お知らせ • Jul 31
Chugai Pharmaceutical Files For Additional Indication Of Enspryng For Prevention Of Relapse In MOG Antibody-Associated Disease In Japan Chugai Pharmaceutical Co., Ltd. filed a regulatory application with the Ministry of Health, Labour and Welfare for an additional indication of 'prevention of relapse in MOG antibody-associated disease' for Enspryng [generic name: satralizumab (genetical recombination)], a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody created by Chugai. Enspryng received forerunner designation in 2023 as a treatment for the disease. If approved, Enspryng would become the first treatment covered by health insurance in Japan for the disease. This filing is based on results from METEOROID, a global phase III clinical study in adults and adolescents (aged 12-17 years) with MOGAD. Development in Japan is conducted by Chugai, and Japanese patients have participated in this study. Enspryng, created by Chugai, is a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, which was the first product developed by applying Chugai's proprietary recycling antibody technology. Recycling antibody technology received 'The Imperial Invention Prize,' the highest honor of the Fiscal Year 2026 National Commendation for Invention. Enspryng is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in approximately 90 countries, including Japan, the United States, and Europe. A global phase III clinical study is currently ongoing in autoimmune encephalitis (AIE). In addition, the U.S. Food and Drug Administration (FDA) has accepted the filing for thyroid eye disease (TED) and granted priority review. MOG antibody-associated disease (myelin oligodendrocyte glycoprotein antibody-associated disease, MOGAD) is an autoimmune disease involving demyelination by which a pathogenic autoantibody, an anti-MOG antibody, binds to MOG, which is expressed on the surface of the myelin sheath in the central nervous system. MOGAD causes inflammation of the optic nerves, spinal cord and brain, with symptoms such as visual impairment, loss of sensation, motor dysfunction and dysuria. Currently, no approved therapies exist for the prevention of relapse in MOGAD, and in about 80% of adult patients, the disease is chronic and characterized by a relapsing course with currently used therapies. The inflammatory cytokine IL-6 may play a role in the pathogenesis of MOGAD by promoting the production of autoantibodies and inducing inflammatory effects. The number of patients in Japan is estimated to be approximately 1,700. お知らせ • Mar 23
Chugai Pharmaceutical Co., Ltd. Announces Discontinuation Of Development Of GYM329 (Emugrobart) In Spinal Muscular Atrophy And Facioscapulohumeral Muscular Dystrophy Chugai Pharmaceutical Co., Ltd. announced that Roche has decided to discontinue the clinical development of GYM329 (emugrobart), an investigational anti-latent myostatin sweeping antibody, for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD). This decision follows a rigorous assessment of data from the Phase II/III MANATEE study (Part 1) in SMA and the Phase II MANOEUVRE study in FSHD. While emugrobart showed a favorable safety profile and target engagement by reducing mature myostatin, it did not translate into the intended functional outcomes. Specifically, muscle growth and exploratory functional efficacy were neither consistent nor robust enough across study participants to provide sufficient confidence for Phase III development in SMA and FSHD. Emugrobart was well tolerated across both studies, with no serious adverse events or treatment withdrawals. The discontinuation of these studies was not due to safety concerns. As the scientific rationale for continuing to investigate emugrobart in obesity remains strong, this decision does not impact the development of emugrobart in obesity. Obesity is a chronic metabolic disease with symptoms and underlying causes being fundamentally different from neuromuscular conditions like SMA and FSHD. In obesity, muscle quality is not primarily affected by a neurodegenerative (nerve-wasting) or myopathic (muscle-wasting) process and there is generally more myostatin for an anti-myostatin antibody to act on. Consequently, the Phase II development of emugrobart in obesity will continue as planned. お知らせ • Feb 24
