Part of Roche Holding AG
Japanese drug manufacturer specializing in pharmaceutical research, development and production; majority-controlled by Roche (about 62%) while maintaining its own listing on the Tokyo Stock Exchange (4519).
Clinical Trials
639
33 active
Approvals
9
Total approvals
Agencies
1
Regulatory bodies
Founded
1925
Active, not recruiting
21
3.3%
Completed
318
49.8%
Enrolling By Invitation
1
0.2%
Not yet recruiting
11
1.7%
Recruiting
59
9.2%
Suspended
1
0.2%
Terminated
6
0.9%
Unknown
1
0.2%
- The EMA's CHMP recommended approval of intravenous Ocrevus (ocrelizumab) for patients aged 10 years and older with relapsing forms of multiple sclerosis. - The positive opinion rests on the Phase 3 OPERETTA 2 trial, which tested Ocrevus against fingolimod, the current standard treatment for pediatric MS. - Ocrevus was non-inferior to fingolimod on relapse control and cut relapse risk by 48%, with 48% fewer new or enlarging T2 lesions. - The safety profile in children and adolescents matched the established adult profile, and no OPERETTA 2 participants discontinued treatment for adverse events.
- Chugai obtained MHLW approval on June 17, 2026 for FoundationOne CDx as a companion diagnostic for tovorafenib in BRAF V600 alteration- and BRAF fusion-positive glioma. - The approval allows the comprehensive genomic profiling test to guide treatment decisions for tovorafenib, an anti-cancer BRAF inhibitor marketed in Japan by IPSEN. - Tovorafenib's efficacy and safety in relapsed or progressive low-grade glioma were evaluated in the overseas Phase II FIREFLY-1 study. - With the glioma indication added, FoundationOne CDx now holds companion diagnostic capabilities spanning 9 cancer types, including solid tumors.
- Yanagisawa Masashi of the University of Tsukuba shared the Lasker Basic Medical Research Award with Stanford's Emmanuel Mignot for identifying orexin and its role in narcolepsy. - Three Chugai Pharmaceutical researchers received the Clinical Medical Research Award for developing Hemlibra, an antibody treatment for hemophilia A. - The four are the first Japanese scientists in 12 years to win the awards, which the Lasker Foundation will present in New York on September 17. - Lasker Awards are widely viewed as predictors of Nobel Prizes, with past winner Shinya Yamanaka later receiving the 2012 Nobel Prize in Physiology or Medicine.
- Three Chugai scientists who led the creation of Hemlibra (emicizumab) for hemophilia A have received the Lasker-DeBakey Clinical Medical Research Award, one of the world's most prestigious scientific honors. - The award recognizes the unconventional concept of replacing coagulation Factor VIII's function with a bispecific antibody, enabling subcutaneous administration and sustained bleed prevention regardless of inhibitor status. - An integrated analysis of phase III HAVEN 1–4 studies showed an annualized bleeding rate of 1.4 events per year, with 82.4% of participants experiencing zero treated bleeds by Weeks 121–144. - Hemlibra is now approved in more than 120 countries and has been used by over 30,000 people with hemophilia A worldwide as of June 30, 2026.
- Chugai Pharmaceutical's research on nemolizumab, a humanized anti-IL-31 receptor A monoclonal antibody, has been selected for the 11th JBDA Award for Drug Discovery. - The award recognizes the integrated drug discovery effort spanning target identification, disease biology elucidation, antibody generation, and clinical development for pruritus. - Nemolizumab addresses pruritus associated with atopic dermatitis and prurigo nodularis, symptoms that can significantly impair patients' quality of life. - The drug is marketed as Mitchga in Japan by Maruho and as NEMLUVIO by Galderma in the United States, Europe, and other regions.
- Chugai Pharmaceutical filed a regulatory application with Japan's Ministry of Health, Labour and Welfare for vamikibart, an anti-IL-6 monoclonal antibody, to treat uveitic macular edema associated with non-infectious uveitis. - Vamikibart received orphan drug designation for this indication on June 23, 2026, and the filing is supported by the global Phase III MEERKAT and SANDCAT studies. - The Phase III trials evaluated vamikibart 0.25 mg and 1 mg versus sham intravitreal injection, with a primary endpoint of at least 15-letter BCVA improvement at Week 16. - Uveitic macular edema is the leading cause of moderate to severe vision loss in uveitis, with an estimated 26,000 patients in Japan currently reliant on corticosteroid therapy.
- Chugai Pharmaceutical reported solid Q2 FY2026 results with core operating profit exceeding prior-year levels, driven by strong Hemlibra exports and growing royalty income from NEMLUVIO and FOUNDAYO. - Global sales of NEMLUVIO by Galderma reached $433 million in H1, capturing approximately 42% of new prescription share for prurigo nodularis in the United States. - The U.S. FDA granted Fast Track designation to AQUA07, an allosteric ALK inhibitor utilizing Chugai's proprietary SnipeTide mid-molecule technology, based on preclinical data. - The company established a Strategic Investment Department to deploy its ¥962.6 billion net cash position toward M&A and in-licensing for growth acceleration.
- Chugai Pharmaceutical and UCSF have entered into a multi-year Master Collaboration Agreement to advance drug discovery research in disease biology, novel drug targets, and new therapeutic approaches. - The partnership will combine UCSF's translational research capabilities with Chugai's proprietary antibody engineering, SnipeTide™ macrocyclic peptide, and small molecule platforms. - An initial research project is already underway with a UCSF principal investigator, signaling immediate momentum under the new framework. - The agreement was facilitated by Chugai Partnering U.S., based in South San Francisco, and UCSF Innovation Ventures, reflecting Chugai's global open innovation strategy.
- The FDA has accepted and granted priority review to Roche's supplemental Biologics License Application for Enspryng (satralizumab) for the treatment of thyroid eye disease, with a decision expected by 15 October 2026. - In the pivotal phase III SatraGO-2 trial, 53% of patients treated with Enspryng achieved a proptosis reduction at week 24 compared to 23% on placebo, meeting statistical significance. - Enspryng, a humanised monoclonal antibody targeting the IL-6 receptor, could become the first at-home subcutaneous disease-modifying standard of care for TED, a progressive autoimmune disease affecting approximately 155 per 100,000 people. - The SatraGO programme also demonstrated improvements in clinical activity score and diplopia, with no new safety signals identified beyond the established profile in over 10,000 NMOSD patients.
- Chugai Pharmaceutical received regulatory approval from Japan's MHLW for Alecensa as the world's first tumor-agnostic therapy for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients. - The approval was based on the TACKLE study, which demonstrated a 76.5% response rate in ALK fusion gene-positive patients across all cohorts, with a safety profile consistent with previous studies. - This milestone expands Alecensa's use beyond non-small cell lung cancer and anaplastic large cell lymphoma to a wide range of cancer types harboring ALK gene abnormalities. - FoundationOne CDx Cancer Genomic Profile received companion diagnostic approval to identify patients who could benefit from this tumor-agnostic treatment approach.
