Intas Pharmaceuticals Ltd.

The partnership focuses on sialidase enzyme therapeutics in conjunction with Henlius’ rituximab. Credit: Jarun Ontakrai/Shutterstock. Palleon Pharmaceuticals and Shanghai Henlius Biotech have entered a licence agreement and partnership for the former’s sialidase enzyme therapeutic, E-602, to treat autoimmune diseases. The partnership focuses on the first-in-class therapeutic, in conjunction with Henlius’ HANLIKANG (rituximab), for individuals with autoimmune conditions such as lupus nephritis. Henlius has secured an exclusive licence to develop and commercialise E-602 in China. Palleon will receive $95.3m in development and commercial milestones, plus royalties on the commercialisation of E-602 in the Chinese region. Henlius will fund and conduct the development of the therapy in the country for lupus nephritis treatment. The collaboration builds on the existing Palleon-Henlius oncology partnership established in June 2022, for the co-development of targeted sialidase therapies for cancer. Henlius Biotech CEO and executive director Dr Jason Zhu stated: “We are pleased to expand our collaboration with Palleon Pharmaceuticals. HANLIKANG is the only rituximab approved for an autoimmune indication in China. “We are committed to bringing better therapies to patients who suffer from lupus nephritis and other autoimmune conditions for which current treatment options are not always sufficient.” Derived from Palleon’s EAGLE glycan editing platform, E-602, in conjunction with rituximab, yields improved outcomes compared to rituximab alone in preclinical studies. This combination does not carry the risks of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which are potential side effects of other treatments such as T cell engagers and CAR T. Palleon Pharmaceuticals CEO and founder Jim Broderick stated: “Palleon’s glycan editing therapeutic has the potential to significantly improve treatment outcomes in patients who have autoimmune diseases including lupus nephritis, with a therapy that achieves optimal patient accessibility, including delivery in community outpatient settings. “We look forward to continuing our successful partnership with Henlius and expanding glyco-immunology drug development to address a new category of patients in need of better treatment options.” In October 2023, Intas Pharmaceuticals entered an exclusive agreement with Henlius to develop and commercialise serplulimab in Europe and India.

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.”

LONDON, Dec. 16, 2024 /PRNewswire/ -- Accord announces that the European Commission (EC has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for a range of immune medicated inflammatory diseases. The EC approval follows a positive opinion issued on 19 October 2024 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein. The CHMP positive opinion is based on a comprehensive package of analytical, non-clinical, and clinical similarity data, including a multi-regional phase III clinical trial in patients with plaque psoriasis. The study confirmed therapeutic equivalence, in the primary outcome, between DMB-3115 and Stelara®, alongside a comparable safety profile. The marketing authorisation paves the way for the launch of Imuldosa® in the EU ustekinumab market, valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data. Intas holds exclusive licensing rights to commercialise Imuldosa® worldwide, excluding Japan, Korea, and certain other Asian countries. Imuldosa® was already approved by the USFDA on October 10, 2024. Accord Healthcare Limited (Accord) announces that the European Commission (EC) has granted marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar of Stelara® (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson. Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which may play an important role in inflammatory and immune responses. Stelara® is indicated for range of immune medicated inflammatory diseases and has recorded global sales of US$ 19 billion of which US$D 3.2 billion sales coming from Europe as per IQVIA MAT Jun'24 data. Joe Dunford, VP of Speciality Brands stated, "Accord is committed to becoming a significant player in the autoimmune space, and we are delighted that the European Commission (EC) has granted marketing authorisation for our fifth biosimilar in Europe, Imuldosa®. This approval ensures that patients have access to high-quality therapies in Europe and beyond. We remain dedicated to advancing our biosimilar pipeline, with the goal of launching 20 biosimilars by 2030. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED