Industry Press Releases

Sino-foreign Pharmaceuticals' HEMLIBRA® is approved for use in Taiwan with hemophilia A with an eighth factor antibody

Thursday, Dec 06, 2018

Chugai Pharmaceutical Co., Ltd. announced that the Ministry of Health and Welfare Taiwan Food and Drug Administration (TFDA) approval of a wholly owned subsidiary of Chugai Pharmaceutical Chugai Pharma Taiwan Ltd. of the bispecific monoclonal antibody HEMLIBRA ® once weekly subcutaneous injections for routine prophylactic treatment of hemophilia a with factor VIII antibodies of bleeding episodes.

Dr. Yasushi Ito, Executive Vice President, Project and Lifecycle Management of Sino-foreign Pharmaceuticals, said: "We are very pleased that HEMLIBRA is now approved for use in Taiwan with hemophilia A with the eighth factor antibody. Chinese and foreign pharmaceuticals will In cooperation with Taiwanese Chinese and foreign pharmaceuticals, HEMLIBRA benefits patients with hemophilia A with inhibitory antibodies, and these patients have limited treatment options."

The approval was based on two pivotal studies in patients with hemophilia A with an eighth factor antibody: HAVEN 1 study in children and adolescents (NCT02622321), HAVEN 2 study in children (NCT02795767) Interim analysis.


HEMLIBRA is a bispecific monoclonal antibody developed using proprietary antibody engineering technology from Chugai Pharmaceutical. This drug is intended to bind Factor IXa and Factor X. Through this effect, HEMLIBRA can provide a cofactor function of the eighth factor for patients with hemophilia A, and a deficiency of factor VIII or impaired coagulation in patients with hemophilia A1 , 2) .
HEMLIBRA has been approved in more than 50 countries. In November 2017, the US Food and Drug Administration (FDA) approved the product worldwide for routine preventive treatment to prevent or reduce type A blood with the eighth factor antibody. The number of bleeding episodes in adult and child patients with a friend's disease (congenital factor VIII deficiency).
In Japan, HEMLIBRA was approved for routine prophylactic treatment in March 2018 to prevent or reduce the number of bleeding episodes in patients with congenital factor VIII deficiency (ie hemophilia A) with a factor VIII antibody, 2018 In May of this year, the product went on the market.

1) Kitazawa, et al. Nature Medicine 2012; 18(10): 1570
2) Sampei, et al. PLoS ONE 2013; 8: e57479

About Chugai Pharmaceutical

Chugai Pharmaceutical Co., Ltd. is one of Japan's leading research-based pharmaceutical companies with strong capabilities in biotechnology products. Headquartered in Tokyo, Chugao Pharmaceuticals specializes in prescription drugs and is listed on the first section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugao Pharmaceutical actively participates in R&D activities in Japan and overseas. Sino-foreign Pharmaceuticals is particularly committed to developing innovative products to meet unmet medical needs, with a primary focus on the oncology sector.
In Japan, Sino-foreign Pharmaceuticals' research and development facilities in Gotemba and Kamakura are working together to develop new drugs, while the laboratory in the floating room is promoting technology development research for industrial production. Overseas, Chugai Pharmabody Research in Singapore is primarily engaged in research and development, focusing on the development of a new generation of new antibody drugs using proprietary Chinese and foreign pharmaceutical antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe conduct clinical development activities in the US and Europe.
Sino-foreigner's consolidated revenue in 2017 totaled 534.2 billion yen and its operating income was 103.2 billion yen (using the International Financial Reporting Standards (IFRS) core standard).
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Disclaimer: The original version of this announcement is an officially licensed version. The translation is for your convenience only. Please refer to the original text. The original version is the only legally valid version.

Media : Tomoko Shimizu , Media Relations Group, Corporate Communications Department, Chuowai
Pharmaceutical Co., Ltd. Tel: +81-3-3273-0881 Email:

Taiwan Media,
Taiwanese Chinese and Foreign Pharmaceutical Co., Ltd.
Susan Chou (Zhou Shusheng)
Tel: +886-2-2715-2000

Investor Toshiya Sasai , Investor Relations Group, Corporate Communications Department,
Chugai Pharmaceutical Co., Ltd. Tel: +81-3-3273-0554 Email:



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