RegulationFast Track (United States), Orphan Drug (United States), Conditional marketing approval (China), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Sequence Code 315610456H

Source: *****

133

Clinical Trials associated with Envafolimab

NCT04910386

/ Not yet recruitingPhase 2

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

Start Date01 Jun 2027

Sponsor / Collaborator

3D Medicines (Sichuan) Co., Ltd.

NCT07729033

/ Not yet recruitingPhase 2IIT

A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.

This is a prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Up to 28 eligible patients will be enrolled.After screening, eligible patients receive sacituzumab tirumotecan (5 mg/kg IV, d1, Q2W) plus envafolimab (300 mg SC, d1, Q2W) for 3 cycles, with subsequent treatment at the investigator's discretion.
Tumor imaging assessments per RECIST v1.1 are performed at Week 6, then every 6 weeks (up to 48 weeks) and every 12 weeks (thereafter) until disease progression, new therapy, loss to follow-up, or death. Post-treatment survival follow-up is conducted by phone every 3 months.
The study includes a safety run-in (6 patients) followed by an expansion phase using Simon's two-stage design (first stage: 15 patients; second stage: total 28 patients). The safety run-in stops if >2 DLTs occur; expansion proceeds if ≤2 DLTs. The trial is terminated if ≤1 objective response is observed in the first 15 expansion patients.
The primary endpoint is ORR(investigator-assessed per RECIST v1.1). Secondary endpoints include OS, PFS, DCR, DOR, safety, and tolerability.

Start Date01 Aug 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07738055

/ Not yet recruitingNot ApplicableIIT

An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma

This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1/3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1/3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.

Start Date31 Jul 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Envafolimab

100 Translational Medicine associated with Envafolimab

100 Patents (Medical) associated with Envafolimab

Literatures (Medical) associated with Envafolimab

31 Dec 2026·Human Vaccines & Immunotherapeutics

Anlotinib plus envafolimab as neoadjuvant therapy in a patient with chemotherapy-refractory advanced endometrial cancer: A case report

Article

Author: Wang, Lijie ; Xiao, Wenjing ; Dong, Lina ; Sun, Yang ; Xu, Jinpeng ; Zhuang, Dunmin

We report a case of a 51-y-old female presenting with synchronous double primary malignancies: advanced endometrial cancer and early-stage lung cancer. One year a post-chemotherapy withdrawal due to toxicity, she developed severe urinary retention and poor performance status caused by pelvic tumor progression. Considered ineligible for standard chemoradiotherapy, she received anlotinib (a novel multi-target TKI) combined with envafolimab (a subcutaneous PD-L1 antibody). This regimen resulted in rapid symptom resolution and significant tumor regression, successfully converting the patient to surgical candidacy. She subsequently underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy, achieving an R0 resection. The lung lesion was treated with stereotactic body radiation therapy. She remains disease-free at follow-up. The combination of anlotinib and envafolimab shows promise as an effective conversion therapy for endometrial cancer, particularly in patients with advanced stage, poor performance status, or intolerance to intensive treatments.

01 Aug 2026·Magnetic resonance letters

Production of isotope-labeled nanobody KN035 in Pichia pastoris yields native-like conformation and PD-L1 binding activity comparable to KN035 expressed in mammalian cells

Article

Author: Jiang, Mengzhen ; Wang, Shenlin ; Ren, Piaoran

Stable isotope-labeled proteins are indispensable for NMR-based structural studies. E. coli is a cost-effective and high-yield expression host, but it often fails to support proper folding and post-translational modifications required for functional human proteins. While mammalian cell systems produce correctly folded and modified proteins, their high cost limits widespread use. The methylotrophic yeast Pichia pastoris (P. pastoris) presents a compelling alternative as a single-celled eukaryotic host that combines advantages of simple and cost-effective microbial cultivation and eukaryotic protein processing capabilities. In this study, we systematically compared the spectra and ligand-binding activity of the VHH domain of therapeutic nanobody KN035, expressed in E. coli, P. pastoris, and HEK293 cells to discuss the feasibility of using P. pastoris to produce labeled nanobody for NMR studies. KN035 produced in P. pastoris and mammalian HEK293 cells displayed nearly identical ¹H-¹⁵N HSQC spectra, indicating highly similar folding. In contrast, KN035 expressed in E. coli formed inclusion bodies and, after refolding, exhibited conformational heterogeneity with largely different spectral patterns with HEK293 expressed KN035. NMR titration experiments with PD-L1 further revealed that P. pastoris-expressed KN035 bound its target with a mode indistinguishable from the HEK293-produced protein, while the E. coli-expressed sample showed altered spectra of the binding complex. Our results concluded that P. pastoris, with its simple single-cell culture requirements, can produce structurally similar and functionally active KN035, simulating mammalian cells production. This work establishes single-celled P. pastoris as a practical host for producing isotope-labeled nanobodies, combining the ease of microbial cultivation with the ability to generate properly folded eukaryotic proteins for structural and interaction studies.

