BAT1308 / Bio-Thera Solutions - LARVOL DELTA

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=59 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed | N=148 ➔ 59

Enrollment change • Trial completion • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • PD-L1

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Solid Tumor

BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer (clinicaltrials.gov) - P2/3 | N=5 | Terminated | Sponsor: Bio-Thera Solutions | N=140 ➔ 5 | Trial completion date: Dec 2025 ➔ Aug 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Nov 2025 ➔ May 2025; Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.

dMMR • Enrollment change • Mismatch repair • Trial completion date • Trial primary completion date • Trial termination • Endometrial Cancer • Oncology • Solid Tumor

Primary efficacy and safety results of BAT1308, a PD-1 inhibitor, + chemotherapy ± bevacizumab in phase 2 trial for persistent, recurrent, or metastatic cervical cancer. (ASCO 2025) - P2/3 | "Patients received BAT1308 (300 mg Q3W for up to 24 months) plus platinum-based chemotherapy (paclitaxel 175 mg/m2 + cisplatin 50 mg/ m2 or carboplatin AUC 5) and, per investigator discretion, bevacizumab (15 mg/kg). BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy showed durable anti-tumor activity and manageable safety profile for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. These data are consistent with the earlier results and provide support for further studies."

Clinical • Metastases • P2 data • Alopecia • Anemia • Cervical Cancer • Immunology • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Thrombocytopenia

Bio-Thera Solutions Presents Clinical Data for multiple products at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "Bio-Thera Solutions Inc...will have an oral presentation in collaboration with medical centers at the 2025 ASCO Annual Meeting entitled 'Safety and efficacy of BAT8006, a Folate Receptor α (FRα) antibody drug conjugate (ADC), in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial'. Three posters will be also presented in the poster session, covering TROP2-ADC BAT8008, HER2-ADC BAT8010, BAT1006 (an ADCC-enhanced anti-HER2 mAb with a different epitope from BAT8010) , and a novel PD-1 mAb BAT1308 in various solid tumors."

Clinical data • Platinum resistant • Cervical Cancer • Ovarian Cancer • Solid Tumor

BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer (clinicaltrials.gov) - P2/3 | N=140 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Nov 2024 ➔ Nov 2025

dMMR • Mismatch repair • Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor

BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer (clinicaltrials.gov) - P2/3 | N=526 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2024 ➔ Jan 2027 | Trial primary completion date: Apr 2024 ➔ Sep 2026

Enrollment open • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy with BAT1308 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=148 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Mar 2025

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Bio-Thera Solutions | N=204 ➔ 112

Enrollment change • Metastases • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=204 | Recruiting | Sponsor: Bio-Thera Solutions | N=50 ➔ 204

Enrollment change • Metastases • Oncology • Solid Tumor

BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer (clinicaltrials.gov) - P2/3 | N=140 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2027 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Nov 2024

Combination therapy • Enrollment closed • Metastases • Mismatch repair • Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Biotech’s BAT1308 (PD-1) combined with BAT8006 (ADC-FRα) has received clinical approval for the treatment of advanced solid tumors [Google translation] (Bio-thera Press Release) - "Biotech Biopharmaceutical...The company announced today that it has received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, and the company's clinical trial application for the company's research drug BAT1308 combined with BAT8006 for the treatment of advanced solid tumors has been approved."

New trial • Solid Tumor

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1/2 trial • Oncology • Solid Tumor

BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer (clinicaltrials.gov) - P2/3 | N=140 | Recruiting | Sponsor: Bio-Thera Solutions

Combination therapy • Metastases • Mismatch repair • New P2/3 trial • Endometrial Cancer • Oncology • Solid Tumor

Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Biotech (688177.SH): Clinical trial application for BAT8008 combined with BAT1308 in the treatment of advanced solid tumors was approved [Google translation] (Investing.com) - "Zhitong Finance APP news, Biotech...announced that the company has recently received the 'Drug Clinical Trial Approval Notice' approved and issued by the State Food and Drug Administration...The company is developing The clinical trial application for the drug BAT8008 combined with BAT1308 to treat advanced solid tumors was approved."

New trial • Oncology • Solid Tumor

Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1 | N=210 | Not yet recruiting | Sponsor: Bio-Thera Solutions

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

Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1 | N=210 | Not yet recruiting | Sponsor: Bio-Thera Solutions

Metastases • New P1 trial • Oncology • Solid Tumor

BAT1308 Combined With Platinum-Based Chemotherapy± Bevacizumab For PDL1-Positive (CPS ≥1) Cervical Cancer (clinicaltrials.gov) - P2/3 | N=526 | Not yet recruiting | Sponsor: Bio-Thera Solutions

Metastases • New P2/3 trial • Cervical Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • PD-L1

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Bio-Thera Solutions | N=29 ➔ 13 | Trial completion date: Jun 2024 ➔ Mar 2023 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Mar 2023; Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.

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

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Bio-Thera Solutions | N=29 ➔ 13 | Trial completion date: Dec 2024 ➔ Mar 2023 | Not yet recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Mar 2023; Considering that the high budget will affect the subsequent development, it is decided to terminate the test voluntarily

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

Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients (clinicaltrials.gov) - P1 | N=29 | Recruiting | Sponsor: Bio-Thera Solutions | Trial primary completion date: Oct 2022 ➔ Oct 2023

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

Bio-Thera Solutions Announces First Patient Dosed in a Phase 1 Study in Australia Evaluating BAT6026, an Anti-OX40 Antibody with Enhanced ADCC Effect, in Combination with BAT1308, an Anti-PD-1 Antibody (Businesswire) - "Bio-Thera Solutions, Ltd...announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials...This Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of the combination of BAT6026 and BAT1308 in advanced solid tumor patients."

Trial status • Oncology • Solid Tumor

Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT1308 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=148; Recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MRI • PD-1 • PD-L1