Progress in Regulatory Approvals, Applications, and Clinical Development
First written in FY2016. 24 of 42 entries say "Advanced", first in FY2017-Q3. Latest entry: 2026-08-19.
7 other companies' latest entry also says "Advanced".
- FY2026AdvancedAnnual report
「In clinical development, the company obtained marketing authorization in June 2025 for an additional pediatric dosage and administration and 600 mg tablets for Lialda. It obtained marketing authorization in March 2026 for tocilizumab BS “MA,” a treatment for rheumatoid arthritis and other conditions. In China, the company obtained new drug approval from the National Medical Products Administration in December 2025 for the high-purity EPA formulation MND-21, which it had been developing in partnership with Marubeni Pharma (Suzhou) Co., Ltd. (formerly Sumitomo Pharma (Suzhou) Co., Ltd.), for the indication of severe hypertriglyceridemia. The product name in Japan is Ep adel S.」
The company describes several development and commercialization milestones, including additional indications and dosage forms for Lialda, approval of tocilizumab BS “MA,” and approval of MND-21 in China. - FY2025AdvancedAnnual report
「The company obtained marketing authorization in September 2024 for an additional indication for inhaled treprostinil for pulmonary hypertension associated with interstitial lung disease. It submitted a marketing authorization application in March 2025 for RGB-19, a biosimilar of tocilizumab for rheumatoid arthritis. It began a Phase II/III clinical trial for MD-352, a treatment for dysmenorrhea, in October 2024.」
The company describes several development and commercialization milestones, including approval of an additional indication, the approval application for RGB-19, and the start of the Phase II/III clinical trial for MD-352. - FY2025-H1RestatedAnnual report
「Omvoh, a treatment for ulcerative colitis launched in June 2023, and Cortiment, a treatment for ulcerative colitis launched in September 2023, also contributed.」
The company reconfirms the sales contributions of Omvoh and Cortiment, which have already been launched, but no new regulatory approval or launch milestones are indicated. - FY2024AdvancedAnnual report
「In clinical development, the company obtained marketing authorization in September 2023 for Pegfilgrastim BS “Mochida”/“Nipro,” a biosimilar of the long-acting G-CSF product pegfilgrastim (development code: MD-110). Nextera Pharma Japan Co., Ltd. submitted a marketing authorization application in October 2023 for ACT-541468, a treatment for insomnia being co-developed with the company. The company submitted an application in December 2023 for an additional indication for inhaled treprostinil for pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema.」
The company describes specific development milestones, including marketing authorization for MD-110, the approval application for ACT-541468, and the application for an additional indication for inhaled treprostinil. - FY2024-Q3RestatedAnnual report
「Treprostinil inhalation solution, a treatment for pulmonary arterial hypertension launched in May 2023, Omvoh, an anti-IL-23p19 monoclonal antibody and treatment for ulcerative colitis launched in June 2023, and Cortiment, a treatment for ulcerative colitis launched in September 2023, also contributed.」
The company reconfirms the contribution to sales during the cumulative third-quarter consolidated period of 3 products whose launches had already been reported. No new regulatory approval or launch milestones are indicated. - FY2024-Q2AdvancedAnnual report
「In addition, we have been marketing the ulcerative colitis treatment Cortiment since September 2023.」
The company describes the launch of Cortiment in September 2023 as a new commercialization milestone. - FY2024-Q1Termination of an individual co-development agreementAnnual report
「Pfizer Inc. Japan Joint development, importation and joint sales of the antidepressant “MD-120” 2019」
The company states that its co-development, import and co-commercialization agreement with Pfizer Inc. for MD-120 has ended. - FY2024-Q1AdvancedAnnual report
「The company has been selling inhaled treprostinil, a treatment for pulmonary arterial hypertension, since May 2023 and Omvoh, an anti-IL-23p19 monoclonal antibody and treatment for ulcerative colitis, since June 2023.」
The company describes the commercialization progress of inhaled treprostinil and Omvoh, which were launched in May and June 2023, respectively. - FY2023AdvancedAnnual report
