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Tuesday, 27 October 2026Published 08:00 Beijing time

Biomedicine Daily · Tuesday, 27 October 2026

CBA FRONTIER INSIGHTS

No. 5427October 2026Tuesday
53events16sources3first-hand60 min read
Lead

DeLLphi-305 Interim Analysis: Durvalumab Plus Tarlatamab First-Line Maintenance Cuts Death Risk 58% in Extensive-Stage Small Cell Lung Cancer

In the Phase III DeLLphi-305 trial, first-line maintenance durvalumab plus tarlatamab reduced the risk of death by 58% versus durvalumab alone in extensive-stage small cell lung cancer. Median OS was 21.1 months with the combination versus 12.7 months with monotherapy (OS HR 0.42; 95% CI 0.32-0.54; p<0.001). Median PFS was 7.4 versus 1.9 months (PFS HR 0.34; 95% CI 0.28-0.42; p<0.001).

mp.weixin.qq.comSource
01

Clinical readouts and safety

mp.weixin.qq.com

Phase III VOLGA: Perioperative Durvalumab Plus Neoadjuvant Enfortumab Vedotin Cuts Muscle-Invasive Bladder Cancer Recurrence Risk 49% and Death Risk 42%

Phase III VOLGA data show perioperative durvalumab plus neoadjuant enfortumab vedotin significantly improved EFS and OS in muscle-invasive bladder cancer. In a prespecified interim analysis of patients ineligible for or refusing cisplatin-based chemotherapy, the combination (n=233) versus control (n=229) showed an EFS HR of 0.51 (95% CI 0.38-0.67; p<0.0001) and an OS HR of 0.58 (95% CI 0.40-0.83; p=0.0027).

mp.weixin.qq.com

Merck's sacituzumab tirumotecan global Phase III shows longer PFS and OS; FDA grants priority review

Merck reported the global Phase III TroFuse-005/ENGOT-en23/GOG-3095 trial of sacituzumab tirumotecan in endometrial cancer patients previously treated with platinum chemotherapy and anti-PD-(L)1 therapy, where both PFS and OS beat chemotherapy. The study enrolled 776 patients: PFS was 7.2 vs 3.9 months (HR=0.59, P<0.0001), OS was 19.0 vs 12.1 months (HR=0.68, P=0.0001), and ORR was 35.1% vs 17.3%. The US marketing application has been accepted by FDA with priority review.

mp.weixin.qq.com

Roche divarasib head-to-head in KRAS-mutant lung cancer: 338 patients, response rate 58.4%

Roche reported phase III head-to-head results for divarasib on October 25. The trial randomized 338 previously treated KRAS G12C lung cancer patients; median overall survival was 17.7 months versus 12.0 months, with a 44% reduction in risk of death. The source describes it as the first phase III head-to-head study of a next-generation KRAS G12C inhibitor against an approved first-generation inhibitor, and the headline gives a response rate of 58.4%.

02

Regulatory and policy

mp.weixin.qq.com

Xinjiang Completes DRG/DIP Half-Year Settlement Across 14 Regions, Paying 166.23 Hundred Million Yuan

Xinjiang's medical insurance bureau has completed a DRG/DIP half-year settlement covering 14 pooling regions and 2758 medical institutions, with cumulative payments of 166.23 hundred million yuan. From January to June 2026, 8065.25 ten-thousand person-times of insurance benefits were paid across the region, with fund spending of 243.86 hundred million yuan. The settlement used case quality control, cost review, result verification and a closed-loop process of online double-blind review plus tiered review, reviewing more than 4.4 ten-thousand cases and paying 7.66 hundred million yuan.

statnews.com

STAT+: NIH’s new vaccine injury center has broad goals beyond RFK Jr.’s focus on shots

