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罗氏2018财报:Perjeta稳定增长露王者之相,Ocrevus业绩闪耀成多发性硬化症新标杆

医药魔方 医药魔方 来源:医药魔方
2019-02-03
罗氏 财报
原文

2月1日,罗氏集团公布2018年财报,全年收入568.46亿瑞士法郎。相比2017年的532.99亿瑞士法郎增长7%。其中制药业务439.67亿瑞士法郎,诊断业务128.79亿瑞士法郎。财报显示,制药业务增长主要由Ocrevus,Perjeta,Tecentriq,Alecensa和Hemlibra这几款药物推动。


罗氏是Her2+乳腺癌药物市场的标杆,持续提高临床治疗标准和竞争门槛,乳腺癌药物三驾马车的市场总份额也不断创下新高。2018年12月17日,Perjeta在中国的上市申请获得国家药品监督管理局批准,用于治疗具有高复发风险的人表皮生长因子受体2(HER2)阳性早期乳腺癌患者的辅助治疗(见:罗氏Perjeta获批!临床金标准曲妥珠单抗+帕妥珠单抗开启中国乳腺癌治疗新时代)。不过受生物类似药上市的影响,Herceptin在欧洲的收入下降16%。随着Herceptin增长陷入停滞,Perjeta凭借稳定的高增长,接棒成为罗氏Her2+领域新王者。


罗氏Her2+乳腺癌药物年销售额(百万瑞士法郎)


罗氏另外一个明显感受到生物类似物威胁的是MabThera/Rituxan(利妥昔单抗),欧洲市场收入下滑了47%,2018年全球收入下滑8%。好的一方面是,Gazyva作为利妥昔单抗的升级产品,2018年增幅达到40%。就在几天前,Gazyva+伊布替尼刚刚获批一线治疗CLL/SLL,业绩增速有望进一步提升。


2018年罗氏药品销售额(亿瑞士法郎)


Ocrevus(ocrelizumab)在2017/3/28被FDA批准用于治疗多发性硬化症,不仅是目前为止最长效的MS治疗药物(6个月注射1次),也是首个获批可以治疗两种类型MS的药物(见:2017年FDA批准的新药),2018年销售收入激增172%,达到惊人的23.53亿瑞士法郎,成为罗氏TOP5药品的同时,也给合作伙伴Bioge贡献了4.78亿美元的联盟分成收入。与Biogen多发性硬化症业务的萎靡表现相比,Ocrevus俨然成为这个领域新的标杆产品。


罗氏另一个表现出众的产品是治疗ALK阳性NSCLC的Alecensa,尽管上市晚于辉瑞和诺华的同类产品,但是凭借出色的疗效,Alecensa的2018年收入达到6.37亿瑞士法郎,取得绝对领先优势(见:重磅!alectinib获批一线用药,将成ALK+肺癌市场新王者)。


2018年罗氏在新药审批方面也收获了不菲成绩。就在去年12月份,FDA批准PD-L1肿瘤免疫疗法Tecentriq(atezolizumab)联合Avastin(bevacizumab)及化疗(紫杉醇+卡铂),用于无EGFR或ALK基因组肿瘤畸变的转移性非鳞状非小细胞肺癌(NSq NSCLC)患者的一线治疗。Tecentriq在2018销售额增长59%,达到7.72亿瑞士法郎。


此外,FDA还加速批准venetoclax与去甲基化剂(阿扎胞苷或地西他滨),或低剂量阿糖胞苷(LDAC)化疗联用,治疗新确诊75岁以上、或因慢性健康问题和疾病无法使用高强度化疗的AML患者。


2018年10月25日,FDA批准了单剂量口服药物Xofluza(baloxavir marboxil)用于治疗12岁及以上人群的急性,无并发症或流感。


FDA基于IMpower133研究,已批准对Tecentriq(atezolizumab)的补充生物制剂许可申请(sBLA)进行优先审查,用于与卡铂和依托泊苷联合用于广泛期小细胞肺癌(ES-SCLC)患者的一线治疗。FDA同时授予该申请优先审评资格,预计将在2019年3月18日之前做出关于批准的决定。


机器翻译

On Feb. 1, the Roche Group reported its 2018 annual earnings of 568.4.6 billion Swiss francs.Compared to 532 in 2017.9. 9 billion Swiss francs up 7%.Of which pharmaceutical business 439.6.7 billion Swiss francs, 128.7.9 billion Swiss francs.Pharmaceutical business growth was driven largely by the drugs Ocrevus, Perjeta, Tecentriq, Alecensa and Hemlibra, according to the report.

Roche is the benchmark of Her2 + breast cancer drug market, continuously raising the clinical treatment standard and competitive threshold, and the total market share of breast cancer drug troika also continuously hit a new high.On December 17, 2018, the marketing application of Perjeta in China was approved by China Food and Drug Administration for the adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2) -positive early breast cancer at high risk of recurrence (see: Roche Perjeta approved!The clinical gold standard trastuzumab + pertuzumab opens a new era of breast cancer treatment in China).However, Herceptin's revenue in Europe fell 16 percent because of the availability of biosimilars.With Herceptin growth stagnating, Perjeta has emerged as Roche's new Her2 + king with steadily high growth.

Roche Her2 + Breast Cancer Drug Sales (million Swiss francs)On the plus side, Gazyva, an upgraded rituximab product, is up 40% in 2018.Just a few days ago, Gazyva + Ibrutinib was approved for the first-line treatment of CLL/SLL, and the performance growth rate is expected to be further improved.

Roche pharmaceutical sales in 2018 (100 million Swiss francs)

Ocrevus(ocrelizumab)Approved by the FDA for the treatment of multiple sclerosis in 2017/3/28, it is not only the longest-lasting MS treatment (1 injection in 6 months), but also the first drug approved to treat two types of MS. (See: 2017 FDA approved new drugs), sales revenue surged 172% in 2018, reaching an amazing23.53 billion Swiss francs, while becoming a Roche TOP5 drug, also contributed to partner Bioge 4.The $7.8 billion coalition is divided into revenues.Ocrevus is a new benchmark in the field, compared with Biogen's sluggish multiple sclerosis business.

Another outstanding product of Roche is Alecensa for ALK positive NSCLC. Although it is marketed later than Pfizer and Novartis like products, Alecensa's revenue in 2018 is up to 6.3.7 billion Swiss francs, an absolute lead (see: Heavy!Alectinib is approved for first-line use and will become the new king of ALK + lung cancer market.

In 2018, Roche has also made great achievements in the approval of new drugs.Just last December, the FDA approved the PD-L1 tumor immunotherapy Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy (paclitaxel + carboplatin) for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSq NSCLC) without EGFR or ALK genomic tumor aberrations.Tecentriq sales rose 59% to 7. 5% in 2018.7.2 billion Swiss francs.

In addition, the FDA has accelerated approval of venetoclax in combination with demethylating agents (azacitidine or decitabine), or low-dose cytarabine (LDAC) chemotherapy, for newly diagnosed patients over 75 years of age.Or AML patients who cannot use high-intensity chemotherapy due to chronic health problems and diseases.

On October 25, 2018, the FDA approved a single oral dose of XOFLUZA (baloxavir marboxil) for the treatment of acute, uncomplicated or influenza in people 12 years of age and older.

The FDA has approved a priority review of the Supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) based on the IMpower 133 study.The FDA also granted the application a priority review status and is expected to make a decision on approval by March 18, 2019.

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