RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Fast Track (United States)

Structure/Sequence

Sequence Code 315610456H

Source: *****

120

Clinical Trials associated with Envafolimab

NCT06059261

/ RecruitingPhase 2IIT

A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin in Locally Advanced Nasopharyngeal Carcinoma.

This is a single-center, prospective, single-arm, phase II clinical study, to evaluate the therapeutic efficacy and safety of envafolimab combined with chemoradiotherapy and recombinant human endostatin in patients with locally advanced nasopharyngeal carcinoma.

Start Date09 Feb 2026

Sponsor / Collaborator

Chongqing University Cancer Hospital

NCT07243626

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Envafolimab Combined With Doxorubicin and Ifosfamide as First-line Treatment for Advanced Soft Tissue Sarcoma

Soft tissue sarcoma (STS) is a rare, highly heterogeneous malignancy with a poor prognosis. The standard first-line treatment for advanced patients is anthracyclines (doxorubicin, A) combined with ifosfamide (I, AI regimen), but the efficacy is limited, and some subtypes do not respond well. Immune checkpoint inhibitors (ICI) have shown potential in specific STS subtypes. Anthracyclines can induce immunogenic cell death and upregulate PD-L1, providing a theoretical basis for combined immunotherapy. Previous studies have shown that ICI combined with chemotherapy (such as pembrolizumab + doxorubicin) is more effective than chemotherapy alone. Envolizumab is the world's first subcutaneously injected PD-L1 single-domain antibody-Fc fusion protein, with significant advantages: (1) small molecular weight (
80kDa) and strong tissue penetration; (2) high stability and can be stored at room temperature; (3) convenient subcutaneous injection and good tolerability (Phase II study of MSI-H/dMMR solid tumors ORR 42.7%, grade 3-4 TEAE 15.5%). In 2022, the FDA granted orphan drug designation for the treatment of STS.
This study aims to evaluate the efficacy (ORR, PFS, OS, etc.) and safety of Envolizumab combined with an AI regimen (doxorubicin + ifosfamide) as a first-line treatment for advanced STS.

Start Date30 Dec 2025

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

NCT07256223

/ Not yet recruitingPhase 2IIT

A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases

This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.

Start Date01 Dec 2025

Sponsor / Collaborator

Fudan University

[+1]

100 Clinical Results associated with Envafolimab

100 Translational Medicine associated with Envafolimab

100 Patents (Medical) associated with Envafolimab

Literatures (Medical) associated with Envafolimab

01 Feb 2026·Journal of Extracellular Vesicles

A Dually Nanobody‐Engineered Milk‐Derived Extracellular Vesicle Nanomedicine Targeting Tumour‐Associated Macrophages and Cancer Cells for Cancer Therapy

Article

Author: Cheng, Han ; Liu, Zhiang ; Wang, Yuanben ; Chen, Ying ; Wu, Zhimeng ; Huang, Zhaohui ; Cui, Kaisa ; Cao, Yulin ; Feng, Yuyang ; Yao, Surui ; Hong, Haofei ; Zhang, Yanchao ; Yin, Yuan ; Tang, Junhui ; Bian, Zehua

ABSTRACT:

Tumour development and progression are driven by intricate interactions among various cell types within the tumour microenvironment (TME). Targeting a single cell type often fails to eradicate cancer, highlighting the need for strategies to co‐target multiple cell types. MicroRNA‐21‐5p, highly abundant in tumour cells and tumour‐associated macrophages (TAMs), exerts strong cancer‐promoting effects. Epidermal growth factor receptor (EGFR) is overexpressed in various cancer types, and programmed death‐ligand 1 (PD‐L1) is expressed predominantly by TAMs in multiple cancers. In this study, we developed a dual‐targeted engineered milk‐derived extracellular vesicles system (7D12/KN035‐iEVs), decorated with 7D12 (an EGFR nanobody) and KN035 (a PD‐L1 nanobody), to specifically deliver miR‐21‐5p inhibitors into EGFR + and/or PD‐L1 + tumour cells and TAMs, thereby inhibiting tumour progression while reprogramming immunosuppressive TME. Notably, this dual‐targeting nanomedicine synergistically inhibits tumour growth when combined with immunotherapy and radiotherapy. In summary, this mEV‐based nanomedicine represents a promising universal strategy for cancer treatment, offering a versatile platform for targeting multiple components of the TME.