「In clinical development, the company obtained marketing authorization in December 2022 for inhaled treprostinil, a treatment for pulmonary arterial hypertension (development code: MD-711). The pediatric indication for Lialda, MND-21, a treatment for hypertriglyceridemia being developed in China in partnership with Sumitomo Pharma (Suzhou), ACT-541468, a treatment for insomnia being co-developed with Idorsia Pharmaceuticals Japan Ltd., and the pediatric indication for Yuris are in Phase III clinical development.」
The company describes development and commercialization progress, including marketing authorization for MD-711 and several products in Phase III clinical development. Meanwhile, development of the pediatric indication for Lexapro and MD-120 is described as having been discontinued. - FY2023-Q2RestatedAnnual report
「Among new products, sales of Lialda, Goofice, Movicol and Yuris grew, while sales of the antidepressant Lexapro fell below those in the same period of the previous year. Sales of new products overall nevertheless exceeded those in the same period of the previous year. Sales of long-listed products fell below those in the same period of the previous year. Sales in the generic products business exceeded those in the same period of the previous year.」
The company describes sales growth for existing new products and generic products and a decline in sales of long-listed products, but no new milestones such as regulatory approvals or launches are indicated. - FY2023-Q1RestatedAnnual report
「Among new products, sales of the antidepressant Lexapro fell below those in the same period of the previous year, while sales of Lialda, Goofice, Movicol and Yuris grew.」
The company describes sales growth and declines for new products that are already on the market, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2022AdvancedAnnual report
「Marketing authorization applications are pending for the novel high-purity EPA formulation MND-2119 and the inhaled formulation of treprostinil, MD-711, for pulmonary arterial hypertension. The company also began a Phase III clinical trial for the pediatric indication of Yuris in April 2022.」
The company describes specific development progress, including approval applications for MND-2119 and MD-711, several products in Phase III clinical development, and the start of the pediatric indication trial for Yuris. - FY2022-Q3RestatedAnnual report
「Sales of new products, including the antidepressant Lexapro, Lialda, Goofice and Movicol, and Dinagest, a treatment for dysmenorrhea, grew. Yuris, a treatment for gout and hyperuricemia launched in May 2020, also contributed.」
The company describes sales growth and contributions from new products and other products that have already been launched, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2022-Q2RestatedAnnual report
「Sales of new products, including the antidepressant Lexapro, Lialda, Goofice and Movicol, and Dinagest, a treatment for dysmenorrhea, grew. Yuris, a treatment for gout and hyperuricemia launched in May 2020, also contributed.」
The company reconfirms sales growth and contributions from new products and other products that have already been launched, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2022-Q1RestatedAnnual report
「Sales of new products, including the antidepressant Lexapro, Lialda, Goofice and Movicol, and Dinagest, a treatment for dysmenorrhea, grew. In contrast, sales of long-listed products, including Ep adel, a treatment for hyperlipidemia and arteriosclerosis obliterans, Tramacet, a treatment for chronic pain and post-extraction pain, and Ataleec, a sustained-release calcium-channel blocker antihypertensive, fell below those in the same period of the previous year.」
The company describes sales growth for existing new products and a decline in sales of long-listed products, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2021AdvancedAnnual report
「For “Epadel,” the overseas subsidiary of the partner obtained import and marketing approval in Thailand in October 2020 for the indication of hypertriglyceridemia and began sales in April 2021. In Vietnam, the partner’s affiliated partner applied for import and marketing approval.」
The company describes specific development and commercialization milestones, including approval and launch for import and sale of Epadel in Thailand and a regulatory approval application in Vietnam. - FY2021-Q3RestatedAnnual report
「Sales of new products, including Lialda, a treatment for ulcerative colitis, and Goofice and Movicol, treatments for chronic constipation, grew. Yuris, a treatment for gout and hyperuricemia launched in May 2020, and Dinagest, a treatment for dysmenorrhea, also contributed.」
