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Terumo Announces Regulatory Approval of Drug-Device Combination Product Co-Developed with Kyowa Kirin

Expected to Reduce the Burden on Patients Receiving Chemotherapy

8/2/2022 - TOKYO, JAPAN

Terumo Corporation (TSE: 4543) today announced that "G-Lasta® Subcutaneous Injection 3.6 mg BodyPod", a drug-device combination product co-developed with Kyowa Kirin Co., Ltd. (TSE: 4151) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on July 28.


"G-Lasta® Subcutaneous Injection 3.6 mg BodyPod" is a combination product of G-Lasta® [generic name: pegfilgrastim (genetical recombination)] and an automated injection device. G-Lasta® is used to reduce the incidence of febrile neutropenia* in patients receiving chemotherapy, and Kyowa Kirin has been marketing the drug in Japan since 2014. The drug G-Lasta® is usually administered subcutaneously at the hospital, at least one day after patients receive chemotherapy. The automated injection device is newly designed to deliver the drug at a certain time, and it is used by attaching it on the patient's body.


The combination product takes in the characteristics of both drug and device. Healthcare providers use this novel combination product to patients on the day of chemotherapy, allowing patients to skip the required outpatient visit on the day after chemotherapy.


"With this approval, we are excited to provide new values to patients and healthcare providers involved in cancer chemotherapy. At Terumo we always strive to provide solutions to reduce the burden on patients and healthcare providers," commented Noritsugu Fujita, Executive Officer and Division President of Pharmaceutical Solutions Division, Medical Care Solutions Company.


Terumo will continue to collaborate with pharmaceutical companies to provide drug delivery solutions that will enhance and maximize drug effectiveness.

*Febrile neutropenia is a complication in patients receiving chemotherapy. It refers to when the patient has a fever with low neutrophil count and is at risk of serious infection.


For Reference

  • Press Release: A Novel Drug-Device Combination Product Using Terumo's Automated Injection Device Completes Clinical Study in Japan (February 8, 2021)

  • About Pharmaceutical Solutions Division

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.


Media Contact

Corporate Communication Dept., Terumo Corporation

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