JS111 / Suzhou Junjing Biomedical, Shanghai Junshi Bioscience - LARVOL DELTA

AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=32 | Terminated | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | N=156 ➔ 32 | Recruiting ➔ Terminated; The study was stopped because of a change in the study strategy

Enrollment change • First-in-human • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Huan Zhou

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

JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations (clinicaltrials.gov) - P1/2 | N=44 | Active, not recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2027 ➔ Sep 2028 | Trial primary completion date: Dec 2025 ➔ Jul 2028

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

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

JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd. | Not yet recruiting ➔ Recruiting

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

JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Suzhou Junjing BioSciences Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AP-L1898 Capsule in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2; N=156; Recruiting; Sponsor: Suzhou Junjing BioSciences Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Junshi Bio’s EGFR inhibitor nodded for NSCLC study in China (GBI Health) - "Shanghai-based biotech Junshi Biosciences (HKEX:1877; SSE:688180) announced receipt of a clinical trial approval from the National Medical Products Administration (NMPA) in China for JS111 (APL1898), the firm’s pipeline tyrosine kinase inhibitor (TKI) targeting epidermal growth factor receptor (EGFR) exon20 insertion and other rare mutations. The drug can now be assessed in advanced non-small cell lung cancer (NSCLC)."

Non-US regulatory • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Junshi Biology JS111 Project Obtained Notification of Acceptance of Drug Clinical Trial Application [Google translation] (Eastmoney.com) - "Junshi Biopharmaceutical issued an announcement stating that Suzhou Junjing Biomedical Technology Co., Ltd., which was jointly invested by the company and Weijing Biomedical Technology...received the National Drug Administration. Board approved the issuance of the 'acceptance notice book', EGFR inhibitors uncommon mutant capsules AP-L1898 (item code-named 'JS111') clinical trial application is accepted...The development of JS111 is expected to bring new treatments to cancer patients with EGFR mutations such as EGFRexon20 insertion mutations."

Non-US regulatory • Oncology