Skip to content

#罗氏

Today 0 items
Oct 14Wed
  1. jamanetwork.com73

    From Biological Insight to a New Class of Medicines for Hemophilia A

    The 2026 Lasker-DeBakey Clinical Medical Research Award recognizes researchers who developed a bispecific antibody mimicking blood coagulation factor VIII. The antibody offers a new class of medicines for hemophilia A, a life-threatening bleeding disorder caused by lack of factor VIII. The winners describe how biological insight drove the drug's development.

    Why it matters: Lasker award spotlights a bispecific antibody that created a new treatment class for hemophilia A.

  2. biopharmadive.com64

    Roche extends China deal streak with $1B pact for RNAi obesity drug

    Roche licensed an experimental RNA interference obesity medicine targeting ALK7 from China-based Rona Therapeutics, paying $100 million upfront for full ownership and up to just over $1 billion in milestones plus royalties. The drug joins five other experimental obesity medicines in Roche's pipeline. It is Roche's fifth deal with a China-based drugmaker since the end of August and 10th since the beginning of 2025.

Oct 13Tue
  1. biospace.com65

    Roche expands obesity R&D footprint with Rona deal worth $1B+

    Roche has licensed an RNAi-based ALK7 obesity drug candidate from China's Rona Therapeutics, paying up to $100 million upfront and in near-term milestones plus as much as $1.06 billion in future milestones. ALK7 inhibition may reduce fat deposits while preserving muscle, an option GLP-1 drugs lack. The deal follows Roche returning its anti-myostatin therapy emugrobart to subsidiary Chugai after a mid-stage analysis found it unlikely to produce meaningful weight loss.

Oct 9Fri
  1. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 8Thu
  1. statnews.com40

    STAT+: Roche goes beyond licensing in deal with Chinese biotech

    Roche is partnering with Chinese startup Defand Therapeutics to discover new medicines rather than merely license existing drug candidates, a departure from how pharma companies have approached China in recent years. Defand will discover multiple molecular glue degraders for cancer and immune-driven diseases, drugs designed to attach to problematic proteins and destroy them. Interest in the class grew after Revolution Medicines' molecular glue Rasonque nearly doubled survival in pancreatic cancer patients. Financial terms and next milestones were not disclosed.

  2. statnews.com51

    STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    Roche has signed a discovery collaboration with Chinese startup Defand Therapeutics to develop molecular glue medicines for cancer and immune-driven diseases. Financial terms were not disclosed, but a source said the deal could be worth close to $1 billion in upfront fees and milestone payments tied to preclinical, clinical and regulatory goals. Defand will discover and develop multiple drugs under the partnership.

    Why it matters: A big pharma pays a Chinese biotech for discovery-stage molecular glue work rather than late-stage assets.

Oct 7Wed
  1. biospace.com40

    Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more

    Genmab and AbbVie's bispecific antibody Epkinly, approved in May 2023 for diffuse large B cell lymphoma after at least two prior systemic lines, cut risk of disease progression or death by 51% in a Phase 3 trial when combined with R-CHOP in the frontline setting. In deals, Shionogi bought IntraBio for $2 billion, Novartis committed up to $7.8 billion to Abogen Biosciences, Eli Lilly added up to $870 million with Gate Bioscience, and Sanofi and Regeneron renewed their collaboration with a $1 billion upfront. Sarepta shared Elevidys data in older Duchenne patients at the World Muscle Society meeting, with Jefferies citing upcoming readouts and an FDA decision on Amondys 45 and Vyondys 53.

Oct 5Mon
  1. biopharmadive.com40

    Optogenetics researchers win a Nobel Prize; Roche bets on Alector brain drug

    The Nobel Prize in Physiology or Medicine went to Peter Hegemann, Georg Nagel and Karl Deisseroth for optogenetics, a light-based method for studying neurons. Alector licensed its preclinical Parkinson's therapy AL050 to Roche's Genentech for $100 million in guaranteed cash and up to $1.17 billion in milestones plus royalties. Separately, the FDA approved Lilly's Jaypirca as a first-line treatment for CLL or SLL patients without a 17p deletion.

    Why it matters: Nobel recognition for optogenetics and a sizeable Roche-Alector brain drug deal matter to neuroscience-focused readers.

  2. biospace.com58

    Genentech pens $1.27B deal to access Alector’s preclinical blood-brain barrier asset

    Genentech is paying $100 million upfront for exclusive development and commercialization rights to Alector's preclinical AL050, a blood-brain barrier-crossing glucocerebrosidase enzyme replacement therapy for neurodegenerative diseases including Parkinson's and Alzheimer's, with up to $1.17 billion in milestones plus tiered royalties. Genentech will handle development, regulatory, manufacturing and commercialization, while Alector retains its Alector Brain Carrier platform. The deal extends Alector's cash runway into 2029 and funds its anti-Aβ antibody AL137 and siRNA programs.

