A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

开始日期2025-06-10

申办/合作机构

ENSEM Therapeutics, Inc.

CTR20255260

/ Not yet recruiting临床1/2期

一项关于泛突变选择性PI3Kα抑制剂ETX-636作为单一疗法及与其他抗癌疗法联合使用在晚期实体瘤患者中的安全性、耐受性、药代动力学和初步疗效的1/2期、开放标签、首次人体研究

评估ETX-636作为单一疗法及与其他抗癌疗法联合使用在晚期实体瘤患者中的安全性、耐受性、药代动力学和初步疗效

开始日期-

申办/合作机构

上海昂胜医疗科技有限公司

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100 项与 ETX-636 相关的临床结果

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100 项与 ETX-636 相关的转化医学

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100 项与 ETX-636 相关的专利（医药）

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项与 ETX-636 相关的文献（医药）

2026-02-01·LUNG CANCER

Inavolisib for PIK3CA-mutant non-small cell lung cancer: A case report

Article

作者: Cheng, Lei ; Nie, Wei ; Zhang, Xueyan ; Wang, Dongying ; Zhong, Hua ; Han, Baohui

INTRODUCTION:

PIK3CA mutations are oncogenic drivers in 2-4% of non-small cell lung cancers (NSCLC), often co-occurring with other drivers and conferring therapeutic resistance. This report is unique in describing the efficacy of the novel, highly selective PI3Kα inhibitor inavolisib in two heavily pre-treated patients with PIK3CA-mutant NSCLC harboring divergent co-drivers (EGFR and KRAS).

CASE PRESENTATION:

We present a 71-year-old male with EGFR/PIK3CA-mutant adenocarcinoma and brain metastases, and a 54-year-old female with KRAS/PIK3CA-mutant squamous cell carcinoma. Both patients reported rapid symptomatic improvement (hoarseness and shoulder pain, respectively) within two weeks of initiating inavolisib.

DIAGNOSIS, INTERVENTION, AND OUTCOMES:

Both patients received oral inavolisib (6 mg daily). Follow-up imaging after one month revealed significant tumor reduction. Notably, regressing intrapulmonary lesions exhibited tumor cavitation, and the male patient demonstrated a marked regression of central nervous system (CNS) metastases. The treatment was well-tolerated, with only Grade 1 oral mucositis reported.

CONCLUSION:

The primary take-away lesson is that selective PI3Kα inhibition with inavolisib can induce potent systemic and intracranial responses in PIK3CA-mutant NSCLC, regardless of the primary oncogenic co-driver. The observed tumor cavitation suggests a potential anti-angiogenic mechanism, warranting further investigation.

2026-01-06·CLINICAL CANCER RESEARCH

PI3Kα Inhibitor and Degrader Inavolisib Can Co-opt FGFR2 to Enhance Responses in Patients with PIK3CA -Mutated Solid Tumors and in Preclinical Models

Article

作者: Fredrickson, Jill ; Schmid, Peter ; Jhaveri, Komal L. ; Hwang, Michael S. ; Zingg, Daniel ; Sokol, Ethan S. ; Rees, Matthew G. ; Wong, Alice ; Hutchinson, Katherine E. ; Cervantes, Andrés ; Schutzman, Jennifer L. ; Dey, Anwesha ; Juric, Dejan ; Song, Kyung ; Gambardella, Valentina ; Pham, Trang ; Oliveira, Mafalda ; Turner, Nicholas C. ; Roth, Jennifer A. ; Martin, Scott ; Shankar, Noopur ; Maddalo, Danilo ; Ronan, Melissa M. ; Gendreau, Steven ; Bedard, Philippe L. ; Saura, Cristina ; Jin, Yanling ; Cheeti, Sravanthi ; Kuang, Zheng ; Royer-Joo, Stephanie ; Hamilton, Erika ; Italiano, Antoine ; Accordino, Melissa K. ; Krop, Ian E. ; Hilz, Stephanie ; Sodir, Nicole M. ; Aimi, Junko ; Whitfield, Zachary J. ; Lau, Jeffrey T. ; Varga, Andreea ; Yauch, Robert L. ; Kalinsky, Kevin ; Hafner, Marc ; Johnson, Radia M. ; Lin, Eva ; Peters, Ubong

Abstract:

Purpose::

PIK3CA mutations frequently drive solid tumors, particularly hormone receptor–positive breast cancer. Inavolisib, an ATP-competitive p110α inhibitor, also promotes the degradation of mutated p110α. PI3K inhibitors have generally shown modest single-agent activity and have safety concerns.

