北京若生智能科技有限公司
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KD2-305 (KD2305 / KD 2305)

✓ Approved

Meiji Holdings · 重组蛋白 · 重组蛋白

什么是 KD2-305？

KD2-305 是一种重组蛋白，由Meiji Holdings研发。该药已获批，用于治疗相关适应症，给药途径：Unknown。

药物档案

商品名KD2305, KD 2305
公司Meiji Holdings
药物类别重组蛋白
给药途径Unknown
状态Approved
来源： ClinicalTrials.gov, Meiji Holdings

治疗适应症

KD2-305 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Congenital, familial and genetic disordersFactor IX deficiency✓ Approved
Congenital, familial and genetic disordersFactor VIII deficiency✓ Approved

相关研究文献

PubMedThe New England journal of medicine2026-10-26

Tarlatamab-Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer.

Pérol Maurice M, Yoshida Tatsuya T, Ahn Myung-Ju MJ, Gay Carl M CM et al.

Patients with extensive-stage small-cell lung cancer have poor outcomes, with a median overall survival of approximately 12 to 13 months. Tarlatamab (a bispecific T-cell engager targeting delta-like ligand 3 [DLL3] and CD3) was previously shown to improve survival as second-line therapy. Whether adding tarlatamab to durvalumab (an anti-programmed death ligand 1 agent) after initial chemoimmunotherapy could significantly improve survival in the context of maintenance therapy after first remission has been unclear. In this phase 3, international, open-label, randomized trial, we compared tarlatamab-durvalumab with durvalumab as first-line maintenance therapy in patients with extensive-stage small-cell lung cancer without progression after initial chemoimmunotherapy. Overall survival and progression-free survival were assessed from randomization at the start of maintenance therapy as the primary and key secondary end points, respectively. Results of the prespecified interim analysis (data-cutoff date, July 7, 2026) are reported here. A total of 563 patients were randomly assigned to receive tarlatamab-durvalumab (282 patients) or durvalumab (281 patients). At a median follow-up of 15.9 months in the tarlatamab-durvalumab group and 16.1 months in the durvalumab group, the estimated median overall survival was 21.1 months (95% confidence interval [CI], 20.8 to could not be estimated) with tarlatamab-durvalumab and 12.7 months (95% CI, 11.2 to 14.8) with durvalumab (hazard ratio for death, 0.42; 95% CI, 0.32 to 0.54; P<0.001). The median progression-free survival was 7.4 months (95% CI, 5.6 to 9.1) with tarlatamab-durvalumab and 1.9 months (95% CI, 1.9 to 2.0) with durvalumab (hazard ratio for disease progression or death, 0.34; 95% CI, 0.28 to 0.42; P<0.001). Adverse events of grade 3 or higher occurred in 46.8% of the patients who received tarlatamab-durvalumab and in 40.6% of those who received durvalumab alone. Cytokine release syndrome, mainly of grade 1 or 2, was seen in nearly half the patients receiving tarlatamab-durvalumab. Tarlatamab-durvalumab maintenance therapy resulted in significantly longer overall survival and progression-free survival than durvalumab alone among patients with extensive-stage small-cell lung cancer. (Funded by Amgen and AstraZeneca; DeLLphi-305 ClinicalTrials.gov number, NCT06211036.).

PMID 42929702
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PubMedJournal of exposure science & environmental epidemiology2026-10-26

Toxic cookware: lead exposure from aluminum pots in Bangladesh.

Kim Raphael R, Namayandeh Alireza A, McGoran Hannah H, Lopez Alandra A et al.

