Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; “Taisho”) announced today that it received approval to manufacture and market Nanozora^Ⓡ 30mg Syringes for S.C. Injection ("Nanozora^Ⓡ"), the anti-TNFα NANOBODY^Ⓡ therapeutic licensed from Ablynx [Ghent (Belgium)] (currently a Sanofi company) in 2015 and developed by Taisho in Japan (generic name: ozoralizumab (genetically recombined)) from the Ministry of Health, Labour and Welfare for the indication of rheumatoid arthritis (RA), which is inadequately managed by the current available treatments.

Nanozora^Ⓡ is the first trivalent anti-TNFα NANOBODY^Ⓡ compound approved in Japan that combines two anti-TNFα NANOBODY^Ⓡ VHHs and one anti-serum albumin NANOBODY^Ⓡ VHH. It takes effect following subcutaneous injection at intervals of 4 weeks. The approval of Nanozora^Ⓡ was based on two clinical studies in Japanese patients with RA who had an inadequate response to csDMARDs. Results of the phase II/III clinical studies in patients with RA inadequately managed by methotrexate (MTX) treatments (OHZORA study) show that Nanozora^Ⓡ demonstrated superiority over placebo in the primary endpoint ACR20 at Week 16, that is, the rate of the patients with at least a 20% improvement in the American College of Rheumatology criteria. For other efficacy endpoints, including DAS28-CRP, Nanozora^Ⓡ demonstrated a significant reduction in disease activity from Day 3 of treatment initiation, compared to placebo. In the phase III clinical study in patients with RA not concomitantly treated with MTX (NATSUZORA study), Nanozora^Ⓡ also showed improvement of clinical symptoms and physical functions. Throughout the clinical trials, Nanozora^Ⓡ was well tolerated.

Taisho intends to market Nanozora^Ⓡ and provide new treatment options for the estimated 800,000 patients with RA in Japan.

Outline of the approval

Brand name: Nanozora^Ⓡ 30mg Syringes for S.C. Injection
Generic name: Ozoralizumab (recombinant)
Indication: Rheumatoid arthritis, which is inadequately managed by the current available treatments
Dosage and administration: An adult patient to be treated by subcutaneously injecting 30 mg ozoralizumab (recombinant) per treatment at intervals of 4 weeks.

About NANOBODY® VHHs

NANOBODY^ⓇVHHs are molecules derived from a special type of antibody produced naturally by llamas and other camelid species. At 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 engage 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 and can be generated rapidly for large-scale production.

NANOBODY^Ⓡ is a registered trademark of Ablynx N.V..