China's National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) approval for JS212, a novel bispecific antibody-drug conjugate (ADC) developed by Junshi Biosciences. The approval marks a significant advancement in next-generation ADC therapeutics and allows the company to initiate clinical trials for this innovative oncology candidate.
JS212 represents a new class of bispecific ADCs that simultaneously target two critical tumor-associated proteins: epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). Both targets are highly expressed across multiple tumor types, including lung cancer, breast cancer, and head and neck cancer.
Dual-Targeting Mechanism Offers Potential Advantages
Unlike conventional ADCs that target a single protein, JS212's bispecific design enables it to attack tumors through either EGFR or HER3 pathways. This dual-targeting approach potentially increases the therapeutic's effectiveness against a broader range of cancers while helping overcome the drug resistance that often develops with single-target therapies.
Dr. Jing Tong, Deputy Director of Junshi Biosciences' Innovation Research Institute, highlighted the significance of the approval: "This 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."
Strategic CDMO Partnership
The development of JS212 was supported by BioDlink, a contract development and manufacturing organization (CDMO) specializing in complex biologics. BioDlink provided end-to-end development and manufacturing support for the technically demanding bispecific ADC.
"As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics," stated Dr. Jun Liu, CEO and Executive Director of BioDlink. "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."
BioDlink's contribution included leveraging its comprehensive ADC platform, which enables efficient, centralized production of antibody intermediates, drug substances, and finished products. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.
Expanding the ADC Landscape
Antibody-drug conjugates have emerged as a powerful class of cancer therapeutics that combine the targeting precision of monoclonal antibodies with the cytotoxic potency of small molecule drugs. The field has seen significant growth in recent years, with several ADCs gaining regulatory approval for various cancer indications.
Bispecific ADCs represent the next evolution in this therapeutic approach, potentially addressing limitations of first-generation ADCs by expanding target engagement and reducing escape mechanisms that lead to treatment resistance.
About Junshi Biosciences
Founded in 2012, Junshi Biosciences has built a diverse R&D pipeline comprising over 50 drug candidates across five therapeutic areas: cancer, autoimmune, metabolic, neurological, and infectious diseases. The company has already secured approvals for five products in China and international markets, including toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody.
With approximately 2,500 employees across China and the United States, Junshi Biosciences operates under the mission of "providing patients with world-class, trustworthy, affordable, and innovative drugs."
The timeline for JS212's clinical development and potential target indications for initial trials have not yet been disclosed. However, the IND approval represents a significant milestone in advancing this novel bispecific ADC toward clinical evaluation.
