RC148 / Rongchang Pharma, AbbVie - LARVOL DELTA

RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA) (ESMO 2025) - P1/2 | "RC118 plus toripalimab (Tor) or RC148 is expected to enhance antitumor activity. Conclusions RC118 plus either RC148 or Tor showed promising ORR and manageable safety in CLDN18.2-positive la/m G/GEJA. A trend toward improved PFS was observed with RC118 + RC148."

IO biomarker • Late-breaking abstract • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • PD-L1

A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=700 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

New P2/3 trial • Colorectal Cancer • Oncology • Solid Tumor

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: RemeGen Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC) (clinicaltrials.gov) - P3 | N=574 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

AbbVie and RemeGen Announce Exclusive Licensing Agreement to Develop A Novel Bispecific Antibody for Advanced Solid Tumors (AbbVie Press Release) - "RC148 is a novel PD-1/VEGF bispecific antibody being evaluated in multiple advanced solid tumors including certain lung cancers....Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory. RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory."

Licensing / partnership • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A Phase 1/2 Study of RC148 (PD-1/VEGF bispecific antibody) monotherapy or in combination with docetaxel for the treatment of first- or second-line locally advanced or metastatic non-small-cell lung cancer (la/mNSCLC) without actionable genomic alterations (AGA) (ESMO-IO 2025) - P1/2 | "ORR: objective response rate; DCR: disease control rate; PFS: progression-free survival; CI: confidence interval; NR: not reached.Conclusions RC148 monotherapy showed encouraging anti-tumor activity and an acceptable safety profile in 1L PD-L1-positive la/m NSCLC pts. RC148 + docetaxel also showed promising efficacy in la/m NSCLC pts who were previously treated with PD-(L)1 inhibitor and platinum-based chemo; the dose of 20mg/kg Q3W was well-tolerated and demonstrated more favorable efficacy over 10mg/kg Q3W and thus, selected as the optimal dose."

Clinical • Combination therapy • Metastases • Monotherapy • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Rongchang Biopharma (09995): The National Medical Products Administration's Center for Drug Evaluation has granted Breakthrough Therapy Designation to RC148 for the treatment of non-small cell lung cancer. [Google translation] (Zhitong Finance) - "The inclusion of RC148 in the Breakthrough Therapy designation by the CDE is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China."

Breakthrough therapy • Non Small Cell Lung Cancer

RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA (PRNewswire) - "On August 8th, RemeGen Co., Ltd...announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US."

IND • New P2 trial • Oncology • Solid Tumor

Efficacy and safety of disitamab vedotin in combination with RC148 versus albumin-bound paclitaxel ± toripalimab for patients with HR-negative HER2-low-expressing unresectable locally advanced or metastatic breast cancer: An open-label, randomized, controlled phase II study. (ASCO 2025) - P2 | "The secondary endpoints are ORR in the PD-L1-positive pts; investigator-assessed progression-free survival, disease control rate, duration of response, and overall survival in all pts and the PD-L1-positive pts. This study was initiated in August 2024."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Monotherapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Feb 2025

Enrollment open • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=25 ➔ 221

Enrollment change • Phase classification • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Combination therapy • Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

RC148, a novel bispecific antibody targeting PD-1 and VEGF for cancer immunotherapy (AACR 2024) - "RC148 allows dimeric VEGF crosslinking and gradually enhances PD-1 binding activity, potentially reduces systemic toxicity of anti-VEGF therapy and enhances antitumor potency via VEGF trigged enrichment in tumor areas. In preclinical studies, RC148 blocks the binding of VEGF to VEGFR and PD-1 to PD-L1, prevents the growth and migration of human umbilical vein endothelial cells, enables efficient T cell activation, exhibited synergistic antitumor effects in rodent models and showed safety profiles in non-human primate studies."

Oncology

A Study of RC148 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • PD-1