The company reconfirms sales growth and contributions from products that have already been launched, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2021-Q2AdvancedAnnual report
「In the generic products business, sales exceeded those in the same period of the previous year, supported by growth in the biosimilar Etanercept BS “MA” and the contribution of Teriparatide BS “Mochida,” a biosimilar launched in November 2019. The company also launched Yuris, a treatment for gout and hyperuricemia, and Dinagest, a treatment for dysmenorrhea, in May 2020.」
The company describes the sales contribution of Teriparatide BS “Mochida” following its launch and reconfirms the May 2020 launches of Yuris and Dinagest. - FY2021-Q1AdvancedAnnual report
「The company launched Yuris, a treatment for gout and hyperuricemia, and Dinagest, a treatment for dysmenorrhea, in May 2020.」
The company describes the launches of Yuris and Dinagest in May 2020 as specific commercialization milestones. - FY2020AdvancedAnnual report
「The company obtained marketing authorization in September 2019 for Teriparatide BS “Mochida.” Fuji Pharma Co., Ltd. obtained marketing authorization in January 2020 for Yuris, a treatment for gout and hyperuricemia that it had co-developed with the company. The company obtained marketing authorization in January 2020 for an additional indication for Dinagest for dysmenorrhea.」
The company describes specific development and commercialization milestones, including regulatory approval for Teriparatide BS “Mochida,” Yuris and Dinagest. - FY2020-Q3RestatedAnnual report
「Sales of new products, including the antidepressant Lexapro, Lialda, a treatment for ulcerative colitis, and Goofice, a treatment for chronic constipation, grew. Movicol, a treatment for chronic constipation launched in November 2018, also contributed.」
The company describes the sales contribution of existing new products and Movicol, which was launched in November 2018, but no new regulatory approvals, launches or clinical development milestones are indicated. - FY2020-Q1RestatedAnnual report
「Sales of new products, including the antidepressant Lexapro, Lialda, a treatment for ulcerative colitis, and Goofice, a treatment for chronic constipation, grew. Movicol, a treatment for chronic constipation launched in November 2018, also contributed.」
The company describes the sales contribution of existing new products and Movicol, but no new milestones such as regulatory approvals or product launches are indicated. - FY2019AdvancedAnnual report
「EA Pharma Co., Ltd. obtained marketing authorization in September 2018 for Movicol (development code: AJG555), which it had co-developed with the company. For FYU-981, a treatment for gout and hyperuricemia being co-developed with Fuji Pharma Co., Ltd., Fuji Pharma has an application for marketing authorization pending. An application for marketing authorization is pending for an additional indication for Dinagest for dysmenorrhea. MND-2119, a novel high-purity EPA formulation, the pediatric indication for Lialda, the pediatric indication for Lexapro, and the antidepressant desvenlafaxine (generic name), for which the company entered into an agreement with Pfizer Inc. in March 2019 covering development, sales and other matters, are each in Phase III clinical development. MD-711, a treatment for pulmonary arterial hypertension, is in Phase II/III clinical development.」
The company describes the approval of Movicol, several products with approval applications pending or in clinical development, and the execution of a development and sales agreement for desvenlafaxine, indicating progress in development and commercialization. - FY2019-Q3AdvancedAnnual report
「Doxil, an anticancer drug launched in January 2018, and Goofice, a treatment for chronic constipation launched in April of the same year, also contributed. The company launched Movicol, a treatment for chronic constipation, in November of the same year. Tramacet, a treatment for chronic pain and post-extraction pain, faced the launch of a generic product in December 2018, but sales exceeded those in the same period of the previous year.」
The company describes the launch of Movicol, a treatment for chronic constipation, and the launch of a generic version of Tramacet in December 2018, indicating specific progress in product commercialization and market conditions. - FY2019-Q2RestatedAnnual report