Patients and Methods::

A first-in-human phase 1 study (NCT03006172) evaluated oral inavolisib in patients with PIK3CA-mutated solid tumors to determine the maximum tolerated dose and safety. Correlative analyses included ctDNA. Preclinical studies in cell lines and xenografts elucidated the role of FGFR2.

Results::

The maximum tolerated dose was 9 mg daily, with a manageable safety profile (e.g., hyperglycemia and diarrhea). Inavolisib showed linear pharmacokinetics, consistent pharmacodynamic modulation, and antitumor activity in hormone receptor–positive PIK3CA-mutated breast cancer (26% objective response rate and 45% clinical benefit rate). FGFR2 hotspot mutations in ctDNA were strongly associated with clinical benefit. Preclinically, oncogenic FGFR2 signaling enhanced inavolisib sensitivity by engaging HER3, RAS, and p85β, that facilitated mutated p110α degradation, surpassing nondegrading inhibitors. Combination therapy with FGFR2 inhibitors showed synergy and delayed resistance.

Conclusions::

These findings highlight a novel cooperativity between FGFR2 and p110α that boosts the effectiveness of inavolisib. The data support advancing precision oncology beyond single biomarkers to complex algorithms utilizing co-occurring alterations, suggesting that combining inavolisib with FGFR2 inhibitors may offer enhanced and more durable responses in PIK3CA/FGFR2-altered tumors.

2026-01-01·KIDNEY INTERNATIONAL

Drug repurposing in PIK3CA-related overgrowth spectrum: breakthroughs from overgrowth syndromes to kidney disease

Review

作者: Canaud, Guillaume ; Isnard, Pierre ; Morin, Gabriel

Phosphoinositide 3-kinase α (PI3Kα) is a ubiquitous lipid kinase that transduces extracellular growth, proliferation, and metabolism signals. Genes involved in the PI3Kα signaling pathway are frequently mutated in cancer. Apart from malignant conditions, monogenic rare disorders, called PIK3CA-related overgrowth syndromes, are also caused by mosaic mutations in PIK3CA, the gene encoding the catalytic subunit of PI3Kα, resulting in increased signaling promoting abnormal growth and proliferation. Recent studies have shown that alpelisib, a PI3Kα inhibitor initially designed for breast cancer, is also effective at treating PIK3CA-related overgrowth syndrome. Linking rare malformation syndromes and kidney disease, the improvement of kidney function following treatment with alpelisib in a patient with PIK3CA-related overgrowth syndrome with nonspecific glomerular lesions shed light on the involvement of PI3Kα across various nephropathies. Moreover, the identification of a PIK3CA mosaic variant in his glomerular epithelial cells suggested that mosaic variants of the PI3Kα pathway might explain cases of chronic kidney disease of undetermined etiology. Finally, the deleterious role of the PI3Kα pathway also extends to a wide variety of kidney diseases, such as lupus nephritis, diabetes, or autosomal dominant polycystic kidney disease. In unrelated disorders, PI3Kα involvement has been reported in various cell types, such as mesangial, tubular, and immune cells. This review aims at summarizing the available evidence on the involvement of the pathway in monogenic disorders and kidney disease, highlighting PI3Kα as a potential novel therapeutic target in various nephropathies.