A new NIH vaccine injury center will bring post-infection long-term symptoms into its research scope, covering groups such as long Covid patients. Earlier this month, Robert F. Kennedy Jr. and other federal health officials announced the center would focus on patients with vaccine injuries; days later, two NIH leaders said its goals also include long-term symptoms after infection. One senior NIH official, speaking anonymously, said it is hard to distinguish whether long Covid symptoms stem from a vaccine or an infection because many patients have experienced both, and the immunological response mechanism and treatment are similar.

fda.govFirst-hand

Statement on improving adverse event reporting of compounded drugs to protect patients

The FDA announced it is strengthening oversight of adverse event reporting for compounded drugs, requiring outsourcing facilities to meet their reporting obligations and taking appropriate enforcement action against non-compliant facilities. During a 2018 inspection of BioTE Medical, the FDA found 4,202 adverse events that had never been reported, involving compounded hormone pellets occurring between 2013 and 2018; because key information was missing, the FDA could attribute only 61 of them to pellets containing testosterone.

mp.weixin.qq.com

Ivonescimab Plus Chemotherapy for First-Line Biliary Tract Cancer Proposed for CDE Priority Review

A new indication for ivonescimab, filed by Akeso/Summit (Kangfang Sainuo), combining ivonescimab with chemotherapy as first-line treatment for locally advanced or metastatic biliary tract cancer, has been proposed for priority review by the CDE. The information appeared on the CDE website on October 23, 2026. Biliary tract cancer is usually diagnosed late with poor prognosis; patients with advanced disease have a survival rate of only 2-3%.

fda.govFirst-hand

The Center for Drug Evaluation and Research's ARC Program Releases 2026 Annual Report

FDA CDER's Accelerating Rare disease Cures (ARC) Program has released its 2026 Annual Report, summarizing annual progress under three goals: scientific and regulatory innovations, engagement and education, and operations. The report presents the ARC 2025–2030 Strategic Plan, along with the LEADER 3D case studies and expanded educational resources, advances in statistical methods, translational science research, and international regulatory collaboration. According to the report, half of CDER's novel drug approvals in 2025 represented rare disease treatments.

03

Industry and deals

mp.weixin.qq.com

China Innovation Drug BD Potential Deal Value Nears $100 Billion in First Half, Pharma Majors Press On

Potential deal value of out-licensing (BD) transactions for China's innovative drugs approached $100 billion in the first half as multinational pharma continued pursuing deals. Since September, Gilead Sciences reached a definitive agreement with PepStar Therapeutics to acquire its oral IL-23R inhibitor program, whose lead candidate is HCXT-2001, for a $1.275 billion cash upfront payment. In late September, Ciprapirin (SPR2015 developer) and Merck signed a global exclusive license for preclinical oral KRAS G12D (ON) inhibitor SPR2015, with $400 million upfront and total potential value up to $2.13 billion; the deal has taken effect.

mp.weixin.qq.com

Gilead Acquires PepStar's Oral IL-23R Program for $1.275 Billion Upfront

Gilead will acquire the oral IL-23R inhibitor program of PepStar Therapeutics for an upfront cash payment of $1.275 billion, gaining global rights including lead candidate HCXT-2001. HCXT-2001 is in clinical development as an oral macrocyclic peptide IL-23R inhibitor with a long half-life, offering a potential differentiated therapy for IBD and possible expansion into psoriasis. Closing remains subject to customary conditions and is expected in the fourth quarter of 2026. Eight Roads was PepStar's angel investor and added investments across three consecutive rounds.

mp.weixin.qq.com

MetaTen Pharma and Eli Lilly Strike AI Drug Delivery Deal Worth Up to 1.1 Billion Dollars

MetaTen Pharma (7666.HK) announced a strategic collaboration with Eli Lilly carrying an upfront payment of over ten million US dollars and a total value of up to 1.1 billion US dollars, focused on AI-driven drug delivery solutions. The partners will jointly develop novel lipid nanoparticle (LNP) delivery systems and explore tissue-specific delivery technology adaptable to multiple therapeutic modalities, with Lilly mobilizing resources across drug discovery, clinical development and commercialization.