28 Jan 2026·ACS Applied Materials & Interfaces

PD-L1 Blockade with Biodegradable Envafolimab-Loaded Microspheres Synergizes with Transarterial Chemoembolization to Overcome Myeloid-Derived Suppressor Cell-Driven Immune Escape in Hepatocellular Carcinoma

Article

Author: Wang, Zixuan ; Dai, Shipeng ; Liu, Hanyuan ; Chai, Yue ; Hao, Xiaopei ; He, Yanshu ; Tang, Weiwei ; Xu, Jintao ; Cao, Hengsong ; Xiong, Fei ; Huang, Jinxin ; Yu, Na ; Song, Jinhua ; Wang, Nuofan ; Zhang, Zongkang ; Kong, Jie

Transarterial chemoembolization (TACE) remains a cornerstone locoregional therapy for hepatocellular carcinoma (HCC), yet post-TACE tumor recurrence remains a critical challenge. Our single-cell RNA analysis reveals that tumor recurrence is mechanistically linked to TACE-induced expansion of PD-L1⁺ myeloid-derived suppressor cells (MDSCs).To counterbalance these paradoxical effects, we developed a self-degradable microsphere (MS) composed of hyaluronic acid and gelatin for sustained local delivery of the anti-PD-L1 antibody Envafolimab (KN035) to reshape the immunosuppressive tumor microenvironment (TME). Comprehensive characterization validated KN035-MS's spherical morphology, high drug-loading efficiency, and controlled release kinetics. In BALB/c-hPD-L1 murine HCC models, transhepatic arterial embolization with KN035-MS post-TACE achieved superior tumor suppression compared to systemic KN035 administration while demonstrating favorable biocompatibility. Mechanistically, KN035-MS effectively counteracted TACE-induced PD-L1⁺ MDSC infiltration and reprogrammed the TME by enhancing CD8+/CD4+ T-cell activation, increasing the number of innate lymphocytes (ILC), and polarizing macrophages toward an M1 phenotype. Critically, localized delivery via KN035-MS prolonged intratumoral drug retention, overcoming the rapid systemic clearance observed with conventional administration. These findings establish KN035-MS as a synergistic adjunct to TACE, addressing both inefficient drug delivery and postembolization immune evasion. This dual-mechanism strategy provides a clinically translatable approach to mitigate HCC recurrence, warranting further investigation in combinatorial locoregional-immunotherapy paradigms.

15 Dec 2025·CANCER

Efficacy and safety of PD‐L1 blockade envafolimab as neoadjuvant treatment in mismatch repair‐deficient, locally advanced colorectal cancer: An open‐label, single‐arm study

Article

Author: Zheng, Zongheng ; Huang, Jianglong ; Yang, Xiaofeng ; Fang, Jiafeng ; Wei, Hongbo ; Zhou, Dagui ; Liu, Jianpei ; Huang, Lijun ; Chen, Tufeng

Abstract:

Background:

Mismatch repair‐deficient (dMMR) colorectal cancer (CRC) is characterized by poor response to traditional chemotherapy but heightened sensitivity to immune checkpoint inhibitors (ICIs). However, it is unclear whether envafolimab, a subcutaneous programmed death‐ligand 1 inhibitor, provides comparable efficacy and safety as a neoadjuvant treatment in these patients compared to programmed cell death‐1 inhibitors.