项与 ETX-636 相关的新闻（医药）

2025-12-12

·EndPoints

#SABCS25: Celcuity further details Phase 3 win; Relay’s PI3Kα inhibitor’s consistent performance; and more

Roche and BioNTech stole the show at this year’s San Antonio Breast Cancer Symposium. The Swiss drugmaker unveiled Phase 3 data for its oral SERD giredestrant, showing the drug slashed the risk of disease recurrence in certain early-stage breast cancers. Meanwhile, BioNTech shared triple-negative breast cancer (TNBC) data for its PD-L1xVEGF-A bispecific contender. But other drugmakers, such as Celcuity, Relay Therapeutics, and Anixa Biosciences, also had a notable presence at the confab. Celcuity’s Phase 3 subgroup analysis for multi-target drug: The biotech’s gedatolisib plus standard of care palbociclib and AstraZeneca’s selective estrogen receptor degrader (SERD) Faslodex achieved 12.4 months of progression-free survival in a group of breast cancer patients whose time to progression on prior therapy was over 18 months. The result is numerically higher than the 1.9-month PFS seen with Faslodex alone in the same type of patients. Celcuity has projected that gedatolisib could hit up to $3 billion in annual peak sales. The drug acts on a trio of targets: PI3K, AKT and mTOR. The SABCS data came from a cohort of patients without a PIK3CA mutation enrolled in the VIKTORIA-1 trial, which is testing gedatolisib in previously treated HR-positive, HER2-negative advanced breast cancer. Celcuity first announced positive results from the PIK3CA wild-type cohort back in October, but the company waited until Thursday to unwrap details. The company said patients who had reported lower-grade stomatitis as a side effect largely saw it resolve within two weeks. TD Cowen analysts said the new data help alleviate safety concerns that had cropped up during the trial’s initial readout. Relay’s breast cancer drug works consistently across subgroups : The biotech on Friday presented updated data from the first human trial of zovegalisib. The drug, also called RLY-2608, is a PI3Kα inhibitor and is Relay’s lead candidate. The data concern patients in an arm of Relay’s Phase 1/2 ReDiscover study that tested zovegalisib plus Faslodex. In 64 patients who received 600 mg of zovegalisib twice daily, 44% had received two or more prior lines of therapy, 52% had taken a SERD (either Faslodex or an oral SERD), and 29% had detectable ESR1 mutations at baseline. The results come from a cutoff date of Oct. 15. Among the total efficacy population of 52 patients without a PTEN or AKT co-mutation, zovegalisib plus Faslodex yielded a median PFS of 10.3 months, Relay said . Based on a Nov. 29 note by Jefferies analysts, these results appear inferior to Celcuity’s Phase 1b data on gedatolisib in a similar population. Relay also said Friday that among the 31 patients with measurable disease, the ORR was 39%. In second-line patients, median PFS was 11.4 months and ORR was 47%. The PFS here is unchanged from a data cut released a year ago , but the response rate has improved. Meanwhile, in patients who had had prior SERD treatment, median PFS was 11.4 months and the ORR was 44%, Relay said. Among those with a mutated ESR1 gene, which encodes the estrogen receptor, median PFS was 8.8 months and ORR was 60%. SERDs tend to work best in patients who have ESR1 mutations. ReDiscover will go on to test higher doses of zovegalisib and will also investigate triplet cohorts in which a CDK4/6 inhibitor is added to the combo. Relay said this will identify a regimen for use in a future frontline trial in metastatic disease. A Phase 3 study, called ReDiscover-2, is currently testing zovegalisib and Faslodex in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer. Anixa’s early data for cancer vaccine: The company said its unnamed vaccine triggered “protocol-defined” α-lactalbumin (aLA)-specific T cell responses in more than 70% of 35 participants in a Phase 1 trial. The idea is that patients given Anixa’s vaccine will develop a pre-emptive immune response if breast cancer cells that express aLA protein emerge. The vaccine targets aLA, which is usually only found in breast tissue during lactation, but is also expressed by many types of breast cancer. The Phase 1 trial enrolled TNBC patients who were being treated with Keytruda after surgery, as well as certain women at risk of developing TNBC again or for the first time. Those receiving Keytruda also reported promising T cell responses with no major new side effects, Anixa said. The biotech is now planning for a Phase 2 study, including a potential combination trial with Keytruda in the newly-diagnosed, neoadjuvant setting.