13 Jul 2026·ACS Biomaterials Science & Engineering

MT3-KN035 Nanoparticles Based on PD-L1 Nanobodies Allow for Multiple Drug Conjugations that Promote Chemo- and Immunosynergistic Therapies

Article

Author: Li, Ruiyan ; Zhu, Xinjie ; Wei, Yingrui ; Zhou, Peng ; Weng, Naiqiang

Nanobody-based therapeutics that incorporate multifunctional drug molecules into nanobodies (nanobody-drug conjugates, NDCs) have gained substantial attention as promising therapeutic strategies in biomedicine due to their unique ability to precisely target specific cancer cells. However, the efficacy of NDCs depends on efficient internalization of the antibody-antigen complex to facilitate intracellular drug release in the lysosome, and not all surface antigens suffer from internalization upon antibody binding, posing a significant limitation to the effectiveness of NDCs. To address this gap, we rationally designed and constructed MT3 and anti-PD-L1 nanobody (Nb-PD-L1:KN035) fusion protein that enabled self-assembly into nanoparticles during the expression process. The MT3 domain of MT3-KN035 fusion protein nanoparticles did not interrupt the binding affinity between KN035 and PD-L1. In addition, MT3-KN035 protein nanoparticles not only migrated from the PD-L1-positive cell surface to intracellular lysosomes in vitro but also hold a huge targeting potential for tumor regions in vivo. Meanwhile, MT3-KN035 conjugated multiple aldoxorubicin (hereafter, these conjugates are referred to as MT3-KN035-DOX) via an acidic cleavable linker; MT3-KN035-DOX^High induced tumor apoptosis and exhibited significant antitumor efficacy via facilitating immune cell infiltrations. This work provides a novel therapeutic strategy via nanobody-mediated target engagement and internalization that achieves synergistic therapeutic efficacy between chemotherapy and immune checkpoint blockade therapy.

119

News (Medical) associated with Envafolimab

03 Aug 2026

·www.biospace.com

Pathos AI Enters Global Licensing Agreement with Alphamab Oncology on JSKN016, a First-in-Class TROP2/HER3 Bispecific ADC

