CS1002 (ipilimumab biosimilar) / CStone Pharma, Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase III Study of SHR-8068 in Combination With Adebrelimab and Platinum-Containing Chemotherapy Versus Durvalumab in Combination With Platinum-Containing Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer (BTC) (clinicaltrials.gov) - P3 | N=604 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Other Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom (clinicaltrials.gov) - P1/2 | N=139 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

CATALIS: Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

dMMR • Mismatch repair • MSI-H • New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Oncology • Solid Tumor

A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=460 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer (clinicaltrials.gov) - P2 | N=153 | Active, not recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | N=240 ➔ 153 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Hengrui Pharmaceuticals’ SHR-8068 Gains NMPA Approval for NSCLC and Colorectal Cancer Trials (flcube.com) - "China-based Jiangsu Hengrui Pharmaceuticals...announced that the National Medical Products Administration (NMPA) has approved SHR-8068 injection for two clinical trials. The trials will evaluate SHR-8068 in combination with aumolertinib for advanced non-small cell lung cancer (NSCLC) and with anti-tumor drugs (adebrelimab, bevacizumab, or apatinib) for colorectal cancer."

New trial • Colorectal Cancer • Non Small Cell Lung Cancer

A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P2 trial • Oncology • Solid Tumor

2025 ASCO | Hengrui Medicine's SHR-8068 combined with Adebelimumab and Bevacizumab for the treatment of advanced hepatocellular carcinoma study results released [Google translation] (Jiangsu Hengrui Press Release) - P1b/2 | N=129 | NCT05444088 | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | "At this meeting, the results of a national multicenter study...were disclosed....As of October 31, 2024, a total of 101 subjects were enrolled....In the combined cohort 2 (SHR-8068 4 mg/kg single agent combined with adebelimumab and bevacizumab), the ORR assessed by the researchers based on RECIST v1.1 was 47.2% (25/53; 95% CI 33.3-61.4%), the median DoR was 12.7 months (95% CI 5.8-NR), and the median PFS reached 8.7 months (95% CI 5.5-11.6). Numerically, the ORR and survival results of the combined cohort 2 were higher than those of the combined cohorts 1 and 3....Overall, the safety of SHR-8068 combined with adebelimumab and bevacizumab was controllable, and no new safety signals were found."

P1/2 data • Hepatocellular Cancer

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation (The Manila Times) - "The 2025 ASCO Annual Meeting successfully concluded in Chicago on June 3 (local time). Hengrui Pharma delivered a strong international presence, featuring 15 innovative drugs and 72 research outcomes. These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts."

Clinical data • Breast Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

SHR-8068 plus adebrelimab and bevacizumab for advanced hepatocellular carcinoma (aHCC): A phase 1b/2 study. (ASCO 2025) - P1/2, P3 | "SHR-8068 combined with adebrelimab and bevacizumab showed promising efficacy and manageable safety in aHCC. A more favorable benefit-risk profile was observed for SHR-8068 given as a priming dose. A phase 3 trial (NCT06618664) is currently underway to further assess the combination as 1L treatment for aHCC."

Metastases • P1/2 data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P1/2 trial • Cervical Cancer • Oncology • Solid Tumor

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=876 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Hengrui Medicine (600276.SH) subsidiary obtains clinical trial approval for SHR-A1811 combination regimen for injection [Google translation] (Sina Corp) - "Hengrui Medicine...announced that its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Shanghai Shengdi Pharmaceutical Co., Ltd. received the 'Drug Clinical Trial Approval Notice' for SHR-A1811 for injection, bevacizumab injection, adebelimumab injection, and SHR-8068 injection approved by the National Medical Products Administration. The clinical trial is specifically: an open, multicenter Phase Ib/II clinical study of the combination regimen of SHR-A1811 for injection in the treatment of advanced solid tumors."

New P1/2 trial • Oncology • Solid Tumor

A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

A clinical study of SHR8068 combined with adebrelimab and irinotecan liposomes in the treatment of advanced metastatic esophageal squamous cell carcinoma after first-line PD-1/PD-L1 monoclonal antibody therapy failure (ChiCTR) - P2 | N=46 | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-1 • PD-L1