/11百济神州Novartis替雷利珠单抗(PD-1,批准上市)北美、日本、欧盟等22.06.515.52023/1/5药明生物GSK双抗及至多3款TCE抗体(临床前及早期发现阶段)全球15.00.414.62022/5/16科伦博泰MSDSKB264(TROP-2 ADC,III期临床)中国外地区14.10.4713.632017/7/
78、5百济神州新基替雷利珠单抗(PD-1,II期临床)(后因BMS收购新基,新基支付百济1.5亿终止费)亚洲外地区13.92.69.82020/10/26基石药业EQRxCS1003(PD-1,II期临床)舒格利单抗(PD-L1,III期临床)大中华地区以外13.01.511.52022/8/16天境生物AbbVieCD47(I期临床)大中华地区以外中至高单位数12.9512.952022/7/28石药集团ElevationSYSA1801(CLDN18.2,I期临床)大中华地区以外最高至双位数11.950.2711.682023/2/23康诺亚阿斯利康CMG901(CLDN18.2 ADC,Ia
79、期临床)全球11.880.6311.252023/1/23和黄医药Takeda呋喹替尼(VEGFR13,获批上市)大中华地区以外11.34.07.32021/2/1君实生物Coherus特瑞普利单抗(PD-1,批准上市)美国、加拿大11.01.57.62020/8/18信达生物Eli Lilly信迪利单抗(PD-1,批准上市)中国外地区双位数10.32.08.32021/7/12诺诚健华Biogen奥布替尼(BTK,批准上市)多发性硬化症全球权益自免中国外地区权益十几9.41.38.12020/6/1加科思AbbVie加科思SHP2管线,包括JAB-3068(I/II期临床)及JAB-3312
80、(I期临床)全球权益,加科思海外AbbVie支付低至中双位数国内加科思支付中至高单位数8.60.58.12017/8/17誉衡药业药明生物Arcus赛帕利单抗(PD-1,I期临床)北美、欧洲、日本及其他几个地区高个位数至低双位数8.20.28.0资料来源:医药魔方,HTI31For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 在
81、考量药物批准概率时,我们认为最重要的是申报药物有没有“非批不可”的理由。我们归纳信达/礼来ODAC会议上FDA的观点,总结出4个客观维度去分析以下中国创新药美国上市的成功概率:1)头对头标准疗法(SOC)是否必须。2)申报药物有否进行对照SOC的关键临床试验。3)入组人群能否代表美国人群。4)临床终点选择。结论:分析结果乐观,关键原因在于药物的疗效证据确切、罕见病、未满足需求。*以启动临床日期为准公司公司PDUFADate相关药物相关药物靶点靶点/形式形式适应症适应症临床临床对照对照组为组为美国美国标准疗法标准疗法?*主要临床地点主要临床地点备注备注传奇生物传奇生物2022/02/28cilt
82、a-celBCMA CAR-TR/R MM末线单臂美国成功;突破性疗法百济神州百济神州2023/01/20泽布替尼BTK小分子CLL/SLLSEQUOIA:是,vs B+RALPINE:是,vs伊布替尼全球多中心,含欧美人群成功信达生物信达生物2022/03信迪利单抗PD-1单抗1L 肺癌否否失败,2022/02 ODAC会议上14:1被否决和黄医药和黄医药2022/04/30索凡替尼VEGFR/FGFR小分子神经内分泌肿瘤否中国美国桥接临床失败,需纳入更多代表美国人群的MRCT孤儿药认定,快速通道资格和黄医药和黄医药/呋喹替尼VEGFR小分子3L结直肠癌否全球多中心,100+例美国人群滚动递
83、交中;快速通道资格亿帆医药亿帆医药2022/03/30F-627贝格司亭长效G-CSFCIN是欧洲延迟,国际旅行限制GMP现场核查君实生物君实生物2022/04/30特瑞普利PD-1单抗1L 鼻咽癌2L+鼻咽癌JUPITER-02:是POLARIS-02:单臂,缺乏SOC中国延迟,国际旅行限制GMP现场核查突破性疗法百济神州百济神州2022/07/14替雷利珠PD-1单抗2L+食管鳞癌是全球多中心,100+例欧美人群延迟,国际旅行限制GMP现场核查资料来源:FDATracker,clinicaltrials.gov,HTI32For full disclosure of risks,valua
84、tion methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 2022年至今国内创新药在年至今国内创新药在FDA获批获批2款、失败款、失败2款、审批中款、审批中4款款随着中国新药研发持续投入,国产药品大量实现出口创汇。根据传奇生物官网,公司BCMA CAR-T西达基奥仑赛与杨森公司合作,已先后获得美国、欧盟、日本等国批准治疗多发性骨髓瘤。根据医药魔方,治疗新冠病毒感染的巴尼伟单抗联合埃特司韦单抗2021年
85、销售额达22.39亿美元。根据百济神州微信公众号,公司在ALPINE试验中显示,泽布替尼对比伊布替尼用于治疗复发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤取得最终PFS优效性结果(HR:0.65 95%CI,0.49-0.86,P=0.0024)。根据医药魔方数据库,2021年艾伯维与强生伊布替尼合计销售69.4亿美元。泽布替尼泽布替尼西达基奥仑赛西达基奥仑赛埃特司韦单抗埃特司韦单抗多款中国新药出海,验证多款中国新药出海,验证best-in-class能力能力资料来源:医药魔方,HTI33For full disclosure of risks,valuation methodologies
86、 and target price formation on all HTI rated stocks,please refer to the latest full report on our website at 呋喹替尼(和黄医药)是VEGFR1-3抑制剂,在中国获批治疗3L结直肠癌,2022Q4市占率达到44%、远超瑞戈非尼(29%)。4L结直肠癌患者治疗尚无标准方案,存在未满足临床需求。结直肠癌患者治疗尚无标准方案,存在未满足临床需求。结直肠癌的标准1L及2L治疗包括化疗、抗VEGF治疗及抗EGFR治疗(RAS野生型),标准3L治疗为瑞戈非尼或TAS-102。目前,针对1-3L标准治
87、疗失败的结直肠癌患者尚无有效疗法。FRESCO-2研究针对研究针对4L结直肠癌患者,为结直肠癌患者,为MRCT。基于中国FRESCO研究结果及海外监管沟通,公司开展FRESCO-2全球多中心临床研究。研究纳入4L结直肠癌患者,在美国(18%)、欧洲(71%)、日本(8%)、澳大利亚(3%)开展。FRESCO-2研究与研究与FRESCO研究保持高度一致,疗效及安全性优于瑞戈非尼及研究保持高度一致,疗效及安全性优于瑞戈非尼及TAS-102。在疗效上,呋喹替尼较安慰剂组mOS延长2.6月,mPFS延长1.9月,高于瑞戈非尼(mOS延长1.4月,mPFS延长0.2月)、TAS-102(mOS延长1.8
88、月,mPFS延长0.3月)。安全性方面,未观察到瑞戈非尼的肝毒性及TAS-102的重度骨髓抑制。海外授权武田制药海外授权武田制药,交易规模11.2亿美元+销售分成;美国、欧洲、日本上市申请计划于2023年内完成递交。呋喹替尼呋喹替尼FRESCO-2数据积极,海外授权武田,数据积极,海外授权武田,FDA滚动递交中滚动递交中资料来源:和黄医药演示材料,clinicaltrials.gov,HTI34For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stoc
89、ks,please refer to the latest full report on our website at 全球10亿美金级别的重磅产品有百余个。2015-2020年,全球年销售额达10亿美金的“重磅炸弹”均有百余个。其中2020年,有123个“重磅炸弹”年销售额超10亿美金其中,日本药企新药30年共约20个品种全球销售10亿美金以上。中国的优势:工程师红利,巨大的病人基数及统一的市场。全球每年销售超全球每年销售超10亿美金的药品超百个亿美金的药品超百个59亿美元亿美元58.9-30亿亿美元美元29.9-20亿美元亿美元19.9-10亿美亿美元元合计合计201
