August 1, 2023

Notification of Approval to Manufacture and Market Nanozora® 30mg Autoinjectors for S.C. Injection in Japan

Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; "Taisho") announced that as of July 28, 2023 it received approval to manufacture and market Nanozora® 30mg Autoinjectors for S.C. Injection (generic name: ozoralizumab (recombinant), the "Drug"), which is a new dosage form of Nanozora®, a TNFα inhibitor. 

As a result of this latest approval, there are now two types of Nanozora® for S.C. Injection available: the syringe dosage form Nanozora® 30mg Syringes for S.C. Injection and the newly added autoinjector dosage form. 

The Drug is a single-use autoinjector dosage form, filled with the same drug as the Nanozora® 30mg Syringes for S.C. Injection, launched in December 2022. The Drug can be easily injected just by pressing the injector against the skin, and the needle covering will be locked after injection to prevent needlestick accidents. 

Taisho expects to be able to continue further contributing to the health and wellbeing of patients with RA, their families and healthcare professionals by offering Nanozora® 30mg Autoinjectors for S.C. Injection as a new therapeutic option.

Outline of the approval

Brand name

Nanozora® 30mg Autoinjectors for S.C. Injection

Generic name

Ozoralizumab (recombinant)


Rheumatoid arthritis, which inadequately responded to the current available treatments

Dosage and administration

An adult patient to be treated by subcutaneously injecting 30mg ozoralizumab (recombinant) per treatment at intervals of 4 weeks.

About Nanozora®

Ozoralizumab, an active ingredient of Nanozora®, is an anti-TNFα NANOBODY® compound initially discovered by Ablynx [Ghent (Belgium)] (currently a Sanofi company). It has a molecular weight of approximately 25% of conventional IgG antibodies. Nanozora® binds to TNFα by its two subunits and potently neutralizes its activity. Nanozora® also has prolonged serum half-life by interacting with human serum albumin which is highly retained in blood, enabling patients to receive treatment once every 4 weeks. Due to these positive features, Nanozora® is expected to show potentially enhanced penetration to inflamed tissues and clinical efficacy even in the early stage of treatment.

* "Nanozora" is a registered trademark of Taisho Pharmaceutical Co., Ltd.


NANOBODY® VHHs are molecules derived from a special type of antibody produced naturally by llamas and other camelid species. At nearly a tenth the size of conventional antibodies, NANOBODY® VHHs have the potential to reach disease targets in the human body that are inaccessible to conventional antibodies. The small, simple architecture allows the creation of "multivalent" NANOBODY® compounds that can act on multiple targets at the same time by linking the individual NANOBODY® VHHs together. NANOBODY® therapeutics offer the possibility to replace complex treatment regimens with single, multi-action medicines for a wide range of human diseases. Moreover, they can be generated rapidly for large-scale production.

* "NANOBODY" is a registered trademark of Ablynx NV, an affiliate of Sanofi. Ablynx NV originally discovered and performed initial development of the NANOBODY® compound ozoralizumab.