SHR-2002 / Jiangsu Hengrui Pharma - LARVOL DELTA

Announcement fromJiangsu Hengrui Pharmaceutical Co., Ltd. on its subsidiary’s receipt of drug clinical trial approval notice [Google translation] (Shanghai Securities News) - "Recently, Shanghai Shengdi Pharmaceutical Co., Ltd. and Suzhou Shengdia Biopharmaceutical Co., Ltd., subsidiaries of Jiangsu Hengrui Pharmaceutical Co., Ltd...received approval from the State Food and Drug Administration (hereinafter referred to as the 'State Food and Drug Administration') The 'Drug Clinical Trial Approval Notice' for aderbelimab injection, SHR-2002 injection and SHR-8068 injection was approved and issued, and clinical trials will be carried out in the near future."

New trial • Oncology • Solid Tumor

A phase II study of SHR-2002 combined with Adebrelimab and Docetaxel in Advanced Non-small-cell lung Cancer (NSCLC) with negative driver genes previously treated with immunosuppressive agents and platinum-based doublet-chemotherapy (ChiCTR) - P2 | N=16 | Not yet recruiting | Sponsor: Fujian Cancer Hospital; Fujian Cancer Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Atridia Pty Ltd. | Active, not recruiting ➔ Completed | N=50 ➔ 19 | Trial completion date: Sep 2025 ➔ Feb 2024 | Trial primary completion date: Jul 2025 ➔ Jul 2023

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

LAE113, a novel TIGIT/PVRIG bispecific antibody for the treatment of cancer (SITC 2023) - "Conclusions LAE113 is an extremely potent TIGIT and PVRIG signaling blocker, outperforming existing competitors (Tiragolumab, COM701, SHR-2002 and SIM0348) in modulating T cell and NK cell functions, and exhibiting a favorable developability profile. It significantly enhanced T cell activity when combined with PD-L1 blockade. These findings suggest that LAE113 holds great promise as a candidate for cancer immunotherapy."

Oncology • CD8 • IFNG • NECTIN2 • PVR • TIGIT

Subsidiary of Hengrui Medicine (600276.SH) Obtained Clinical Trial Approval for adebrelimab Injection and SHR-2002 for Injection [google translation] (Zhitong Finance) - "Zhitong Finance APP news, Hengrui Medicine...announced that recently, the company's subsidiaries Shanghai Shengdia Pharmaceutical Co., Ltd. and Suzhou Shengdia Biomedicine Co., Ltd. Bureau) approved the issuance of the 'Drug Clinical Trial Approval Notification' for adebrelimab injection and SHR-2002 for injection, and clinical trials will be carried out in the near future."

New trial • Oncology

A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients (clinicaltrials.gov) - P1 | N=240 | Enrolling by invitation | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Combination therapy • Enrollment open • Oncology

A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients (clinicaltrials.gov) - P1; N=240; Not yet recruiting; Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Combination therapy • New P1 trial • Oncology

Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Atridia Pty Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Oncology