TQB2868 / Sino Biopharm - LARVOL DELTA

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (clinicaltrials.gov) - P3 | N=566 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P3 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

SINO BIOPHARM's TQB2868 Injection Approved by CDE for Phase III Clinical Study (iis.aastocks.com) - "SINO BIOPHARM...announced that TQB2868 injection 'PD-1/TGF-β bi-functional fusion protein', a Class 1 innovative drug developed by the Group, combined with anlotinib hydrochloride capsules and chemotherapy as first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) demonstrated excellent efficacy and good safety in early clinical trials. The Group recently submitted an application for a Phase III clinical study of the drug to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China and received written approval from the CDE to initiate the study."

New P3 trial • Pancreatic Ductal Adenocarcinoma

TQB2868 combined with anlotinib and nab-paclitaxel plus gemcitabine as first-line treatment for metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase 2 study. (ASCO 2025) - P2 | "TQB2868 combination regimen as first-line treatment was demonstrated to be tolerable, with promising anti-tumor activity in mPDAC."

Clinical • IO biomarker • Metastases • P2 data • Anemia • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Thrombocytopenia • PD-1 • TGFB1

DATA FROM PHASE II STUDY OF TQB2868 'PD-1/TGF-β BI-FUNCTIONAL FUSION PROTEIN' PRESENTED AT 2025 ASCO ANNUAL MEETING (HKEXnews) - P2 | N=50 | NCT06767813 | "As of January 2025, 40 patients suffering stage IV mPDAC have been enrolled in the study, 36 of which were evaluable. The preliminary data showed that: the objective remission rate (ORR) of TQB2868 combined with anlotinib and AG chemotherapy was 63.9%, which was 2-3 times that of the historical data of the AG chemotherapy regimen (23%-36%); the disease control rate (DCR) was 100%, which was 1.6 times that of the AG chemotherapy regimen (62.3%); the median progression-free survival (PFS) was not yet achieved, and the 6-month PFS rate was 86%, which was 2 times that of the AG chemotherapy regimen (43.2%); the median overall survival (OS) was not yet achieved, and it is expected to be over 1 year."

P2 data • Pancreatic Ductal Adenocarcinoma

Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and Safety of HAIC in Combination With TQB2868 and Ramucirumab for Second-line Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Fudan University

Combination therapy • Metastases • New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=39 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cervical Cancer • Oncology • Solid Tumor

A Trial of TQB2868 Plus Platinum-based Chemotherapy With or Without Bevacizumab in the First-line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

IO biomarker • Metastases • New P2 trial • Cervical Cancer • Oncology • Solid Tumor • CD8

Clinical Trial of TQB2868 Injection in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=280 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2022 ➔ Apr 2022

Enrollment open • IO biomarker • Trial initiation date • Oncology • Solid Tumor • PD-L1 • TGFB1