更新于：2024-04-26
Icotinib Hydrochloride
盐酸埃克替尼
更新于：2024-04-26
概要
基本信息
药物类型 小分子化药 |
别名 Conmana、Icotinib、埃克替尼 + [5] |
作用机制 EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、EGFR21外显子L858R突变抑制剂 |
在研适应症 |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2011-06-07), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国) |
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结构
分子式C22H22ClN3O4 |
InChIKeyPNNGXMJMUUJHAV-UHFFFAOYSA-N |
CAS号1204313-51-8 |
关联
94
项与 盐酸埃克替尼 相关的临床试验A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
开始日期2022-09-01 |
申办/合作机构 |
Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study
Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.
开始日期2022-01-01 |
申办/合作机构 |
A Phase II, Single-Arm, Prospective Study of Neoadjuvant Icotinib With Chemotherapy for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable for Stage II to IIIB(N2) Non-small Cell Lung Cancer
This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer
开始日期2021-10-25 |
申办/合作机构- |
100 项与 盐酸埃克替尼 相关的临床结果
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100 项与 盐酸埃克替尼 相关的转化医学
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100 项与 盐酸埃克替尼 相关的专利（医药）
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368
项与 盐酸埃克替尼 相关的文献（医药）2024-01-26·Medicine
Complete pathologic response to neoadjuvant icotinib in stage IIIA EGFR-mutant lung adenosquamous carcinoma: A case report
Article
作者: Li, Xiaobin ; Huang, Jishui ; Cai, Zhongfu ; Dai, Wenliang ; Hong, Wencong ; Hong, Youzhi
Rationale::
Radical surgery offers the best chance of cure, it is critical to expand surgery opportunities for patients with early-stage lung cancer to prolong overall survival. However, evidence is still limited regarding the application of neoadjuvant therapy with EGFR-tyrosine kinase.
Patient::
The patient reported here was a 53-year-old woman with right lower lung adenosquamous carcinoma.
Diagnoses::
The lung cancer was staged as T3N1M0. Tumor genotype disclosed EGFR Exon19 c.2235-2249de p.E746-A750del.
Intervention::
After neoadjuvant treatment with icotinib, she underwent thoracotomy and achieved pathological complete response.
Outcomes::
She is currently receiving adjuvant icotinib therapy without recurrence or metastasis during 18-month follow-up.
Lessons::
Our case indicated that the feasibility of neoadjuvant icotinib in EGFR-mutant lung adenosquamous carcinoma.
2024-01-12·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases
[Clinical analysis of lung adenocarcinoma with epidermal growth factor receptor mutation transformed into sarcoma].
Review
作者: Shen, D ; Du, M Z ; Zhu, Q Q ; Huang, J A ; Wu, W T ; Guo, L C
Objective: To analyze the clinical data of a case of lung adenocarcinoma with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) resistance transforming into sarcoma, and to conduct a literature review to improve the understanding of the resistance mechanism. Histological transformation is a unique form of acquired resistance of EGFR-TKIs in non-small cell lung cancer (NSCLC). Thereinto, the transformation of small cell carcinoma is more common, and the transformation of sarcoma is rarely reported. Methods: Clinicopathological data on the treatment process, pathological features, and clinical outcome of the patient with EGFR-TKIs-resistance lung adenocarcinoma transforming into sarcoma were collected. The literature was reviewed to analyze the pathogenetic mechanism for sarcomatoid carcinoma or sarcoma transformation after drug resistance of adenocarcinoma, as well as the clinical characteristics of the patients and the corresponding therapeutic schemes. Results: We reported a patient with lung adenocarcinoma who developed EGFR-T790M mutation after first-line treatment with icotinib and sarcoma transformation after second-line treatment with almonertinib. Chemotherapy, radioactive particle implantation, antiangiogenic therapy and immunotherapy were followed, but the results were unsatisfactory. There was no report of EGFR-TKIs-resistant lung adenocarcinoma transforming into sarcoma. Among the 14 reports of adenocarcinoma transforming into sarcomatoid carcinoma, 8 cases had EGFR mutation, 3 cases had ALK mutation, 2 cases had ROS1 mutation, and 1 case had no asscoiated sensitive mutation. The median survival of 14 patients with adenocarcinoma transforming to sarcomatoid carcinoma was only 3 months. Conclusions: Sarcoma transformation can be one of the forms of drug resistance in patients with lung adenocarcinoma with EGFR-TKIs. The prognosis of patients with adenocarcinoma after transformation into sarcoma is poor.