NEW YORK--(BUSINESS WIRE)--Pathos AI, a clinical-stage AI and technology company advancing its own pipeline of cancer therapies, today announced a licensing agreement with Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Alphamab”), a wholly-owned subsidiary of Alphamab Oncology (Stock Code: 9966.HK), on JSKN016, a first-in-class (FIC) TROP2/HER3 bispecific antibody-drug conjugate (ADC) independently developed by Alphamab. Pursuant to the licensing agreement, Alphamab granted Pathos an exclusive license to research, develop, manufacture and commercialize JSKN016 in territories outside the Chinese Mainland, Hong Kong, Macau and Taiwan, with Pathos bearing all related development and commercialization costs and expenses under the agreement. Alphamab retains its full and exclusive rights to develop, manufacture and commercialize JSKN016 in the Chinese Mainland, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Alphamab is entitled to receive a non-refundable upfront payment of US$125 million and milestone payments based on the achievement of certain development and commercialization milestones, totaling up to US$2,093 million, as well as tiered royalties at high-single digit to low-double digit percentage rates according to aggregate annual net sales in the licensed territories. Accelerated by AI: The Foundry Advantage ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); JSKN016 was identified and prioritized through Foundry, Pathos’s proprietary AI-driven decision platform for oncology drug development. Foundry utilizes thousands of AI agents working in parallel, powered by the Pathos’ proprietary AI models, to analyze biological, clinical, and real-world data at scale; surfacing high-potential assets, designing clinical trials, and matching the right patients to the right therapies faster and more safely than traditional methods allow. Every major asset-level decision at Pathos flows through Foundry. JSKN016 becomes the fourth clinical-stage program advanced into the Pathos pipeline through the platform. "JSKN016 is a next-generation bispecific ADC with the potential to address significant unmet need across a range of solid tumors, and we are excited to advance it in partnership with Alphamab. This program was identified through Foundry, the same platform that continues to guide portfolio decisions across our clinical pipeline. This collaboration reflects our shared commitment to bringing differentiated therapies to patients." — Iker Huerga, CEO of Pathos AI "JSKN016 represents the best of our next-generation bispecific ADC platform, and we are excited to partner with Pathos. With Pathos's leading capabilities in AI-driven precision development, we are confident this collaboration will accelerate the global clinical advancement of JSKN016 and bring a potential breakthrough therapy to more patients with solid tumors. This partnership reflects our shared commitment to delivering differentiated innovation to patients worldwide." — Dr. Ting Xu, Chairman and CEO of Alphamab Oncology A Growing Mission to Transform Oncology The addition of JSKN016 expands Pathos’s clinical pipeline to four assets across multiple solid tumor indications. JSKN016, a TROP2/HER3 bispecific ADC, joins pocenbrodib, currently in development for metastatic castration-resistant prostate cancer (mCRPC) and relapsed/refractory multiple myeloma (RRMM); DO-2, for MET-altered non-small-cell lung cancer (NSCLC); and AZD4241, an ERα PROTAC for ER+/HER2- breast cancer being advanced under a collaboration with AstraZeneca. Every program in the Pathos pipeline has been identified, evaluated, or accelerated by the Foundry platform, reinforcing the company’s commitment to AI-native drug development. About JSKN016 JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells, blocks the corresponding signaling pathways and releases topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. JSKN016 has demonstrated superior efficacy and a favorable safety pro multiple solid tumors. Multiple clinical studies of JSKN016 as monotherapy and in combination therapies for lung cancer, breast cancer, and other indications have been initiated. The Phase III clinical study evaluating JSKN016 for the treatment of triple-negative breast cancer (TNBC) is currently ongoing. The Phase Ib clinical study in China and the Phase I clinical study in Australia of the subcutaneous formulation of JSKN016 are both ongoing. About Pathos AI Pathos AI is an AI and technology company advancing its own pipeline of cancer therapies. Its Foundry platform redesigns drug development from first principles: identifying clinical assets, making portfolio decisions with continuously updated probability-of-success calculations, and helping clinical teams guide clinical trials with AI-native monitoring. Pathos’s pipeline includes clinical-stage programs in mCRPC, multiple myeloma, MET-altered NSCLC, ER+/HER2- breast cancer, and TROP2/HER3-expressing solid tumors. About Alphamab Oncology Alphamab Oncology (Stock Code: 9966.HK) is an innovative biopharmaceutical company focused on oncology. 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. Two products have 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; and Anbenitamab (KN026, brand name: 恩尼妥®), the first domestically developed HER2 bispecific antibody approved for marketing in China, redefining the standard of treatment for second-line HER2-positive gastric cancer. Six bispecific ADC and dual-payload ADC candidates are currently in clinical development, and next-generation ADC pipelines are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, Glenmark, and Pathos AI, 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, enabling patients to achieve long-term, high-quality survival and delivering China-innovated cancer therapies to benefit patients worldwide. Forward-Looking Statements This press release contains forward-looking statements. These statements involve risks and uncertainties that may cause actual results to differ materially. Pathos AI undertakes no obligation to update any forward-looking statement. Contacts For inquiries, please reach out to press@pathos.com

