SKB518 / Sichuan Kelun Pharma - LARVOL DELTA

Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline (The Manila Times) - "The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026...SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing; SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China; SKB500 (novel ADC): The Phase 2 study is ongoing in China."

New P1/2 trial • Platinum sensitive • Trial status • Cervical Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Peritoneal Cancer • Small Cell Lung Cancer • Solid Tumor

A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors (clinicaltrials.gov) - P2 | N=290 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Monotherapy • New P2 trial • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor • BRCA

A Study of SKB518 in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=192 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=80 ➔ 192 | Trial completion date: Jun 2027 ➔ Oct 2027 | Trial primary completion date: Jun 2027 ➔ Feb 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SKB518 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

SKB518, SKB535/MK-6204 and SKB445: (PRNewswire) - "Novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535."

Licensing / partnership • Trial status • Solid Tumor

A Study of SKB518 in Patients With Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P2 trial • Lung Cancer • Oncology • Solid Tumor

INVESTIGATIONAL NEW DRUG CLEARANCE FOR INNOVATIVE ADC DRUG SKB518 BY THE US FOOD AND DRUG AMINISTRATION (HKEXnews) - "The board (the 'Board') of directors ('Directors') of the Company is pleased to announce that the Company has been granted the clearance of investigational new drug (IND) application to initiate clinical studies of its innovative antibody-drug conjugate (ADC) drug SKB518 from the United States Food and Drug Administration (FDA)."

IND • Solid Tumor

Another innovative ADC drug from Kelun Biotech was approved for clinical trials [Google translation] (Sina Corp) - "On June 18, Kelun Biotech announced that its independently developed innovative antibody-drug conjugate (ADC) SKB518 for injection has been approved for clinical trials in China, and plans to conduct clinical trials in patients with advanced solid tumors. SKB518 for injection is an innovative ADC developed by Kelun Biotech based on the biological characteristics of the target, and has shown good efficacy and safety window in preclinical studies."

New trial • Preclinical • Oncology • Solid Tumor

A Study of SKB518 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P1 trial • Oncology • Solid Tumor