Junshi Biotech’s first ADC dual drug has been approved for clinical use, with the potential to be widely effective in treating tumors while overcoming drug resistance

March 24, 2025  Source: drugdu 53

Junshi Biotech Advances Dual-Target ADC Therapy JS212 into Clinical Trials
By Thomas Yuan

SHANGHAI — Junshi Biotechnology announced yesterday that it has received official approval from China’s National Medical Products Administration to begin clinical trials for JS212, a novel antibody-drug conjugate (ADC) targeting two key cancer receptors: EGFR and HER3. The investigational drug marks the company’s first dual-drug ADC to enter the clinical phase and signals a major milestone in its pipeline of innovative oncology therapies.

JS212 is a recombinant humanized bispecific antibody conjugate, designed to treat advanced malignant solid tumors such as lung cancer, breast cancer, and head and neck cancers. These tumor types often exhibit high co-expression of EGFR and HER3, which are known to drive cancer proliferation, migration, and resistance to existing therapies.

“JS212 represents an important step forward in our pursuit of precision oncology,” Junshi said in its statement. “Its bispecific targeting could offer broader therapeutic reach and help address EGFR resistance mechanisms in aggressive tumors.”

 

Overcoming Resistance Through Dual Targeting

Unlike traditional single-target ADCs, JS212 is engineered to simultaneously bind EGFR and HER3, two receptors that often function in tandem to sustain tumor growth and evade treatment. HER3 overexpression has been identified as a key contributor to resistance in EGFR inhibitor therapies, especially in patients with metastatic disease.

Preclinical data showed high affinity binding of JS212 to both receptors and significant tumor suppression across various animal models. The drug also demonstrated an acceptable safety profile, laying the foundation for early-stage human trials.

JS212’s design reflects a broader trend in medical technology and biopharmaceutical development, where bispecific platforms are being increasingly used to enhance drug specificity, reduce systemic toxicity, and expand the scope of cancer immunotherapy.

 

A Robust and Competitive Pipeline

Junshi Biotech has emerged as a leading player in China’s life sciences ecosystem, with an expansive pipeline of bispecific antibodies and immuno-oncology therapies. In addition to JS212, its portfolio includes:

  • JS207: a PD-1 × VEGF bispecific antibody for tumor immune modulation,

  • JS213/AWT020: a PD-1 × IL-2 fusion protein under clinical development,

  • JS203: a CD3 × CD20 T cell adaptor targeting hematologic malignancies.

All of these candidates have reached either IND clearance or Phase I clinical trials, highlighting the company’s ability to develop next-generation biologic therapies with diverse mechanisms of action.

 

Market Outlook and Capital Market Sentiment

The approval of JS212 comes at a time when the global ADC market is rapidly expanding, driven by demand for high-value health products and precision medicines targeting complex cancers. While Junshi’s innovation roadmap has drawn attention from the medical community, the company continues to navigate a volatile capital market environment.

Analysts note that JS212’s advancement may lift investor sentiment and expand Junshi’s potential in the competitive oncology therapeutics space. Whether this clinical milestone can reverse recent declines in market valuation remains uncertain, but the scientific and commercial significance of the program is clear.

With clinical trials now underway, Junshi Biotechnology is positioning itself at the frontier of targeted cancer treatment, joining a global push toward smarter, safer medical solutions and reshaping the landscape of next-generation biopharmaceuticals.

By editor
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