2018년 FDA 승인 신약 : 네이버 블로그 (2019/1/4)

2018년에는 모두 62개의 신약이 FDA 승인을 얻었습니다. FDA 공식 웹사이트에는 59개로 되어있지만 2018년 마지막날인 12/31에 승인을 받은 Inbrija는 리스트에 업데이트가 안되어 있습니다 (아마도 정부 셧다운 영향인듯). 여기에 NDA가 아닌 BLA로 승인을 얻은 Andexxa, Jivi 두개의 Biologics를 더하면 모두 62개가 됩니다. 이 62라는 신약의 숫자는 아래 그래프에서 보듯 1996년 이래로 최대치입니다.

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출처: https://endpts.com/acorda-celebrates-an-fda-ok-so-does-that-make-them-a-takeover-target/?utm_medium=email&utm_campaign=634%20Wed%20010218%20%20Atlas%205%20grab%20a%20250M%20biotech%20bankroll%20Did%20Moderna%20break%20the%20biotech%20IPO%20market&utm_content=634%20Wed%20010218%20%20Atlas%205%20grab%20a%20250M%20biotech%20bankroll%20Did%20Moderna%20break%20the%20biotech%20IPO%20market+CID_5d51c116ddb41e4fc97b96cfb27bddfb&utm_source=ENDPOINTS%20emails&utm_term=Acorda%20celebrates%20an%20FDA%20OK%20%20so%20does%20that%20make%20them%20a%20takeover%20target

2018년 승인받은 신약들의 각각의 특징과 스토리, 트랜드 등을 이해하시려면 아래 링크를 참조하시면 될 것 같습니다. 특히 세번째 FierceBiotech의 리포트를 추천드립니다.

Drug Innovation > Novel Drug Approvals for 2018

Novel Drug Approvals for 2018 Share Tweet Linkedin Pin it Email Print Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step o...

www.fda.gov

 

신속심사 효과...작년 FDA 신약허가 59건 역대 최다

미국식품의약국(FDA)의 신약허가건수가 급증했다. 지난해 FDA 시판허가를 받은 신약은 총 59건으로 53개의 신약을 배출했던 1996년보다 6건 증가하면서 22년만에 최고기록을 세웠다. 획기적치료제 지정(BTD)과 우선심사, 가속허가 등 신약개발과 관련된 지원제도 활용사례가 늘어나면서 허가건수 증가로 이어지고 있다는 분석이다. FDA는 최근 홈페이지를 통해 지난해 승인받은 신약 명단을 공개했다. 지난해 FDA 신...

www.dailypharm.com

Special Report—2 years after sluggish 2016, new drug approvals hit their stride in 2018

If in 2017, the FDA was trying to make up for lost time, the agency went into overdrive in 2018, approving more than 50 new molecular entities.

www.fiercebiotech.com

주식 투자의 관점에서 보면 새로 시장에 진입하는 성장 초기의 회사들은 언제나 매력적인 투자 후보입니다. 아래 표에는 FierceBiotech을 참고하여 각각의 신약의 최대 예상 매출과 회사의 현재 마켓캡을 정리해봤습니다. 미국에 상장되어 있는 회사들만을 대상으로 했고, 해당 신약이 그 회사의 첫번째~세번째 출시 제품인 경우 따로 표시했습니다.

