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赛诺菲2018财报:Dupixent大展鸿图,Kevzara星辰大海

医药魔方 医药魔方 来源:医药魔方
2019-02-09
赛诺菲 财报
原文

2月7日,赛诺菲公布2018年业绩,全年净收入344.64亿欧元,相比2017年增长2.5%,其中新兴市场增长强劲,全年收入101.12亿欧元(+7.5%),尤其是中国市场收入的增幅达到12.7%,是赛诺菲增长最快的区域。2018年赛诺菲研发投入58.94亿欧元,占收入比重17.1%,相比2017年增长10.3%。



糖尿病业务一直是赛诺菲的优势,但是在王牌产品Lanuts遭遇专利悬崖的时候,赛诺菲在后继产品补位上的节奏似乎总踩得不太准:吸入胰岛素Afrezza的合作无疾而终;Toujeo作为升级版Lantus增长缓慢;Soliqua被视作王炸组合(胰岛素+GLP-1),赛诺菲甚至动用了优先审评券来抢占市场先机,最终却跟诺和诺德Xultophy同日获批,业绩也是相形见绌(0.85 vs 2.56亿美元);长效GLP-1如日中天,赛诺菲有点交友不慎但又无法回头,跟韩美的合作也是打了折扣;新靶点SGLT-2的舞台上也是一直没有赛诺菲的戏份;甚至礼来的甘精胰岛素类似物Basaglar也红火大卖8亿美元。如此种种,赛诺菲的糖尿病业务板块近年整体表现不佳就不难理解了。


好的一点在于,赛诺菲的SGLT-1/2抑制剂sotagliflozin(索格列净)在2019Q1可能会迎来FDA的批准,作为1型糖尿病患者胰岛素之外的辅助口服药物,也是赛诺菲糖尿病领域值得期待的亮点之一。



罕见病、多发性硬化症、疫苗业务则属于赛诺菲的传统强项,表现稳定,不再赘言。免疫疾病业务可以说是赛诺菲2018年的最大亮点。Dupixent(dupilumab)是靶向IL-4/IL-13的抗体药物,2017年3月获得FDA批准用于治疗成人中重度特应性皮炎(湿疹),2018年10月又新增了哮喘的适应症,销售收入达到7.88亿欧元(约9.22亿美元),已经是一个准重磅炸弹。赛诺菲在2018年11月提交了12-17岁湿疹的sNDA(已获优先审评),在12月提交了鼻窦炎的sNDA,计划在2019年和2020年陆续提交鼻息肉病、6~11岁青少年湿疹的新适应症上市申请。EvaluatePharma预测Dupixent的2024年销售额可以达到80.6亿美元。


Kevzara(sarilumab)是全球第2款IL-6R单抗,2017年3月获批用于治疗类风湿关节炎,2018年销售收入为0.83亿欧元(约0.97亿美元)。罗氏同类药物托珠单抗借助CAR-T的人气已经把年销售额做到了21.6亿瑞士法郎(+12%),有这样一个成功榜样在前,Kevzara的未来也充满了想象力。


血液疾病也是赛诺菲收购Bioverativ之后的一块亮点业务,除了继承了Eloctate、Alprolix这两款成熟血友病产品外,赛诺菲2018年花费39亿欧元收购的专注于纳米抗体药物研发的Ablynx为其带来了回报,Cablivi (caplacizumab-yhdp)先后被欧盟和FDA批准上市,用于成人获得性血栓性血小板减少性紫癜(见:FDA批准首个纳米抗体,治疗获得性血栓性血小板减少性紫癜),这也是一个非常大的适应症,是赛诺菲未来业绩增长的一个驱动力。


肿瘤业务曾经给赛诺菲带来过辉煌,但是要追溯到铂类药物和多烯紫杉醇的化疗时代了。在当下的肿瘤免疫治疗时代,赛诺菲的存在感还有待加强。和再生元联合开发的PD-1单抗Libtayo(cemiplimab-rwlc)在2018年9月获批上市治疗皮肤鳞状细胞癌,销售收入1500万美元,为赛诺菲打开了一个好局面。


进入2019年之后,赛诺菲在肿瘤领域也表现出了更远大的志向,包括:1)重新修订与Regeneron的I-O新药发现及开发协议框架,除了与对方继续开发两款双特异性抗体(BCMA/CD3, MUC16/CD3),赛诺菲在独立处置其早期I-O资产方面有了更大灵活性。2)延长了与BioNTech在mRNA肿瘤免疫疗法开发上的合作。随之而来的好消息是CD38单抗isatuximab的关键III期研究获得成功(见:赛诺菲CD38单抗关键III期研究成功,显著延长多发性骨髓瘤患者PFS)。在肿瘤领域,赛诺菲可以说是已经鸟枪换炮了。


截至2019年2月,赛诺菲的管线中有81个在研项目,其中包括33个新分子实体。在赛诺菲的所有在研项目中,有35个处于III期或提交上市申请的阶段。在2019-2022年间,赛诺菲计划提交9个新药的上市申请以及25个新适应症的上市申请。这是一个有未来的公司。



机器翻译

On february 7th sanofi reported 2018 results, with annual net income of 344. 5%.6.4 billion euros, up from 2017 2.5%, including strong growth in emerging markets, with annual income of 101. 5%.1.2 billion €(+ 7.5%), especially in China, where revenue grew by 12. 5%.7%, the fastest growing region in Sanofi.Sanofi R & D investment in 2018 58.9.4 billion euros, accounting for 17 percent of revenue.1%, an increase of 10 compared to 2017.3%.