biospace.com

US biotechs take lion’s share of $54.5B VC money raised since 2025

From early 2025 through the third quarter of 2026, global biopharma financing reached $54.5B, of which U.S. companies raised $37.2B, about 68%. The San Francisco Bay Area and Boston raised $12.8B and $10.2B respectively, together about 62% of U.S. funding, while European biopharma companies raised $9.2B. Half of the $1.1B raised in the most recent quarter came from 5 of 32 rounds, and J.P. Morgan projects full-year 2026 financing of about $33B.

biopharmadive.com

Corxel, an obesity drugmaker, to go public via SPAC deal

Corxel plans to go public through a merger with the U.S. SPAC Amanat Acquisition Corp., along with a $300 million private financing to advance late-stage development of CX11. The deal centers on CX11, an oral GLP-1 drug in-licensed from Vincentage Pharma, and a preclinical obesity candidate targeting amylin. JX10, an acute ischemic stroke drug obtained from Biogen, is excluded and will remain with the private parent company.

biospace.com

Biotech IPOs raise $7.5B as sector’s performance rally flattens

Biotech IPOs raised $7.5 billion across 22 offerings in the first three quarters of 2026, according to J.P. Morgan. The XBI fell less than 1% in the third quarter as the sector's rally flattened. Parabilis Medicines' summer debut raised $670 million, the largest IPO raise in biotech history, and at least 31 biotechs had gone public as of Oct. 26.

04

Research papers

reddit.com

Scientists made a 'low-oxygen hypoxia pill': two drugs that make blood release less oxygen into tissues. Given daily to mice that already had Parkinson's-like movement problems, it improved their movement within 1-2 weeks. It also more than doubled lifespan in mice with a rare energy disorder.

A PNAS study shows that an oral hypoxia combination of GBT601 and PT2399 improves Parkinson's-like motor deficits and extends lifespan in Leigh syndrome mice. In the Ndufs4-knockout Leigh syndrome model, median lifespan increased from 62 days to 158 days. The combination also reversed motor phenotypes in an alpha-synuclein toxicity model of Parkinson's disease and halted progression of motor problems in a Friedreich ataxia model. DOI: 10.1073/pnas.2618654123.

doi.org

Colorectal cancers with distinct metastatic potential trigger divergent early T cell responses

Colorectal cancers with different metastatic potential induce distinct early T cell responses: nonmetastatic tumors trigger cytotoxic and Th1-like programs, while pro-metastatic tumors leave T cells in a naïve-like, hypoactivated state. Using orthotopic organoid transplantation and T cell fate mapping, the study found that pro-metastatic tumors downregulate MHCII, and targeting Ciita reduced CD4+ clonal expansion in nonmetastatic organoids and promoted tumor progression.

cell.com

How the TREX-2 complex associates with the nuclear pore

Agnieszka Obarska-Kosinska and colleagues built an extended model of the human nuclear pore, adding five nucleoporins and resolving how the nuclear basket and the TREX-2 complex attach to the nuclear ring. Combining cryo-electron tomography, AI-assisted modeling and crosslinking mass spectrometry, the work reveals the spatial organization of the pore relevant to mRNP export.

cell.com

Amyloid-mediated RNA uptake by sperm for embryonic delivery

Amyloid fibrils in seminal plasma can bind RNA, enter sperm, and deliver their RNA cargo to the zygote at fertilization. After entry into the zygote, molecular chaperones release the RNA cargo for translation, explaining how extracellular RNA in semen influences early embryonic development.

cell.com

The 9-1-1 complex protects ssDNA gaps in BRCA2-deficient cancer

Research shows that the 9-1-1 complex protects BRCA2-deficient cancer cells from lethal ssDNA gap accumulation by suppressing PRIMPOL-dependent gap formation and promoting POLζ-mediated filling. The mechanism also restrains EXO1 degradation and reveals an ATR-independent role in post-replicative repair; the study establishes gap length as a key determinant of repair pathway choice.

