Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. This study will explore the application of ctDNA MRD in guiding adjuvant therapy in these patients.
This prospective, randomized, interventional trial will evaluate a ct-DNA MRD-guided adjuvant therapy strategy in PAAD patients who have undergone radical resection at our institution. Prior to adjuvant chemotherapy, patients will be randomized (1:1) to either the experimental arm (Arm A) or the control arm (Arm B). Arm A will receive ct-DNA MRD-guided therapy, while Arm B will receive non-ctDNA-driven standard of care post-operative adjuvant therapy.
In Arm A, patients will receive a physician-selected, guideline-recommended adjuvant therapy regimen in 12-week cycles. ctDNA MRD will be assessed before the end of first cycle and at weeks 8 and 11. If two consecutive post-treatment MRD tests are negative, therapy will be "de-escalated" (discontinued) with regular follow-up as determined by the clinician. Otherwise, another treatment cycle will be administered, with the same MRD assessment. Following the second cycle, patients without two negative MRD results (only tested at week 8 and week 11 within each cycle) will "escalate" to a longer duration of chemotherapy (comparing to the 6-month standard of care) at the clinician's discretion. Treatment will continue until disease progression, intolerance, or study termination.
Arm B will receive standard post-operative adjuvant therapy for a duration recommended by CSCO guidelines (typically 6 months), followed by regular follow-up every 8 weeks.
The primary endpoint is to compare the prognosis, tolerability, and treatment completion rates between the two arms.

开始日期2025-06-01

申办/合作机构

臻和（北京）生物科技有限公司

NCT06242418

/ Recruiting临床2期IIT

Value of CtDNA in Surveillance of Adjuvant Chemosensitivity and Regimen Adjustment in Stage III Colon Cancer: a Phase II Randomized Controlled Trial (REVISE Trial)

Colon cancer is one of the most common malignant tumors with an increasing incidence rate in China. Surgical resection is still the main treatment for colon cancer at present. Radical surgery followed by three/six months chemotherapy is the standard of care for stage III colon cancer; however, patients with different risk factors have different prognosis. The IDEA trial divided stage III colon cancer patients into low-risk (T1-3/N1) and high-risk (T4 or N2) groups, and showed that for some low-risk patients, three months chemotherapy did not decrease survival outcomes, while for some high-risk patients, the recurrence risk was still high even after six months chemotherapy. Therefore, it's worth to explore other risk stratification factors beyond T and N stage for these patients.
Circulating tumor DNA (ctDNA) is derived from cancer cells and can be detected in blood. Literatures have reported that ctDNA can be used for tumor diagnosis, therapeutic monitoring, and prognosis assessment in multiple cancers, including colon cancer. The GERCOR-PRODIGE trial, an accompanying study of IDEA, reported that in the high-risk group of stage III colon cancer, patients with ctDNA-positive and receiving six months chemotherapy had similar prognosis to these with ctDNA-negative and receiving three months chemotherapy; in the low-risk group, patients with ctDNA-negative and receiving three or six months chemotherapy had similar prognosis to patients with ctDNA-positive and receiving 6 months chemotherapy, but patients with ctDNA-positive and receiving three months chemotherapy had the worst prognosis. The results of this trial suggests that ctDNA can be potentially used as a further stratification factor to guide adjuvant chemotherapy for stage III colon cancer.
Several RCTs have shown that double-drug regimens chemotherapy based on oxaliplatin (FOLFOX and XELOX) can improve the prognosis of patients with stage III colon cancer. Therefore, the ESMO, NCCN, and CSCO guidelines recommend FOLFOX or XELOX for stage III colon cancer. The 2-year disease-free survival rate of these patients who received FOLFOX or XELOX chemotherapy was about 80%. It is worth to further explore how to improve the prognosis of these patients. Recently, the triple-drug regimens of oxaliplatin, irinotecan, and fluoropyrimidine (FOLFOXIRI) has been found to be superior to FOLFOX or XELOX for metastatic colorectal cancer in terms of response rate and survival. Currently, research on FOLFOXIRI plus targeted therapy in metastatic colorectal cancer is progressing rapidly, but there is little research on the use of FOLFOXIRI as adjuvant chemotherapy for stage III colon cancer. There is an ongoing international multicenter phase III RCT comparing FOLFOXIRI and FOLFOX6 adjuvant chemotherapy for high-risk stage III colon cancer patients, but it did not further stratify patients based on postoperative ctDNA status, which may result in some patients receiving excessive chemotherapy.
The present study plans to enroll patients with stage III colon cancer with positive ctDNA within 1 month after surgery. These patients will receive 2 cycles of XELOX chemotherapy followed by retesting ctDNA. During the waiting period of the ctDNA results (approximately 3 weeks due to the testing time), all patients will receive another cycle of XELOX chemotherapy. If the ctDNA remains positive, the patients will be randomly assigned to receive 8 cycles of FOLFOXIRI as intensified adjuvant chemotherapy or 5 cycles of XELOX regimen as standard adjuvant chemotherapy. If the ctDNA is negative, the patients will continue to receive 5 cycles of XELOX chemotherapy. Within 3 weeks after the completion or termination of chemotherapy, ctDNA will be retested again. The aims of this study are to explore the value of ctDNA in surveillance of chemosensitivity and to preliminarily evaluate whether the intensified chemotherapy with FOLFOXIRI can increase ctDNA clearance as well as its safety in stage III colon cancer.

