Taisho Pharmaceutical Co., Ltd. (Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara; "Taisho") announced today that it submitted an application to the Ministry of Health, Labour and Welfare for the approval of the manufacturing and marketing of a new dosage form of Nanozora^® 30mg Autoinjectors for S.C. Injection (generic name: ozoralizumab (recombinant), the "Drug"), an anti-TNFα multivalent NANOBODY^® compound.

The Drug is autoinjector dosage form of Nanozora^® 30mg Syringes for S.C. Injection, which was approved on September 26, 2022 for rheumatoid arthritis (RA), which is inadequately managed by the current available treatments. The injector device contains the same drug as the Nanozora^® 30mg Syringes for S.C. Injection. Users can easily inject the drug just by pressing the injector against the skin. The product is equipped with a function that identifies the start and finish of the injection using a sound and an inspection hole for visually checking the progress of injection. The needle covering will be locked after injection to prevent needle piercing accidents.

Taisho will continue to contribute to the health and wellbeing of patients with RA, their families and healthcare professionals by offering the Drug as a new therapeutic option.

About Nanozora^®

Nanozora^®, initially discovered by Ablynx [Ghent (Belgium)] (currently a Sanofi company), is a trivalent humanized low molecular weight compound that combines two anti-TNFα NANOBODY^® VHHs and one anti-serum albumin NANOBODY^® VHH. The drug has a molecular weight of approximately 25% of conventioinal IgG antibodies. Nanozora^® binds to two subunits of TNFα and potently neutralizes its action. Nanozora^® also has prolonged serum half-life by interacting with serum albumin, which is highly retained in blood, enabling patients to decrease treatment frequency to once every 4 weeks. Thanks 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^® was approved as the first potential NANOBODY^® therapeutic in Japan.

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..