Meiji Seika Pharma Co., Ltd.

TOKYO--( BUSINESS WIRE )--Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo, President: Daikichiro Kobayashi) announced the establishment of a local subsidiary, "Taiwan Meiji Pharma Co., Ltd." (Headquarters: Taipei City, Taiwan, Chairman: Kenshi Murase), on December 18 th . This subsidiary will focus on pharmaceutical sales and other related activities in Taiwan and is scheduled to commence operations in February 2025. 1. Purpose and Background of Establishment Meiji Seika Pharma aims to become "a leading company in Asia in the field of infectious diseases" as part of the "Meiji Group 2026 Vision" targeting the year 2026. By establishing Taiwan Meiji Pharma Co., Ltd. in Taiwan, the fifth largest pharmaceutical market in Asia, we aim to build a business foundation and achieve further growth by supplying products. Taiwan Meiji Pharma Co., Ltd. plans to launch "REZUROCK" (product name in Japan, generic name: belumosudil mesylate), a selective ROCK2 inhibitor for the treatment of chronic graft-versus-host disease (Chronic GVHD), which is currently under application for regulatory approval with the Taiwan Food and Drug Administration (TFDA). Chronic GVHD is a disease that occurs following hematopoietic stem cell transplantation performed for the treatment of leukemia. We will also consider the continuous introduction of other products such as antibiotics and vaccines. 2. Company Overview (1) Name: Taiwan Meiji Pharma Co., Ltd. (2) Location: 14F, No.51 Section2 Keelung Rd. Xinyi District, Taipei city, 110502, Taiwan (R.O.C) (3) Representative (Chairman): Kenshi Murase (4) Business Description: Sales of pharmaceutical medicines, etc. (5) Capital: 30 million New Taiwan Dollars (6) Date of Establishment: December 18 th , 2024 (7) Shareholder Composition: Wholly owned subsidiary with 100% investment by Meiji Seika Pharma Co., Ltd. Through Taiwan Meiji Pharma Co., Ltd., Meiji Seika Pharma will stably supply products needed by patients and contribute to the health of the people in Taiwan.

SEOUL, South Korea--( BUSINESS WIRE )-- Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active Ingredient: Ustekinumab), has received marketing authorization from the European Commission (EC) as of December 18. This landmark approval comes just two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicine Agency (EMA) recommended the product for approval in October. Combined with its successful U.S. Food and Drug Administration (FDA) approval in October, IMULDOSA is now fully authorized to enter the global market. IMULDOSA , a biosimilar referencing Stelara of Janssen Pharmaceuticals, is indicated for treating inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Stelara, with its active ingredient ustekinumab, is among the top-grossing biologics worldwide, generating $20.323 billion in cumulative global sales in 2023, according to IQVIA. The development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. In July 2020, the development and commercialization rights held by Dong-A Socio Holdings were transferred to Dong-A ST to ensure the efficient execution of the global project. Since then, Dong-A ST and Meiji Seika Pharma have continuously collaborated to develop it. In July 2021, Dong-A ST signed a global out-licensing agreement with multinational pharmaceutical company Intas Pharmaceuticals for IMULDOSA . Through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada, IMULDOSA is set to be launched in multiple regions. A representative for Dong-A ST commented, “With the consecutive approvals in the United States and Europe, IMULDOSA is now one step closer to entering the global pharmaceutical market. We will continue to dedicate our efforts to ensure that IMULDOSA establishes a strong presence in the market, providing an effective treatment option to patients worldwide.”

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Samsung Biologics has secured a number of manufacturing deals worth a total of $668 million with an unnamed European pharma client, the CDMO said Tuesday. The deals expire in 2031. Sanofi is investing €40 million ($42.1 million) to expand its bioproduction facility in Lyon, France, the company said Friday. In particular, €25 million ($26.3 million) will be used to make the antibody for Thymoglobulin and €15 million ($15.7 million) to make monoclonal antibodies for type 1 diabetes clinical-stage therapies. The UK regulatory agency MHRA has appointed University of Oxford professor Anthony Harnden as its new chair, according to a Tuesday release. Harnden replaces Stephen Lightfoot, who stepped down in April 2023. LIfT BioSciences has launched a new subsidiary called Eolaíocht Bhitheach LIfT Teoranta, which will operate from Galway, Ireland, the company said Monday. The subsidiary will collaborate with the University of Galway and medical tech manufacturer HookeBio to provide manufacturing and clinical services. Lonza has manufactured its first batch of drug products at its mammalian manufacturing facility in Portsmouth, NH, the company said Wednesday. Convergent Therapeutics has received its first shipment of the radioisotope actinium-225 from Cardinal Health to make its Phase 1/2 prostate cancer radiopharmaceutical, according to a Monday release. Meiji Seika Pharma is investing in the CDMO and mRNA vaccines company Arcalis to improve its supply of mRNA vaccines in Japan, according to a Thursday release. Arcalis will make the API for Meiji’s Covid-19 vaccine. No financial details were disclosed. India-based Unexo Life Sciences was handed an FDA warning letter published Tuesday. It outlined two key issues: failure to produce certain batch record data and dirty air conditioner vents above drug production areas. The White House published a report , dubbed Building a Vibrant Domestic Biomanufacturing Ecosystem, on Friday. It states that the US needs more infrastructure and technology to produce drugs domestically and outlines 11 actions that policymakers should consider to improve manufacturing.