  3. nature.com75

    COPD trial wins spur broad respiratory hopes

    AstraZeneca's tozorakimab, an IL-33-targeted antibody, reduced COPD exacerbations by up to 30% in current and former smokers in two trials, with an FDA decision expected in the first quarter of 2027. Unlike dupilumab and mepolizumab, it worked across patients with all blood eosinophil counts, addressing non-eosinophilic COPD. The success, after mixed results for other IL-33 agents like itepekimab, is reviving industry interest in IL-33 and alarmin targets across respiratory disease.

    Why it matters: First IL-33 win in COPD works regardless of eosinophil count, reshaping the inflammatory biologic landscape.

Oct 1Thu
  1. N Engl J Med64

    Giredestrant plus Everolimus in Advanced Breast Cancer.

    An all-oral regimen of giredestrant plus everolimus significantly prolonged progression-free survival over standard endocrine therapy plus everolimus in ER-positive, HER2-negative advanced breast cancer after a CDK4/6 inhibitor. Among 207 patients with ESR1-mutated tumors, median progression-free survival was 10.0 versus 5.5 months (hazard ratio 0.38); in the overall population of 373 patients, it was 8.8 versus 5.5 months (hazard ratio 0.56). Adverse-event rates were similar between groups.

    Why it matters: Phase 3 data show an all-oral targeted combination doubles progression-free survival after CDK4/6 inhibition, especially in ESR1-mutated tumors.

  2. Nat Med60

    Werner helicase inhibitor for advanced microsatellite instability solid tumors: a phase 1 trial.

    RO7589831 (VVD-133214), a first-in-class covalent inhibitor of Werner syndrome helicase, showed manageable safety and early antitumor activity in 88 patients with MSI and/or mismatch repair-deficient advanced solid tumors in part 1 of a phase 1 trial. TEAEs were mostly grade 1-2, with no grade 5 events and discontinuation in 3.4% (3/88). In 66 MSI efficacy-evaluable patients, disease control rate was 74.2%, objective response rate 10.6% (7 partial responses), median PFS 6.7 months and median OS 17.6 months; 150 mg and 600 mg BID were selected as recommended phase 2 doses.

    Why it matters: First-in-human data on a WRN covalent inhibitor, a synthetic lethal target for MSI cancers.

  3. biopharmadive.com50

    FDA starts review of Roche’s multiple sclerosis pill

    The FDA has accepted Roche's approval application for fenebrutinib, an experimental multiple sclerosis pill, under a priority review with a six-month timeline, covering both relapsed and primary progressive forms of the disease. The application rests on three late-stage studies that met their main objectives, but approval chances could be complicated by an imbalance in deaths, eight among fenebrutinib recipients versus one on Aubagio in two Phase 3 trials, and a case of liver enzyme elevations meeting Hy's law. Roche did not say when a decision might come.

    Why it matters: Fenebrutinib could become the first BTK inhibitor approved for two major forms of MS despite unresolved safety concerns.

Sep 29Tue
  1. nature.com54

    Werner helicase inhibitor for advanced microsatellite instability solid tumors: a phase 1 trial

    RO7589831, a first-in-class inhibitor of the synthetic lethal target Werner syndrome helicase, showed some partial responses in the dose-escalation stage of a phase 1 trial in patients with microsatellite instability and/or DNA mismatch repair-deficient solid tumors. The maximum tolerated dose was not reached.

    Why it matters: First clinical data for a Werner helicase inhibitor, a new synthetic lethal strategy in MSI tumors.

Sep 24Thu
  1. fiercebiotech.com42

    Roche pens backloaded $2B deal with Atavistik to discover allosteric CVRM drugs

    Roche has struck a licensing deal worth up to $2 billion with Atavistik Bio to discover allosteric small molecules for cardiovascular, renal and metabolic diseases. Roche pays $70 million up front, with up to $1.9 billion in milestones; the partners will use Atavistik's AMPS platform, with Atavistik handling discovery and Roche taking over preclinical work and beyond. The deal extends Roche's CVRM push, which includes the zilebesiran partnership with Alnylam, the $3.5 billion purchase of 89bio and the $2.7 billion Carmot takeover.

    Why it matters: Roche pays $70 million up front in a $2 billion deal to enter allosteric cardiometabolic drug discovery.

Sep 22Tue
  1. Nature Medicine52

    Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial

    A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.

    Why it matters: First data on adding trastuzumab and nivolumab to standard gemcitabine-cisplatin in HER2-positive biliary tract cancer.

  2. medrxiv.org54

    Genomic foundation models extend clinicopathologic and transcriptomic prognostication in soft tissue sarcoma

    Evo2, a genomic foundation model, was used to embed short variants, fusions and rearrangements from 102 patients with soft tissue sarcoma and 129 TCGA-SARC cases into patient-level genomic representations for Cox survival modelling. Adding Evo2 to SARCULATOR raised the OS C-index from 0.620 to 0.770 in the study cohort and from 0.595 to 0.716 in TCGA-SARC; in TCGA-SARC it also improved CINSARC-based OS prediction from 0.476 to 0.653. These descriptive point estimates support altered tumor sequence context as an independent prognostic layer for sarcoma risk stratification.