90、206530783079362123序号序号品种品种公司公司适应症适应症机制机制/靶点靶点销量销量(亿美元亿美元)1Xtandi(恩杂鲁胺)安斯泰来前列腺癌AR36.62Entyvio(维得利珠单抗)武田溃疡性结肠炎、克罗恩氏病4731.83Immunoglobin武田27.44Vyvanse(赖右苯丙胺)武田ADHDTAAR125.15Latuda(鲁拉西酮)住友精神分裂症、双向I型障碍的重度抑郁5-HT17.46Prograf(他克莫司)安斯泰来重症肌无力、器官移植排斥FKBP-1
91、217.77Myrbetriq(米拉贝隆)安斯泰来膀胱过度活动症肾上腺素能314.88Advate武田血友病重组因子14.59Samsca(托伐普坦片)大冢低钠血症伴心力衰竭加压素13.710Velcade(硼替佐米)武田多发性骨髓瘤蛋白酶抑制剂10.811Lixiana(依度沙班)第一三共静脉血栓栓塞、肺栓塞等Xa因子10.612Leuprorelin(亮丙瑞林)武田前列腺癌、乳腺癌、子宫内膜异位、子宫肌瘤、性早熟GnRH10.013Abilify Maintena(阿立哌唑)大冢精神分裂症5-HT 9.314Actos(吡格列酮)武田II型糖尿病PPAR-36.0(in 2011)15Pr
92、evacid(兰索拉唑)武田胃食道逆流、胃及十二指肠溃疡、ZollingerEllison syndrome质子泵抑制剂28.3(in 2000)16Blopress(坎地沙坦)武田高血压ARB14.2(in 2013)17Vesicare(索利那新)安斯泰来多动性膀胱、神经源性逼尿肌过度活动M3受体12.4(in 2015)18Harnal/Omnic(坦索罗辛)安斯泰来良性前列腺增生、慢性前列腺炎/慢性骨盆疼痛综合征肾上腺素能110.4(in 2010)19Olmesartan(奥美沙坦)第一三共高血压、心脏衰竭、糖尿病生病ARB22.1(in 2010)20Levofloxacin(左氧
93、氟沙星)第一三共细菌感染氟喹诺酮10.0(in 2007)日本新药日本新药30年共约年共约20个品种全球销售个品种全球销售10亿美金以上亿美金以上展望未来展望未来全球全球10亿美金药品百余个,国产新药应有一席之地亿美金药品百余个,国产新药应有一席之地资料来源:医药魔方,各公司年报,HTI35For full disclosure of risks,valuation methodologies and target price formation on all HTI rated stocks,please refer to the latest full report on our webs
94、ite at 新兴技术的崛起能够在一定程度上能够改变现有治疗指南,比如CAR-T能够大幅提高ORR,Protac意图解决难成药靶点的问题;创新靶点、致病通路研究等基础研究是自主创新的弱项,新技术的出现能够一定程度弥补这个缺点。但是随着高端人才回归,国内新技术发展与国际前沿差距越来越小,新技术突破将成为自主创新的重要驱动力。国内新技术发展与国际前沿差距趋于缩小国内新技术发展与国际前沿差距趋于缩小国内新技术发展与国际前沿差距趋于缩小国内新技术发展与国际前沿差距趋于缩小资料来源:HTI36For full disclosure of risks,valuation methodologies and
95、 target price formation on all HTI rated stocks,please refer to the latest full report on our website at APPENDIX 1Summary-Desensitization from macro negatives and recovery of hospital visits supporting potential rebound of pharmaceutical sectorvaluation.Pharmaceutical sectors are susceptible to mac
96、ro influence,including increase in interest rate.We believe the valuation ofpharmaceutical sector gradually desensitized from macro factors,from October 2022.Meanwhile,from statistics review on hospitalvisits in Mainland China and Hong Kong,in 2023,we expect a rapid recovery in regular hospital care
97、 from negative influence ofCOVID-19 from the past 3 years.-The best investment timing of pharmaceutical companies are at the early commercialization stage of potential blockbuster drug.Chinas pharmaceutical market is vast and uniform,with rapid growth on innovative drug due to regulatory support inn
98、ovation andVBP.Meanwhile,we are witnessing R&D breakthrough in NASH,Alzheimers disease,GLP-1 dual-agonist,Tumor-Treating Field,andRSV vaccine,as well as blockbuster potential in GLP-1R agonists and zoster vaccine.-Supported by positive signals in regulation side,payment side,and globalization,valuat
99、ion repair for Chinas pharmaceuticalcompanies is on the way.On regulation side,the policy of“Drug Development Under Guidance of Clinical Need”by CDE shaped theR&D pipelines in pharmaceutical companies,largely reduced redundant development,therefore,enhancing development efficiency.On payment side,Na
100、tional Health Insurance Institute released new guidance on price reduction rules if included in NRDL.Onglobalization,successful example by BeiGene and Legendary Bio paved a clear pathway in NDA/BLA of innovative medicine in the US.These changes in fundamental,in a way,reversed the markets pessimisti
101、c expectations toward Chinas pharmaceutical companies,subsequently bringing valuation repair.37APPENDIX 2重要信息披露重要信息披露本研究报告由海通国际分销,海通国际是由海通国际研究有限公司(HTIRL),Haitong Securities India Private Limited(HSIPL),Haitong International Japan K.K.(HTIJKK)和海通国际证券有限公司(HTISCL)的证券研究团队所组成的全球品牌,海通国际证券集团(HTISG)各成员分别在其许