开始日期2024-03-25

申办/合作机构

四川大学华西医院（四川省国际医院）

[+1]

NCT05479708

/ Enrolling by invitationN/AIIT

Postoperative ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma: A Prospective Observational Cohort Study

Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.

开始日期2023-08-09

申办/合作机构

臻和（北京）生物科技有限公司

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项与臻和（北京）生物科技有限公司相关的文献（医药）

2025-07-01·JNCI-Journal of the National Cancer Institute

Dynamic ctDNA informs whole-course postoperative precise management of NSCLC (LUNGCA study)

Article

作者: Liu, Chengwu ; Yuan, Yong ; Lin, Feng ; Wang, Wenping ; Xu, Yuyang ; Li, Qingyun ; Pu, Qiang ; Li, Chuan ; Liu, Zheng ; Wang, Yun ; Liu, Lunxu ; Zhang, Xiaolong ; Xia, Liang ; Lin, Yidan ; Mei, Jiandong ; Li, Kaidi ; Du, Bo ; Deng, Senyi ; Che, Guowei ; Ma, Lin ; Gan, Fanyi ; Feng, Gang ; Kang, Ran ; Yang, Ying ; Guo, Chenglin ; Chen, Longqi ; Xie, Dan ; Liao, Hu ; Wu, Zhu ; Kou, Yingli ; Deng, Yulan ; Shen, Shensi ; Hu, Yang ; Li, Lu ; Chen, Yaohui ; Chen, Weizhi ; Zhu, Yunke

Abstract:

Background:

Circulating tumor DNA (ctDNA) is valuable for detecting minimal residual disease (MRD). However, studies involving long-term blood sampling are required to comprehensively interpret the clinical use of ctDNA analyses.

Methods:

We conducted a prospective multicenter cohort study (LUNGCA) for dynamic ctDNA monitoring in lung cancer patients receiving curative-intent surgery. ctDNA analysis was conducted on preoperative plasma samples, at postoperative 3 days and 1 month, and then every 3-6 months for up to 3 years.

Results:

In total, 233 non-small cell lung cancer (NSCLC) patients and 2336 longitudinal plasma samples were included; the median follow-up was 51.4 months. Post-comprehensive treatment (after radical surgery + necessary adjuvant therapy) MRD status was better at predicting relapse than postoperative MRD status (positive predictive value: 100% vs 90.0%; negative predictive value: 90.3% vs 90.1%). Patients with positive pre-adjuvant ctDNA and targetable mutations in tumor tissues had improved recurrence-free survival (RFS) with corresponding adjuvant tyrosine kinase inhibitor (TKI) treatment (hazard ratio [HR] = 0.01, P = .005), but adjuvant chemotherapy failed to improve RFS (HR = 0.6, P = .491). Of patients receiving adjuvant therapies, patients with a negative- or positive-negative ctDNA change pattern had favorable and similar RFS (P = .419), whereas patients with a positive- or negative-positive pattern had worse RFS (P < .001). TKI therapy was more effective than chemotherapy in clearing ctDNA. Post-relapse ctDNA negativity was associated with favorable OS (HR = 0.4; P = .029).

