Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; "Taisho") announces that the Nanozora^® 30 mg syringes for Subcutaneous Injection (generic name: ozoralizumab, genetically recombined, "Nanozora^®"), a TNFα inhibitor, has been included in the NHI drug price list as from November 16 this year and is launched today.

Nanozora^® is a trivalent anti-TNFα NANOBODY^® compound that is composed of two anti-TNFα NANOBODY^® VHHs and one anti-serum albumin NANOBODY^® VHH. It takes effect following subcutaneous injection at once every 4 weeks. The efficacy and safety of Nanozora^® were demonstrated in the phase II/III clinical studies in patients with RA which inadequately responded to methotrexate (MTX) treatments (OHZORA study) and the phase III clinical study in patients with RA without MTX (NATSUZORA study). The manufacturing and marketing application of Nanozora^® was approved on September 26 this year for the indication of rheumatoid arthritis (RA) which  inadequately responded to the current available treatments.

Taisho intends to market Nanozora^® and provide new treatment options for patients with RA in Japan.

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.

In the OHZORA study, patients with RA inadequately responding to methotrexate (MTX) treatments received subcutaneous administration of Nanozora^® once every 4 weeks concomitantly with MTX. Nanozora^® demonstrated superiority over a placebo in the primary endpoint ACR20 at Week 16. The NATSUZORA study in patients with RA not concomitantly treated with MTX also showed improvements in clinical symptoms and bodily function. Throughout the clinical trials, Nanozora^® was well tolerated.

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

About NANOBODY^® VHHs

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 by large-scale production.

* "NANOBODY" is a registered trademark of Ablynx N.V..

Brand name

Nanozora® 30mg Syringes for Subcutaneous Injection

Generic name

Ozoralizumab (recombinant)

Dosage form

Injectable drug (pre-filled syringe)

Indications

Rheumatoid arthritis, which inadequately responded to the current available treatments

Dosage and administration

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

Standard unit quantity

30 mg 0.375 mL, 1 syringe

Drug price

112,476 yen

Package

0.375 mL (1 syringe)

Date of approval for manufacturing and marketing

September 26, 2022

Date of NHI drug price listing

November 16, 2022

Date of product launch

December 1, 2022