YL Biologics Ltd. (Head Office: Chuo-ku, Tokyo, President: Toshihiko Hibino)
(YLB) announced that the NDA filing for YLB217, a biosimilar product of
long-acting erythropoiesis stimulating agent Nesp, which YLB solely
developed, was executed through Yoshindo Inc. (Head Office: Toyama, Japan,
President: Hiroki Kitamura).
YLB contracted a technology transfer agreement with CJ Healthcare
(currently HK Inno.N, South Korea, Seoul) on September 28, 2017, including
exclusive development and marketing rights for Nesp biosimilar and
started domestic development with the sponsorship of Yoshindo. Since
January 2019, YLB has conducted a clinical phase III study, that was
randomized, double-blind, controlled trial in Japan.
The study enrolled 136 patients with renal anemia at 25 centers in Japan.
Based on the data from this study, Yoshindo submitted a manufacturing and
marketing approval application in Japan.
Although manufacturing of active pharmaceutical ingredients for YLB217 is
subcontracted to PanGen Biotech Inc. (Gyeonggi-do, South Korea),
manufacturing of syringe formulation is outsourced to AY Pharma Co. Ltd.
(Head Office: Chuo-ku, Tokyo), an affiliate company of Yoshindo, that
complies with “Japan Quality”. YLB expects that it is able to provide high
quality biosimilar products that would be “Japan Made” and supplied for
YLB will continuously cope with Yoshindo and has a global focus on
biosimilar products which show high medical needs. YLB will efficiently
develop biosimilar products using their large stock of know-how in
biotechnology products, and expect to provide biosimilar products to not only
the domestic but also the global market with high quality and reliability as
well as contribute to medical economy.
For further information, please contact to
YL Biologics Ltd.
Business development and Liaison Department
About YL Biologics Ltd.
YL Biologics is a joint venture company founded by Yoshindo and Lupin in
2014, which focuses on clinical development, NDA filing and PMDA approval,
and sales and marketing of biosimilar drugs in Japan. Through providing
our drugs to medical field, YL Biologics is committed to contribute to the
society and people by cutting medical spending and reducing financial
burden of patients.
About Yoshindo Inc.
Over the course of Yoshindo’s long history started from 1929, it has made
contributions to human health and social wellbeing through the
manufacturing and sales of generic pharmaceutical products. At present,
Yoshindo is advancing research and development into biopharmaceuticals
and essential drugs for transfusion and dialysis. Yoshindo is building new
technologies and know-how, with the aim of remaining an irreplaceable
pharmaceutical company for Japan moving into the future.