图片来源：图虫创意
本文来源：时代财经 作者：张羽岐
明星大单品司美格鲁肽正迎来越来越多的中国竞争者。
日前，又一款GLP-1（胰高血糖素样肽-1）类药物在国内商业化上市。2月11日，银诺医药GLP-1RA创新药依苏帕格鲁肽α（商品名：怡诺轻）在上海交通大学医学院附属第六人民医院和南京大学医学院附属鼓楼医院同步开出首张处方。2月12日，时代财经从多个渠道获悉，怡诺轻已经在线上开售。该药物于今年1月获得国家药监局批准上市，用于治疗成人2型糖尿病。目前为一周注射一次，半衰期为204h，未来有望支持2周一针。
2月17日，阿里健康大药房工作人员告诉时代财经，怡诺轻在该平台1mg/盒售价为532元，3mg/盒售价为1232元，每盒内均为两支装。在次日的回访电话中，阿里健康大药房工作人员告诉时代财经，目前该药物在平台参与“早鸟价”，“1mg*2+3mg*2”售价1764元，下单后可返还765元健康卡，可以用于在平台购买药物。上述工作人员进一步对时代财经表示，“该药物于2月18日开始支付尾款，尾款支付后3天内发货给患者。”
此外，2月20日，上述工作人员还对时代财经表示，目前在其平台仅有3mg/盒单独包装选择，价格为1398元，其余为两种剂量套组，优惠后核算价格为999元。
在怡诺轻获批之前，已有3款国产GLP-1药物获批上市，分别为翰森制药（03692.HK）的聚乙二醇洛塞那肽（商品名：孚来美）、华东医药（000963.SZ）的利拉鲁肽（商品名：利鲁平），以及仁会生物的贝那鲁肽（糖尿病版商品名：谊生泰；减重版商品名：菲塑美）。
另据时代财经统计，中国涉足GLP-1赛道的企业包括恒瑞医药（600276.SH）、信达生物（01801.HK）、华东医药等多家头部企业，也有如四川双马（000935.SZ）等企业跨界而来，亦有如九源基因（02566.HK），依靠司美格鲁肽仿制药获得关注，最终成功登陆港交所，成为“司美格鲁肽仿制药第一股”。而据Insight数据显示，截至2024年12月3日，在国内GLP-1赛道，在适应症方面含有“肥胖”的有75项，2024年进展更新共49项。
多家入局GLP-1赛道的企业告诉时代财经，GLP-1赛道已经逐渐成长为与PD-1/PD-L1匹敌的“超级赛道”，越来越的企业加入战局，尤其是GLP-1减肥市场，其前景广阔，随着人均摄入热量的持续增加，该赛道在减重领域还有很大的发展空间。但他们也同时指出，尽管中国生物制造在GLP-1领域已崭露头角，但是“卷”出来的难度非常大。
那么，谁能冲进赛道前列，谁又会被滚滚浪潮淘汰？
国产GLP-1“上桌”
2016年年底，第一款国产GLP-1类药物“谊生泰”获批上市，这一药物由仁会生物自主研发，获批的适应症为治疗2型糖尿病。
彼时，司美格鲁肽还未在全球市场现身，GLP-1减肥药市场的热情也尚未被点燃，中国GLP-1赛道的参与者更是寥寥无几。在谊生泰之前，中国GLP-1市场仅有礼来制药/艾米林生物的短效GLP-1受体激动剂艾塞那肽（英文商品名：Byetta；中文商品名：百泌达）和诺和诺德的长效GLP-1受体激动剂利拉鲁肽（商品名：诺和力）两款药物获批上市，且适应症均为治疗2型糖尿病。
2017年，诺和诺德的司美格鲁肽横空出世。作为当时最长半衰期的GLP-1药物，其半衰期长达165h，患者只需一周注射一次，就可以稳定血糖。这一药物于2021年上半年在中国获批，用于治疗2型糖尿病。
彼时，中国市场已有百泌达、诺和力、谊生泰、阿斯利康的艾赛那肽微球（商品名：百达扬）、礼来制药的度拉糖肽（商品名：度易达）、翰森制药的聚乙二醇洛塞那肽，以及赛诺菲的利司那肽（商品名：利时敏）等数款GLP-1类产品获批用于治疗2型糖尿病患者，因此司美格鲁肽的上市并未引起过多关注。
真正让司美格鲁肽“出圈”并在全球范围内掀起GLP-1风潮的，是其在减肥方面的优异疗效。
2021年，减重版司美格鲁肽在美国获批上市，拉开了全球GLP-1市场火爆的序幕。
时至今日，司美格鲁肽俨然成为了GLP-1赛道的标签。诺和诺德最新财报显示，它是眼下GLP-1市场里最瞩目的产品，也成为众多入局GLP-1赛道企业对标的对象和头对头试验的最优选择。
诺和诺德2024年财报显示，三款司美格鲁肽产品全年合计收入2018.49亿丹麦克朗（约合292.96亿美元）。这一数字与全球“药王”默沙东的K药相差不到2亿元。民为生物副总经理宋文鑫对时代财经表示，“司美格鲁肽的表现完全符合预期，如果没有有史以来最快销量增长的慢病药物替尔泊肽的强势狙击，销售额早就超过K药了。”
如果礼来制药的大单品替尔泊肽没有加入这场竞争，GLP-1赛道也许不会这么内卷。如今，替尔泊肽是司美格鲁肽的最大竞争对手。礼来2024年财报显示，降糖版替尔泊肽Mounjaro全年销售额为115.401亿美元，同比增长124%；减重版替尔泊肽Zepbound全年销售额为49.257亿美元，同比增长270%，两者合计销售额为164.458亿美元。此时，距离替尔泊肽首个适应症在美获批上市过去不到3年，目前该药物已经在全球市场获批降糖及减重适应症。