The diabetes business has always been the advantage of Sanofi, but when the ace product Lanuts encounters a patent cliff, Sanofi seems to be overstepped in the rhythm of subsequent product replenishment: the cooperation of inhaling insulin Afrezza is endless; Toujeo as an upgrade The version of Lantus is growing slowly; Soliqua is considered a king-explosive combination (insulin + GLP-1), and Sanofi even used the priority review voucher to seize market opportunities, but it was approved on the same day as Norderox Xultophy. Dwarfed (0. 85 vs 2.56 billion US dollars); long-lasting GLP-1 is in full swing, Sanofi is a little friend who is careless but can't look back, and the cooperation with Hanmei is also discounted; the new target is on the stage of SGLT-2 There is also no scene for Sanofi; even Lhasa's insulin-salt analog Basaglar is also selling for $800 million. As such, Sanofi's diabetes business sector is not difficult to understand in recent years. p>

A good point is that Sanofi's SGLT-1/2 inhibitor sotagliflozin (Sogliflozin) may be FDA approved in 2019Q1 as an adjunct to oral medications other than insulin in patients with type 1 diabetes. One of the highlights of Sanofi's diabetes field.

Rare disease. Multiple sclerosis. Vaccine business is a traditional strength of Sanofi, stable performance, no longer rumors. The immune disease business can be said to be the biggest highlight of Sanofi in 2018. Dupixent (dupilumab) is targeted to IL- 4/IL-13 antibody drug, approved by the FDA in March 2017 for the treatment of moderate to severe atopic dermatitis (eczema) in adults. In October 2018, an additional indication for asthma was added, with sales revenue reaching 788 million. The euro (about 922 million US dollars) is already a quasi-blockbuster. Sanofi submitted a sNDA of 12-17 years old eczema in November 2018 (which has been given a priority review) and submitted sinusitis in December. sNDA, plans to submit nasal polyps in 2019 and 2020. New applications for 6-11 year old adolescent eczema are filed. EvaluatePharma predicts that Dupixent's sales in 2024 can reach $8.06 billion.

Kevzara (sarilumab) is the world's second IL-6R monoclonal antibody, approved for the treatment of rheumatoid arthritis in March 2017, with a sales income of 0.83 billion euros (approximately $0.97 billion) in 2018. Roche The drug tobuzumab has achieved annual sales of CHF 2.16 billion (+12%) with the popularity of CAR-T. With such a successful example, Kevzara's future is also full of imagination.

Blood disease is also a highlight of Sanofi's acquisition of Bioverativ. In addition to the two mature hemophilia products Elopate. Alprolix, Sanofi spent 3.9 billion euros in acquisition of Ablynx, which focuses on nanobody drug development. In return, Cablivi (caplacizumab-yhdp) has been approved by the European Union and FDA for adult-acquired thrombotic thrombocytopenic purpura (see: FDA approved first Nanobody for treatment of acquired thrombotic thrombocytopenic purpura) ), this is also a very large indication, is a driving force for Sanofi's future performance growth.

The oncology business has brought glory to Sanofi, but it dates back to the era of chemotherapy for platinum drugs and docetaxel. In the current era of tumor immunotherapy, the presence of Sanofi needs to be strengthened. The developed PD-1 monoclonal antibody Libtayo (cemiplimab-rwlc) was approved for treatment of squamous cell carcinoma of the skin in September 2018, with a sales income of 15 million US dollars, which opened a good situation for Sanofi.

After entering 2019, Sanofi also showed a greater ambition in the field of cancer, including: 1) Revising the framework for the IO drug discovery and development agreement with Regeneron, in addition to continuing to develop two bispecific antibodies (BCMA) /CD3, MUC16/CD3), Sanofi has greater flexibility in independently disposing of its early IO assets. 2) Extending cooperation with BioNTech in the development of mRNA tumor immunotherapy. The good news that comes with it is The key phase III study of CD38 mAb isatuximab was successful (see: Sanofi CD38 mAb critical phase III study success, significantly prolonging PFS in patients with multiple myeloma). In the field of oncology, Sanofi can be said to have been shotgun.

As of February 2019, there are 81 research projects in Sanofi's pipeline, including 33 new molecular entities. Of all the Sanofi research projects, 35 are in Phase III or submitting applications for listing. Between 2019 and 2022, Sanofi plans to submit a listing application for nine new drugs and a listing application for 25 new indications. This is a company with a future.

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