Roche Industry News

Roche

May 23, 2026
Alzheimer's Diagnostics: Automated Platforms Outperform Manual Assays – Fujirebio Highlights Lumipulse G Superiority in PUMCH Cohort Study
A recent study published in the Journal of Alzheimer's Disease (2025) compared the diagnostic accuracy of automated (Fujirebio Lumipulse G, Roche Elecsys) and manual (Fujirebio INNOTEST) assays for Alzheimer’s disease cerebrospinal fluid biomarkers in a Chinese cohort from Peking Union Medical College Hospital. Analyzing 309 participants, the research demonstrated that automated platforms—particularly Lumipulse G—achieved higher diagnostic accuracy across multiple clinical scenarios, especially when using biomarker ratios like Aβ1–42/Aβ1–40 and p-tau181/Aβ1–42. The findings support method-specific cutoffs tailored to local populations and underscore the superiority of automation in reliable, high-performance AD diagnostics.
April 07, 2026
IVD Giant Hologic Goes Private as Longtime CEO Stephen P. MacMillan Retires Following $18.3B Blackstone-TPG Buyout
Hologic, a leading in vitro diagnostics (IVD) and women's health company, has completed its $18.3 billion privatization transaction with Blackstone and TPG, marking its delisting from Nasdaq. Longtime CEO Stephen P. MacMillan retired upon deal closure on April 7, 2026, concluding a 12-year tenure that saw 65% revenue growth and strategic transformation. The company will no longer provide quarterly guidance, signaling a shift from public-market pressures to long-term strategic execution under private ownership. José E. Almeida, former Baxter CEO, assumes leadership as Hologic pivots toward integrated care solutions amid industry-wide structural shifts from product-centric to platform-driven competition.
January 13, 2026
CD20 Therapeutics: From Oncology to Autoimmunity – A New Horizon for Gazyva and Beyond
Roche's CD20-targeting monoclonal antibody Gazyva (obinutuzumab) has demonstrated positive Phase III results in systemic lupus erythematosus (SLE), significantly reducing disease activity when combined with standard therapy. Originally approved for B-cell malignancies, Gazyva’s expansion into autoimmune indications—including lupus nephritis and now SLE—highlights the broad therapeutic potential of CD20 as a target across oncology and autoimmune diseases. This transition underscores CD20’s role in modulating pathogenic B cells while preserving immune reconstitution, validating its versatility. The evolving CD20 landscape now spans monoclonal antibodies, bispecifics, trispecifics, ADCs, CAR-T, and myeloid-engager therapies, with increasing focus on safer, more durable B-cell modulation for chronic autoimmune conditions. Supported by robust clinical data and expanding indications, CD20-targeted therapies are entering a new era of cross-disease application.
January 12, 2026
ACROBiosystems Partners with bioSeedin to Host JPM Spotlight Event, Advancing Global Strategic Opportunities
On January 11, 2026, ACROBiosystems, as a strategic partner, co-hosted the BIOSeedin Winter Innovation Partnering Summit alongside bioSeedin in San Francisco, on the eve of J.P. Morgan Healthcare Conference 2026. Themed 'Global Alignment of Chinese Innovation Assets,' the summit gathered over 500 industry leaders from more than 10 countries, including top pharma executives, investors, and biotech innovators, to explore licensing collaborations and global strategies for innovative therapeutics. Supported by Lilly, Roche, and Fangda Partners, the event featured deep-dive discussions on internationalization pathways for Chinese biopharma, covering license-in/out models, global clinical development, and market access. ACROBiosystems reaffirmed its mission as a global platform company—'Connecting the world, your partner from discovery to the clinic'—and showcased its comprehensive portfolio across drug discovery, CMC, and clinical development through brands like Resilient Supply, Star Staining, and Aneuro, serving over 11,000 clients worldwide.
November 14, 2025
Roche's PD-L1 Subcutaneous Injection Approved in China
On November 14, Roche’s atezolizumab subcutaneous injection (Tecentriq SC) received approval from China’s National Medical Products Administration (NMPA), marking the first imported PD-(L)1 subcutaneous formulation approved in the country. The product combines atezolizumab with Halozyme Therapeutics’ Enhanze drug delivery technology, enabling administration in approximately 7 minutes compared to 30–60 minutes for intravenous infusion. Approval was based on the Phase III IMscin001 trial, which demonstrated comparable efficacy, safety, and pharmacokinetics between subcutaneous and intravenous formulations. Atezolizumab is indicated for over 10 oncology indications globally, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, and melanoma. In 2023, Tecentriq generated global sales of $4.198 billion.