临床结果临床3期临床1期临床2期疫苗

2025-11-26

·武汉生物样本库

热点资讯| 上周小结，16款1类新药首次在中国获批临床！

CDE新药一周小结中国国家药监局药品审评中心（CDE）官网及公开资料，11月17日至11月22日期间，共有16款1类创新药首次在中国获得临床试验默示许可（IND）。这批新药横跨小分子、抗体、ADC、细胞治疗、基因治疗等多个前沿技术赛道，瞄准溃疡性结肠炎、肝癌、抑郁症、晚期实体瘤等多个临床需求迫切的疾病，为患者带来全新治疗希望。一、肿瘤领域：双抗、ADC、靶向药多点突破 01 基因泰克（Genentech）注射用 RO7837195：靶向 TL1A 和 IL12 p40 的双特异性抗体，已在美国推进至 2 期临床，此次获批中国临床拟用于治疗溃疡性结肠炎，为炎症性肠病患者提供新的免疫调节方向。 02 威斯津生物 WGc-0201 注射液：一款兼顾抗病毒与抗肿瘤的 mRNA 治疗性疫苗，搭载自主研发的高效靶向 LNP 递送系统，可激活针对 HBV 及相关肿瘤的双重免疫反应，打破免疫耐受。继 10 月获美国 FDA IND 批准后，本周顺利拿下中国临床资格，拟攻坚 HBV 阳性肝细胞癌，有望突破传统疗法对肿瘤异质性控制不足的瓶颈。 03 昂胜医药 ETX-636：针对 PI3Kα 突变体的创新型变构抑制剂与降解剂，亮点在于能特异性诱导突变型 p110α 蛋白酶体依赖性降解，且不影响野生型蛋白（这是传统抑制剂不具备的优势），可实现更持久的通路抑制。拟用于治疗携带 PIK3CA 突变的晚期实体瘤，该突变在激素受体阳性乳腺癌中占比高达 40%，覆盖人群广泛。 04 阿斯利康（AstraZeneca）双料获批：抗 EGFR/cMET 双特异性抗体 FPI-2053 与放射性偶联药物 [111In]-FPI-2107 同步获批，均聚焦晚期实体瘤治疗，前者凭借双靶点协同作用精准打击肿瘤，后者则以放射性治疗为核心开辟新赛道。 05 普灵生物 PLB-002：靶向 Claudin 6 的 ADC 药物，以 “治疗窗＞25、安全性优异、脱靶毒性低” 为核心优势，为晚期实体瘤患者提供更安全的靶向治疗选择。 06 辉瑞（Pfizer）双药联合出击： MEK 抑制剂 PF-07799544 与 BRAF 抑制剂 PF-07799933 均具备脑渗透特性，二者联合在非临床模型中对 BRAF V600 突变驱动的颅内疾病展现显著抗肿瘤活性，拟用于治疗该突变的实体瘤患者（黑色素瘤和结直肠癌除外）。 07 和记黄埔注射用 HMPL-A251：创新型 PI3K/AKT/mTOR（PAM）-HER2 抗体靶向偶联药物（ATTC），通过可裂解连接子将高选择性 PI3K/PIKK 抑制剂与抗 HER2 抗体偶联，发挥靶向治疗与通路抑制的协同作用，拟用于不可切除的局部晚期或转移性 HER2 表达实体瘤。二、自身免疫与罕见病：细胞治疗、基因治疗带来新希望 01 启函生物 QT-019B 细胞注射液：靶向 CD19 和 BCMA 的通用型双靶点 CAR-T 产品，通过基因编辑敲除 TCR 以降低移植物抗宿主病（GvHD）风险，同时优化免疫原性减少排斥反应，具备同时清除两种靶点阳性细胞的能力，拟用于治疗难治性系统性红斑狼疮，为自身免疫病治疗提供全新思路。 02 健达九州 GA001 注射液：针对视网膜色素变性（RP）导致晚期盲症的基因治疗药物，有望为这类罕见病患者带来重见光明的可能。三、其他重大疾病：抗抑郁、麻醉、神经退行性疾病新突破 01 翊石医药 SYH2056 片：选择性 5-HT2A 受体激动剂，打破传统抗抑郁药起效慢的痛点，单次给药即可快速见效且药效持久，更关键的是完全无致幻风险。