Drug	Company Name	Symbol	Approval date	Disease	Peak Sales Est	Market Cap*	Comments
Lutathera	Novartis	NVS (ADR)	2018-01-26	gastroenteropancreatic neuroendocrine tumors	$0.5~$2B	195.45B	​
Biktarvy	Gilead Sciences	GILD	2018-02-07	HIV	$6B	84.41B	​
Symdeko	Vertex	VRTX	2018-02-13	Cystic fibrosis	$2.8B	41.84B	​
Erleada	Johnson & Johnson	JNJ	2018-02-14	non-metastatic prostate cancer	$1.3B	337.18B	​
Tavalisse	Rigel Pharmaceuticals	RIGL	2018-04-17	Chronic immune thrombocytopenia	$300M	361.61M	company's 1st product
Crysvita	Ultragenyx	RARE	2018-04-17	X-linked hypophosphatemia	$1B	2.02B	company's 2nd product, first-in-classs
ANDEXXA	Portola Pharamceuticals	PTLA	2018-05-03	Factor Xa - Xarelto (JNJ), Eliquis (BMY, PFE) - bleeding antidote	$0.5~$0.7B	1.19B	company's 2nd product
Aimovig	Amgen	AMGN	2018-05-17	migraine	$1.2B	120.42B	​
Aimovig	Novartis	NVS (ADR)	2018-05-17	migraine	$1.2B	195.45B	​
Lokelma	AstraZeneca	AZN	2018-05-18	hyperkalemia	> $1B	95.25B	​
Doptelet	Dova Pharmaceuticals	DOVA	2018-05-21	thrombocytopenia in people with chronic liver disease	$648M	238.61M	company's 1st product
Palynziq	BioMarin	BMRN	2018-05-24	rare inherited blood disorder phenylketonuria	$0.5B	14.99B	​
Olumiant	Eli Lilly	LLY	2018-05-31	rheumatoid arthritis	$1.8B	109.40B	​
Olumiant	Incyte	INCY	2018-05-31	rheumatoid arthritis	$1.8B	14.48B	​
Epidiolex	GW Pharma	GWPH (ADR)	2018-06-13	Lennox-Gastaut syndrome and Dravet syndrome	$1B	3.22B	1st cannabis-based prescription medicine, company's 1st product, ADR, UK
Zemdri	Achaogen	AKAO	2018-06-25	complicated urinary tract infections	$0.5B	54.42M	company's 1st product
Mektovi/Braftovi	Array BioPharma	ARRY	2018-06-27	BRAF-mutated melanoma	N/A	3.13B	company's 3rd product
TPOXX	SIGA Technologies	SIGA	2018-07-13	smallpox	N/A	592.84M	first-in-classs
Tibsovo	Agios Pharmaceuticals	AGIO	2018-07-20	relapsed or refractory acute myeloid leukemia patients with the IDH1 mutation	$300M	2.67B	company's 1st product
Krintafel	GlaxoSmithKline	GSK (ADR)	2018-07-20	Plasmodium vivax malaria	N/A	92.95B	​
Orilissa	AbbVie	ABBV	2018-07-23	endometriosis	$2B	129.80B	​
Orilissa	Neurocrine Biosciences	NBIX	2018-07-23	endometriosis	$2B	6.29B	company's 2nd product
Mulpleta	Shionogi	SGIOF:OTC	2018-07-31	boosts platelet count in chronic liver disease patients before surgery	$38M	18.60B	​
Onpattro	Alnylam	ALNY	2018-08-10	peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis	$1B	7.40B	1st siRNA drug
Annovera	TherapeuticsMD	TXMD	2018-08-10	New vaginal ring used to prevent pregnancy for an entire year	​	918.22M	​
Galafold	Amicus Therapeutics	FOLD	2018-08-10	Fabry disease	$534M	1.96B	company's 1st product
Takhzyro	Shire	SHPG (ADR)	2018-08-23	hereditary angioedema	$1.8B	52.28B	​
Xerava	Tetraphase Pharmaceuticals	TTPH	2018-08-27	complicated intra-abdominal infections	$340M	68.10M	company's 1st product
Pifeltro	Merck	MRK	2018-08-30	HIV-1	$0.5B	192.53B	​
JIVI	Bayer	BAYRY:OTC	2018-08-29	hemophilia	N/A	65.16B	​
Lumoxiti	AstraZeneca	AZN (ADR)	2018-09-13	hairy cell leukemia	$0.5B	95.25B	​
Ajovy	Teva Pharmaceutical Industries	TEVA (ADR)	2018-09-14	migraine	$0.5B	17.96B	​
Copiktra	Verastem Oncology	VSTM	2018-09-24	third-line treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma	$0.5~$0.85B	259.01M	company's 1st product
Emgality	Eli Lilly	LLY	2018-09-27	migraine	$0.7B	109.40B	​
Vizimpro	Pfizer	PFE	2018-09-27	EGFR-mutated non-small cell lung cancer	N/A	243.01B	​
Libtayo	Regeneron	REGN	2018-09-28	metastatic cutaneous squamous cell carcinoma	$1.4B	40.23B	Sixth anti-PD-1
Libtayo	Sanofi	SNYNF:OTC	2018-09-28	metastatic cutaneous squamous cell carcinoma	$1.4B	108.15B	Sixth anti-PD-1
Seysara	Paratek Pharmaceuticals	PRTK	2018-10-01	Moderate to severe acne	$150~$200M	179.99M	company's 1st product
Seysara	Almirall	LBTSF:OTC	2018-10-01	Moderate to severe acne	$150~$200M	2.61B	​
Nuzyra	Paratek Pharmaceuticals	PRTK	2018-10-03	Community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections	$0.5B	179.99M	company's 2nd product
Tegsedi	Ionis	IONS	2018-10-05	hereditary transthyretin-mediated amyloidosis	N/A	7.28B	company's 3rd product
Tegsedi	Akcea	AKCA	2018-10-05	hereditary transthyretin-mediated amyloidosis	N/A	2.69B	company's 1st product
Talzenna	Pfizer	PFE	2018-10-16	BRCA-mutated, HER2-negative breast cancer	N/A	243.01B	​
Xofluza	Roche	RHHBY:OTC	2018-10-24	influenza	$1B	214.31B	Potential replacement for Tamiflu
Xofluza	Shionogi	SGIOF:OTC	2018-10-24	influenza	$1B	18.60B	Potential replacement for Tamiflu
Lorbrena	Pfizer	PFE	2018-11-02	ALK-positive non-small cell lung cancer	N/A	243.01B	​
Yupelri	Mylan	MYL	2018-11-08	chronic obstructive pulmonary disorder (COPD)	$250M	14.04B	​
Yupelri	Theravance	TBPH	2018-11-08	chronic obstructive pulmonary disorder (COPD)	$250M	1.42B	​
Aemcolo	Cosmo Pharmaceuticals	​	2018-11-16	travelers’ diarrhea	$200~$250M	​	​
Gamifant	Sobi (licensed from Novimmune)	​	2018-11-20	primary hemophagocytic lymphohistiocytosis	$330M	​	​
Daurismo	Pfizer	PFE	2018-11-21	acute myeloid leukemia in adult patients	N/A	243.01B	​
Vitrakvi	Bayer	BAYRY:OTC	2018-11-26	solid tumors with NTRK gene fusion	$0.85B	65.16B	first-in-class
Vitrakvi	Loxo Oncology	LOXO	2018-11-26	solid tumors with NTRK gene fusion	$0.85B	4.01B	company's 1st product, first-in-class
Firdapse	Catalyst Pharmaceuticals	CPRX	2018-11-28	Lambert-Eaton myasthenic syndrome	$364M	222.94M	company's 1st product
Xospata	Astellas	ALPMY:OTC	2018-11-28	acute myeloid leukemia	N/A	24.37B	​
Motegrity	Shire	SHPG (ADR)	2018-12-14	chronic idiopathic constipation	N/A	52.28B	​
Elzonris	Stemline Therapeutics	STML	2018-12-21	blastic plasmacytoid dendritic cell neoplasm	N/A	272.10M	company's 1st product, only drug for BPDCN
Ultomiris	Alexion	ALXN	2018-12-21	paroxysmal nocturnal hemoglobinuria	$5B	22.36B	Improved and cheaper Soliris
Inbrija	Acorda Therapeutics	ACOR	2018-12-31	Parkinson’s disease	$0.6B	756.18M	company's 3rd product