Methods:

This open‐label, single‐arm phase 2 trial enrolled patients with locally advanced dMMR CRC. Participants received subcutaneous envafolimab (300 mg every 3 weeks) for three to four cycles. Tumor response was assessed using computed tomography/magnetic resonance imaging and endoscopy, with pathological response evaluated postsurgery. The primary end point was the complete response rate (CR), including clinical complete response (cCR) and pathological complete response (pCR). The secondary end points included R0 resection rate, 3‐year disease‐free survival, 5‐year overall survival, and treatment‐related adverse events (AEs).

Results:

Between August 22, 2022, to August 22, 2024, 15 patients were enrolled and received at least one dose of envafolimab. Two patients were excluded from efficacy analyses due to loss of follow‐up or patient refusal. Of the remaining 13 patients, seven (53.8%) achieved a complete response (two, cCR; five, pCR). The median time to CR was 3.1 months. Eleven patients underwent radical surgery, with no disease recurrence observed during follow‐up. Treatment‐related AEs were mild and of low incidence (28.6%), with only one patient experiencing a grade 3 fever. Subcutaneous administration of envafolimab demonstrated high patient convenience and satisfaction.

Conclusions:

This preliminary study suggests that envafolimab is a promising effective and safe neoadjuvant option for locally advanced dMMR CRC; confirmation in larger cohorts is awaited.

118

News (Medical) associated with Envafolimab

28 Oct 2025

·www.drugs.com

Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROC

Suzhou, China, October 28, 2025 - Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), not restricted by HER2 expression. This marks another accelerated review recognition for JSKN003 from an internationally authoritative regulatory agency, following two previous Breakthrough Therapy Designations from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) and an Orphan Drug Designation from the FDA for gastric cancer/gastroesophageal junction cancer (GC/GEJ) this year. As a significant milestone in its global development progress, this achievement fully validates the drug's substantial clinical potential and market prospects. Ovarian cancer (OC) is one of the most common malignant tumors of the female reproductive system. Most patients are diagnosed at an advanced stage, and the disease is characterized by a high recurrence rate and significant treatment challenges. The standard treatment regimens recommended by authoritative guidelines both domestically and internationally include surgery combined with platinum-based chemotherapy and targeted therapy maintenance. However, about 80% of OC cases recur, and eventually progress to PROC, leaving patients with limited effective treatment options and poor prognosis. The U.S. National Comprehensive Cancer Network (NCCN) recommended single-agent non-platinum chemotherapy with or without bevacizumab as preferred regimens for PROC. However, these non-platinum chemotherapies demonstrate limited efficacy, with the objective response rate (ORR) of only 10% to 15%, a median progression-free survival (mPFS) of only 3 to 4 months, and a median overall survival (OS) of approximately 12 months, highlighting an urgent need for new treatment options. The grant of FTD is based on the promising clinical data of JSKN003. The Company has presented a pooled analysis of the phase I clinical study in Australia (JSKN003-101, NCT05494918) and the phase I/II clinical study in China (JSKN003-102, NCT05744427) at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). As of February 28, 2025, 46 patients with PROC, including 21 patients (45.7%) with HER2 IHC 0 and 18 patients (39.1%) with HER2 IHC 1+, 2+, 3+, were enrolled. Among all 46 patients, the ORR was 63.0%, the median PFS was 7.7 months. In patients with HER2 IHC 1+, 2+ and 3+, the ORR was 72.2%, the median PFS was 9.4 months. JSKN003 demonstrated robust PFS improvement in PROC, and the efficacy was observed across different HER2 expression subgroups. The Phase III clinical study of JSKN003 for PROC is currently underway in China, while a Phase II study has been approved to initiate in the U.S. The granting of FTD by the FDA will further accelerate the clinical development and regulatory review process of JSKN003, offering new hope to global patients with PROC who face limited treatment options. About JSKN003 JSKN003 is developed by site-specific conjugation to the Fc glycans of anbenitamab, resulting in a homogeneous and stable ADC with a DAR of 4. JSKN003 binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. Compared to similar ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window. Multiple registrational studies of JSKN003 are ongoing, including trials in HER2-positive breast cancer (BC), all-comer platinum-resistant ovarian cancer (PROC), HER2-low BC, and HER2-positive colorectal cancer (CRC). JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for gastric cancer (GC) and gastroesophageal junction cancer (GEJ); It has been granted two Breakthrough Therapy Designations by the National Medical Products Administration (NMPA) for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and HER2-positive advanced CRC that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. (“JMT-Bio”), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (“CSPC”) (stock code: 1093.HK). JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003. About Alphamab Oncology Alphamab Oncology is an innovative biopharmaceutical company focused on oncology. On December 12, 2019, the Company was successfully listed on the Main Board of the Hong Kong Stock Exchange (Stock Code: 9966.HK). Leveraging proprietary platforms-including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations-the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies. One product has received market approval: Envafolimab (KN035, brand name: 恩维达 ® ), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The NMPA has accepted the new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer. Four bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines—such as dual-payload ADCs—are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms. Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, delivering China-innovated cancer therapies to benefit patients worldwide. Alphamab Oncology Forward-Looking Statements This press release contains statements related to our future business，financial performance and future events involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and relevant assumptions, statements regarding plans and expectations and statements regarding future activities, operations and performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," or words of similar meaning. Such statements are based on the certain assumptions of Alphamab Oncology’s management and business operations, which are subject to various risks and uncertainties, including but not limited to political, economic, legal and business environment. The actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statements. Unless otherwise required by applicable laws, Alphamab Oncology does not undertake obligation to publicly update any forward-looking statement nor liability for the failure to materialize such forward-looking statements, whether because of new information, future events or otherwise. Pharmaceutical Information Statements Alphamab Oncology does not recommend the clinical use of any already approved or under-development drugs/indications. Any information contained in this press release should not be regarded as any drug application, promotion or advertisement. Source: Alphamab Oncology