临床前研究显示其能促进中枢神经元树突与树突棘生成，实现神经重塑，在多种抑郁动物模型中表现出优异活性，为抑郁症患者带来全新治疗体验。 02 麻沸散医药注射用 MFS-16：全新化药新药，获批临床拟用于全身麻醉的诱导与维持，有望丰富临床麻醉用药选择。 03 羿旻生物医药 ARC001 注射液：生物制品 1 类新药，聚焦肌萎缩侧索硬化（ALS）这一难治性神经退行性疾病，为渐冻症患者带来新的治疗期待。 04 信立泰药业 SAL0139 片：创新小分子药物，临床前研究显示具备显著降低 LDL-C（低密度脂蛋白胆固醇）的潜力，拟用于治疗高脂血症，为血脂管理提供新选项。 05 基因启明生物 GKL-006RTU 注射液：异体即用型 iNKT 细胞注射液，无需个性化制备，可直接用于临床，拟治疗感染导致的中、重度急性呼吸窘迫综合征，为重症感染救治增添新武器。四、更多潜力新药从 mRNA 疫苗到双靶点 CAR-T，从基因治疗到创新 ADC，这批 1 类新药的集中获批，既展现了全球药企在前沿医药领域的研发实力，也反映了中国对创新药的高度重视与审评效率。期待这些在研新药后续临床研发一路顺利，早日落地上市，为更多患者带去战胜疾病的新希望！来源丨CDE官网编辑丨马千里审校丨许秀勤 More... 点击图片查看往期精彩热点资讯| 上周小结，18款1类新药首次在中国获批临床！热点资讯| 上周小结，7款1类新药首次在中国获批临床！热点资讯| 上周小结，12款1类新药首次在中国获批临床！热点资讯| 全国首批！武汉生物技术研究院牵头建设平台入选首批国家级产业知识产权运营中心热点资讯| 上周小结，6款1类新药首次在中国获批临床！热点资讯| 司法部及国家卫生健康委负责人就《生物医学新技术临床研究和临床转化应用管理条例》答记者问热点资讯| 2025年诺贝尔生理学或医学奖授予三位免疫学家！热点资讯| CDE发布两则最新征求意见稿，事关药物临床试验与药物上市！热点资讯| 上周小结，10款1类新药首次在中国获批临床！热点资讯| 国务院：审议通过《生物医学新技术临床研究和临床转化应用管理条例（草案）》热点资讯| 上周小结，14款1类新药首次在中国获批临床！热点资讯| 中国目前合规收费细胞和基因疗法清单（含价格）热点资讯| 2025国自然，放榜！（文中附最近5年资助结果）热点资讯| 首次揭露！2025年13款小分子新药结构揭晓热点资讯| 礼来、艾伯维、强生、罗氏、辉瑞、阿斯利康等全球34家大药厂2025年第二季度和上半年财报业绩汇总热点资讯| 2025年7月中国干细胞药物注册申报新增10款受理和3款默示许可热点资讯| 感染病例已超4000例，什么是基孔肯雅热，普通人应当如何预防？热点资讯| 重磅发布！一图读懂《东湖高新区突破性发展生物医药产业的若干措施》热点资讯| 铅中毒离我们有多远？注意身边这些隐患！热点资讯| 9款1类新药首次在中国获批临床！热点资讯| 首次明确，外泌体正式纳入细胞治疗监管体系！热点资讯| 创新药重大利好消息，60日即将缩短至30日！热点资讯| 我国首款干细胞药物定价公布：单次1.98万元，完整疗程15.84万元（8次）热点资讯| 截止2025年5月，全国148家干细胞临床备案医院+133个项目名单揭晓！热点资讯| 最新！CDE发布《阿尔茨海默病药物临床试验技术指导原则（试行）》热点资讯| CDE五连发！药企紧急通知：4大新政意见征求倒计时，错过或将影响审批！热点资讯| 首次发现！这种基因突变可致患帕金森患病风险增加7倍热点资讯| 《人源类器官研究伦理指引》发布热点资讯| 武汉生物技术研究院连续四年获湖北省新型研发机构绩效评价“优秀”等次热点资讯| FDA宣布终结百年动物实验！AI+类器官如何重塑药物研发版图？

