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

CHUGAI PHARMACEUTICAL CO., LTD.

(4519)
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Chugai Pharmaceutical : Obtains Approval for Additional Indication and Formulation for Tecentriq in PD-L1-Positive Triple Negative Breast Cancer

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09/23/2019 | 04:35am EDT

TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer.

It has also obtained approval for an additional formulation of Tecentriq 840 mg. Tecentriq 840 mg was developed to provide an optimal formulation for breast cancer for which approved dosage is 840 mg once every 2 weeks.

VENTANA OptiView PD-L1 (SP142), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of VENTANA OptiView PD-L1 (SP142) as a companion diagnostic of Tecentriq was approved on August 20, 2019 to allow physicians to identify patients with PD-L1-positive breast cancer who could benefit from Tecentriq.

'We are very pleased that Tecentriq has been approved as the first immune checkpoint inhibitor for the treatment of PD-L1-positive triple-negative breast cancer (TNBC) in Japan,' said Dr. Yasushi Ito, Chugai's Executive Vice President, Co-Head of Project & Lifecycle Management Unit. 'This approval provides a novel cancer immunotherapy-based treatment for TNBC, a rapidly-progressing cancer with limited therapeutic options. We are committed to contribute to patients through the treatment.'

This approval is based on the results from the phase III IMpassion130 study. Tecentriq in combination with nab-paclitaxel (albumin-bound) met primary endpoint with a significant reduction in the risk of disease worsening or death (PFS) compared with nab-paclitaxel (albumin-bound) alone in the intention-to-treat (ITT) population (median PFS=7.2 vs 5.5 months; hazard ratio [HR]=0.80, 95%CI: 0.69-0.92, p=0.0025) and in people who were tested positive for PD-L1 expression (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p

(C) 2019 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
ChangeLast1st jan.
CHUGAI PHARMACEUTICAL CO., LTD. -1.11% 5685 End-of-day quote.69.20%
ROCHE HOLDING AG 1.23% 329.6 Delayed Quote.5.85%
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Financials
Sales 2020 755 B 7 031 M 7 031 M
Net income 2020 217 B 2 023 M 2 023 M
Net cash 2020 330 B 3 070 M 3 070 M
P/E ratio 2020 47,1x
Yield 2020 0,85%
Capitalization 9 339 B 86 883 M 86 942 M
EV / Sales 2019
EV / Sales 2020 11,9x
Nbr of Employees 7 394
Free-Float 37,7%
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Mean consensus HOLD
Number of Analysts 12
Average target price 4 369,50 JPY
Last Close Price 5 685,00 JPY
Spread / Highest target 23,1%
Spread / Average Target -23,1%
Spread / Lowest Target -79,5%
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Managers
NameTitle
Tatsuro Kosaka Chairman & Chief Executive Officer
Osamu Okuda President, COO & Representative Director
Itagaki Toshiaki CFO, Manager-Information Technology & Accounting
Hisafumi Okabe Senior Executive Officer & Head-Research
Hisanori Takanashi Executive Officer & GM-Clinical Development
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