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참고로, 아래 표는 위의 표에서 제외된 Private이나 OTC 마켓에 없는 Non-US 회사들입니다.

Drug	Company Name	Symbol	Approval date	Disease	Peak Sales Est	Market Cap*	Comments
Asparlas	Servier	​	2018-12-20	acute myeloid leukemia	> $200M	​	​
Omegaven	Fresenius Kabi	​	2018-07-27	pediatric cholestasis	​	​	​
Ilumya	Sun Pharma	​	2018-03-20	psoriasis	N/A	​	​
Oxervate	Dompé	​	2018-08-22	neurotrophic keratitis	N/A	​	​
Revcovi	Leadiant Biosciences	​	2018-10-05	adenosine deaminase severe combined immunodeficiency in pediatric and adult patients	​	​	​
Poteligeo	Kyowa Hakko Kirin	​	2018-08-08	Mycosis fungoides and Sézary disease	N/A	​	​
Lucemyra	US WorldMeds	​	2018-05-16	opioid withdrawal symptoms	N/A	​	​
Moxidectin	Medicines Development for Global Health	​	2018-06-25	urinary tract infections	​	​	​
Diacomit	BioCodex	​	2018-08-20	Dravet syndrome for patients taking clobazam	N/A	​	​
Akynzeo	Helsinn Healthcare SA	​	2018-04-19	nausea and vomiting associated with cancer chemotherapy	​	​	​
Trogarzo	TaiMed Biologics	​	2018-03-06	Multidrug-resistant HIV-1	> $1B	​	​

* Market Cap as of 2019/01/03

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개인적으로는 처음 시장에 진입하는 회사의 경우 첫 제품이 출시된 후 적어도 4분기 정도는 매출 증가 추이를 보고 투자를 결정하는 것이 좋다고 생각합니다. 그런면에서 지금 당장의 투자 대상을 찾고 싶으시다면 2016년과 2017년에 새로 시장에 진입한 회사들을 살펴보시는 것이 도움이 되리라 생각합니다.

 

바이오텍 투자 – 성장하는 기업 고르기 (2)

앞선 글 (https://blog.naver.com/woojkim71/221255452295)에서는 2012-2015년에 FDA 승인을 얻은 신약...

blog.naver.com