「Doxil, an anticancer drug launched in January 2018, and Goofice, a treatment for chronic constipation launched in April of the same year, also contributed. Sales of long-listed products, including Epadel, a treatment for hyperlipidemia and arteriosclerosis obliterans, Ataleec, a sustained-release calcium-channel blocker antihypertensive, and Dinagest, a treatment for endometriosis and uterine adenomyosis, fell below those in the same period of the previous year, due in part to the impact of drug price revisions and measures to promote generic drug use. In the generic products business, sales exceeded those in the same period of the previous year, supported by growth in the authorized generic of Dinagest and the contribution of Etanercept BS “MA,” a biosimilar launched in May 2018.」
The company continues to describe the sales and sales contributions of Doxil, Goofice and Etanercept BS “MA,” but no new regulatory approval or launch milestones are indicated. - FY2019-Q1AdvancedAnnual report
「Doxil, an anticancer drug launched in January 2018, and Goofice, a treatment for chronic constipation launched in April of the same year, also contributed. In the generic products business, sales exceeded those in the same period of the previous year, supported by growth in the authorized generic of Dinagest and the contribution of Etanercept BS “MA,” a biosimilar launched in May 2018.」
The company describes specific commercialization progress, including the launches of Doxil and Goofice and the launch of Etanercept BS “MA” in May 2018, together with their contributions to sales. - FY2018AdvancedAnnual report
「The company obtained marketing authorization in January 2018 for Etanercept BS “MA,” a biosimilar of etanercept for rheumatoid arthritis (development code: LBEC0101). EA Pharma Co., Ltd. obtained marketing authorization in January 2018 for Goofice, a treatment for chronic constipation that it had co-developed with the company. Goofice was launched on 19 April of the current year.」
The company describes specific development and commercialization milestones, including marketing authorization for the biosimilar, approval of the co-developed product and the launch of Goofice. - FY2018-Q3RestatedAnnual report
「Sales of the new chronic pain and post-extraction pain treatment Tramacet, the antidepressant Lexapro and other products exceeded sales in the same period of the previous year. Sales of Lialda, a treatment for ulcerative colitis launched in November 2016, also grew steadily.」
The company continues to report sales growth for Lialda following its launch, but no new regulatory approvals or clinical development milestones are indicated. - FY2018-Q2AdvancedAnnual report
「Sales of generic products exceeded sales in the same period of the previous year, supported by growth in sales of biosimilars and generic anticancer drugs, as well as the contribution from the launch of an authorized generic of Dinagest.」
The authorized generic of Dinagest was launched, contributing to sales of generic products. - FY2018-Q1AdvancedAnnual report
「Sales of the new chronic pain and post-extraction pain treatment Tramacet, the antidepressant Lexapro and other products exceeded sales in the same period of the previous year. Sales of Lialda, a treatment for ulcerative colitis launched in November 2016, also grew steadily.」
For Lialda, whose launch had been reported by the previous quarter, the company states that sales grew steadily after launch. - FY2017-Q3AdvancedAnnual report
「The company has been selling Lialda, a treatment for ulcerative colitis, since 28 November 2016.」
The company describes the launch of Lialda as a specific commercialization milestone for the development product. - FY2017-Q2RestatedAnnual report
「There were no material changes in the status of the Group's research and development activities during the cumulative second quarter.」
Explicitly stating that there were no material changes in research and development activities. - FY2017-Q1RestatedAnnual report
「There were no material changes in the status of the Group's research and development activities during the cumulative first quarter.」
The company expressly states that there have been no material changes in the status of its R&D activities. - FY2016First statedAnnual report
「The company obtained approval in November 2015 for an additional indication for Lexapro for social anxiety disorder. It submitted a marketing authorization application for MD-0901, a treatment for ulcerative colitis. It also submitted an application for approval of an additional indication for Dinagest for uterine adenomyosis.」
The company describes regulatory approvals, approval applications and clinical trial progress for several development products.