灵麦快讯LMLB125
本周灵麦医药与您分享10大领域，41个欧洲进口仿制药项目
LMC5000469是一家总部位于欧洲的，为创新者和仿制药业提供产品和服务的全球性的制药公司。自其创立开始，其使命就不曾变过，带着巨大的社会使命感，深耕健康行业，致力于提高全球人民的健康水平，为全球人类提供最有效治疗药物来攻克所有的疑难杂症。就是在这样的使命的驱动下，LMC5000469公司现已有多达10多年的仿制药及新药研发的经验，在全球9个国家地区设立了办公室。
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表1：10大领域41个进口仿制药项目
项目分析：
1．西他列汀 进口防药
根据EvaluatePharma预估医药数据库，西他列汀各品牌中，销量第一的是Merck & Co的Januvia, 其2016年销售额高达39.08亿美金，根据世界顶级投行的综合预测，到2022年稳中有降，但仍会有28.26亿美金的销售额。
图1：西他列汀各品牌历史销量及未来预测
来源：EvaluatePharma预估医药数据库
根据Source China博源数据库，目前中国市场上仅有1家公司获批生产成剂型次（图2）。
图2：西他列汀中国注册情况
来源：Source China博源数据库
2. Caspofungin进口仿药
根据EvaluatePharma预估医药数据库，默克公司的Cancidas于2001年上市，将于2017年9月专利到期。2016年历史销售额高达5.58亿美金，预计到2022年由于仿制药的进入市场，约一半的市场份额将被不断兴起的仿制药取代。
图3：Caspofungin（卡泊芬净）的历史销量及未来预测
来源：EvaluatePharma预估医药数据库
根据Source China博源数据库，目前中国市场上仅有2家公司获批生产成剂型的卡泊芬净，以及1家获批原料药的公司（图3）。
图4：卡泊芬净中国注册情况
Source: Source China博源数据库
Lingmed European Generic assets feeding involving 10 TAs
LMC5000469 is a pharmaceutical company, headquartered in Spain, which provides products and services to its clients in both the innovator and generic industries. The company’s goal has not changed since day one: combine a healthy growing business with a strong social commitment to improve people’s health and lives. Dedicated to provide patients with the most effective medicine to overcome disease, LMC5000469 had over 10 years’ experience in drug development with 9 offices around the world.
The spirit of overcoming is essential to a team striving for excellence in the health sector. LMC5000469 helped their customers and partners to become more competitive, launching finished Dosage Forms and strengthening their market positions through innovation and flexibility and offer turn-key solutions for the entire value chain: from registration, to quality assurance, to batch release and supply.
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Feel free to contact us: info@lingmed.net/86 21 53863003.
Or let's meet at CPhI China held at Shanghai New International Expo Center from June 20 to June 22.
Table1: 41 Generic assets in 10 therapeutic areas
Asset initial analysis：
According to the EvaluatePharma database, the Best sell product in Sitagliptin is Januvia from Merck & Co, with the sales up to 3908 million dollars in 2016. But the sales in the year of 2022 will decrease to 2826 million dollars after a steady phase.
Figure 1：Historic sales and future forecast for Sitagliptin
Source: EvaluatePharma database
According to the Source China database, there is only one company has been approved by CFDA to produce Sitagliptin
Figure 2：Chinese registration summary for Sitagliptin
Source：Source China database
2. Caspofungin
According to EvaluatePharma database, Cacidas was first launched at 2001 and patent expire at Sep 2017. The historic sales at 2016 was 558 million dollars but in 2022, approximately 50% market share will be replaced by the emerging generics.
Figure 3：Historic sales and future forecast for Caspofungin
Source：EvaluatePharma database
According to Source China, there are totally 2 companies have been approved to produce formulated products and 1 for API.
Figure 4：Chinese registration summary for Caspofungin
Source：Source China database
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