2023-11-30·Journal of pharmaceutical and biomedical analysis
A fully validated method for simultaneous determination of icotinib, osimertinib, gefitinib and O-desmethyl gefitinib in human plasma using UPLC-MS/MS for therapeutic drug monitoring.
Article
作者: Li, Shu ; Chen, Wenqian ; Li, Pengmei ; Lu, Hongkai ; Liu, Xiaoyang ; Yang, Meng ; Liu, Fang ; Liu, Lihong ; Li, Bo ; Qin, Wei ; Wang, Xiaoxue ; Zuo, Xianbo ; Zhang, Xianglin ; Wang, Guan
BACKGROUND AND AIMS:
A few researches have reported the exposure-efficacy/toxicity relationships of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs). On account of the large interpatient pharmacokinetic variability, therapeutic drug monitoring (TDM) seems promising for optimizing dosage regimen and improving treatment efficacy and safety. Therefore, a rapid and convenient ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the determination of icotinib, osimertinib, gefitinib and O-demesthyl gefitinib in human plasma for TDM.
MATERIALS AND METHODS:
Icotinib-D4 and osimertinib-13CD3 were used as the internal standards (ISs). The samples were prepared by protein precipitation using acetonitrile. Chromatographic separation was achieved on a 40 ℃ Shimadzu Shim-pack Scepter C18-120 column (2.1 ×50 mm, 3.0 µm, Japan) by a Shimadzu 30 A solvent management system. Detection was carried out using a Shimadzu LC-MS 8050CL triple quadrupole mass spectrometer coupled with an electrospray ionization source in positive mode.
RESULTS:
This analytical method was fully validated with selectivity, carry-over, linearity, lower limit of quantification, accuracy (from 92.68% to 106.62%) and precision (intra- and inter-day coefficients of variation ranged from 0.92% to 9.85%), matrix effect, extraction recovery, stability and dilution integrity. The calibration curves were developed to be within the concentration ranges of 200-4000 ng/mL for icotinib, 50-1000 ng/mL for osimertinib, gefitinib and O-desmethyl gefitinib in human plasma which meet the needs of routine TDM.
CONCLUSIONS:
The proposed method was used in 100 patients with non-small cell lung cancer for monitoring plasma concentration of the mentioned EGFR-TKIs. The trough concentrations of ICO were distributed between 226.42 ng/mL and 3853.36 ng/mL, peak concentrations were between 609.20 ng/mL and 2191.54 ng/mL. The trough concentrations of OSI were distributed between 110.48 ng/mL and 1183.13 ng/mL. The trough concentrations of GEF were distributed between 117.71 ng/mL and 582.74 ng/mL, while DeGEF was distributed from 76.21 ng/mL to 1939.83 ng/mL with two less than 20 ng/mL. The results of therapeutic drug monitoring aimed to investigate exposure-efficacy/toxicity relationship and improve the efficacy and safety of targeted therapies.
