Junshi Biosciences (688180.SH): JS212 Clinical Trial Application for Advanced Solid Tumors Approved by US FDA
BEIJING, December 14 – Junshi Biosciences (688180.SH) announced late evening on December 14 that the company recently received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for JS212, an EGFR/HER3 bispecific antibody-drug conjugate (ADC), has been approved for the treatment of advanced solid tumors.
According to the announcement, JS212 is a recombinant humanized bispecific ADC targeting the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is primarily intended for the treatment of advanced malignant solid tumors. The company stated that the drug can bind to EGFR or HER3 to exert tumor-inhibiting effects, is expected to be effective against a broader range of tumors such as lung cancer and colorectal cancer, and may potentially overcome drug resistance issues. Preclinical studies showed that JS212 demonstrated significant tumor suppression and acceptable safety in multiple animal models.
The drug’s application was previously accepted by the National Medical Products Administration (NMPA) in January 2025 and approved in March 2025. Currently, JS212 is undergoing a Phase I/II clinical trial for advanced solid tumors in mainland China, and the IND application for its multi-cohort combination therapy clinical trial was also approved by the NMPA in November 2025.
For the first three quarters of the year, Junshi Biosciences achieved a total operating revenue of 1.806 billion CNY, representing a year-over-year increase of 42.06%.

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