102、可的司法管辖区内从事证券活动。IMPORTANT DISCLOSURESThis research report is distributed by Haitong International,a global brand name for the equity research teams of Haitong International Research Limited(“HTIRL”),Haitong Securities India Private Limited(“HSIPL”),Haitong International Japan K.K.(“HTIJKK”),Haitong I
103、nternational Securities Company Limited(“HTISCL”),and anyother members within the Haitong International Securities Group of Companies(“HTISG”),each authorized to engage in securities activities in its respectivejurisdiction.HTIRL分析师认证分析师认证Analyst Certification:我,孟科含,在此保证(i)本研究报告中的意见准确反映了我们对本研究中提及的任何
104、或所有目标公司或上市公司的个人观点,并且(ii)我的报酬中没有任何部分与本研究报告中表达的具体建议或观点直接或间接相关;及就此报告中所讨论目标公司的证券,我们(包括我们的家属)在其中均不持有任何财务利益。I,Kehan Meng,certify that(i)the views expressed in this research report accurately reflect my personal views about any or all of the subjectcompanies or issuers referred to in this research and(ii)n
105、o part of my compensation was,is or will be directly or indirectly related to the specific recommendationsor views expressed in this research report;and that I(including members of my household)have no financial interest in the security or securities of the subjectcompanies discussed.我,袁艺琳,在此保证(i)本研
106、究报告中的意见准确反映了我们对本研究中提及的任何或所有目标公司或上市公司的个人观点,并且(ii)我的报酬中没有任何部分与本研究报告中表达的具体建议或观点直接或间接相关;及就此报告中所讨论目标公司的证券,我们(包括我们的家属)在其中均不持有任何财务利益。I,Yilin Yuan,certify that(i)the views expressed in this research report accurately reflect my personal views about any or all of the subjectcompanies or issuers referred to i
107、n this research and(ii)no part of my compensation was,is or will be directly or indirectly related to the specific recommendationsor views expressed in this research report;and that I(including members of my household)have no financial interest in the security or securities of the subjectcompanies d
108、iscussed.38APPENDIX 2利益冲突披露利益冲突披露Conflict of Interest Disclosures海通国际及其某些关联公司可从事投资银行业务和/或对本研究中的特定股票或公司进行做市或持有自营头寸。就本研究报告而言,以下是有关该等关系的披露事项(以下披露不能保证及时无遗漏,如需了解及时全面信息,请发邮件至ERD-D)HTI and some of its affiliates may engage in investment banking and/or serve as a market maker or hold proprietary trading pos
109、itions of certain stocks orcompanies in this research report.As far as this research report is concerned,the following are the disclosure matters related to such relationship(As the followingdisclosure does not ensure timeliness and completeness,please send an email to ERD-D if timely and comprehens
110、ive information is needed).海通证券股份有限公司和/或其子公司(统称“海通”)在过去12个月内参与了1877.HK and 2179.HK的投资银行项目。投资银行项目包括:1、海通担任上市前辅导机构、保荐人或主承销商的首次公开发行项目;2、海通作为保荐人、主承销商或财务顾问的股权或债务再融资项目;3、海通作为主经纪商的新三板上市、目标配售和并购项目。Haitong Securities Co.,Ltd.and/or its subsidiaries(collectively,the Haitong)have a role in investment banking p
111、rojects of 1877.HK and 2179.HK within the past 12months.The investment banking projects include 1.IPO projects in which Haitong acted as pre-listing tutor,sponsor,or lead-underwriter;2.equity or debtrefinancing projects of 1877.HK and 2179.HK for which Haitong acted as sponsor,lead-underwriter or fi
112、nancial advisor;3.listing by introduction in the new threeboard,target placement,M&A projects in which Haitong acted as lead-brokerage firm.作为回报,海通拥有2196.HK 及 2179.HK一类普通股证券的1%或以上。The Haitong beneficially owns 1%or more of a class of common equity securities of 2196.HK and 2179.HK.1877.HK,1672.HK,21