221
项与 盐酸埃克替尼 相关的新闻（医药）2024-04-25
2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜 教授，上海交通大学附属胸科医院 口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰 教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力 教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚 教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧 教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华 教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎 教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛 教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅 教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚 教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云 教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波 教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国 教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐 教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需 教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕 教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏 教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松 教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑 教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军 教授，北京大学肿瘤医院 快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮 教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫 教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春 教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田 教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦 教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮 教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红 教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰 教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文 教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余 教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云 教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇 教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健 教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑 教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松 教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉 教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心 临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英 教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联 教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼 医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉 教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明 教授，中山大学肿瘤防治中心 BiG 十周年预告 本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会 会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？
ASCO会议临床结果
2024-04-23
·研发客
// 这些Biotech盈利主要归因为三大类：产品销售+授权合作、产品销售为主、授权合作为主。2023年，康方生物、复宏汉霖、和铂医药纷纷宣布实现自创立以来的首次年度盈利。此前，贝达药业、微芯生物、艾力斯、上海谊众等均已凭借核心产品上市扭亏为盈，并在2023年保持盈利，和黄医药则在连亏6年后首度盈利。当然，也有由盈转亏的案例。2021年，荣昌生物和百奥泰凭借产品授权合作分别盈利约2.76亿元和8194万元，康希诺则靠新冠疫苗实现约19.14亿元的净利润。2022年之后，三家公司又重回亏损状态。除去早年曾凭借处方药和消费保健品实现盈利的和黄医药，这些Biotech在首次实现盈利时平均成立时间大约12年，大多数已有商业化产品，且首创新药的增长潜力日渐凸显。与此同时，授权合作带来的大额收入也成为公司盈利的一大助力。拓展阅读 投资biotech真的赚钱吗？如何实现盈利？在本次统计样本中，康方生物、和黄医药凭借产品销售+授权合作实现盈利；复宏汉霖、艾力斯、上海谊众、贝达药业、微芯生物等以产品销售为主要盈利点；和铂医药则纯靠授权合作扭亏为盈。其中，2023年盈利最多的Biotech当属康方生物。年报显示，该公司2023年总收入达45.26亿元，净利润19.42亿元。根据康方生物年报，其转亏为盈主要原因之一是PD-1/VEGF双抗依沃西部分海外权益许可给Summit公司，该合作共计约29亿元的首付款已在2023年一季度到账。另一大原因要归功于PD-1/CTLA-4双抗卡度尼利销售收入稳步提升，该产品上市不足半年便取得5.46亿元销售收入，2023年更是增长149%至13.58亿元。拓展阅读 康方速度和黄医药与康方生物类似。年报显示，该公司2023年总收入为8.38亿美元（折合人民币约60.61亿元），净收益为1.008亿美元（约7.29亿元）。其中超2亿美元来自4款抗肿瘤新药，VEGFR抑制剂呋喹替尼年收入突破1亿美元。和黄医药在年报中表示，其2023年表现出色很大程度上得益于与武田达成呋喹替尼合作的收入。该药已于去年11月在美国获批，为和黄带来3.12亿美元的首付款加里程碑付款。复宏汉霖则与前两家公司不同，其盈利主要源于核心产品持续销量扩大。该公司5款商业化产品的2023年销售收入合计约45.54亿元，同比增长70.2%，占总收入的比重高达84.4%。其中，4款生物类似药占所有产品收入的比例高达74.4%，尤其是抗肿瘤核心产品汉曲优（曲妥珠单抗），2023年全球收入合计已达27.37亿元。PD-1创新药斯鲁利单抗也表现不俗，2023年收入约11.20亿元，同比增长230.2%。