2024年5月和7月，替尔泊肽获得国家药监局批准上市，共用商品名为穆峰达，分别适用于糖尿病患者及减重患者。截至目前，这两项适应症也均在中国商业化上市。
司美格鲁肽的火爆也让国内企业对GLP-1药物趋之若鹜。实际上，在2016年第一款国产GLP-1药物上市后的整整3年里，国产GLP-1赛道再无动静。直至2019年5月，翰森制药的孚来美上市，这是一款国产原研药物，用于治疗2型糖尿病。不过，这一药物的上市也并未激起多大浪花，甚至若不仔细观察，很难有人记得在司美格鲁肽进入中国市场之前，已有2家国内企业在GLP-1赛道中获得成功。
2023年，华东医药的利拉鲁肽与仁会生物的贝那鲁肽相继在中国市场获批减重适应症，在市场中引发诸多关注，这也使得国产GLP-1药物不再隐身，逐渐走上台前。
探索商业化
没有人愿意放弃可能到手的“肥肉”。
GLP-1药物在糖尿病市场和减重市场均掀起了不小的风浪。尤其是减重市场，受到肥胖影响的人数逐年增高，有药物支撑以后，自主性减肥排后，用药减肥前置。
2024年10月国家卫健委办公厅印发的《肥胖症诊疗指南（2024年版）》指出，近年来，我国超重和肥胖人群的患病率呈持续上升趋势。根据《中国居民营养与慢性病状况报告（2020年）》，按照我国标准，中国成年人（≥18岁）超重率为34.3%，肥胖症患病率为16.4%。
在此背景下，中国企业们也瞄准了这一赛道，试图从中分得一杯羹。彭博行业研究指出，全球超过90家的药企涉足减重市场，最少有120种相关药物处于临床阶段。约30%为中资药企，占到研发管线资产（处于I期或更晚阶段）的25%左右，绝大多数是基于GLP-1的治疗方案。
涌进的企业越多，意味着市场红海将至。那么，在中国市场势头正猛的司美格鲁肽与替尔泊肽能给这些国产GLP-1药物留下多少空间？
多家已有GLP-1类药物上市的企业告诉时代财经，它们在中国市场的销售渠道覆盖面广泛，商业化进程也在有序推进。华东医药方面告诉时代财经，国内GLP-1赛道竞争日益激烈，但利鲁平仍占据利拉鲁肽国产市场的主导地位。目前，其销售渠道包括医院、线下药店及线上平台等，销售表现也符合华东医药的预期。
翰森制药2023年年报显示，2023年，包括孚来美在内的代谢及其他药物总计收入约12.99亿元，占公司当年总收入的约12.9%。
仁会生物方面则告诉时代财经，在减重适应症方面，目前，仁会生物既有自营团队，针对产品特点，主要覆盖生殖、妇产等科室；同时也与代理商合作，覆盖其它医疗终端，上药康德乐是代理商之一。自营及代理按照不同区域、不同终端划分，均有销量。“菲塑美进入商业化后，我们积极推动医生观念的转变，传递产品学术信息，按计划有序推进，目前进展基本符合预期。”仁会生物方面称。
针对刚刚进入商业化阶段的怡诺轻，银诺医药对时代财经透露，公司已建立自营和对外合作并行，线上和线下全渠道、广覆盖的商业化模式，并已组建与之配套的商业化团队。
银诺医药在2024年年底提交的招股书显示，公司的核心商业化团队已经组建完成。在怡诺轻及其他候选药物的商业化方面，其综合营销战略包括全渠道法，即无缝整合医院、零售药店以及各种在线和线下平台。
在医保方面，银诺医药表示，其希望旗下商业化产品能以合适的价格进入国家医保目录，以及其他政府资助的医疗保险计划的报销清单等。
除已经上市的国产GLP-1药物，还有众多产品等待进入赛道的商业化战队。
信达生物此前告诉时代财经，预期减重版玛仕度肽将在今年上半年上市。另据信达生物在今年摩根大通年度医疗健康大会（JPM）上披露的信息，降糖版玛仕度肽也预计将在今年下半年获批上市。
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http://rcehb.com/v2l/detail/t5f
http://5555wan.com/d1v/detail/m1v
http://kjdexp.com/e5u/detail/v7d
http://ghcrc.com/e8g/detail/n2t
http://eaene.com/g9t/detail/b8s
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http://gbtcu.com/v8y/detail/i9t
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http://slroo.com/o1m/detail/k7h
http://rcehb.com/d2j/detail/a8f
http://5555wan.com/p8s/detail/l5v
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http://eaene.com/w3k/detail/z2w
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http://fitsq.com/v6d/detail/u4u
