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Other Disclosures4534Mochida Pharmaceutical Co.,Ltd.Pharmaceuticals

Notice of Marketing Approval in Japan for Tocilizumab BS “MA”

Mochida Pharmaceutical Co.,Ltd. obtained marketing approval in Japan for 5 tocilizumab biosimilar products. Under a domestic marketing partnership, Mochida Pharmaceutical Co.,Ltd. will supply the products to あゆみ製薬株式会社, which will market them.

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Announced details

Tocilizumab BS intravenous infusion 80 mg “MA”Tocilizumab BS intravenous infusion 200 mg “MA”Tocilizumab BS intravenous infusion 400 mg “MA”Tocilizumab BS subcutaneous injection 162 mg syringe “MA”Tocilizumab BS subcutaneous injection 162 mg auto-injector “MA”
Applicable field (uses covered by this announcement)

Rheumatoid arthritis; polyarticular juvenile idiopathic arthritis; systemic juvenile idiopathic arthritis; Castleman disease; cytokine release syndrome associated with treatment of malignant tumors; and pneumonia caused by SARS-CoV-2

Relationship between the counterparty and the company
Mochida Pharmaceutical Co.,Ltd.4534
Relationship with the Company

Mochida Pharmaceutical Co.,Ltd. and あゆみ製薬株式会社 have entered into a domestic marketing partnership agreement. Mochida Pharmaceutical Co.,Ltd. will supply the products, and あゆみ製薬株式会社 will market them. Mochida Pharmaceutical Co.,Ltd. and Gedeon Richter Plc. jointly developed these products.

Counterpartyあゆみ製薬株式会社, Gedeon Richter Plc.

あゆみ製薬株式会社: Head office: Chuo-ku, Tokyo; Representative Director and President: Tsumura Jugo (津村重吾). Gedeon Richter Plc.: No details provided.

Registration number and expiry date

Development code: RGB-19. Approval date: 23 March 2026. Registration number and validity period: Not disclosed.

Location (as indicated in this announcement)

Mochida Pharmaceutical Co.,Ltd.: Shinjuku-ku, Tokyo. あゆみ製薬株式会社: Chuo-ku, Tokyo.

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Announced details
ItemDetails
Names of Products / Services CoveredTocilizumab BS intravenous infusion 80 mg “MA”, Tocilizumab BS intravenous infusion 200 mg “MA”, Tocilizumab BS intravenous infusion 400 mg “MA”, Tocilizumab BS subcutaneous injection 162 mg syringe “MA”, Tocilizumab BS subcutaneous injection 162 mg auto-injector “MA”
Counterpartyあゆみ製薬株式会社, Gedeon Richter Plc.
Counterparty overviewあゆみ製薬株式会社: Head office: Chuo-ku, Tokyo; Representative Director and President: Tsumura Jugo (津村重吾). Gedeon Richter Plc.: No details provided.
Relationship with the CompanyMochida Pharmaceutical Co.,Ltd. and あゆみ製薬株式会社 have entered into a domestic marketing partnership agreement. Mochida Pharmaceutical Co.,Ltd. will supply the products, and あゆみ製薬株式会社 will market them. Mochida Pharmaceutical Co.,Ltd. and Gedeon Richter Plc. jointly developed these products.
Applicable areaRheumatoid arthritis; polyarticular juvenile idiopathic arthritis; systemic juvenile idiopathic arthritis; Castleman disease; cytokine release syndrome associated with treatment of malignant tumors; and pneumonia caused by SARS-CoV-2
Registration number and expiry dateDevelopment code: RGB-19. Approval date: 23 March 2026. Registration number and validity period: Not disclosed.
LocationMochida Pharmaceutical Co.,Ltd.: Shinjuku-ku, Tokyo. あゆみ製薬株式会社: Chuo-ku, Tokyo.
Items this document does not state (11)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To expand treatment options for rheumatoid arthritis and other conditions through the launch of these products and meet the needs of patients and healthcare professionals.

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Notice of Marketing Approval in Japan for Tocilizumab BS “MA” | Mochida Pharmaceutical Co.,Ltd. (4534) timely disclosure | Komori