拓展阅读复宏汉霖2023年净利润5.46亿元，首次实现全年盈利|新闻稿此外，主要凭借商业化产品实现盈利的，还有艾力斯（甲磺酸伏美替尼片）、上海谊众（注射用紫杉醇聚合物胶束）、贝达药业（盐酸埃克替尼片、盐酸恩沙替尼胶囊等）、微芯生物（西达本胺、西格列他钠）等。这些公司已连续两年以上盈利，尤其艾力斯仅靠一款产品年收入就有近20亿元。纯靠授权合作实现扭亏为盈的代表为和铂医药。该公司自2022年11月开始通过和铂医疗和诺纳生物两大支柱持续推动业务增长，2023年收入增长主要得益于与辉瑞、Cullinan Oncology和科伦博泰的授权合作，涉及靶向人间皮素的ADC、B7H4/4-1BB双抗等产品授权，以及诺纳生物全H2L2转基因Harbour Mice平台的使用。拓展阅读和铂医药：专注细分患者需求，提升行业创新实力持续盈利的关键是？2023年，泽布替尼以13亿美元的全球销售额，成为中国首款“十亿美元分子”。即便如此，百济神州去年仍亏损超67亿元。创新药一枝独秀并不少见，但对一家想要持续盈利的Biotech而言，终究是独木难支。埃克替尼之后，贝达药业一直在寻找新的增长点。但从年报来看，其后续推出的恩沙替尼和贝伐珠单抗并未对业绩做出重要贡献。过去三年，该公司营业收入增速逐年放缓，2022年净利润甚至下降62.04%。对此，资本市场已做出判断，4月23日贝达药业收盘价仅有38.65元/股，较最高峰值跌超75%。拓展阅读埃克替尼之后，贝达还有什么微芯生物凭借核心产品西达本胺，自2016年便扭亏为盈，但直到2021年10月糖尿病新药西格列他钠获批，才打破了该公司单一商业化产品的局面。不过从年报来看，微芯生物这两年营收并未大幅上涨，盈利也没有突破1亿元，股价较巅峰时期跌超83%。要想迈入持续商业化盈利，研发不能停还得会卖药。康方生物推出卡度尼利和派安普利后，仍在全面推进管线开发。其中，肿瘤领域PD-1/VEGF双抗依沃西已递交NDA并获得优先审评，非肿瘤领域还有抗PCSK9单抗伊努西单抗及IL-12/IL-23单抗依若奇单抗均已递交上市申请。和黄医药除了4款已商业化产品，另有10多款肿瘤候选药物正在临床试验阶段，且多款已进入注册申报阶段，比如新型Syk抑制剂索乐匹尼布、FGFR 1/2/3抑制剂HMPL-453、PI3Kδ抑制剂安迪利塞等。拓展阅读和黄医药：最大突破来自海外上市复宏汉霖则继续贯彻“生物类似药和创新药双轮驱动”的战略，在研管线中有抗体、ADC、小分子等16款产品进入临床。该公司计划于2024年递交帕妥珠单抗HLX11、地舒单抗HLX14、抗VEGF单抗HLX04-O等多个产品的上市申请。相比之下，艾力斯、上海谊众可谓走在独木桥上，上市产品单一，在研管线大多处在临床前阶段。谁能成为爆款？从各公司商业化产品来看，市场表现较好的主要是创新程度较高的1类新药。比如贝达药业核心产品埃克替尼。作为中国首款针对EGFR突变的肺癌靶向药，该药自2011年上市后一直是该公司收入及利润的主要来源，截至2023年底累计销售已超过150亿元。不过自从进入国家医保后，埃克替尼不仅降价50%以上，其销量在2023年上半年也开始出现下滑趋势。埃克替尼能辉煌多久尚未可知，但来自新一代肺癌靶向药的冲击已到眼前，艾力斯第三代EGFR-TKI伏美替尼就是其中之一。据艾力斯介绍，伏美替尼具有“脑转强效、疗效优异、安全性佳、治疗窗宽”等特点，已在中国获批用于EGFR敏感突变和T790M突变的非小细胞肺癌患者。它在2021年上市首年便创造2.36亿元的营收，次年进入医保后收入更是翻了三倍以上，到2023年已增长至19.72亿元。同样销售势如破竹的还有康方生物的PD-1/CTLA-4双抗卡度尼利。该药于2022年6月在中国获批单药用于宫颈癌2线/3线治疗，是全球首个获批上市的肿瘤双免疫检查点抑制剂，上市不足半年便收入5.46亿元，2023年更是增长149%至13.58亿元。相较之下，康方生物的PD-1抑制剂派安普利表现不甚理想。该产品2023年销售收入在2.73亿元左右，同比下降56%。国内同靶点产品竞争激烈，来自百济神州、信达生物和复宏汉霖的PD-1抑制剂2023年销售额均在10亿元以上。其中，复宏汉霖的斯鲁利单抗作为第7款国产PD-1抑制剂，尽管2022年3月才“姗姗来迟”，但通过切入MSI-H实体瘤这一相对空白市场和后续差异化的肿瘤布局，2023年销售额已反超君实生物、康方生物和誉衡生物的同类产品。2023年12月，斯鲁利单抗还在印度尼西亚获批，成为首个在东南亚国家获批上市的国产抗PD-1单抗。拓展阅读中国PD-1在新兴市场有机会吗?不过，以生物类似药起家的复宏汉霖，目前最畅销的还是汉曲优。作为中国首个中欧双批单抗药物，汉曲优一经上市就迅速打开海内外市场并逐年放量。2023年该药年收入已超过27亿元，贡献了复宏汉霖营收的半壁江山，同时也成为本次统计样本中销售最多的药品。编辑 | 戴佳凌dai.jialing@PharmaDJ.com 总第2094期访问研发客网站可浏览更多文章www.PharmaDJ.com