http://gbtcu.com/r8f/detail/w3r
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http://rcehb.com/y7q/detail/f4q
http://5555wan.com/p1z/detail/x2o
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http://fitsq.com/l6x/detail/q1h
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http://rcehb.com/u8x/detail/j9l
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http://slroo.com/p5r/detail/g7p
http://rcehb.com/x1d/detail/e8o
http://5555wan.com/c1z/detail/e4u
http://kjdexp.com/e2t/detail/q3z
http://ghcrc.com/h1w/detail/w6i
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http://fitsq.com/i1x/detail/j6a
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研发竞速
竞争日趋激烈之下，国产GLP-1药物研发也进入竞速阶段。进入2025年，国内“入局者”纷纷公布相关GLP-1产品的临床进展。
甘李药业（603087.SH）2月14日在其官方微信公众号表示，其自主研发的GLP-1RA双周制剂博凡格鲁肽（研发代号：GZR18）在治疗2型糖尿病方向启动了全球首项III期临床研究，其目前已经完成该阶段首例受试者给药。恒瑞医药在今年1月则对外表示，其GLP-1/GIP双靶点激动剂HRS9531、口服小分子GLP-1激动剂HRS-7535均已推进至Ⅲ期临床阶段，GLP-1/GIP/GCG三靶点激动剂HRS-4729也已获批临床。
而华东医药则对时代财经表示，目前，其旗下有口服小分子GLP-1受体激动剂HDM1002、双靶点激动剂HDM1005、长效三靶点激动剂DR10624等多款产品在研。其中，华东医药对时代财经表示，其自主研发的口服小分子GLP-1受体激动剂HDM1002已获得中国和美国的IND批准，计划于2025年3月启动中国体重管理适应症Ⅲ期临床研究。
不过，入局并不意味着就能顺利跑出。无论企业大小，都会被动地被裹挟在与司美格鲁肽的竞争中，也无法走出司美格鲁肽与替尔泊肽垄断之下的阴影。在这种背景下，国内企业怎么“卷”出来，避免被踢出局？
多位受访者对时代财经指出，和所有新药一样，差异化疗效、差异化市场尤为重要。
宋文鑫告诉时代财经，在2型糖尿病治疗领域，由于替尔泊肽已经让糖化血红蛋白6.5%达标率达到了非常高的水准，因此在这一领域中几乎没有给“追随者”空间。在减重方面，司美格鲁肽与替尔泊肽在减重的速度和幅度上不断发力，除非超越它，否则难以创下新的奇迹。
“当下GLP-1减重药物还有很多体重下降之外的问题需要解决，首先，包括用药是否能够促使面部脂肪和肌肉得到保护、也要避免头部毛囊损伤和减少停药后反弹；其次，在用药的依从性方面是否可以改进，包括给药频次减少为每月乃至每半年注射一次，或者从皮下注射改为口服，提供胃肠道反应更轻微的产品；此外，肥胖所带来的不仅仅是体重的变化，同时血脂尤其是低密度胆固醇（LDL-C）的升高、血压，血糖，尿酸等均有升高，如果一款产品能够在多个指标上产生获益，于患者而言非常重要。”宋文鑫进一步告诉时代财经。
目前，司美格鲁肽在全球及中国市场在研或正在申请上市的新适应症，其中便包括治疗心血管疾病、肥胖相关膝骨关节炎、代谢功能障碍相关脂肪性肝炎、慢性肾病（CKD）等。上述多位受访者指出，这也是国内GLP-1的企业需要效仿的，在一些缺乏有效治疗药物的顽疾治疗领域可能大有所为，比如多囊卵巢综合征，老年痴呆症等，它们患者人数众多且治疗困难。
华东医药在“华东医药投资者关系”公众号上公布其全资子公司中美华东在研的创新多肽类人GLP-1受体和GIP受体（葡萄糖依赖性促胰岛素多肽）的双靶点长效激动剂HDM1005注射液的新进展，结果显示，该药物目前已获得Ia期、Ib期临床试验的顶线结果，正在积极推进II期临床试验相关工作，体重管理适应症II临床试验已于25年2月完成首例受试者给药。同时，该产品用于代谢相关脂肪性肝病（MAFLD）/代谢相关脂肪性肝炎（MASH）适应症的中国IND申请已获得批准。
仁会生物方面则对时代财经表示，公司下一个发力方向将考虑青少年减重。“中国青少年肥胖形势严峻，但治疗药物空白。此外，12-18周岁青少年也可能会伴有情绪问题和发育问题，贝那鲁肽在安全性方面具有优势，希望可以将其开发成未来青少年减重的理想药物。”
