JS212 / Shanghai Junshi Bioscience - LARVOL DELTA

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

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour (clinicaltrials.gov) - P1/2 | N=374 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Trial completion date: Apr 2027 ➔ Dec 2028 | Trial primary completion date: Jul 2026 ➔ Dec 2027

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

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

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=864 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=42 ➔ 78 | Trial completion date: Apr 2027 ➔ Apr 2028 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • ERBB3 • HER-2 • KRAS • NTRK • PD-L1 • RET • ROS1

Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Melanoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

JS212 Combination Therapies in Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment open • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

Preliminary results from a first-in-human phase I/II study of JS212, an EGFR/HER3-targeted bispecific antibody-drug conjugate (ADC), in patients with advanced solid tumors (AACR 2026) - P1/2 | "JS212 showed encouraging antitumor activity across a range of dose levels and multiple solid tumor types with a tolerable safety profile."

ADC • Bispecific • Clinical • First-in-human • IO biomarker • Metastases • P1/2 data • Breast Cancer • Esophageal Squamous Cell Carcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • EGFR • ERBB3 • HER-2

JS212, a novel bispecific ADC targeting EGFR and HER3, demonstrates superior and broad antitumor activity in preclinical evaluation (AACR 2026) - "JS212 also had better antitumor activity than BL-B01D1 in an osimertinib-resistant HCC827 model. Additionally, JS212 induced near complete regression in either BL-B01D1 or patritumab-deruxtecan resistant SW620 model... JS212 is a promising EGFR and HER3 dual targeting ADC that shows superior and broad-spectrum antitumor activities and a favorable safety and pharmacokinetic profiles in preclinical evaluation, supporting its first-in-human studies. Its phase I clinical trial is ongoing, and results will be reported elsewhere."

ADC • Bispecific • First-in-human • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3

A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

#1715: Preclinical evaluation of JS212 (GlobeNewswire) - "Shanghai Junshi Biosciences...announced that early...results from...its innovative pipeline were presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting....In multiple cell-derived xenograft (CDX) models, JS212 showed enhanced antitumor efficacy compared to the benchmark agent. Notably, it demonstrated efficacy in osimertinib-resistant, patritumab deruxtecan-resistant, and BL-B01D1-resistant CDX models."

Preclinical • Solid Tumor

#CT128: Preliminary results from JS212’s first-in-human (FIH) phase 1/2 study in advanced solid tumors (GlobeNewswire) - "Shanghai Junshi Biosciences...announced that early clinical results from four studies across its innovative pipeline were presented at the 2026...AACR Annual Meeting....This FIH phase 1/2 study (NCT06888830) was designed to assess the safety, tolerability, PK, and preliminary efficacy of JS212 in patients with advanced solid tumors....As of March 26, 2026, a total of 63 patients have been enrolled. JS212 was administered every three weeks....In the 4.2 mg/kg and 4.6 mg/kg dose cohorts, ORR reached 44.4% and 50.0% respectively, with a DCR of 100.0% in both groups. The median DoR has not yet been reached. An ORR of 50.0% was observed in HER2-negative breast cancer and 38.9% in esophageal squamous cell carcinoma."

First-in-human • P1/2 data • Esophageal Squamous Cell Carcinoma • HER2 Negative Breast Cancer

A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=280 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

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

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=480 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Monotherapy • New P2 trial • Melanoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

JS212 Combination Therapies in Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Understanding the heat stress mitigation mechanisms during pollen development in Gossypium hirsutum L. (PubMed, Mol Biol Rep) - "Tolerant genotypes showed higher expression of both genes under heat stress as compared to the sensitive genotypes. These results suggest that integration of physiological screening and gene expression profiling provides a reliable approach to screen heat tolerant genotypes and highlights GhADF7 and GhFLA14 as key factors enabling reproductive thermotolerance."

Journal

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=864 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Lung Cancer • Oncology • Solid Tumor

Junshi Biosciences…announced on December 14th that it has received notification from the U.S. Food and Drug Administration (FDA) that its clinical trial application for the EGFR/HER3 bispecific antibody-drug conjugate (code name: JS212) for the treatment of advanced solid tumors has been approved by the FDA [Google translation] (Sina Corp)

IND • Solid Tumor

BioDlink…extends its congratulations to Junshi Biosciences...on receiving Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) for JS212 (News-Medical) - "JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 — two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer."

New trial • Solid Tumor

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour (clinicaltrials.gov) - P1/2 | N=374 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

BioDlink Congratulates Junshi Biosciences on IND Approval of JS212, a Bispecific ADC Therapeutic Candidate (PRNewswire) - "BioDlink congratulates Junshi Biosciences on receiving IND approval from China's NMPA for JS212, the company's first bispecific ADC; JS212 combines dual-targeting antibody technology with a cytotoxic payload, representing a next-generation therapeutic; BioDlink provided end-to-end development and manufacturing support, showcasing its industry-leading ADC capabilities."

New trial • Solid Tumor

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour (clinicaltrials.gov) - P1/2 | N=374 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor

JS212 RECEIVED THE NOTICE OF APPROVAL FOR CLINICAL TRIAL (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that the Company has received the Notice of Approval for Clinical Trial...issued by the National Medical Products Administration. The investigational new drug application for the JS212 injection (project code: 'JS212') has been approved....The application for clinical trial of JS212 injection accepted on 8 January 2025 meets the relevant requirements for drug registration, and it has been approved to conduct clinical trials as a monotherapy in patients with advanced solid tumors."

New trial • Solid Tumor