2025-11-23

·信狐药迅

小编震惊了，这也太多了！51个品规仿制药上市申请、6个品规进口上市申请收到通知件| 新获批(11.17-11.23）

每周药品注册获批数据，分门别类呈现，一目了然。(11.17-11.23）新药上市申请无新药临床申请药品名称企业注册分类受理号 HRS-1780 片山东盛迪医药有限公司 1 CXHL2500993 HRS-1780 片山东盛迪医药有限公司 1 CXHL2500992 注射用MFS-16 成都麻沸散医药科技有限公司 1 CXHL2500977 注射用莱古杉醇上海亲合力生物医药科技股份有限公司 1 CXHL2500976 D-2570片益方生物科技(上海)股份有限公司 1 CXHL2500975 QLS1304片齐鲁制药有限公司 1 CXHL2500967 QLS1304片齐鲁制药有限公司 1 CXHL2500966 QLS1304片齐鲁制药有限公司 1 CXHL2500965 QLC1401片齐鲁制药有限公司 1 CXHL2500964 SYH2056片上海翊石医药科技有限公司 1 CXHL2500957 SYH2056片上海翊石医药科技有限公司 1 CXHL2500956 HP518片海创药业股份有限公司 1 CXHL2500947 SAL0139片深圳信立泰药业股份有限公司 1 CXHL2500943 SAL0139片深圳信立泰药业股份有限公司 1 CXHL2500942 SAL0140片深圳信立泰药业股份有限公司 1 CXHL2500896 伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司 2.4 CXHL2500994 阿贝西利片齐鲁制药有限公司 2.4 CXHL2500963 阿贝西利片齐鲁制药有限公司 2.4 CXHL2500962 阿贝西利片齐鲁制药有限公司 2.4 CXHL2500961 冻干结核病mRNA疫苗瑞佶(北京)生物科技有限公司 1.1 CXSL2500732 注射用HS-20110 上海翰森生物医药科技有限公司 1 CXSL2500786 注射用HMPL-A251 和记黄埔医药(上海)有限公司 1 CXSL2500784 FS-8002注射液上海菩莳医药科技有限公司 1 CXSL2500783 AWT020注射用无菌粉末上海君实生物医药科技股份有限公司 1 CXSL2500782 注射用JS212 上海君实生物医药科技股份有限公司 1 CXSL2500780 注射用GEN1184 金麦安博生物制药(苏州)有限公司 1 CXSL2500779 SYS6043 石药集团巨石生物制药有限公司 1 CXSL2500776 PLB-002 普灵生物医药(深圳)有限公司 1 CXSL2500777 TQB2922注射液(皮下注射) 上海正大天晴医药科技开发有限公司 1 CXSL2500773 注射用ZG006 苏州泽璟生物制药股份有限公司 1 CXSL2500769 ARC001滴鼻液羿旻生物医药科技(东阳)有限公司 1 CXSL2500748 ARC001注射液羿旻生物医药科技(东阳)有限公司 1 CXSL2500747 WGc-0201 注射液成都威斯津生物医药科技有限公司 1 CXSL2500735 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500742 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500741 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500740 G01滴眼液青岛万明赛伯生物医药有限公司 1 CXSL2500739 QT-019B细胞注射液杭州启函生物科技有限公司 1 CXSL2500745 LBM801 上海博赛美生物科技有限公司 1 CXSL2500734 GA001注射液健达九州(北京)生物科技有限公司 1 CXSL2500729 GKL-006RTU注射液北京基因启明生物科技有限公司 1 CXSL2500721 SHR-A1811(sc)注射液苏州盛迪亚生物医药有限公司 2.1 CXSL2500781 仿制药申请药品名称企业注册分类受理号盐酸拉贝洛尔注射液九华华源药业(桂林)有限公司 3 CYHS2501089 盐酸普罗帕酮注射液江苏润恒制药有限公司 3 CYHS2404164 盐酸纳美芬注射液安徽瑞旗药业有限公司 3 CYHS2404010 熊去氧胆酸片美享生物科技(海南)有限公司 3 CYHS2403770 注射用硫酸多黏菌素B 海南广升誉制药有限公司 3 CYHS2403176 盐酸纳洛酮注射液山西振东泰盛制药有限公司 3 CYHS2402759 马来酸阿塞那平舌下片哈尔滨三联药业股份有限公司 