Envafolimab(KN035)* is an independently developed subcutaneous PD-L1 single-domain antibody Fc fusion protein. It was approved for marketing in China in November 2021, for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors.
Envafolimab efficiently blocks the binding of PD-1 and PD-L1, thereby activating an immune response against tumors. With a molecular weight half that of a conventional antibody, it exhibits enhanced tissue penetration and reaches tumor tissues via the lymphatic circulation system.
KN035 : Crystal Structure
Envafolimab offers significant advantages in convenience and compliance by avoiding intravenous infusion and can be administered in just 30 seconds, making it particularly suitable for frail, elderly, or IV-intolerant patients.
Multiple clinical trials for Envafolimab are currently underway to further expand its indications.
Envafolimab has been granted two Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) for the treatment of advanced biliary tract cancer and soft tissue sarcoma; it has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) for the treatment of unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H).
ASCO 2020 poster：Envafolimab (KN035) in advanced tumors with mismatch-repair deficiency
ASCO 2019 poster：Phase I Study of KN035, the first subcutaneously administered, novel fusion Anti-PD-L1 Antibody in Patients with Advanced Solid Tumors in China
ESMO 2018 poster：Phase I Study of KN035, a novel fusion anti-PD-L1 antibody administered subcutaneously in Patients with Advanced Solid Tumors in the USA
Anbenitamab (KN026)* is an anti-HER2 bispecific antibody developed using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). Anbenitamab can simultaneously bind two non-overlapping epitopes of HER2, resulting in HER2 signal blockade. Through antibody-induced receptor clustering, it enhances ADCC and CDC effects while promoting the down-regulation of HER2 receptors on the cell surface.
KN026 : Crystal Structure
In September 2025, the first New Drug Application (NDA) for anbenitamab injection has been accepted by the National Medical Products Administration (NMPA) for the treatment of HER2-positive gastric cancer (GC). Currently, several pivotal clinical trials of KN026 for second-line or above HER2-positive GC/gastroesophageal junction cancer (GEJ), first-line HER2-positive breast cancer (BC), neoadjuvant treatment of HER2-positive BC are being conducted.
Anbenitamab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive or low expressing GC; it has been granted Breakthrough Therapy Designation by NMPA for the treatment of patients with HER2-positive GC/GEJ who have failed first-line standard treatment.
SABCS 2022 poster：KN026 in combination with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer: A single arm, multicenter, phase 2 study
ASCO 2022 poster：A phase II study evaluating KN026 monotherapy in patients with previously treated, advanced HER2-expressing gastric or gastroesophageal junction cancers
ASCO 2021 Abstract：The Preliminary Efficacy of KN026 (Anti-HER2 BsAb) in Advanced Gastric and Gastroesophageal Junction Cancer Patients with HER2 Expression
Anbenitamab repodatecan (JSKN003) is developed by site-specific conjugation to the Fc glycans of anbenitamab (KN026), resulting in a homogeneous and stable ADC with a drug-to-antibody ratio (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.
Patient enrollment has been completed for the Phase III clinical trial of JSKN003 in second-line HER2-positive breast cancer (BC), and a New Drug Application (NDA) is expected to be submitted in 2026. Additionally, several other registrational studies are ongoing, including trials in 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.
ESMO 2025 poster：Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC)
ESMO 2025 poster：Efficacy and Safety of JSKN003, a Biparatopic anti-HER2 Antibody Drug Conjugate (ADC), in Patients with HER2-positive Metastatic Colorectal Cancer (mCRC)
ASCO 2025 poster：JSKN003, a biparatopic HER2-targeting ADC, in heavily pretreated HER2-positive breast cancer: A pooled analysis of early-phase studies
ESMO 2024 poster：JSKN003, a HER2-targeting antibody-drug conjugate, in patients with platinum-resistant ovarian cancer: A pooled analysis of two studies
ESMO 2024 poster：Evaluation of the safety and efficacy of JSKN003 in patients with advanced HER2-positive (IHC 3+) solid tumors (excluding breast cancer)
ASCO 2024 poster：Evaluation of the safety, pharmacokinetics, and efficacy of JSKN003 in patients with advanced solid tumors: A phase I/II clinical study
JSKN016 is a TROP2/HER3 bispecific antibody-drug conjugate (ADC) independently developed using the proprietary single-domain antibody and glycan-specific conjugation platform.
JSKN016 binds to TROP2 and/or HER3 on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects.
JSKN016 has demonstrated promising antitumor activity and a favorable safety profile across multiple solid tumors. Dose optimization and dose confirmation have been completed, and it is poised to advance into Phase III clinical studies.
JSKN033 is an independently developed high-concentration subcutaneous formulation, combining the ADC (JSKN003)* with PD-L1(Envafolimab)* .
JSKN033 combines the benefits of immunotherapy and ADCs while enhancing safety and convenience through subcutaneous administration.
Currently, Phase I/II clinical trials of JSKN033 for the treatment of solid tumors is being conducted in China and Australia.
JSKN022 is a first-in-class antibody-drug conjugate (ADC) targeting both PD-L1 and integrin αvβ6. It is produced through enzymatic catalysis of glycans followed by a click chemistry reaction, resulting in a site-specific conjugate with a drug-to-antibody ratio (DAR) of approximately 4.
The molecule is designed to bind to PD-L1 and/or integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The linker is hydrolyzed by proteolytic enzymes, releasing cytotoxic topoisomerase I inhibitor, which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can block TGFβ signaling to modulate immune function, and kill antigen-negative cells through the bystander effect, thereby achieving multiple anti-tumor activity.
The Phase I clinical study of JSKN022 has been conducted in China.
KN019 is a biosimilar of Belatacept (Nulojix®).
KN019 has completed Phase II clinical study with positive results. In November 2023, KN019 received clinical trial approval from the National Medical Products Administration (NMPA) for its subcutaneous formulation.
KN046 is an independently developed PD-L1/CTLA-4 bispecific antibody, engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.
Multiple clinical trials of KN046 are ongoing in China, the U.S., and Australia.
KN046 : Crystal Structure
KN046 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of thymic epithelial tumors.
ESMO 2023 poster：KN046 in Patients with ≥2L R/M Thymic Carcinoma: A Prospective, Single-arm, Multi-center, Phase 2 Study
WCLC 2020 Mini oral report：Preliminary safety, efficacy results of KN046 (bispecific anti-PD-L1/CTLA4) in subjects with rare thoracic tumors
WCLC 2020 poster：A phase II study of KN046 (a bispecific anti-PDL1/CTLA-4) in patients (pts) with metastatic nonsmall cell lung cancer (NSCLC)
ASCO-GI 2020 poster：The preliminary efficacy and safety of KN046 plus concurrent chemoradiation therapy in recurrent and metastatic esophageal squamous cell carcinoma
ASCO 2020 poster：The preliminary efficacy and safety data of KN046 (bispecific anti-PD-L1/CTLA4) in patients failed on prior immune checkpoint inhibitors therapy