Clinical ResultLicense out/inOrphan DrugFast TrackASCO

24 Sep 2025

·www.fiercepharma.com

In potential $1.1B deal, Glenmark grabs certain rights to Hengrui's ADC rival to Enhertu

Jiangsu Hengrui Pharmaceuticals is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to Glenmark. Jiangsu Hengrui Pharmaceuticals’ dealmaking spree rolls on, with a potential $1.1 billion transaction on a rival to AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu being the latest addition.Hengrui is licensing certain rights to its HER2 antibody-drug conjugate trastuzumab rezetecan to a subsidiary of India’s Glenmark Pharmaceuticals, the two parties announced (PDF) Wednesday.The deal is heavily back-loaded, as it features an upfront payment of $18 million and up to $1.09 billion in regulatory and commercial milestones, plus sales-based royalties.The focus is on emerging markets; the partnership excludes the U.S., Canada, Europe, Japan, greater China, Central Asia and a few other countries.“This collaboration with Glenmark is a significant step in Hengrui’s ongoing strategy to deepen its presence in emerging markets,” Jo Feng, president of Hengrui Pharma, said in a Sept. 24 statement (PDF). “We look forward to working together to enhance the accessibility of innovative therapies and to bring new hope to patients in more countries and regions.”For Glenmark, the deal dovetails with the company’s strategy to expand its oncology pipeline, Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, said in a statement. Last year, the Indian pharma bagged rights in certain territories to envafolimab, a subcutaneous PD-L1 inhibitor developed by a trio of Chinese companies. However, that drug has since failed in a pivotal trial in undifferentiated pleomorphic sarcoma or myxofibrosarcoma, forcing its U.S. partner Tracon Pharmaceuticals to close up shop.Hengrui is angling trastuzumab rezetecan as a direct competitor to Enhertu, which generated $3.75 billion in global sales last year and $2.29 billion in the first half of 2025. Both ADCs use trastuzumab as the antibody guide and both utilize an exatecan derivative as the toxic payload. The Hengrui med carries rezetecan, whereas Enhertu leverages deruxtecan.Rezetecan “has high membrane permeability, enabling a bystander killing effect, which further enhances the antitumor efficacy,” Hengrui explained in a securities filing.Trastuzumab rezetecan was approved in China in May 2025 for the treatment of second-line non-small cell lung cancer with HER2-activating mutations, with a breast cancer application also under review by Chinese authorities. The Glenmark licensing deal follows the granting of an orphan drug designation from the FDA for the drug in combination with Hengrui’s PD-L1 inhibitor adebrelimab and chemo in stomach cancer.Besides Enhertu, Hengrui’s HER2 ADC faces another competitor in RemeGen’s China-approved disitamab vedotin, which has been out-licensed to Pfizer. Hengrui has been busy with business development lately. Its recent deals include a potential $12 billion biobucks, up-to-12-asset deal with GSK and a lipoprotein(a) cardiovascular partnership with Merck & Co. that could be worth nearly $2 billion.In addition to HER2, Hengrui’s ADC pipeline covers other popular targets such as TROP2 (targeted by Gilead Sciences’ Trodelvy and AZ and Daiichi’s Datroway), Nectin-4 (targeted by Pfizer and Astellas’ Padcev), Claudin 18.2 (Astellas’ Vyloy), HER3 (Merck and Daiichi’s patritumab deruxtecan) and CD79b (Roche’s Polivy).

License out/inDrug ApprovalOrphan DrugADC

08 Sep 2025

·pharma.economictimes.indiatimes.com

Glenmark advances PD-L1 plans with Envafolimab entry in Phase 3 trials

Mumbai: Advancing its PD-LI plans, Glenmark Pharmaceuticals has announced the initiation of the Phase 3 trial for its lung cancer therapy Envafolimab , across multiple sites including India. The clinical program is designed to assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB Non-Small Cell Lung Cancer (NSCLC) in the adjuvant setting. “By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment today,” said Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals. Glenmark has also submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico to further expand the global footprint of the multi-nation study. Envafolimab, a novel anti-PD-L1 inhibitor, a key checkpoint protein expressed by various tumours. By blocking its interaction with PD-1 receptors, it enables T-cell activation, leading to an anti-tumor immune response. Invented by Alphamab Oncology, the immunotherapy was co-developed by 3D Medicines Inc and the Indian drugmaker licensed its India, Latin America among several other market development and market rights in 2024. The license agreement outlined a consideration of a “low double-digit million US dollar amount up to launch, along with a “triple-digit million US dollar milestone payments” with a royalty fee of single-to-double-digits percentage according to the level of net sales. In 2021, the Chinese regulator approved Envafolimab brand ‘Enwedia’ for the treatment of advanced unresectable or metastatic solid tumors (MSI-H) and since December 2023 the therapy is further investigated in a Phase 3 study for NSLC sponsored by 3D Medicines Inc in China. PD-LI therapies once part of big pharma portfolio are gaining a strong traction among Indian drugmakers and a standout case is Unloxcyt—an onco-derma drug approved by the FDA for advanced cutaneous squamous cell carcinoma— acquired by Sun Pharma as part of its $355 million deal to buy the therapy owner Checkpoint Therapeutics. By Online Bureau ,