Conclusions:

Comprehensive interpretation of dynamic ctDNA monitoring data can inform precise whole-course postsurgical management of NSCLC patients.

2025-06-01·Journal of Thoracic Oncology

AYVM to AYMM Transition on HER2 Exon 20 Insertion Induces Tyrosine Kinase Inhibitor Resistance in NSCLC

Article

作者: Zhang, Jiao ; Li, Fei ; Zhu, Xiaoyu ; Wu, Chunyan ; Mao, Shiqi ; Zhang, Wei ; Liu, Xinyu ; Li, Xingya ; Wang, Yan ; Li, Baobin ; Chen, Xiaoxia ; Jiang, Tao ; Li, Xuefei ; Wang, Qiming ; Gao, Guanghui ; Lin, Xiang ; Ren, Shengxiang ; Yang, Shuo ; Zhou, Caicun ; Wang, Lin ; Wu, Fengying

INTRODUCTION:

Pyrotinib, a novel pan-HER tyrosine kinase inhibitor, has demonstrated substantial anti-tumor activity in patients with NSCLC harboring HER2 mutations. Nevertheless, the inevitable resistance to pyrotinib necessitates an in-depth understanding of the underlying mechanisms.

METHODS:

Resistance-associated mutations were identified through genomic sequencing of paired baseline and post-resistance samples from 40 patients. Integrated computational and experimental approach were utilized to validate the resistance mechanisms and explore strategies for overcoming resistance in vitro and in vivo.

RESULTS:

Analysis of novel mutations upon the development of resistance did not identify any predominant secondary HER2 mutations. Nevertheless, 12 secondary HER2 mutations (38.7%) occurred either as single nucleotide variations (75%) or insertions-deletions (25%), on the basis of HER2 p.Y772_P775dup mutation. Only two mutations led to HER2 autophosphorylation and IL3-independent proliferation of Ba/F3 cells from the in vitro experiments, implying that the remaining 10 secondary mutations were passenger mutations. Further in vivo and in vitro validation showed that the HER2 p.E770_A771insAYMM mutation diminished the sensitivity of murine HER2 mutant lung adenocarcinoma cell line to pyrotinib, with ineffective inhibition of HER2 and its downstream pathways. Drug screening indicated that mobocertinib and dacomitinib could effectively restrain the growth of tumors bearing the HER2 p.E770_A771insAYMM mutation.

CONCLUSIONS:

Our findings unveil a new form of resistance-a secondary mutation superimposed on the original mutation-and offer insights into a potentially sequential strategy for overcoming resistance to pyrotinib.

2025-04-01·Translational Lung Cancer Research

Development and validation of machine learning models based on molecular features for estimating the probability of multiple primary lung carcinoma versus intrapulmonary metastasis in patients presenting multiple non-small cell lung cancers

Article

作者: Mei, Jiandong ; Qin, Diyuan ; Liu, Ning ; Wang, Weiya ; Luo, Xu ; Liu, Bin ; Jiang, Lili ; Zhang, Benxia ; Guo, Fuchun ; Tang, Jie ; Li, Dan ; Ma, Qizhi ; Xiao, Fei ; Tang, Xiaojun ; Li, Xue ; Chen, Weizhi ; Shu, Pei ; Chen, Yue ; Tang, Yuan ; Zhu, Daxing ; Wang, Yongsheng

Background:

Discrimination of multiple non-small cell lung cancers (NSCLCs) as multiple primary lung cancers (MPLCs) or intrapulmonary metastases (IPMs) is critical but remains challenging. The aim of this study is to develop and validate the machine learning (ML) models based on the molecular features for estimating the probability of MPLC or IPM for patients presenting multiple NSCLCs.

