HRS-7058 / Jiangsu Hengrui Pharma - LARVOL DELTA

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma’s Emerging Innovation Power (The Manila Times) - "This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology."

Clinical data • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

HRS-7058, a KRAS G12C inhibitor (G12Ci), in advanced solid tumors with KRAS G12C mutation: A phase I, multi-center, first-in-human study (ESMO 2025) - P1 | "ORR and DCR was 23.1% and 100.0% in KRAS G12Ci-pretreated NSCLC, 43.8% and 87.5% in CRC, 100.0% and 100.0% in PDAC. Conclusions HRS-7058 was well tolerated and showed promising antitumor activity in multiple tumor types with KRAS G12C mutation, including NSCLC (KRAS G12Ci naive or prior KRAS G12Ci), CRC and PDAC."

Clinical • First-in-human • Metastases • P1 data • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors. (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors. (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Oncology • Solid Tumor

A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Solid Tumor

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Oncology • Solid Tumor

A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour (clinicaltrials.gov) - P1 | N=151 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor