JS212 / Shanghai Junshi Biosci - LARVOL DELTA

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) - "Abstract is embargoed at this time."

ADC • Bispecific • Clinical • First-in-human • Metastases • P1/2 data • Oncology • Solid Tumor

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 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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

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

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