Methods:

A total of 72 multiple NSCLCs patients with 157 surgical resection tumor lesions from January 2012 to January 2018 at two institutions were included for developing and testing models. Specifically, 46 patients with 103 tumors which were defined as definitive MPLC or IPM according to International Association for the Study of Lung Cancer (IASLC) criteria were used to develop models. They were spilt into training and validation sets using stratified random sampling and five-fold cross-validation. The developed models were tested in other 26 patients whose tumors were undetermined by traditional methods. Whole-exome sequencing (WES) was performed on all included tumor samples. Four molecular features were calculated to characterize tumors relatedness and served as model inputs, including genetic divergence, shared mutation number, Pearson correlation coefficient and early mutation number. Decision trees (DT), random forests (RF), and gradient boosting decision trees (GBDT) were employed, with performance assessed by areas under the curve (AUCs), accuracy, precision, recall, and F1 score in validation set. Disease-free survival (DFS) were used to evaluate model performance in test cohort. Clinical and genetic characteristics were then compared between MPLC and IPM populations.

Results:

All of the four molecular features showed significant differences between MPLC and IPM patients in development cohort. That is, MPLC exhibited higher genetic divergence, lower shared mutation number, Pearson correlation and early mutation number than IPM (P<0.001). DT model, RF model and GBDT model were developed with these factors and achieved a mean AUC of 0.94 [standard deviation (SD) 0.09], 1.00 (SD 0.00) and 1.00 (SD 0.00) in validation set, respectively. DT model, RF model and GBDT model discriminated the undetermined multiple NSCLCs as MPLC (n=15) and IPM (n=11) consistently. MPLC identified by ML models had significantly prolonged DFS [hazard ratio =0.21; 95% confidence interval (CI): 0.04-1.0; P=0.04] than that of IPM. MPLC patients had a relative higher prevalence of family history of first-degree relatives with cancer, and more than half of these patients reported a family history of lung cancer. EGFR remains the most common mutated driver both in MPLC and IPM populations.

Conclusions:

ML models based on the molecular features effectively distcriminate primary tumors from metastases in multiple NSCLCs, which improve the accuracy of multiple NSCLCs diagnosis and assist in clinical decision-making, particularly in challenging cases.

项与臻和（北京）生物科技有限公司相关的新闻（医药）

2025-08-26

·Illumina因美纳

融合全球前沿，共建本土生态——因美纳亮相中华医学会病理年会

【CSP2025会后报告】融合全球前沿，共建本土生态因美纳亮相中华医学会病理年会盛夏骄阳，难挡全国病理人交流求知的热情。2025年8月21日~24日，中华医学会病理学分会第三十次学术会议暨第十四届病理年会在上海隆重召开。因美纳以“融合全球前沿，共建本土生态——助力肿瘤病理新发展”为主题，亮相本次盛会。因美纳携手本土病理学科专家与优秀合作伙伴，通过特装展台和系列学术活动，展示基因组和多组学标志物在实体肿瘤、血液肿瘤、中枢神经系统肿瘤等的分子病理领域创新成果，获得参会专家学者的热烈反响。国内“实验室自建检测模式(HDT)”的积极试点近日，第二批医疗机构自行研制使用体外诊断试剂“HDT”试点名单发布，实验室自建检测模式再次成为行业关注热点。来自第一批“HDT”项目成功备案单位——复旦大学附属中山医院的江峥增主管技师，分享了“人胆管癌5基因变异检测试剂盒（可逆末端终止法）”的备案过程和经验体会。同时，针对院内NGS检测对规范化的要求，江老师分享了中山医院使用全景变异NGS，进行组织和液体活检样本性能确认的实践经验。另外，针对院内NGS对高质量的要求，江老师从ESMO2024 NGS推荐出发，提出融合突变检测推荐使用RNA杂交捕获测序技术，以HRD为代表的复杂生物标志物检测需要与国际认可金标准进行充分的一致性分析。本次展会上本次展会上，因美纳面向参会嘉宾分享了在肿瘤临床领域的大Panel检测产品——全球首个获得FDA批准上市的全景变异分析伴随诊断试剂盒——因美纳TruSight™ Oncology Comprehensive（TSO COMP）。TSO COMP有泛癌种伴随诊断CDx和丰富的药企合作管线，以及FDA认可的优异性能表现。因美纳期望融合全球分子诊断经验，与本土分子病理专家深入合作，助力中国实验室自建检测。实体肿瘤NGS 分子病理实验室建设温州医科大学附属第一医院林日旭主任，结合迈景基因NGS一站式落地方案，详细阐述了从提取、建库、测序到生信分析的全流程要点，并以迈景基因NGS大Panel（600基因）为例，指出其凭借比肩国际一流的性能参数和目前国内唯一通过省临检中心审核认证，有望通过高质量性能确认与多样化的迈景基因模式，推动院内肿瘤分子检测标准化与个性化发展。迈景基因2年获3证，全面掌握泛实体瘤NGS大Panel LDT建设方法，可为医院NGS一站式落地提供可靠、合规的解决方案。燃石医学薄义博老师，主导过超30家三甲医院NGS检测平台建设，结合病理科对组织和液体活检并行检测的不断增加的需求，详细分享了组织与血液并行检测的实验室升级方案、标准化操作体系建设和质控要求。海普洛斯付翔老师，围绕院内搭建NGS流程的痛点，提出“无人值守自动化建库平台”的重要价值。付老师详细解读了海普洛斯自主研发的一站式进院解决方案，通过构建全流程自动化体系，实现检测效率的显著提升与稳定性的持续强化。臻和科技魏继雨老师，结合近期发布的《实体瘤常见驱动基因DNA和RNA高通量测序共检的中国专家共识（2025版）》，强调了DNA+RNA NGS共检的重要价值。魏老师以首款NMPA批准的DNA+RNA双癌种伴随诊断试剂盒——臻速安®为例，详细阐述了DNA+RNA共建方案的设计思路、检测策略和性能表现。