财报疫苗生物类似药引进/卖出
2024-04-23
近日，贝达药业发布最新年报，2023年全年，其总营收24.56亿元，同比增长3.35%；净利润3.48亿元，增长139.33%；归母扣非净利润为2.63亿元，大幅增长768.85%。经历了去年可怕的净利润下滑之后，贝达药业通过调整策略，也得益于多款已上市产品的给力销售，终于走出至暗时刻，重新步入增长正轨。01何以为继曾经的贝达药业，仅靠一款埃克替尼就可以包打天下。但这样“躺赚”的日子在进入创新药时代后已一去不复返，迎接贝达药业的是一段青黄不接的尴尬期。好在这样的尴尬并没有持续太久，截至目前，贝达药业已有另外4款产品获批上市接力埃克替尼。恩沙替尼是第一个用于治疗ALK阳性晚期非小细胞肺癌（NSCLC）的国产1类新药，于2020年11月获批。目前获批的适应症包括适用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的ALK阳性的局部晚期或转移性NSCLC患者的治疗、适用于ALK阳性的局部晚期或转移性NSCLC患者的治疗；用于ALK阳性的NSCLC术后辅助治疗适应症）已完成II-IIIB期受试者入组。不过恩沙替尼无法复制埃克替尼的辉煌。一是因为中国非小细胞肺癌ALK突变患者总量不多，二是因为竞争者日众。目前，在我国上市的ALK抑制剂已达到7款，此外中国正在进行临床试验的ALK抑制剂还有10余款，恩沙替尼的处境不容乐观。国内ALK抑制剂竞争格局来源：长城国瑞证券研报事实上，竞争者日众这个问题，贝达药业另一款重磅产品贝福替尼也同样面临。甲磺酸贝福替尼（赛美纳）是贝达药业拥有的全新的、自主知识产权的国家1.1类创新药，是一种新型的国产第三代强效、高选择性的小分子口服EGFR-TKI，能够同时结合EGFR敏感突变和T790M突变。于2018年12月从益方生物License-in，贝达药业拥有大中华区的独家权利。2023年5月，贝福替尼顺利获批，适应症为用于既往经EGFR-TKI治疗出现疾病进展，并且伴随EGFR T790M突变阳性的局部晚期或转移性NSCLC患者的治疗；2023年10月用于具有表皮生长因子受体外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性NSCLC成人患者的一线治疗适应症也得到获批。目前，用于EGFR敏感突变阳性的IB-IIIB（T3N2M0）期伴有EGFR基因敏感突变NSCLC术后辅助治疗和MCLA-129、甲磺酸贝福替尼胶囊联合用药的临床试验正在进行。在此前一线和二线治疗临床研究中，贝福替尼均创下相同治疗情景下PFS（无进展生存期）的新纪录，已被写入《IV期原发性肺癌中国治疗指南（2023版）》等权威指南中。尽管贝福替尼十分优秀，但奈何市场格局已然十分拥挤。目前国内外已上市的非小细胞肺癌EGFR-TKI已超过10种，其中一代3个，二代2个，三代5个，四代1个。虽然贝达药业的埃克替尼仍然占有我国EGFR-TKI市场较大的比重，但当前的格局中，第三代EGFR-TKI占主导地位，其中奥希替尼的强势地位很难撼动。同样作为第三代EGFR-TKI，贝福替尼的国产竞争对手还包括翰森制药的阿美替尼和艾力斯的伏美替尼。阿美替尼背靠翰森制药强大的销售网络，虽然未公布2023年销售额，但从往年成绩来看，销售额在20亿元以上；伏美替尼2023年的成绩更是直接“爆炸”，达到了19.72亿元，增长1.48倍。面对如此强劲的对手，贝福替尼“压力山大”。不过贝福替尼的优势在于，借助埃克替尼的销售渠道加成，或许将后来居上也未可知。国内EGFR-TKI竞争格局来源：长城国瑞证券研报当然，恩沙替尼和贝福替尼面临的竞争，虽然较当年埃克替尼大得多，但不可否认的是这两款产品都十分优秀，只是时代的因素增加了些许不确定性而已。尽管存在这样的不确定性，但短期内，这两款产品将共同支撑起埃克替尼被替代掉的营收，成为贝达药业的支柱。那么，长远来看，后续管线中，贝达药业还有潜在“重磅”的品种吗？