medrxiv.org

Spatial niche organization shapes clinical heterogeneity in Ewing sarcoma

Single-cell and spatial resolution analysis of 135 Ewing sarcoma patients showed that spatial niche composition stratifies patients into four types with distinct overall survival patterns. Analysis of more than 3 million cells identified five recurrent tumor cell transcriptional states, twelve stromal and immune cell types, and eight niches. The four-type classification was validated in bulk transcriptomic data from two independent cohorts.

biorxiv.org

Targeting IGF2BP1 Creates a Mitotic Vulnerability in Colorectal Carcinoma

A bioRxiv preprint shows that targeting IGF2BP1 disrupts mitosis in colorectal cancer, with BTYNB and paclitaxel showing synergistic effects in cell models. IGF2BP1 is highly expressed in CRC, rises with tumor stage, and correlates with poorer survival; its genetic depletion or pharmacological inhibition reduces cell viability and induces mitotic abnormalities and apoptosis.

biorxiv.org

Affinity Maturation Enables Dual Targeting of Cancer-Associated MUC1-Tn/STn and Drives Potent Tumor Control

The anti-MUC1-Tn antibody 5E5 was affinity-matured through structure-guided directed evolution and yeast surface display, yielding variants that recognize both MUC1-Tn and MUC1-STn with high affinity. Co-crystal structures show that HCDR3 residue 98 tunes glycoform preference: Tyr98 favors MUC1-Tn, while His98 strengthens MUC1-STn binding, and both support high-affinity recognition of the two glycoforms.

medrxiv.org

Longitudinal AI Models Predict Cancer Adverse Events

SPARC, a transformer-based model, uses routine longitudinal health data to predict cancer-related adverse event risk and achieved state-of-the-art performance on development, prospective, and external multi-center cohorts. It was pre-trained and fine-tuned on 101,920,379 measurements from 224,047 patients with cancer, with a prospective validation cohort of 23,126 patients, public external datasets of 26,012 patients, and external multi-hospital cohorts reporting 562,620 and 206,840 patients.

JAMA

Pregnancy Outcomes After Living Kidney Donation.

A Canadian matched cohort study of 385 pregnancies among 252 living kidney donors found that pregnancy after donation was associated with a higher risk of a composite endpoint of hospitalization for gestational hypertension, preeclampsia, or eclampsia. The composite endpoint occurred in 11.9% of donor pregnancies versus 8.3% in matched nondonor pregnancies (RR 1.51, 95% CI 1.10-2.08). Small for gestational age at birth occurred in 13.8% versus 7.9% (RR 1.86, 95% CI 1.37-2.52); most postdonation pregnancies were uncomplicated.

arxiv.org

Principia: Test-Time Hypotheses to Principle Construction for Scientific Discovery

Principia is an LLM-based framework that constructs comparative causal hypotheses at test time from related inputs and observed outcomes, then distills recurring relationships into scientific principles that are continually revised as new observations arrive. It outperforms baselines relying on internal knowledge, external sources, or experience summaries across benchmarks in molecular optimization, protein engineering, gene perturbation, and molecular property prediction, and its generated principles are plausible and consistent with the scientific literature. Code: https://github.com/DongkiKim95/Principia

biorxiv.org

Genetic control and tissue specificity of transcriptomic rhythmicity

The team analyzed 50 tissues from GTEx v10 and detected rhythmically expressed genes in 49 of them, identifying 167 cd-eQTLs involving 51 genes across 28 tissues. Most cd-eQTLs altered oscillation amplitude, while others affected acrophase or both; effects on core circadian genes were consistent across tissues, whereas effects on clock-regulated genes were largely tissue-specific.

05

Methods and resources

Nat Biotechnol

Recordanelles capture transient gene expression in single human cells.

Recordanelles, synthetic organelles, can record RNA persisting for several days within single human cells and be read out with single-cell sensitivity. The technology addresses the problem that RNA sequencing cannot capture transient transcriptional changes at a transcriptome-wide scale over long periods. It summarizes research by Reinkemeier et al. published in Nature Biotechnology (DOI: https://doi.org/10.1038/s41587-026-03327-6).