血液肿瘤NGS 分子病理检测前沿旌准医疗董事长兼总经理叶锋教授，结合大量真实案例分析，介绍了NGS在淋巴瘤诊断和MRD检测的应用。在辅助诊断应用中，NGS在基因重排、克隆类型鉴定中与传统CE方案相比展现出明显优势。另外叶教授探讨了淋巴瘤MRD检测，分别基于cfDNA基因重排和基因突变的各自价值，并针对淋巴瘤NGS诊断在标准化、中国人群特点以及更好服务临床等方向进行展望。协和博精NGS解读主管邹俊彦老师，从髓系血液肿瘤AML出发，介绍了血液肿瘤的变异特征，针对复杂拷贝数变异和突变相结合的难点，分享了博益康定制化组学方案的实践案例；同时针对丰富融合突变的难点，结合协和博精NGS靶向测序项目案例分享解读要点。国产化NGS方案支持本土病理学科发展贝瑞基因携NextSeq™ CN500亮相因美纳展台。贝瑞基因郭亚琳老师在讲座中详细介绍了NextSeq™ CN500国产高通量基因测序平台在肿瘤基因检测的应用价值。自2015年获批以来，全国数百家医院和医疗机构已基于NextSeq™ CN500国产基因测序仪，在肿瘤、遗传病检测和病原微生物检测等领域，开展丰富检测项目。同时，郭老师预告了NovaSeq™ 6000Dx-CN-BG国产化基因测序仪，将在近期正式获批，为肿瘤分子病理检测带来更多可能！在积极与合作伙伴开发本地化测序产品与解决方案的同时，因美纳也始终以最高合规标准推动产品的临床注册备案以及市场应用。2025年6月，因美纳CN MiSeq™Dx五款测序反应通用试剂已获得药品监督管理局的一类体外诊断试剂备案（备案号：沪闵械备20250100）。目前，因美纳在华获批的基因测序仪MiSeq™Dx和NextSeq™ 550Dx均拥有配套一类备案的国产测序反应通用试剂，为多种应用场景提供完整、便携的本土化解决方案。多组学标志物推动肿瘤精准研究甲基化标志物在肿瘤精准诊断分类中具有重要价值，中山大学肿瘤防治中心胡婉明副主任医师在因美纳展台华银康专题讲座中，通过风趣的介绍和详实的案例解读，分享了甲基化芯片检测实现甲基化谱聚类分析，从而实现中枢神经系统肿瘤的精准分类。今年刚发布的《胶质瘤分子病理诊断中国专家共识》明确，DNA甲基化分型技术在形态学不典型、免疫表型模糊、分子标志物缺失的病理中具有不可替代的分型优势。另外DNA甲基化图谱在骨与软组织肉瘤、不明原发肿瘤中都具有重要探索转化价值。除了甲基化标志物，更丰富的多组学分析对肿瘤精准分型和转化研究带来更多可能性。因美纳徐佳佳博士，结合全球顶尖学术机构的最新研究报道，系统介绍了因美纳多组学方案通过无需微流控仪器的单细胞捕获技术、更大面积和更高灵敏度/分辨率的空间转录组技术，以及全面覆盖9,500靶标的广泛蛋白组技术，结合因美纳强大的DRAGEN生信分析平台，将有望实现不同组学维度的肿瘤全面洞察。从前沿技术到临床解决方案，因美纳坚定携手中国临床工作者与本土合作伙伴，致力通过更加丰富的交流与合作，共同探索全球创新的本土化应用，助力诊疗规范持续升级。秉持“在中国，为中国”的长期发展战略，因美纳持续深化本土布局，于今年新设北京客户体验中心，旨在构建起科研探索和技术交流的创新平台，更快更好地服务中国市场。未来，因美纳期待与中国专家、合作伙伴汇聚于此，启迪新思，共话科学前沿，以基因的力量以改善人类健康。 .