113、79.HK 及 HCM.US目前或过去12个月内是海通的投资银行业务客户。1877.HK,1672.HK,2179.HK and HCM.US are/were an investment bank clients of Haitong currently or within the past 12 months.39APPENDIX 2石药集团欧意药业有限公司目前或过去12个月内是海通的客户。海通向客户提供非投资银行业务的证券相关业务服务。石药集团欧意药业有限公司 is/was a client of Haitong currently or within the past 12 month
114、s.The client has been provided for non-investment-banking securities-related services.武汉华夏理工学院,武汉当代科技产业集团股份有限公司目前或过去12个月内是海通的客户。海通向客户提供非证券业务服务。武汉华夏理工学院,武汉当代科技产业集团股份有限公司 is/was a client of Haitong currently or within the past 12 months.The client has been provided fornon-securities services.海通在过去12个月
115、中获得对HCM.US提供投资银行服务的报酬。Haitong received in the past 12 months compensation for investment banking services provided to HCM.US.海通预计将(或者有意向)在未来三个月内从2179.HK,GLMD.US 及 HCM.US获得投资银行服务报酬。Haitong expects to receive,or intends to seek,compensation for investment banking services in the next three months from
116、 2179.HK,GLMD.US and HCM.US.海通在过去的12个月中从武汉华夏理工学院,武汉当代科技产业集团股份有限公司获得除投资银行服务以外之产品或服务的报酬。Haitong has received compensation in the past 12 months for products or services other than investment banking from 武汉华夏理工学院,武汉当代科技产业集团股份有限公司.40APPENDIX 2评级定义评级定义(从从2020年年7月月1日开始执行日开始执行):海通国际(以下简称“HTI”)采用相对评级系统来为投资
117、者推荐我们覆盖的公司:优于大市、中性或弱于大市。投资者应仔细阅读HTI的评级定义。并且HTI发布分析师观点的完整信息,投资者应仔细阅读全文而非仅看评级。在任何情况下,分析师的评级和研究都不能作为投资建议。投资者的买卖股票的决策应基于各自情况(比如投资者的现有持仓)以及其他因素。分析师股票评级分析师股票评级优于大市优于大市,未来12-18个月内预期相对基准指数涨幅在10%以上,基准定义如下中性中性,未来12-18个月内预期相对基准指数变化不大,基准定义如下。根据FINRA/NYSE的评级分布规则,我们会将中性评级划入持有这一类别。弱于大市弱于大市,未来12-18个月内预期相对基准指数跌幅在10%
118、以上,基准定义如下各地股票基准指数:日本各地股票基准指数:日本 TOPIX,韩国韩国 KOSPI,台湾台湾 TAIEX,印度印度 Nifty100,美国美国 SP500;其他所有中国概念股其他所有中国概念股 MSCI China.Ratings Definitions(from 1 Jul 2020):Haitong International uses a relative rating system using Outperform,Neutral,or Underperform for recommending the stocks we cover to investors.Inves
119、tors shouldcarefully read the definitions of all ratings used in Haitong International Research.In addition,since Haitong International Research contains more completeinformation concerning the analysts views,investors should carefully read Haitong International Research,in its entirety,and not infe
120、r the contents from the ratingalone.In any case,ratings(or research)should not be used or relied upon as investment advice.An investors decision to buy or sell a stock should depend on individualcircumstances(such as the investors existing holdings)and other considerations.Analyst Stock RatingsOutpe
121、rform:The stocks total return over the next 12-18 months is expected to exceed the return of its relevant broad market benchmark,as indicated below.Neutral:The stocks total return over the next 12-18 months is expected to be in line with the return of its relevant broad market benchmark,as indicated
122、 below.Forpurposes only of FINRA/NYSE ratings distribution rules,our Neutral rating falls into a hold rating category.Underperform:The stocks total return over the next 12-18 months is expected to be below the return of its relevant broad market benchmark,as indicated below.Benchmarks for each stock
123、s listed region are as follows:Japan TOPIX,Korea KOSPI,Taiwan TAIEX,India Nifty100,US SP500;for all other China-conceptstocks MSCI China.41APPENDIX 2评级分布评级分布Rating Distribution42APPENDIX 2截至截至2022年年12月月31日日海通国际股票研究评级分布海通国际股票研究评级分布优于大市优于大市中性中性弱于大市弱于大市(持有持有)海通国际股票研究覆盖率89.4%9.2%1.5%投资银行客户*5.2%7.3%8.3%*
124、在每个评级类别里投资银行客户所占的百分比。上述分布中的买入,中性和卖出分别对应我们当前优于大市,中性和落后大市评级。只有根据FINRA/NYSE的评级分布规则,我们才将中性评级划入持有这一类别。请注意在上表中不包含非评级的股票。此前的评级系统定义此前的评级系统定义(直至直至2020年年6月月30日日):买入买入,未来12-18个月内预期相对基准指数涨幅在10%以上,基准定义如下中性中性,未来12-18个月内预期相对基准指数变化不大,基准定义如下。根据FINRA/NYSE的评级分布规则,我们会将中性评级划入持有这一类别。卖出卖出,未来12-18个月内预期相对基准指数跌幅在10%以上,基准定义如下
125、各地股票基准指数:日本各地股票基准指数:日本 TOPIX,韩国韩国 KOSPI,台湾台湾 TAIEX,印度印度 Nifty100;其他所有中国概念股其他所有中国概念股 MSCI China.Haitong InternationalEquity Research Ratings Distribution,as of Dec 31,2022OutperformNeutralUnderperform(hold)HTI Equity Research Coverage89.4%9.2%1.5%IB clients*5.2%7.3%8.3%*Percentage of investment banki
126、ng clients in each rating category.BUY,Neutral,and SELL in the above distribution correspond to our current ratings of Outperform,Neutral,and Underperform.For purposes only of FINRA/NYSE ratings distribution rules,our Neutral rating falls into a hold rating category.Please note that stocks with an N
127、R designation are notincluded in the table above.Previous rating system definitions(until 30 Jun 2020):BUY:The stocks total return over the next 12-18 months is expected to exceed the return of its relevant broad market benchmark,as indicated below.NEUTRAL:The stocks total return over the next 12-18
128、 months is expected to be in line with the return of its relevant broad market benchmark,as indicated below.For purposes only of FINRA/NYSE ratings distribution rules,our Neutral rating falls into a hold rating category.SELL:The stocks total return over the next 12-18 months is expected to be below
129、the return of its relevant broad market benchmark,as indicated below.Benchmarks for each stocks listed region are as follows:Japan TOPIX,Korea KOSPI,Taiwan TAIEX,India Nifty100;for all other China-concept stocks MSCIChina.43APPENDIX 2海通国际非评级研究:海通国际非评级研究:海通国际发布计量、筛选或短篇报告,并在报告中根据估值和其他指标对股票进行排名,或者基于可能的
130、估值倍数提出建议价格。这种排名或建议价格并非为了进行股票评级、提出目标价格或进行基本面估值,而仅供参考使用。Haitong International Non-Rated Research:Haitong International publishes quantitative,screening or short reports which may rank stocks according to valuation andother metrics or may suggest prices based on possible valuation multiples.Such rankin
131、gs or suggested prices do not purport to be stock ratings or target prices orfundamental values and are for information only.海通国际海通国际A股覆盖股覆盖:海通国际可能会就沪港通及深港通的中国A股进行覆盖及评级。海通证券(600837.CH),海通国际于上海的母公司,也会于中国发布中国A股的研究报告。但是,海通国际使用与海通证券不同的评级系统,所以海通国际与海通证券的中国A股评级可能有所不同。Haitong International Coverage of A-Sha
132、res:Haitong International may cover and rate A-Shares that are subject to the Hong Kong Stock Connect scheme withShanghai and Shenzhen.Haitong Securities(HS;600837 CH),the ultimate parent company of HTISG based in Shanghai,covers and publishes research on these sameA-Shares for distribution in mainl
133、and China.However,the rating system employed by HS differs from that used by HTI and as a result there may be a difference in theHTI and HS ratings for the same A-share stocks.海通国际海通国际优质优质100 A股股(Q100)指数指数:海通国际Q100指数是一个包括100支由海通证券覆盖的优质中国A股的计量产品。这些股票是通过基于质量的筛选过程,并结合对海通证券A股团队自下而上的研究。海通国际每季对Q100指数成分作出复
134、审。Haitong International Quality 100 A-share(Q100)Index:HTIs Q100 Index is a quant product that consists of 100 of the highest-quality A-shares under coverage atHS in Shanghai.These stocks are carefully selected through a quality-based screening process in combination with a review of the HS A-share
135、teams bottom-upresearch.The Q100 constituent companies are reviewed quarterly.44APPENDIX 2MSCI ESG评级免责声明条款:评级免责声明条款:尽管海通国际的信息供货商(包括但不限于MSCI ESG Research LLC及其联属公司(ESG方)从其认为可靠的来源获取信息(信息),ESG方均不担保或保证此处任何数据的原创性,准确性和/或完整性,并明确表示不作出任何明示或默示的担保,包括可商售性和针对特定目的的适用性。该信息只能供阁下内部使用,不得以任何形式复制或重新传播,并不得用作任何金融工具、产品或指数
136、的基础或组成部分。此外,信息本质上不能用于判断购买或出售何种证券,或何时购买或出售该证券。即使已被告知可能造成的损害,ESG方均不承担与此处任何资料有关的任何错误或遗漏所引起的任何责任,也不对任何直接、间接、特殊、惩罚性、附带性或任何其他损害赔偿(包括利润损失)承担任何责任。MSCI ESG Disclaimer:Although Haitong Internationals information providers,including without limitation,MSCI ESG Research LLC and its affiliates(the“ESGParties”),o
137、btain information(the“Information”)from sources they consider reliable,none of the ESG Parties warrants or guarantees the originality,accuracy and/orcompleteness,of any data herein and expressly disclaim all express or implied warranties,including those of merchantability and fitness for a particula
138、r purpose.TheInformation may only be used for your internal use,may not be reproduced or redisseminated in any form and may not be used as a basis for,or a component of,anyfinancial instruments or products or indices.Further,none of the Information can in and of itself be used to determine which sec
139、urities to buy or sell or when to buyor sell them.None of the ESG Parties shall have any liability for any errors or omissions in connection with any data herein,or any liability for any direct,indirect,special,punitive,consequential or any other damages(including lost profits)even if notified of th
140、e possibility of such damages.45APPENDIX 2盟浪义利盟浪义利(FIN-ESG)数据通免责声明条款:数据通免责声明条款:在使用盟浪义利(FIN-ESG)数据之前,请务必仔细阅读本条款并同意本声明:第一条 义利(FIN-ESG)数据系由盟浪可持续数字科技有限责任公司(以下简称“本公司”)基于合法取得的公开信息评估而成,本公司对信息的准确性及完整性不作任何保证。对公司的评估结果仅供参考,并不构成对任何个人或机构投资建议,也不能作为任何个人或机构购买、出售或持有相关金融产品的依据。本公司不对任何个人或机构投资者因使用本数据表述的评估结果造成的任何直接或间接损失负
141、责。第二条 盟浪并不因收到此评估数据而将收件人视为客户,收件人使用此数据时应根据自身实际情况作出自我独立判断。本数据所载内容反映的是盟浪在最初发布本数据日期当日的判断,盟浪有权在不发出通知的情况下更新、修订与发出其他与本数据所载内容不一致或有不同结论的数据。除非另行说明,本数据(如财务业绩数据等)仅代表过往表现,过往的业绩表现不作为日后回报的预测。第三条 本数据版权归本公司所有,本公司依法保留各项权利。未经本公司事先书面许可授权,任何个人或机构不得将本数据中的评估结果用于任何营利性目的,不得对本数据进行修改、复制、编译、汇编、再次编辑、改编、删减、缩写、节选、发行、出租、展览、表演、放映、广播
142、、信息网络传播、摄制、增加图标及说明等,否则因此给盟浪或其他第三方造成损失的,由用户承担相应的赔偿责任,盟浪不承担责任。第四条 如本免责声明未约定,而盟浪网站平台载明的其他协议内容(如盟浪网站用户注册协议盟浪网用户服务(含认证)协议盟浪网隐私政策等)有约定的,则按其他协议的约定执行;若本免责声明与其他协议约定存在冲突或不一致的,则以本免责声明约定为准。SusallWave FIN-ESG Data Service Disclaimer:Please read these terms and conditions below carefully and confirm your agreemen
143、t and acceptance with these termsbefore using SusallWave FIN-ESG Data Service.1.FIN-ESG Data is produced by SusallWave Digital Technology Co.,Ltd.(In short,SusallWave)s assessment based on legal publicly accessible information.SusallWaveshall not be responsible for any accuracy and completeness of t
144、he information.The assessment result is for reference only.It is not for any investment advice for anyindividual or institution and not for basis of purchasing,selling or holding any relative financial products.We will not be liable for any direct or indirect loss of anyindividual or institution as
145、a result of using SusallWave FIN-ESG Data.2.SusallWave do not consider recipients as customers for receiving these data.When using the data,recipients shall make your own independent judgment accordingto your practical individual status.The contents of the data reflect the judgment of us only on the
146、 release day.We have right to update and amend the data andrelease other data that contains inconsistent contents or different conclusions without notification.Unless expressly stated,the data(e.g.,financial performance data)represents past performance only and the past performance cannot be viewed
147、as the prediction of future return.3.The copyright of this data belongs to SusallWave,and we reserve all rights in accordance with the law.Without the prior written permission of our company,noneof individual or institution can use these data for any profitable purpose.Besides,none of individual or
148、institution can take actions such as amendment,replication,translation,compilation,re-editing,adaption,deletion,abbreviation,excerpts,issuance,rent,exhibition,performance,projection,broadcast,information networktransmission,shooting,adding icons and instructions.If any loss of SusallWave or any thir
149、d-party is caused by those actions,users shall bear the correspondingcompensation liability.SusallWave shall not be responsible for any loss.4.If any term is not contained in this disclaimer but written in other agreements on our website(e.g.User Registration Protocol of SusallWave Website,User Serv
150、ice(including authentication)Agreement of SusallWave Website,Privacy Policy of Susallwave Website),it should be executed according to other agreements.If there isany difference between this disclaim and other agreements,this disclaimer shall be applied.46APPENDIX 2重要免责声明:重要免责声明:非印度证券的研究报告非印度证券的研究报告:
151、本报告由海通国际证券集团有限公司(“HTISGL”)的全资附属公司海通国际研究有限公司(“HTIRL”)发行,该公司是根据香港证券及期货条例(第571章)持有第4类受规管活动(就证券提供意见)的持牌法团。该研究报告在HTISGL的全资附属公司Haitong International(Japan)K.K.(“HTIJKK”)的协助下发行,HTIJKK是由日本关东财务局监管为投资顾问。印度证券的研究报告:印度证券的研究报告:本报告由从事证券交易、投资银行及证券分析及受Securities and Exchange Board of India(“SEBI”)监管的Haitong Securiti
152、es IndiaPrivate Limited(“HTSIPL”)所发行,包括制作及发布涵盖BSE Limited(“BSE”)和National Stock Exchange of India Limited(“NSE”)上市公司(统称为印度交易所)的研究报告。HTSIPL于2016年12月22日被收购并成为海通国际证券集团有限公司(“HTISG”)的一部分。所有研究报告均以海通国际为名作为全球品牌,经许可由海通国际证券股份有限公司及/或海通国际证券集团的其他成员在其司法管辖区发布。本文件所载信息和观点已被编译或源自可靠来源,但HTIRL、HTISCL或任何其他属于海通国际证券集团有限公司(
153、“HTISG”)的成员对其准确性、完整性和正确性不做任何明示或暗示的声明或保证。本文件中所有观点均截至本报告日期,如有更改,恕不另行通知。本文件仅供参考使用。文件中提及的任何公司或其股票的说明并非意图展示完整的内容,本文件并非/不应被解释为对证券买卖的明示或暗示地出价或征价。在某些司法管辖区,本文件中提及的证券可能无法进行买卖。如果投资产品以投资者本国货币以外的币种进行计价,则汇率变化可能会对投资产生不利影响。过去的表现并不一定代表将来的结果。某些特定交易,包括设计金融衍生工具的,有产生重大风险的可能性,因此并不适合所有的投资者。您还应认识到本文件中的建议并非为您量身定制。分析师并未考虑到您自
154、身的财务情况,如您的财务状况和风险偏好。因此您必须自行分析并在适用的情况下咨询自己的法律、税收、会计、金融和其他方面的专业顾问,以期在投资之前评估该项建议是否适合于您。若由于使用本文件所载的材料而产生任何直接或间接的损失,HTISG及其董事、雇员或代理人对此均不承担任何责任。除对本文内容承担责任的分析师除外,HTISG及我们的关联公司、高级管理人员、董事和雇员,均可不时作为主事人就本文件所述的任何证券或衍生品持有长仓或短仓以及进行买卖。HTISG的销售员、交易员和其他专业人士均可向HTISG的相关客户和公司提供与本文件所述意见相反的口头或书面市场评论意见或交易策略。HTISG可做出与本文件所述
155、建议或意见不一致的投资决策。但HTIRL没有义务来确保本文件的收件人了解到该等交易决定、思路或建议。请访问海通国际网站 ,查阅更多有关海通国际为预防和避免利益冲突设立的组织和行政安排的内容信息。非美国分析师披露信息:非美国分析师披露信息:本项研究上海品茶上列明的海通国际分析师并未在FINRA进行注册或者取得相应的资格,并且不受美国FINRA有关与本项研究目标公司进行沟通、公开露面和自营证券交易的第2241条规则之限制。47APPENDIX 2IMPORTANT DISCLAIMERFor research reports on non-Indian securities:The research
156、report is issued by Haitong International Research Limited(“HTIRL”),a wholly owned subsidiary ofHaitong International Securities Group Limited(“HTISGL”)and a licensed corporation to carry on Type 4 regulated activity(advising on securities)for the purpose ofthe Securities and Futures Ordinance(Cap.5
157、71)of Hong Kong,with the assistance of Haitong International(Japan)K.K.(“HTIJKK”),a wholly owned subsidiary ofHTISGL and which is regulated as an Investment Adviser by the Kanto Finance Bureau of Japan.For research reports on Indian securities:The research report is issued by Haitong Securities Indi
158、a Private Limited(“HSIPL”),an Indian company and a Securitiesand Exchange Board of India(“SEBI”)registered Stock Broker,Merchant Banker and Research Analyst that,inter alia,produces and distributes research reportscovering listed entities on the BSE Limited(“BSE”)and the National Stock Exchange of I
159、ndia Limited(“NSE”)(collectively referred to as“Indian Exchanges”).HSIPLwas acquired and became part of the Haitong International Securities Group of Companies(“HTISG”)on 22 December 2016.All the research reports are globally branded under the name Haitong International and approved for distribution