02后续弹药库除了恩沙替尼和贝福替尼外，伏罗尼布的前景也颇为可观。伏罗尼布（伏美纳）是具有全新化学结构的新一代多靶点VEGFR/PDGFR抑制剂，可抑制肿瘤血管生成及生长，用于多种癌症的治疗。针对VEGFR、PDGFR、c-Kit、Flt-3、CSF1R等多靶点，伏罗尼布具有抗血管生成的显著疗效，并且能够满足靶点的特殊PK/PD要求，达到保留活性，降低毒性的目的。此前，伏美纳联合依维莫司治疗肾癌患者疗效和安全性的II/III期研究CONCEPT在《欧洲癌症杂志》发表。研究数据显示，IRC评估的伏美纳联合依维莫司组中位PFS为10.0个月，显著优于依维莫司单药组的6.4个月；联合组、依维莫司单药组的中位OS分别为30.4个月、25.4个月；伏美纳联合依维莫司的ORR达到24.8%，显著高于依维莫司单药组的8.3%，DCR达到84.2%，也显著高于单药组。最终于2023年6月，伏罗尼布获批上市，适应症为与依维莫司联合用于既往接受过酪氨酸激酶抑制剂治疗失败的晚期肾细胞癌（RCC）患者。除肾癌领域，伏罗尼布在眼科疾病领域也表现出较强的潜力。湿性年龄相关性黄斑变性是一种与老年相关的严重眼科疾病，该疾病主要影响60岁以上的老年人，因此相关药物受到人口老龄化背景的需求驱动。2023年7月，贝达药业与EyePoint共同申报的EYP-1901玻璃体内植入剂病理性近视脉络膜新生血管（pmCNV）适应症药物临床试验申请已获批准开展。EYP-1901玻璃体内植入剂通过EyePoint专有的可生物降解的缓释技术Durasert E将伏罗尼布注射进入玻璃体内，使伏罗尼布以可控且可耐受的方式持续地在眼部释放。2023年12月，EYP-1901治疗wAMD的II期临床试验DAVIO 2达到所有主要终点和次要终点：主要终点BCVA的变化对比阿柏西普对照组，EYP-1901剂量组（2mg和3mg）分别相差-0.3和-0.4个字母，达到了统计学上的非劣效结论；治疗负担（注射频率）分别减少了89%和85%；65%和64%的受试者可以六个月内无需进行抗VEGF补救治疗。作为中国首个用于治疗肾细胞癌的国产1类靶向新药，以及有望拓展至眼科领域相关适应症，伏罗尼布很有想象力空间。伏罗尼布的相关重点事件来源：长城国瑞证券研报除了上述三款已上市产品，在贝达药业近几年用力“砸钱”之下，诸多管线的进展十分迅速。2021-2023年，贝达药业研发投入占营业收入的比例高达38.32%、41.12%及40.80%；2023年全年研发投入达10亿元，增长2.53%。根据官网数据，贝达药业共有16个处于临床各阶段的项目。其中，BPI-16350已处于临床III期。BPI-16350是贝达药业自主研发的全新的、拥有完全自主知识产权的CDK4/6抑制剂，拟单药或与激素疗法联合，主要用于治疗HR阳性/HER2阴性的晚期或转移乳腺癌患者，还可能用于Rb+的其他癌症的一、二线或联合治疗。BPI-361175是第四代EGFR-TKI，拟治疗携带EGFR C797S突变及其他EGFR相关突变的晚期非小细胞肺癌等实体瘤，已分别于2021年2月和11月获国家药监局和美国FDA批准开展临床试验，正处于临床I期。此外，SHP2口服小分子抑制剂BPI-442096、TEAD棕榈酰化抑制剂BPI-460372、BiDAC降解剂CFT8919都很有看点。03结语就在一周以前，贝达药业开了一场销售团队誓师会，贝达药业董事长助理、丁列明之子丁师哲作了题为《贝达药业未来展望》的主题报告。这份展望很大程度上能反应贝达药业未来的战略规划，报告中提到，未来贝达药业要动态平衡开源节流，引进可持续发展项目，维持并提升目前营收及市场份额，以大博大探索新领域，塑造有力生态环境。结合近段时间以来的一些大动作，我们似乎看到了贝达药业的某种决心。但这份决心是什么，目前还不得而知。后续发展如何，药渡还将持续关注。参考资料贝达药业官网、公告、年报等长城国瑞证券研报《贝达药业：2023全年和2024Q1净利润大幅增长！新药上市获批、海外NDA受理、自研和引进产品达成多项里程碑》，凯莱英药闻，2024-04-22《创新药第一股大裁员：研发部门是“重灾区”》，经济观察报，2024-04-20
财报引进/卖出临床3期
100 项与 盐酸埃克替尼 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 非小细胞肺癌 | 批准上市 | 中国 更多 | |
