BAT3306 (pembrolizumab biosimilar) / Bio-Thera Solutions - LARVOL DELTA

Bio-Thera Solutions…announced a licensing agreement with Avalon Pharma, granting the Saudi Arabia‑headquartered company exclusive rights to distribute and market BAT3306, a biosimilar version of Merck’s Keytruda (pembrolizumab), in Saudi Arabia and the entire North Africa region (flcube.com) - "Financial terms were not disclosed....Next Steps: Regulatory filings in China expected Q2 2026; Avalon to initiate market access activities in Saudi Arabia Q3 2026."

China filing • Licensing / partnership • Solid Tumor

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

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

A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (clinicaltrials.gov) - P3 | N=162 | Terminated | Sponsor: Bio-Thera Solutions | N=676 ➔ 162 | Trial completion date: Oct 2028 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2027 ➔ Jul 2025; The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=59 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jun 2024 | Trial primary completion date: Jan 2025 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (clinicaltrials.gov) - P3 | N=676 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda (Pembrolizumab) (PRNewswire) - "Bio-Thera Solutions...announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda in non-squamous non-small cell lung cancer (nsNSCLC) patients. The study is expected to enroll approximately 676 patients."

Trial status • Non Small Cell Lung Cancer

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=59 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | N=98 ➔ 59

Enrollment change • Enrollment closed

A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (clinicaltrials.gov) - P3 | N=676 | Not yet recruiting | Sponsor: Bio-Thera Solutions

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

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | N=195 ➔ 98

Enrollment change • Enrollment open