160、 by Haitong International Securities CompanyLimited(“HTISCL”)and/or any other members within HTISG in their respective jurisdictions.The information and opinions contained in this research report have been compiled or arrived at from sources believed to be reliable and in good faith but norepresenta
161、tion or warranty,express or implied,is made by HTIRL,HTISCL,HSIPL,HTIJKK or any other members within HTISG from which this research report maybe received,as to their accuracy,completeness or correctness.All opinions expressed herein are as of the date of this research report and are subject to chang
162、ewithout notice.This research report is for information purpose only.Descriptions of any companies or their securities mentioned herein are not intended to becomplete and this research report is not,and should not be construed expressly or impliedly as,an offer to buy or sell securities.The securiti
163、es referred to in thisresearch report may not be eligible for purchase or sale in some jurisdictions.If an investment product is denominated in a currency other than an investors homecurrency,a change in exchange rates may adversely affect the investment.Past performance is not necessarily indicativ
164、e of future results.Certain transactions,including those involving derivatives,give rise to substantial risk and are not suitable for all investors.You should also bear in mind that recommendations in thisresearch report are not tailor-made for you.The analyst has not taken into account your unique
165、financial circumstances,such as your financial situation and riskappetite.You must,therefore,analyze and should,where applicable,consult your own legal,tax,accounting,financial and other professional advisers to evaluatewhether the recommendations suits you before investment.Neither HTISG nor any of
166、 its directors,employees or agents accepts any liability whatsoever for anydirect or consequential loss arising from any use of the materials contained in this research report.48APPENDIX 2HTISG and our affiliates,officers,directors,and employees,excluding the analysts responsible for the content of
167、this document,will from time to time have long orshort positions in,act as principal in,and buy or sell,the securities or derivatives,if any,referred to in this research report.Sales,traders,and other professionals ofHTISG may provide oral or written market commentary or trading strategies to the re
168、levant clients and the companies within HTISG that reflect opinions that arecontrary to the opinions expressed in this research report.HTISG may make investment decisions that are inconsistent with the recommendations or viewsexpressed in this research report.HTI is under no obligation to ensure tha
169、t such other trading decisions,ideas or recommendations are brought to the attention ofany recipient of this research report.Please refer to HTIs website for further information on HTIs organizational and administrative arrangements set up for the preventionand avoidance of conflicts of interest wit
170、h respect to Research.Non U.S.Analyst Disclosure:The HTI analyst(s)listed on the cover of this Research is(are)not registered or qualified as a research analyst with FINRA and are notsubject to U.S.FINRA Rule 2241 restrictions on communications with companies that are the subject of the Research;pub
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