Lead (Pb) is a potent neurotoxin, and exposure through household items is a public health concern, particularly for children. In Bangladesh, artisanal aluminum cookware made from scrap metal is a suspected but under-quantified source of exposure. Here, we quantify Pb extraction from artisanal cookware and transfer to food to assess the risk to consumers. We utilized two experimental approaches: (1) Pb extraction tests using 4% acetic acid to simulate liquid foods and (2) cooking plain rice and a rice dish, khichuri, to assess cooking solid foods. Reaction with acetic acid revealed that Pb release is driven by acidity, usage history, and physical agitation, with abrasive scrubbing yielding the highest Pb concentrations. Scrubbing released around 5 times more Pb than use without scrubbing during the initial use, and nearly 3 times more Pb than use without scrubbing during the second use in new pots. Pb release was highest during the initial uses of new pots. Cooking rice also resulted in the release of Pb. In new pots, mean Pb contents in food reached 305 µg/kg for rice and 420 µg/kg for khichuri during the first use. Even after repeated use, initially new and used pots consistently yielded Pb contents that exceeded the FDA limit of 10 µg/kg in food intended for babies and young children. Our findings demonstrate that artisanal aluminum cookware can represent an important source of dietary Pb exposure that should be considered in public health efforts to reduce Pb exposure. Importantly, Pb release was substantially greater from new pots than from used pots, with the highest concentrations observed during initial use followed by a progressive decline over time, suggesting that the most readily leachable Pb resides in the pot surface and is depleted with continued use. Artisanal aluminum cookware is a significant and underrecognized source of dietary Pb exposure in Bangladesh. This study shows that Pb is readily released into food during typical cooking conditions at quantities consistently exceeding regulatory limits. Lead extraction is highest during the initial use of new pots and is further intensified by common practices such as abrasive cleaning, which accelerates surface degradation. These findings highlight a persistent Pb exposure pathway embedded in everyday food preparation and underscore the need for targeted interventions, improved manufacturing standards, and regulatory oversight to reduce Pb exposure at the household level.

PMID 42928281
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PubMedThe Journal of hand surgery, European volume2026-10-25

Optimal location for bone grafting from the olecranon.

Weber Andreas A, Grau Corinna C, Gaffney Christopher C, Unterfrauner Ines I et al.

Computed tomography of 305 healthy forearms showed that the highest cancellous bone density is 1 cm distal to the olecranon tip, decreasing distally. This site appears optimal for proximal ulna bone graft harvesting in hand and reconstructive orthopaedic surgery.

PMID 42927734
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PubMedQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2026-10-25

Prognostic associations between patient-reported outcomes and progression-free and overall survival in advanced gastric or gastroesophageal junction adenocarcinoma with PD-L1 TAP score ≥ 5%: results from the RATIONALE-305 trial.

Moehler Markus M, Correa Marcia Cruz MC, Oh Do Youn DY, Xu Rui-Hua RH et al.

In RATIONALE-305, tislelizumab plus chemotherapy improved overall survival (OS) versus placebo plus chemotherapy in advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with programmed death-ligand 1 (PD-L1) tumor area positivity (TAP) score ≥ 5% and in all patients. Here, we present a three-component joint model (JM) developed to evaluate associations between patient-reported outcomes (PROs) and risk of progression-free survival (PFS) and OS events. Longitudinal PRO data were analyzed using the EORTC QLQ-C30 and QLQ-STO22. The JM linked: (1) a linear mixed model (LMM) for change from baseline in PRO scores; (2) a Cox model for time to recurrent symptomatic deterioration (RS-D); and (3) a Cox model to evaluate the RS-D event frailty prediction of PFS and OS. 475 patients in the PD-L1 ≥ 5% subgroup (tislelizumab + chemotherapy, n = 238; placebo + chemotherapy, n = 237) were evaluated. In PFS and OS LMMs, tislelizumab + chemotherapy versus placebo + chemotherapy was associated with improved GHS/QoL (global health status/quality of life) (p = 0.01) and reduced dietary restrictions (p = 0.05). In the OS LMM, tislelizumab + chemotherapy was associated with reduced upper GI symptoms (p = 0.01) and reductions in dietary restrictions (p = 0.02). RS-D in GHS/QoL, pain, and dietary restrictions were leading predictors of PFS risk. Across all QLQ-C30 and QLQ-STO22 domains, tislelizumab plus chemotherapy significantly reduced the risk of progression or death (PFS HRs 0.55-0.65; 35-45% reduction) and death (OS HRs 0.65-0.73; 27-35% reduction); all p ≤ 0.01. PROs have significant prognostic value for disease progression and survival in patients with PD-L1 TAP score ≥ 5%. NCT03777657 ( http://clinicaltrials.gov ).