Sarepta Therapeutics, Inc. Announces Commercial Launch of ELEVIDYS in Japan Sarepta Therapeutics, Inc. announced the commercial launch of ELEVIDYS (delandistrogene moxeparvovec) in Japan by Chugai Pharmaceutical Co. Ltd., following its reimbursement listing on Japan's National Health Insurance (NHI) price list. ELEVIDYS is the first gene therapy to be launched in Japan for Duchenne muscular dystrophy (DMD). In Japan, ELEVIDYS is available for ambulatory individuals with Duchenne ages 3-to less than 8-years-old, a deletion of any portion or the entirety of exon 8 and/or exon 9 in the DMD gene, and who are negative for anti-AAVrh74 antibodies. Chugai announced that ELEVIDYS has been launched in Japan following reimbursement listing, enabling access for eligible patients under the conditional and time limited approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) in May 2025. Chugai will be responsible for postmarketing clinical studies and all case postmarketing surveillance in Japan as part of the Roche Group collaboration to further evaluate long-term efficacy and safety. The approval in Japan was based on efficacy and safety data from the ELEVIDYS clinical development program, including results from the global Phase 3 EMBARK study. EMBARK evaluated ELEVIDYS in ambulatory boys with DMD and demonstrated clinically meaningful improvements in key motor function measures. ADVERSE REACTIONS: The most common adverse reactions (incidence 5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, thrombocytopenia, and troponin-I increased. Report negative side effects of prescription drugs to the FDA. お知らせ • Oct 25
Chugai Pharmaceutical Co., Ltd. (TSE:4519) agreed to acquire Renalys Pharma for ¥31 billion. Chugai Pharmaceutical Co., Ltd. (TSE:4519) agreed to acquire Renalys Pharma for ¥31 billion on October 24, 2025. A cash consideration of ¥15 billion will be paid by Chugai Pharmaceutical Co., Ltd. Chugai Pharmaceutical Co., Ltd. will pay an earnout/contingent payment of ¥16 billion cash. As part of consideration, ¥31 billion is paid towards common equity of Renalys Pharma. The expected completion of the transaction is November 30, 2025. お知らせ • Feb 01
Chugai Pharmaceutical Co., Ltd. Provides Guidance for the Financial Year Ending December 31, 2025 Chugai Pharmaceutical Co., Ltd. provided consolidated non-audited earnings guidance for the financial year ending December 31, 2025. For the year, company expects revenues of JPY 1,190,000 million, Core operating profit of JPY 570,000 million, Core net income of JPY 410,000 million and Core earnings per share of JPY 250.00. お知らせ • Jan 31
Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 27, 2025 Chugai Pharmaceutical Co., Ltd., Annual General Meeting, Mar 27, 2025. お知らせ • Jan 16
CHEPLAPHARM K.K. agreed to acquire the Japan business concerning the anti-cancer agent Tarceva® Tablets 25, 100, and 150 from Chugai Pharmaceutical Co., Ltd. (TSE:4519). CHEPLAPHARM K.K. agreed to acquire the Japan business concerning the anti-cancer agent Tarceva® Tablets 25, 100, and 150 from Chugai Pharmaceutical Co., Ltd. (TSE:4519) on January 14, 2025. Upon completion, CHEPLAPHARM group will solely market Tarceva after transferring assets related to Tarceva that are owned by Roche Group and Chugai Pharmaceutical Co., Ltd. (TSE:4519), including the marketing authorization and intellectual property rights (patents and trademarks, etc.).
The transfer of the marketing authorization is scheduled to take place on April 1, 2025, and the sales transfer is scheduled to take place in June 2025. お知らせ • Dec 06
Chugai Pharmaceutical Co., Ltd. to Report Fiscal Year 2023 Results on Feb 01, 2024 Chugai Pharmaceutical Co., Ltd. announced that they will report fiscal year 2023 results at 5:00 PM, Tokyo Standard Time on Feb 01, 2024 お知らせ • Feb 03
Chugai Pharmaceutical Co., Ltd. Provides Consolidated Earnings Guidance for the Financial Year 2023 Chugai Pharmaceutical Co., Ltd. provided consolidated earnings guidance for the financial year 2023. For the year, company expects revenues of ¥1,070,000 million, Core operating profit of ¥415,000 million, Core net income of ¥306,000 million and Core earnings per share of ¥186.00. お知らせ • Nov 01
Chugai Pharmaceutical Co., Ltd. to Report Fiscal Year 2022 Results on Feb 02, 2023 Chugai Pharmaceutical Co., Ltd. announced that they will report fiscal year 2022 results at 5:00 PM, Tokyo Standard Time on Feb 02, 2023