Sci Adv

Multiplexed and implantable fiber sensor for real-time blood monitoring.

A research team developed MIFS, a multiplexed implantable fiber sensor that monitors Na+ and K+ ions in the bloodstream in real time. MIFS integrates three parallel liquid metal channels with a multilayer surface-electrode architecture to enhance sensitivity, reduce sensing drift, maintain mechanical flexibility, and provide the biocompatibility required for vascular implantation. In vivo testing in rabbit models and validation in human blood samples showed real-time, stable sensing consistent with conventional ex vivo measurements. The paper's DOI is 10.1126/sciadv.aei9767.

mp.weixin.qq.com

HDOCK-Multimer Combines Docking and Combinatorial Assembly to Improve Large Protein Complex Structure Prediction

Shengyou Huang's team at Huazhong University of Science and Technology has proposed HDOCK-Multimer (HDM), which integrates molecular docking, combinatorial assembly and a genetic algorithm to improve structural prediction of large multichain protein complexes. Published in Nature Computational Science, the study shows HDM outperformed CombFold, MoLPC and AlphaFold-series methods overall across three benchmark sets: 35 large heteromeric complexes, 172 large protein complexes and 7 CASP15 targets.

youtube.com

Diversifying (Positive) Selection — Harmit Malik

In an iBiology Techniques expert lecture, Harmit Malik explains how sequence analysis identifies genes under diversifying (positive) selection. The core is comparing the nonsynonymous substitution rate with the synonymous substitution rate of protein-coding genes; an elevated nonsynonymous rate at host-virus conflict interfaces suggests potentially beneficial mutations favored by natural selection. Diversifying (positive) selection, also called adaptive evolution, differs from purifying selection: it increases amino acid diversity in protein-coding genes and raises the fixation rate of potentially beneficial variants in populations.

arxiv.org

Controlled Evaluation of EEG Foundation Models: Random Initialisation, Band-Power and Validation-Selected Probes

A controlled evaluation of five publicly released EEG foundation models, with probe layers selected on validation sets, shows random initialisation matches or exceeds pretraining for half of them on sleep and emotion tasks. The evaluation covers five benchmarks, four added task families and multiple seeds, and includes five public models plus an in-house JEPA-style model. No model beats a five-band log-power baseline on emotion or motor imagery.

06

Opinion and commentary

youtube.com

Global Consensus Renames Polycystic Ovary Syndrome as Polyendocrine Metabolic Ovarian Syndrome

In a Lancet program, experts described a renaming of polycystic ovary syndrome (PCOS) that won 98% consensus support. The new name is polyendocrine metabolic ovarian syndrome (PMOS), and the old and new names will run in parallel for 3 years. The condition affects about 170 million women of reproductive age worldwide and many postmenopausal women; the rename aims to highlight its endocrine, metabolic, reproductive, psychological, and skin manifestations. Ultrasound assessment of 2000 women showed PCOS patients do not have more benign or pathological ovarian cysts, but more antral follicles.

youtube.com

Research integrity in the age of AI

Editors at The Lancet describe their processes for safeguarding research integrity at submission, external review, acceptance, and after publication, and introduce a research integrity committee being established. The submission system automatically screens for duplicate submission, plagiarism, and unverified references; before review, editors check protocols, statistical analysis plans, ethics approval numbers, and data verification by at least 2 authors; line-by-line checks after external review and acceptance cover numbers, references, tables, and figures.

nature.com

Nanotherapy targets senescent cells

A study by Hinterleitner et al., published in Science in 2026, shows that senescent-cell-targeted nanotherapy can ameliorate fibrosis in cancer and overcome immune exclusion, DOI 10.1126/science.aeg4791. Cellular senescence can support tissue repair and suppress carcinogenesis, but persistence of senescent cells drives chronic inflammation, fibrosis and immune dysfunction. Drugs targeting senescent cells have shown promise in preclinical models, but toxicity has limited translation.

07

In brief

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