Phase 1License out/inADCDrug Approval

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

100 Deals associated with Envafolimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15769

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colorectal Cancer	China	3D Medicines (Sichuan) Co., Ltd.	24 Nov 2021
MSI-H/dMMR 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	3D Medicines (Sichuan) Co., Ltd.	16 Apr 2018
Metastatic Biliary Tract Carcinoma	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018
Metastatic gallbladder cancer	Phase 3	China	Suzhou Alphamab Co., Ltd.	16 Apr 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05335460 (ASCO2026)	Phase 2	Colonic Cancer Neoadjuvant	29	XELOX (Oxaliplatin + Capecitabine) + Envafolimab	bphydsodyu(qqohgiikpp) = yqfihufqyf jlphozwkkn (njljmvteqc ) View more	Positive	29 May 2026
NCT05335460 (ASCO2026)	Phase 2	Colonic Cancer Neoadjuvant	29	XELOX (Oxaliplatin + Capecitabine) + Envafolimab (pMMR)	bphydsodyu(qqohgiikpp) = qamjxtzdyb jlphozwkkn (njljmvteqc ) View more	Positive	29 May 2026
NCT03478488 (ASCO2026)	Phase 3	Advanced biliary tract cancer First line	462	Envafolimab+GEMOX	jgdqihlfph(icrncflgtk) = hdmvtptoqf wdafgilucj (uorwtbyhbr ) View more	Positive	29 May 2026
NCT03478488 (ASCO2026)	Phase 3	Advanced biliary tract cancer First line	462	GEMOX	jgdqihlfph(icrncflgtk) = reduuqaumr wdafgilucj (uorwtbyhbr ) View more	Positive	29 May 2026
NCT05410197 (ENLIGHTEN, ASCO2026)	Phase 2	Advanced biliary tract cancer First line	42	Envafolimab + Lenvatinib + Gemcitabine + Cisplatin	ztkegktlrk(ubiuxvmvxl) = jiphgkbbpe ofyuzdcoxy (mlxpkqsbyg, 27.7 - 59) View more	Positive	29 May 2026
NCT06698965 (ESMO_ELCC2026)	Phase 2	Extensive stage Small Cell Lung Cancer First line	52	Trilaciclib 240 mg/m + Envafolimab + EC	keyamagmnt(vgrkhxxpwg) = apgyubkkgs iqxmjikxnq (uyvsncaxut ) View more	Positive	25 Mar 2026
NCT06698965 (ESMO_ELCC2026)	Phase 2	Extensive stage Small Cell Lung Cancer First line	52	Envafolimab + EC	keyamagmnt(vgrkhxxpwg) = hobwzmpxhi iqxmjikxnq (uyvsncaxut ) View more	Positive	25 Mar 2026
NCT06321081 (ASCO_GI2026)	Phase 2	RAS/BRAF wild-type \| MSS	20	Irinotecan + Cetuximab + Envafolimab	uncfwhgwoo(jvsdqkrhrb) = rouscmepus eaicbqtxvn (ewykbvsgng ) View more	Positive	08 Jan 2026
ChiCTR2300074241 (ESMO_ASIA2025)	Phase 2	Biliary Tract Neoplasms Adjuvant	111	Envafolimab + Capecitabine + Lenvatinib	wccesqcjwz(rcrgurolak) = bcznwahvhr skqoerjbuo (rbghfjgqzc ) View more	Positive	05 Dec 2025
ChiCTR2300074241 (ESMO_ASIA2025)	Phase 2	Biliary Tract Neoplasms Adjuvant	111	Conventional Therapy	wccesqcjwz(rcrgurolak) = bfozlccebq skqoerjbuo (rbghfjgqzc ) View more	Positive	05 Dec 2025
NCT05414630 (ESMO_ASIA2025)	Phase 2	Non-Small Cell Lung Cancer Consolidation	30	Envafolimab 300 mg	vmthgezwxd(solnzolieu) = eonfbpkckw utsqgniyos (lrcdxhdjon, 5.62 - NR) View more	Positive	05 Dec 2025
NCT05298020 (ESMO2025) Manual	Phase 2	Metastatic Pancreatic Cancer	12	Envafolimab+RhRh-endostatinemcgemcitabine-panab-paclitaxel	xvyjvycttb(sfqzmpvevt) = enzypogidn fqqbdvijbk (gshlvkivro ) View more	Positive	17 Oct 2025
ESMO2025 Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	41	Envafolimab + CapeOX	itgglwmgeb(lomajwaatm) = nszazilfgq ebmwtarkqj (mudqlmsgxg, 42.6 - 81.3) 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))	cscxpjppgk(kdeqvpqicm) = bfbbjltkhw wcxydyzwfl (azabcrbzob ) View more	Positive	17 Oct 2025

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