2025-03-25

·循因缉药

燃石：东升西落，可以缓缓归矣

环球视野，深度视角知识星球首发各位亲爱的股东，大家早上好中午好晚上好。 2025年3月25日，村里的独苗--燃石终于发布2024Q4和全年的财报了。自打泛生子私有化、臻和港股上市停滞、世和A股IPO遇阻，我就只能天天盯着燃石了。好，今天咱们别客气，好好把燃石看一遍。先说结论：2024燃石的转型基本成功了，可以开始期待盈利了。不过，我们得先从一个惊悚的标题开始。注意，文中数字均根据燃石公布的PPT中的为主要来源，non-GAAP会计规则，可能跟他们公告中的略有差异。 #01 “院内失速？” （默认用的non-GAAP会计准则） 2024Q4，燃石录得营收1.261亿，同比增长4.2%，但是环比下滑1.9%。先别急，我们继续看，找找“罪魁祸首”。生物医药合作业务4330万元，同比略微增长5.6%，环比大增73.9% 中心实验室业务3930万元，同比下滑23.4%，环比下滑1.8%。这符合燃石重院内，轻送检的既定方针。院内业务4350万元，同比增长51.5%，环比下滑31.8%。好，问题找到了，是院内业务的环比大幅度下滑造成了2024Q4业绩并不算优秀。我应该学习下，标题改成《震惊，燃石院内业务大幅下滑！转型恐失败！》..应该能火... 呃，跑偏了... 我们回溯下近两年燃石的经营状况，可以看出2022Q4院内业务是当年四个季度收入的倒数第二，2023Q4是当年的倒数第一... 所以，院内业务似乎有一个惯性，Q4就是要差一些。也许跟春节、备货周期等等有关。毕竟，燃石没有代理商，所以也没代理商帮着“压货”... 不过，倒是有一点安慰：院内业务依然高于中心实验室的营收。 #02 “东升西落” 我们看下全年的情况。 2024年，燃石总的营收5.158亿元，略微下降4%。其中，中心实验室业务营收1.757亿元人民币，萎缩25%。院内业务营收2.246亿元人民币，增长19%。也就是说，院内业务成功的完成了补位，维持了总营收的相对不变。从这张图上也可以看出来，燃石2024年总的营收相加与2023年几乎是没有什么波动的。这很有意思，可以从两个角度解读。第一，燃石不行了，业务增长乏力了；第二，燃石在刻意压制自己的规模，调整经营结构。我们更倾向于第二个角度。这种调整大概有3个逻辑，其实我们都或多或少讲过，这次再总结下。第一，增加院内业务，减少中心实验室业务；这无需赘言，已经是既定事实了。第二，减少开支，提高毛利率；这点，从净亏损的变化趋势上就能看到。通过降低资本支出、研发支出和销售管理费用支出，燃石越来越接近盈利转正。第三，控制新项目进度。这条是我硬加的，是推测。大家也许已经发现了，燃石的早筛项目似乎好久没有进展了。那套PPT已经用了很久没换了，似乎停止在了2022年。不过，这对目前的燃石来说，我们认为是好事。毕竟，大家还指望着村里唯一的希望能带领大家发家致富呢~ 所以，燃石一边提升核心业务占比，一边降低开支。东升西落，船小点好调头。毕竟商业还是要回归本质，赚钱的事可以缓缓归矣。 #03 “再现转正” 2023Q2的时候，燃石在扣除销售市场费用、管理费用、基于股票的薪酬和折旧摊销后...毛利转正了。但是，我们认为这是“魔法”，不算数。 2024Q4，我们发现燃石有一个指标又转正了。 “Net operating cash flows” 我们在分析2024Q3财报时提到过：在燃石披露的运营现金流变化也说明了这点，2024Q3的运营现金流为-3030万元，继续缩窄。按照这个趋势，2025年底不得转正啊。我还是小看了燃石啊..特么2024Q4就转正了... 那大家肯定要问，净经营现金流量是怎么算的，代表什么~ 净经营现金流量=经营活动现金流入−经营活动现金流出直观的说，就是公司能够“自我造血”了。这还真不能算魔法。如果，2025年我们能看到净盈利转正，那就真的美滋滋了。燃石，也不会是现在这个市值。中国的NGS行业，也不会是目前这个局面。 #04 最后最后差不多要总结了。哦对了，燃石在2024年生物医药合作上的营收是1.157亿元，相较于2023年的1.159亿元几乎没变化。要给负责这块业务的茅总上上强度？其实，经常关注我们的都知道，在2024年生物医药行业整体也是萎缩的。能保持不下滑就不错了... 我们最后总结下。第一，燃石2024全年营收5.16亿元，下滑4%，基本保持住了市场地位；第二，全年净亏损3.466亿元，相较于2023年的6.537亿元大幅度收窄；第三，院内业务全面超越中心实验室业务，基本转型成功；第四，经营净现金流转正，实现自我造血。我觉得，我们基本可以期待2025年燃石盈利转正. 由于没有公开资料，只能这样了，谁要是说打败燃石了欢迎评论区留言。 END 找小编，扫这里！至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。近期文章：涉及普方生物-艾伯维状告Genmab 学术的尽头是发币？ 23andMe申请破产保护！创始人兼CEO出局！ Human Longevity|为什么同样的事他们说就显得这么高级？这么大的事你不宣传？金斯瑞你糊涂啊！ CACLP之测序仪新品的悄悄上新相关资料：注1：https://ir.brbiotech.com/news-releases/news-release-details/burning-rock-reports-unaudited-fourth-quarter-and-full-year-2024注2：https://ir.brbiotech.com/static-files/12b15916-4489-431d-97bf-72f18af52291