| 非小细胞肺癌 III期 | 无进展 | 中国 更多 | |
| 晚期鼻咽癌 | 无进展 | - | |
| 肺癌脑转移 | 无进展 | 中国 更多 | |
| 胃食管交界处腺癌 | 无进展 | 中国 更多 |
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临床结果
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适应症
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
WCLC2023 人工标引  | 临床1/2期 | 24 | 醖蓋齋鹽簾積廠壓鹹積(積積顧鑰願襯淵膚獵繭) = aumolertinib 110 mg po qd plus icotinib 125mg po tid 鹽窪顧鏇願製蓋壓網積 (窪憲鏇糧遞顧繭淵鑰廠 ) 更多 | 积极 | 2023-09-11 | ||
临床2期 | 109 | 簾積繭積遞鏇壓遞艱鑰(簾選構夢築遞衊憲齋簾) = 醖壓鑰築淵憲範糧鹹獵 醖窪範膚衊蓋壓獵夢鹽 (願構餘簾鑰鏇鬱蓋鑰獵, 26.6 ~ 44.8) | 积极 | 2023-06-20 | |||
簾積繭積遞鏇壓遞艱鑰(簾選構夢築遞衊憲齋簾) = 觸艱鬱積艱觸衊齋選淵 醖窪範膚衊蓋壓獵夢鹽 (願構餘簾鑰鏇鬱蓋鑰獵, 33.1 ~ 70.1) | |||||||
临床2期 | EGFR突变的非小细胞肺癌 EGFR L858R mutation | 30 | 網選構餘鑰鑰簾艱艱艱(鏇願醖獵壓遞鑰醖構襯) = 築夢築蓋獵繭鏇憲簾廠 醖夢製鏇鹽製鹽網遞艱 (鑰範選窪鑰願窪簾顧廠 ) 更多 | 积极 | 2023-05-31 | ||
临床2期 | 128 | 淵繭醖膚築選憲淵顧壓(鹽壓餘餘衊積醖壓壓鏇) = 艱齋構鹹觸選繭襯繭艱 築願膚鏇網鏇壓鬱鬱醖 (襯鹹構積襯遞齋衊觸製, 91.3 ~ 99.9) | 积极 | 2023-03-01 | |||
(Observation) | 淵繭醖膚築選憲淵顧壓(鹽壓餘餘衊積醖壓壓鏇) = 遞獵膚網鬱願膚糧鹽鹽 築願膚鏇網鏇壓鬱鬱醖 (襯鹹構積襯遞齋衊觸製, 75.1 ~ 92.9) | ||||||
N/A | 晚期肺腺癌 一线 | 105 | 襯範廠鏇繭製夢憲膚淵(憲壓製繭鑰簾鬱鬱餘夢) = 願膚鹹願鹽糧憲觸簾醖 簾夢窪網衊鏇範構獵窪 (夢廠憲廠淵齋鬱齋鹹選 ) | - | 2022-12-03 | ||
襯範廠鏇繭製夢憲膚淵(憲壓製繭鑰簾鬱鬱餘夢) = 餘襯襯製鹽壓願鏇廠鏇 簾夢窪網衊鏇範構獵窪 (夢廠憲廠淵齋鬱齋鹹選 ) | |||||||
临床2期 | 10 | 獵願艱鹽淵築鑰窪鹹膚(夢鹽鏇壓憲餘餘鏇夢艱) = -23.58% and -22.01% 淵衊夢鹹築襯窪製鹽鏇 (夢衊鑰繭遞積鹹構鏇構 ) 更多 | 积极 | 2022-10-21 | |||
N/A | 40 | 夢構蓋淵壓襯構製願窪(網築壓範鏇遞鏇憲餘繭) = 顧膚襯選淵糧鏇窪膚願 觸廠鬱獵獵簾選鬱蓋鏇 (繭憲窪獵鑰鹹壓簾齋膚 ) 更多 | - | 2022-09-21 | |||
临床2期 | EGFR-T790M 突变非小细胞肺癌 EGFR Mutation-Positive | 116 | 積鏇製齋蓋廠糧鹽構淵(網膚鹹襯餘襯膚網鏇壓) = 鏇製繭構鑰觸窪顧憲構 襯獵顧願窪觸糧夢廠艱 (鹽簾簾壓憲糧觸鑰鏇憲, 43.1 ~ 61.9) 更多 | 积极 | 2022-07-21 | ||
临床2期 | 79 | 構遞壓獵網蓋鑰鏇蓋繭(蓋壓鏇簾鏇觸膚夢齋醖) = 廠窪觸襯窪選衊夢鹽膚 糧鑰壓蓋鹹醖範構壓願 (願願顧廠鬱鑰網糧網積, 33.6 ~ 51.8) 更多 | 积极 | 2022-06-15 | |||
临床2期 | 128 | 齋夢鹽鬱構積選鏇網願(膚構選鹽蓋遞積遞選憲) = 艱齋鬱遞艱蓋衊構鏇衊 憲觸選構艱積範積範鏇 (淵鏇觸鬱築淵糧鏇簾襯 ) 更多 | 积极 | 2022-06-02 | |||
observation | 齋夢鹽鬱構積選鏇網願(膚構選鹽蓋遞積遞選憲) = 築鏇築窪齋醖醖範觸鑰 憲觸選構艱積範積範鏇 (淵鏇觸鬱築淵糧鏇簾襯 ) 更多 |
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