3 CYHS2402668 普仑司特干糖浆济川药业集团有限公司 3 CYHS2400849 复方匹可硫酸钠颗粒北京柏雅联合药物研究所有限公司 3 CYHS2303242 氨氯地平阿托伐他汀钙片安徽佳和药业有限公司 4 CYHS2503440 依折麦布片海南赛立克药业有限公司 4 CYHS2503424 比拉斯汀片山东鲁抗医药股份有限公司 4 CYHS2503340 蔗糖铁注射液四川美大康佳乐药业有限公司 4 CYHS2503250 棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂 4 CYHS2501986 棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂 4 CYHS2501985 棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂 4 CYHS2501984 依达拉奉右莰醇注射用浓溶液上海凯宝新谊(新乡)药业有限公司 4 CYHS2501390 氟比洛芬凝胶贴膏河北鼎泰制药有限公司 4 CYHS2501079 替格瑞洛片浙江江北药业有限公司 4 CYHS2500786 阿帕他胺片江苏利泰尔药业有限公司 4 CYHS2500248 瑞舒伐他汀依折麦布片(II) 常州市阳光药业有限公司 4 CYHS2500077 罗沙司他胶囊天方药业有限公司 4 CYHS2404505 罗沙司他胶囊天方药业有限公司 4 CYHS2404504 达格列净片上海衡山药业有限公司 4 CYHS2404506 双氯芬酸钠肠溶片四川天德制药有限公司 4 CYHS2404451 利丙双卡因乳膏国大(吉林)制药集团有限公司 4 CYHS2404200 二甲双胍恩格列净片(VI) 宁波科尔康美诺华药业有限公司 4 CYHS2404154 二甲双胍恩格列净片(V) 宁波科尔康美诺华药业有限公司 4 CYHS2404152 二甲双胍恩格列净片(IV) 宁波科尔康美诺华药业有限公司 4 CYHS2404150 二甲双胍恩格列净片(III) 宁波科尔康美诺华药业有限公司 4 CYHS2404148 普拉洛芬滴眼液北京汇恩兰德制药有限公司 4 CYHS2404146 注射用阿立哌唑齐鲁制药有限公司 4 CYHS2404025 注射用阿立哌唑齐鲁制药有限公司 4 CYHS2404024 噻托溴铵吸入粉雾剂苏州欧米尼医药有限公司 4 CYHS2403887 盐酸帕洛诺司琼软胶囊齐鲁制药有限公司 4 CYHS2403825 诺西那生钠注射液重庆药友制药有限责任公司 4 CYHS2402891 雌二醇片/雌二醇地屈孕酮片复合包装扬州奥锐特药业有限公司 4 CYHS2402081 盐酸米诺环素胶囊珠海同源药业有限公司 4 CYHS2401601 盐酸米诺环素胶囊珠海同源药业有限公司 4 CYHS2401600 恩格列净片郑州韩都药业集团有限公司 4 CYHS2401491 恩格列净片郑州韩都药业集团有限公司 4 CYHS2401490 碳酸司维拉姆片江苏天士力帝益药业有限公司 4 CYHS2401359 比索洛尔氨氯地平片宏越科技(湖州)有限公司 4 CYHS2400941 酒石酸美托洛尔片江苏贝佳制药有限公司 4 CYHS2400676 卡左双多巴缓释片重庆华邦制药有限公司 4 CYHS2400443 美沙拉秦肠溶片华益泰康药业股份有限公司 4 CYHS2400135 非布司他片北京双鹭药业股份有限公司 4 CYHS2303216 非布司他片北京双鹭药业股份有限公司 4 CYHS2303215 注射用紫杉醇(白蛋白结合型) 扬子江药业集团有限公司 4 CYHS2201544国;CYHS2201544 注射用卡非佐米上海创诺制药有限公司 4 CYHS2200966国;CYHS2200966 富马酸伏诺拉生山东新华制药股份有限公司 CYHS2460214 注射用重组人凝血因子VIIa 成都蓉生药业有限责任公司 3.4 CXSS2500005 帕博利珠单抗注射液上海宏成药业有限公司 3.3 CXSL2500787 进口申请药品名称企业注册分类受理号替尔泊肽注射液 Eli Lilly Nederland B.V. 2.4 JXHS2400111 替尔泊肽注射液 Eli Lilly Nederland B.V. 2.4 JXHS2400110 替尔泊肽注射液 Eli Lilly Nederland B.V. 2.4 JXHS2400109 替尔泊肽注射液 Eli Lilly Nederland B.V. 2.4 JXHS2400108 替莫唑胺胶囊 SUN PHARMACEUTICAL INDUSTRIES LTD. 5.2 JYHS2300116 乳果糖口服溶液澳美制药厂 5.2 JYHS2000038国;JYHS2000038 