财报IPO

2024-12-12

·ioncology

SABCS 2024丨贾卫娟教授团队发现70基因识别为低风险的中国早期HR+/HER2-年轻乳腺癌患者或可从卵巢功能抑制中获益

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标” 2024年12月10~13日，第47届圣安东尼奥乳腺癌研讨会（SABCS）在美国圣安东尼奥隆重举行。作为乳腺癌研究领域中规模最大、最具盛名的科学聚会之一，SABCS大会集结了近一年来乳腺癌领域的最新研究成果、临床实践经验、治疗进展和技术创新等内容。中山大学孙逸仙纪念医院贾卫娟教授团队的一项中国真实世界研究入选大会壁报交流（摘要号：P1-11-12）。该研究提示中国早期激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）年轻乳腺癌患者或可从卵巢功能抑制中获益。一研究背景多基因检测的引入显著改变了HR+/HER2-早期乳腺癌的辅助化疗指征，其中70基因（MammaPrint™/MP）已被证明有独立的预后评估能力，且无论淋巴结或激素受体状态如何，一旦被MP分类为低风险，即便是高临床风险患者也或可免于辅助化疗。然而，值得注意的是，目前大多数针对MP进行的临床研究主要涉及白人群体。众所周知，乳腺癌在不同种族和民族之间存在生物学和临床差异。在中国，乳腺癌的发病年龄比西方人群早十年，平均诊断年龄为48.7岁，发病高峰期在45~49岁，50岁以下患者中乳腺癌的患病率明显高于西方国家。因此，验证MP在不同人群中的性能以确保其普遍性和可靠性至关重要。本研究旨在探索MP在中国患者中的实际应用情况。二研究方法从2018年3月~2022年6月，本研究通过对637例患者进行基于MP的基因组分析，评估了MP检测确定的不同风险组中临床病理特征的分布情况。此外，本研究还将这一评估结果与关键的MINDACT试验的结果进行了对比，以发现任何显著差异。研究采用Kaplan-Meier方法对生存曲线进行了稳健分析，并使用Cox比例风险模型来估算风险比。三研究结果在参与本研究的637例患者中，261例（占41.0%）患者被检测为高风险，其中大部分患者（214例，82.0%）接受了化疗。相比之下，在376例（59.0%）被归类为低风险患者中，接受化疗的患者比例显著降低，仅为46例（12.2%）。两组之间的风险类别分布存在显著差异，具有统计学意义（P<0.001）。肿瘤分级为1级、Ki67指数<30%以及PR≥20%为特征的患者，被归类为低风险（表1）。表1. 患者和肿瘤的临床病理特征以及MammaPrint™的风险分级（n=637）与MINDACT研究人群相比，本研究队列中的患者明显更年轻（50岁以下的患者比例分别为56.2%和33.3%），肿瘤更大，且肿瘤分级更高（P< 0.001，表2）。值得注意的是，年轻患者、Ki67≥30%的患者和淋巴结阳性患者即使被归类为低风险，也更倾向于接受化疗。相反，高风险亚组中的老年患者接受化疗的可能性较小（图1）。表2. 与MINDACT试验在临床病理特征和MammaPrint™结果的比较图1. 通过单变量和多变量逻辑回归分析临床病理因素对化疗决策的影响中位随访33个月（8~66个月），期间共记录了17起事件。对于所有患者，基因高风险组和低风险组之间的无乳腺癌间期（BCFI）没有显著差异（96.5% vs. 97.3%，P=0.28，图2A）。然而，在50岁或以上的患者中，与高风险组相比，被归类为基因低风险组的患者表现出更高的BCFI（98.9% vs. 97.1%，P=0.047，图2C）。图2. 两组所有患者及根据年龄划分患者的BCFI 我们关注到，在50岁以下且被确定为低风险的患者中，卵巢功能抑制后，BCFI显著改善，这与未接受卵巢功能抑制的患者形成对比（P=0.035，图3A）。然而，对于高风险患者，两组之间并未发现显著差异（P=0.115，图3B）。图3. 50岁以下患者（无论是否接受卵巢功能抑制）的BCFI 四研究结论真实世界的数据清楚地表明，MP检测在降低中国HR+/HER2-早期乳腺癌低基因组风险患者对辅助化疗的需求方面具有益处。高风险组和低风险组的复发率相似，这可能是由于研究人群的良好预后、针对不同风险特征的乳腺癌个体化治疗的有效性以及随访期较短。高风险患者（年龄≥50岁）的预后较差，可能是因为大量老年患者没有接受化疗。总之，研究数据提示，50岁以下的低风险患者可能从卵巢功能抑制中获益。这一发现值得进一步研究。贾卫娟教授中山大学孙逸仙纪念医院乳腺外科主任医师，乳腺肿瘤中心副主任广东省胸部疾病乳腺防治委员会常委广州市抗癌协会乳腺癌专业委员会副主任委员广东省临床医学会临床身心医学和心理治疗专业委员会委员广东省医学会乳腺病学分会委员广东省抗癌协会肿瘤生育力保护专委会委员英国Cardiff大学访问学者关于70基因（MammaPrint） 70基因（MammaPrint）是经过FDA510(k)批准的早期浸润性乳腺癌复发风险的检测产品。用于评估患者远处转移风险，检测结果明确的分为高风险和低风险，为医生和患者提供更精准的治疗建议。臻和科技是国内获得Agendia独家授权进行70基因（MammaPrint）检测的公司。（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果

100 项与臻和（北京）生物科技有限公司相关的药物交易

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100 项与臻和（北京）生物科技有限公司相关的转化医学

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