    Why it matters: It shows genomic foundation model features improve established sarcoma prognostication across cohorts and survival endpoints.

Sep 13Sun
  1. N Engl J Med63

    Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy.

    Obinutuzumab outperformed tacrolimus for inducing complete remission in primary membranous nephropathy in a phase 3 trial of 142 adults. At week 104, complete remission occurred in 26 of 71 patients given obinutuzumab versus 4 of 70 given tacrolimus (37% vs. 6%; adjusted difference, 31 percentage points; P<0.001). Grade 3 or higher adverse events were similar, at 22% and 19%. The finding positions obinutuzumab as an effective alternative to tacrolimus in this disease.

    Why it matters: Phase 3 data show obinutuzumab superior to tacrolimus for complete remission in primary membranous nephropathy.

Sep 10Thu
  1. Nat Med56

    Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial.

    Adding atezolizumab to neoadjuvant taxane-carboplatin-anthracycline chemotherapy did not significantly improve event-free survival in stage II-III triple-negative breast cancer, with an HR of 0.80 (95% CI, 0.62-1.03; P = 0.083) and a 4-year EFS difference of 3.3%. Prespecified subgroup analysis suggested benefit in patients with clinical lymph node involvement (P interaction = 0.039), and an exploratory mRNA subset analysis pointed to basal-like immune-activated tumors as potential responders. Immune-related adverse events occurred in 27.6% with atezolizumab versus 11.4% with placebo.

    Why it matters: Negative phase 3 result for checkpoint inhibition in early TNBC, with subgroup data pointing to who might still benefit.

Sep 5Sat
  1. Lancet72

    Liver resection after atezolizumab and bevacizumab versus maintenance therapy for locally advanced hepatocellular carcinoma (TALENTOP): a multicentre, open-label, randomised, phase 3 trial.

    Liver resection after response to atezolizumab plus bevacizumab prolonged time to treatment failure in advanced hepatocellular carcinoma with macrovascular invasion and no extrahepatic metastasis. In the phase 3 TALENTOP trial, 201 responders were randomised to surgery plus 12 months of the combination or maintenance therapy; median time to treatment failure was 20·4 versus 11·8 months (hazard ratio 0·60, p=0·015). Grade 3 or 4 treatment-related adverse events were more frequent with surgery (39% vs 21%).

    Why it matters: Randomised phase 3 evidence that resection adds benefit after systemic therapy in advanced hepatocellular carcinoma.

Sep 1Tue
  1. nature.com68

    Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial

    Adding atezolizumab to neoadjuvant chemotherapy did not improve event-free survival in the phase 3 NSABP B-59/GeparDouze trial of patients with early-stage triple-negative breast cancer, missing its primary endpoint. Translational analyses identified tumor microenvironment-dependent determinants of response, indicating basal-like immune-activated tumors may respond to atezolizumab plus chemotherapy.

    Why it matters: Negative phase 3 result for atezolizumab in early triple-negative breast cancer, with biomarker data indicating which tumors may still benefit.

Aug 28Fri
  1. fiercebiotech.com57

    Genentech doubles down on ADC-resistant cancers with $1B DualityBio pact

    Roche's Genentech is paying DualityBio $45 million upfront for rights to antibody-drug conjugates built on the Chinese biotech's Dupac platform, with the deal worth more than $1 billion in potential milestones. DualityBio will generate and develop ADCs that deliver Dupac payloads, designed to retain efficacy in tumors that progress on topoisomerase-based ADCs such as Enhertu and Trodelvy, to Genentech-picked targets, with Genentech taking sole responsibility for development after phase 1a. BioNTech, GSK and BeiGene struck earlier deals for DualityBio ADCs in 2023 and 2024.

    Why it matters: A $1 billion licensing deal targeting patients who progress on approved ADCs addresses a growing unmet clinical need.

Aug 25Tue
  1. biocentury.com58

    Roche adds Hanmi’s obesity asset via licensing agreement: Deals Report

    Roche, through its Genentech unit, is paying Hanmi Pharmaceutical $190 million up front for rights to HM17321, a Ucn2 analog for obesity that has begun a Phase I trial in healthy volunteers and patients with obesity. Milestones could raise the deal's value to $2.3 billion, and Hanmi is eligible for royalties outside South Korea, where it retains the program's rights. The asset would complement at least four other clinical programs in Roche's obesity pipeline.

    Why it matters: A large pharma licensing a first-in-class obesity candidate with a $2.3 billion potential deal value.

Aug 21Fri
  1. fiercepharma.com48

    Roche earmarks $750M to double the size of its Oregon manufacturing facility

    Roche will invest $750 million to double the size of its Genentech unit's manufacturing campus in Hillsboro, Oregon, adding a fill-finish plant for drug-delivery devices such as prefilled syringes and auto-injectors. The 75-acre site has produced oncology, immunology and neurology treatments for 20 years. Roche plans to have the new plant operational in 2031 and to add 250 manufacturing jobs, part of a $50 billion U.S. investment pledge announced last April.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org