JS212 / Shanghai Junshi Biosci - LARVOL DELTA

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