医药魔方 / 最新资讯 / 正文

诺和诺德2018财报:利拉鲁肽中国收入激增73%,口服索马鲁肽2019Q1申请上市

医药魔方 医药魔方 来源:医药魔方
2019-02-03
诺和诺德 财报 利拉鲁肽
原文

2月1日,诺和诺德公布2018年业绩,全年实现净收入1118.31亿丹麦克朗(177.10亿美元),相比2017年增长5%,其中中国地区收入112.85亿丹麦克朗(17.87亿美元,+8%),占公司净收入的10.1%。2018年诺和诺德研发总投入148.05亿丹麦克朗(23.45亿美元),占收入比重13.2%,相比2017年增长5.6%。


诺和诺德是糖尿病领域的霸主,产品包括长效胰岛素、预混胰岛素、速效胰岛素、GLP-1等几大类。从2018年的整体表现来看,胰岛素类药物的增长比较困难,GLP-1药物还处于较稳定的高速增长状态。截至2018年11月,诺和诺德的胰岛素产品在全球胰岛素中的市场份额占到46.5%,同比增加了0.5个百分点。而GLP-1产品在全球糖尿病药物中的市场份额为14.5%,同比增加了2.7个百分点。



不过从中国区收入来看,长效、预混、速效胰岛素都还有着较快的增长,弥补了人胰岛素的下滑。


利拉鲁肽虽然一直是全球大卖的降糖药,但是因为价格原因,一直未能打开中国市场。2017年进入国家医保目录后,利拉鲁肽在中国市场有比较明显的放量(见:进医保,能让药品销量增长多少?),2018年销售收入增长了73%,达到5.21亿丹麦克朗(约8250万美元),已经占到中国整个GLP-1药物87%的市场份额,占整个糖尿病药物市场1.3%的份额。



诺和诺德未来的增长点有很大一部分系于索马鲁肽(皮下注射&口服)身上,包括由此而来的肥胖和NASH领域的市场机会上。


Ozempic(索马鲁肽)作为每周注射一次的长效GLP-1受体激动剂,在2018年2月获批,目前在北美和欧洲的11个国家获批,2018年全球收入为17.96亿丹麦克朗(2.84亿美元),开局形势大好。

 

口服索马鲁肽目前的III期PIONEER项目也进展顺利,在PIONEER 9研究中证明对日本2型糖尿病患者的降糖和减重效果优于利拉鲁肽;在PIONEER 6研究中证明具有较好的心血管安全性并且能够显著降低2型糖尿病患者的心血管死亡率和全因死亡率;


诺和诺德在财报中表示,计划2019Q1向FDA提交口服索马鲁肽的上市申请,并且会使用优先审评券(目前尚未见报道诺和诺德从哪个公司买来的优先审评券),2019H1向欧盟提交口服索马鲁肽的上市申请。另外,诺和诺德正与FDA密切沟通,期望凭借SUSTAIN 6和PIONEER 6这两项心血管结局研究的数据申请获得降低心血管风险的适应症,而不需要再针对口服剂型索马鲁肽开展额外的大型心血管结局研究。


机器翻译

On February 1, Novo Nordisk reported its 2018 results, with annual net income of 1118.3.1 billion DKK (177.$1 billion), up 5% from 2017, with Chinese revenue of 11.2%.8.5 billion DKK (17.$8.7 billion, + 8%), accounting for 10. 5% of the company's net income.1%.In 2018, Novo Nordisk invested 148.5 billion DKK (23.$4.5 billion), accounting for a proportion of income 13.2%, up from 2017.5.6%.

Liraglutide has been a global sales of hypoglycemic agents, but for price reasons, it has not been able to open up the Chinese market.After entering the national health insurance catalogue in 2017, liraglutide has a relatively significant volume in the Chinese market (see: how much can we increase the sales volume of drugs by entering medical insurance?), and the sales revenue increased by 73% in 2018, reaching 5.2.1 billion DKK (approximately $82.5 million), which has accounted for 87% of the total GLP-1 drug market in China and accounted for the entire diabetes drug market 1.A 3% share.

The future growth of Novo Nordisk is largely due to semaglutide (subcutaneous & oral), including the resulting obesity and NASH market opportunities.

Ozempic (semaglutide), as a once-weekly long-acting GLP-1 receptor agonist, was approved in February 2018 and is currently approved in 11 countries in North America and Europe, with a global revenue of 17 in 2018.9.6 billion DKK (2.$8.4 billion), which started off well.

 

The current phase III PIONEER project for oral somaglutide is also progressing well, and the PIONEER 9 study demonstrates that the hypoglycemic and weight-reducing effects of Japanese type 2 diabetes patients are better than liraglutide; it is better in the PIONEER 6 study. Cardiovascular safety and can significantly reduce cardiovascular mortality and all-cause mortality in patients with type 2 diabetes;

Novo Nordisk said in the financial report that it plans to submit a market application for oral somaglutide to the FDA in 2019Q1 and will use the priority review voucher (there is no report on the priority of Novo Nordisk from which company) Coupon), 2019H1 submitted a listing application for oral somaglutide to the European Union. In addition, Novo Nordisk is in close communication with the FDA and looks forward to applying data from the SUSTAIN 6 and PIONEER 6 cardiovascular outcomes studies for an indication for cardiovascular risk reduction without the need for additional large cardiovascular outcomes studies with the oral formulation of semaglutide.

扫码实时看更多精彩文章

版权及免责声明 本文由医药魔方原创,版权归医药魔方所有。未经许可,严禁任何媒体或个人以任何形式摘编、改写、复制、转载本文内容。对于恶意侵权行为,医药魔方保留采用法律手段追究的权利。媒体内容及商务合作请联系医药魔方工作人员(微信号:medicube)

魔方微信公众号