PMID 42927580
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PubMedBrain and behavior2026-10-25

Childhood Trauma Exposure Associated With a More Severe Course of Metabolic Disturbances in Bipolar Disorder: A 36-Month Longitudinal Prospective Cohort Study.

Galvez-Florez Juan F JF, Guillen-Burgos Hernán F HF, Moreno-López Sergio S, Ramírez-Posada Mariana M et al.

Childhood trauma (CT) is a recognized risk factor for adverse psychiatric and physical health outcomes in individuals with bipolar disorder (BD). However, few prospective studies have examined how CT relates to the longitudinal course of metabolic dysregulation in BD. This study aimed to describe the association between CT exposure and the progression of metabolic disturbances over 36 months in adults with BD. In this prospective cohort study, 305 adults diagnosed with BD (Types I and II) were followed across 13 visits over 36 months. Participants were stratified according to CT exposure using the Childhood Trauma Questionnaire-Short Form (CTQ-SF). Metabolic outcomes (HbA1c, BMI, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and hs-CRP) were analyzed with inverse probability of treatment weighting (IPTW) and linear mixed-effects models incorporating a group-by-time interaction. Of the 305 participants enrolled, 53 (17.4%) were lost to follow-up. Longitudinal analyses showed significant CT-by-time interactions for all metabolic markers (p < 0.001). At 36 months, participants exposed to CT showed greater increases than non-exposed participants in HbA1c (adjusted least-squares mean difference 1.11%, 95% CI 0.89-1.33), BMI (4.46 kg/m2, 95% CI 3.90-5.03), and hs-CRP (2.68 mg/L, 95% CI 2.52-2.84), together with unfavorable changes in the lipid profile. Effect sizes were large (Cohen's d > 0.8). These associations persisted after IPTW weighting for measured baseline covariates. In this observational cohort, CT exposure was associated with an accelerated trajectory of metabolic deterioration in individuals with BD after weighting for measured baseline characteristics. Because the design is observational and several behavioral, socioeconomic, and illness-course determinants of metabolic risk were not measured, these findings should be interpreted as associations rather than as causal effects. They nonetheless support the value of early trauma-informed assessment and of integrated care strategies addressing both psychiatric and physical health in BD. Future research should incorporate detailed lifestyle and treatment-exposure data, additional inflammatory biomarkers, and preventive interventions to mitigate long-term cardiometabolic risk in this vulnerable population.

PMID 42926321
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PubMedInternational forum of allergy & rhinology2026-10-25

Comparison of Chronic Rhinosinusitis Disease Control Classification Using the Chronic Rhinosinusitis Control Test Versus EPOS Criteria.

Parail Nikhil N, Bernhard Paul A PA, Houssein Firas A FA, Phillips Katie M KM et al.

The objective of this study was to compare classification of CRS control using EPOS criteria and the Chronic Rhinosinusitis Control Test (CRCT) in a real-world cohort of chronic rhinosinusitis (CRS) patients. CRS control was classified as controlled, partly controlled, or uncontrolled in 305 participants using EPOS and CRCT-based classifications. Metrics of CRS disease burden included Overall Symptom Severity (OSS), disease-specific (SNOT-22) and general health-related (EQ-5D VAS) quality of life, and endoscopic disease burden (modified Lund-Kennedy [MLK] score). Convergent and divergent validity were determined by comparing CRS disease burden across different levels of CRS control for each classification scheme. There was 35.7% agreement (κ = 0.366, p < 0.001) between CRS control classification using the CRCT compared to the EPOS criteria. Consistent with how patients and providers have been previously shown to classify CRS control, the CRCT classified more participants as having controlled and partly controlled CRS compared to the EPOS criteria, which heavily skewed toward classifying participants as having uncontrolled CRS. The CRCT control classifications demonstrated convergent and divergent validity by reflecting appropriate levels of disease burden with significant differences between control classes. The EPOS classifications of controlled and partly controlled CRS lacked divergent validity, and the EPOS classification of uncontrolled CRS lacked convergent validity by including patients with very mild CRS disease burden. Compared to the classification scheme proposed by the EPOS guidelines, the classification of CRS control by the CRCT more closely aligns with patients' and providers' assessments of CRS control and has greater convergent and divergent validity.

PMID 42922438
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