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MarketScreener Homepage  >  Equities  >  Tokyo  >  Chugai Pharmaceutical Co., Ltd.    4519   JP3519400000

CHUGAI PHARMACEUTICAL CO., LTD.

(4519)
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Chugai Pharmaceutical : Files for Expanded Use of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Rozlytrek for ROS1-Positive NSCLC

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09/09/2019 | 11:11am EDT

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of FoundationOne CDx Cancer Genomic Profile, a next-generation sequencing based program, as a companion diagnostic for ROS1/TRK inhibitor, Rozlytrek Capsules 100 mg and 200 mg (generic name: entrectinib) for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC).

The filing aims to expand the program for use as a companion diagnostic to identify people that could potentially benefit from Rozlyterk for the treatment of ROS1 fusion-positive locally advanced or metastatic NSCLC by detecting the ROS1 gene fusions using next-generation sequencer. ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is considered to promote cancer cell proliferation.2 The ROS1 fusion gene is prevalent in about 1-2% of non-small cell lung cancer, among them, it is more expressed in adenocarcinoma. 1, 2

Rozlytrek was granted regulatory approval by MHLW for the treatment of NTRK fusion gene positive advanced and recurrent solid tumors on June 18, 2019 and the drug has been launched on September 4. An application has been filed with the MHLW for the extended indication of ROS1 fusion-positive NSCLC on March 15, 2019.

FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device developed by Foundation Medicine Inc. The product detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved to use as a companion diagnostic for 14 molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

About Rozlytrek

Rozlytrek is an oral medicine for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. FDA has approved Rozlytrek for people with ROS1-positive, metastatic NSCLC and NTRK gene fusion-positive solid tumors. Rozlytrek was granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

Contact:

Tel: +81-3-3273-0881

Email: pr@chugai-pharm.co.jp

(C) 2019 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
ChangeLast1st jan.
CHUGAI PHARMACEUTICAL CO., LTD. -0.24% 8300 End-of-day quote.34.30%
ROCHE HOLDING AG 0.35% 288.2 Delayed Quote.19.97%
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Financials (JPY)
Sales 2019 636 B
EBIT 2019 171 B
Net income 2019 127 B
Finance 2019 261 B
Yield 2019 1,25%
P/E ratio 2019 35,5x
P/E ratio 2020 29,5x
EV / Sales2019 6,74x
EV / Sales2020 6,22x
Capitalization 4 543 B
Technical analysis trends CHUGAI PHARMACEUTICAL CO.,
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus HOLD
Number of Analysts 13
Average target price 7 812,50  JPY
Last Close Price 8 300,00  JPY
Spread / Highest target 18,1%
Spread / Average Target -5,87%
Spread / Lowest Target -21,7%
EPS Revisions
Managers
NameTitle
Tatsuro Kosaka President, CEO & Representative Director
Osamu Nagayama Chairman
Itagaki Toshiaki CFO, Manager-Information Technology & Accounting
Hisafumi Okabe Senior Executive Officer & Head-Research
Hisanori Takanashi Executive Officer & GM-Clinical Development
Sector and Competitors
1st jan.Capitalization (M$)
CHUGAI PHARMACEUTICAL CO., LTD.34.30%41 970
JOHNSON & JOHNSON-1.05%337 021
ROCHE HOLDING AG18.88%250 869
MERCK AND COMPANY10.82%216 813
PFIZER-16.47%201 662
NOVARTIS15.10%198 751