PF-07799933片 Pfizer Inc. 1 JXHL2500269 PF-07799933片 Pfizer Inc. 1 JXHL2500268 PF-07799544片 Pfizer Inc. 1 JXHL2500267 PF-07799544片 Pfizer Inc. 1 JXHL2500266 PF-07799544片 Pfizer Inc. 1 JXHL2500265 ETX-636 Ensem Therapeutics, Inc. 1 JXHL2500264 ETX-636 Ensem Therapeutics, Inc. 1 JXHL2500263 Orforglipron片 Eli Lilly and Company 1 JXHL2500262 Orforglipron片 Eli Lilly and Company 1 JXHL2500261 Orforglipron片 Eli Lilly and Company 1 JXHL2500260 Orforglipron片 Eli Lilly and Company 1 JXHL2500259 Orforglipron片 Eli Lilly and Company 1 JXHL2500258 Orforglipron片 Eli Lilly and Company 1 JXHL2500257 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500248 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500247 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500246 MK-0616 片 Merck Sharp & Dohme LLC 1 JXHL2500245 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500237 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500236 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500235 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500234 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500233 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500232 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500231 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500230 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500228 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500227 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500226 FPI-2053 AstraZeneca AB 1 JXSL2500172 [111In]-FPI-2107 AstraZeneca AB 1 JXSL2500171 注射用RO7837195 Genentech, Inc. 1 JXSL2500167 中药相关申请药品名称企业注册分类受理号止咳橘红颗粒康芝药业股份有限公司 2.3 CXZL2500076 荜铃胃痛颗粒扬子江药业集团江苏制药股份有限公司 2.3 CXZL2500074 芙朴感冒颗粒浙江天一堂药业有限公司 2.3 CXZL2500073 注：橙色字体部分结论为不批准或收到通知件；

信使RNA疫苗核酸药物申请上市

100 项与 ETX-636 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床2期	美国	ENSEM Therapeutics, Inc.	2025-06-10
晚期恶性实体瘤	临床2期	中国	ENSEM Therapeutics, Inc.	2025-06-10
HR阳性/HER2阴性乳腺癌	临床2期	美国	ENSEM Therapeutics, Inc.	2025-06-10
PIK3CA阳性实体瘤	临床申请批准	中国	ENSEM Therapeutics, Inc.	2025-11-20