BioDlink, a leading global CDMO, extends its congratulations to Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) for JS212, a bispecific antibody-drug conjugate (ADC) designed to target both EGFR and HER3 receptors.
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. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.
"As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in ADC research, development and manufacturing. The IND approval of JS212 — a technically demanding bispecific ADC — highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We're honored to support the advancement of this important program."
Dr. Jun Liu, CEO and Executive Director of BioDlink
"We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future."
Dr. Jing Tong, Deputy Director of Junshi Biosciences' Innovation Research Institute
BioDlink is a trusted CDMO biologics partner, operating a large-scale, GMP-compliant manufacturing site with integrated production lines dedicated to antibodies and ADCs. Its comprehensive ADC platform, underpinned by advanced R&D capabilities, enables centralized and efficient production of antibody intermediates, drug substances, and finished products—accelerating timelines, minimizing tech transfer costs, and meeting the rigorous standards of global GMP audits.