November 13, 2025
CIIE 2025's report card: record-breaking licensing deals and global pharma's China partnership
Driven by an explosive growth in innovative drug and high-end medical device transactions in recent years, this year's CIIE has effectively become a "super showcase" for numerous international pharmaceutical and device companies to jointly present innovative products developed in collaboration with local partners.
November 11, 2025
Roche Advances First-in-Class FcRH5/CD3 Bispecific Antibody Cevostamab into Phase III Trial for Relapsed/Refractory Multiple Myeloma
On September 23, 2025, Roche announced at its Pharma Day the upcoming initiation of the Phase III Cevolution trial for cevostamab, a first-in-class FcRH5/CD3 bispecific antibody, in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (RRMM) who have received two or more prior lines of therapy. The trial is scheduled to begin in 2026. Data from the Phase I Camma-1 study showed overall response rates of 86% and 88% at 70mg and 105mg doses, respectively, with grade 3 infection rates below 30%. Roche bypassed Phase II development due to promising early efficacy, despite the unvalidated nature of the FcRH5 target and limited competition in this space—only Legend Biotech and Moderna have early-stage assets targeting FcRH5. With FcRH5 expressed on nearly all myeloma cells, cevostamab aims to address significant unmet needs in RRMM as current quadruplet regimens dominate frontline treatment. However, it faces competitive pressure from BCMA-targeted CAR-Ts (e.g., Carvykti) and T-cell engagers (e.g., Tecvayli, Elrexfio), as well as emerging trispecific antibodies. Roche believes cevostamab’s novel mechanism and favorable safety profile position it as an ideal backbone for future combination therapies, and the company is actively exploring partnerships for such strategies.
November 10, 2025
Roche's BTK Inhibitor Fenebrutinib Achieves Primary Endpoint in First Pivotal Phase III Study for Multiple Sclerosis
Roche announced that fenebrutinib, an oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, met the primary endpoint in its first pivotal Phase III trial. Designed as a dual inhibitor of B cells and microglia, fenebrutinib demonstrates high selectivity—130-fold over other kinases—and penetrates the blood-brain barrier to target chronic inflammation in the central nervous system. In the FENhance 2 study, fenebrutinib significantly reduced annualized relapse rates versus teriflunomide in relapsing multiple sclerosis (RMS). Additionally, in the FENtrepid study, it showed non-inferiority to ocrelizumab in delaying disability progression in primary progressive MS (PPMS). Full data will be presented at upcoming medical conferences, with regulatory submissions planned following the release of FENhance 1 results in the first half of 2026.
November 10, 2025
CIIE spotlights global healthcare giants with 60+ debuts deepening China presence
As one of the most popular sections in previous CIIEs, the Medical Equipment and Healthcare Products exhibition area moved to Halls 1.1, 1.2, and 2.2 this year. The world’s top ten medical device giants and 12 Fortune Global 500 pharmaceutical companies gathered in this expansive space exceeding 70,000 square meters.
November 05, 2025
Roche Showcases Over Ten Upcoming and Pipeline Products in China Debut at CIIE, Unveiling Full Disease Area Strategy
At the 8th China International Import Expo (CIIE), Roche, a continuous participant since the event's inception, unveiled over ten soon-to-be-launched and pipeline products across therapeutic areas including oncology, hematology, neuroscience, ophthalmology, immunology, cardiovascular, and metabolic diseases. Highlights include Gazyva® (obinutuzumab) for lupus nephritis—the first anti-CD20 monoclonal antibody to demonstrate significant complete renal response in Phase III trials—and the Port Delivery System (PDS), the world’s first and only intravitreal implant for sustained anti-VEGF delivery. Roche also showcased its end-to-end pharmaceutical value chain in China and a newly invested RMB 2.04 billion biologics manufacturing facility in Shanghai, set to produce Faricimab (Vabysmo®) locally. The company emphasized its strategic shift from a specialty leader in oncology and rare diseases to a comprehensive innovator across all major disease areas, reinforcing its century-long commitment to China ahead of its 100th anniversary in the country.