Phase 3License out/inImmunotherapyDrug Approval

100 Deals associated with Envafolimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Colorectal Cancer	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021
Microsatellite Instability-high Solid Tumors	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	NDA/BLA	China	Suzhou Alphamab Co., Ltd.	12 Jan 2026
Biliary Tract Neoplasms	NDA/BLA	China	3D Medicines (Sichuan) Co., Ltd.	12 Jan 2026
Non-Small Cell Lung Cancer	Phase 3	China	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	27 Nov 2023
Non-small cell lung cancer stage IIIB	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	17 Nov 2023
Locally Advanced Rectal Carcinoma	Phase 3	China	Sir Run Run Shaw Hospital	01 Apr 2023
Bile Duct Neoplasms	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Bile Duct Neoplasms	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05414630 (ESMO_ASIA2025)	Phase 2	Non-Small Cell Lung Cancer Consolidation	30	Envafolimab 300 mg	mwixmyebmj(aqcpdrfkbz) = ywlkgkamti yqmucijlif (dbhreeueal, 5.62 - NR) View more	Positive	05 Dec 2025
ESMO2025 Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	41	Envafolimab + CapeOX	gktcjsxxhi(wtzxczxpop) = keaiqtkshe pprrcgydph (uodnmkbtrj, 42.6 - 81.3) View more	Positive	17 Oct 2025
NCT05298020 (ESMO2025) Manual	Phase 2	Metastatic Pancreatic Cancer	12	Envafolimab+RhRh-endostatinemcgemcitabine-panab-paclitaxel	xrtrfgahgk(ozyjifajta) = yjhqoccpyl ypqugdckjp (ogloszyrlu ) View more	Positive	17 Oct 2025
NCT05397769 (ESMO2025)	Phase 2	Advanced Nasopharyngeal Carcinoma	36	Envafolimab + Gemcitabine + Cisplatin + DDP	fwotaazfur(borqhetfqc) = wbrdfyqwbc bakwmevbpq (wbxqmrnrbx, 0.92 - 1) View more	Positive	17 Oct 2025
NCT05799469 (ESMO2025)	Phase 2	Locally Advanced Cervical Carcinoma	36	Envafolimab 150 mg QW + concurrent chemoradiotherapy (CCRT) (locally advanced cervical cancer (FIGO 2018 stage IB3/IIA2/IIB/III-IVA))	vogfsvpvmr(ailiehsjwv) = lfrpejslwk aakbpiznst (jplqbxiaeg ) View more	Positive	17 Oct 2025
NCT06698965 (ESMO2025)	Phase 2	Small Cell Lung Cancer	19	Trilaciclib + Etoposide + Carboplatin + Envafolimab	dpifbbwnmo(rrbwqtbsii) = qsuhgbswht yvgfqzbval (xjekgdvswa ) View more	Positive	17 Oct 2025
NCT06698965 (ESMO2025)	Phase 2	Small Cell Lung Cancer	19	Etoposide + Carboplatin + Envafolimab	dpifbbwnmo(rrbwqtbsii) = yjhadbcgii yvgfqzbval (xjekgdvswa ) View more	Positive	17 Oct 2025
NCT05422183 (ENLEN-OC-001, Pubmed \| Oncologist)	Phase 2	Platinum-Resistant Ovarian Carcinoma	18	Envafolimab + Lenvatinib + Etoposide	zabufigekq(gwlpjovjcv) = dnmrewbpxp dwwupnogyb (qjlfkbnoff, 21.5 - 69.2) View more	Positive	01 Sep 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB≥13 mut/Mb)	dnfzzwmyqi(nhjzkjabps) = grqgmuxnfk evitpzpoco (gkylsissbk, 15.6 - 55.3) View more	Positive	30 May 2025
NCT04891198 (ASCO2025) Manual	Phase 2	Advanced Malignant Solid Neoplasm TMB-High	70	Envafolimab (tTMB<13 mut/Mb)	dnfzzwmyqi(nhjzkjabps) = jrcyxusuvd evitpzpoco (gkylsissbk, 0.5 - 14.8) View more	Positive	30 May 2025
ChiCTR2100044981 (ASCO2025)	Phase 2	Extensive stage Small Cell Lung Cancer First line	32	Envafolimab + Carboplatin + Etoposide	ljiympbhpi(qtsbvpgptu) = ainiwaessa xeqkkkzuxh (flwmqjgwek, 4.83 - 7.67) View more	Positive	30 May 2025
NCT05243355 (ASCO2025)	Phase 2	Squamous non-small cell lung cancer First line	33	Envafolimab + Rh-endostatin + Paclitaxel + Cisplatin	tyjpmehuoa(txnwcnhozb) = zzeukkkixv lwlavefuxl (pnlpxipdgz, 43.0% - 83.3%) View more	Positive	30 May 2025

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