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Colorectal cancer

Alphamab Oncology's JSKN003 Receives Breakthrough Therapy Designation for Advanced Colorectal Cancer

Strategic Insights

— 2 min read

Alphamab Oncology, a biopharmaceutical company, has made significant strides in its cancer treatment pipeline with the recent breakthrough therapy designation of its bispecific ADC, JSKN003, for advanced colorectal cancer (CRC). This marks the third breakthrough therapy designation for JSKN003, following its approvals for platinum-resistant ovarian cancer and gastric cancer. JSKN003 has demonstrated notable efficacy and a favorable safety profile in clinical studies, showcasing promising therapeutic advantages over existing treatments for patients with HER2-positive advanced CRC.

Key Takeaways:

  • JSKN003, a bispecific ADC developed by Alphamab Oncology, has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan.
  • The designation is the third breakthrough therapy designation for JSKN003, following its approvals for platinum-resistant ovarian cancer and gastric cancer.
  • Clinical studies have demonstrated that JSKN003 monotherapy exhibited a 68.8% overall response rate (ORR) and a disease control rate (DCR) of 96.9% among 32 efficacy-evaluable patients with HER2-positive advanced CRC.
  • JSKN003 has shown a median progression-free survival (mPFS) of 11.04 months and a median overall survival (mOS) of approximately 7 to 10 months, with a 9-month PFS rate of 66.6% among BRAF V600E wild-type patients.
  • In comparison, trastuzumab deruxtecan (DS-8201) previously reported an ORR of 37.8%, a PFS of 5.8 months, and Grade 3 or above adverse events in nearly 50% of patients.
  • JSKN003 is currently being evaluated in multiple Phase II and Phase III clinical studies in China for the treatment of various solid tumors, including breast cancer, ovarian cancer, and gastric cancer.
  • Alphamab Oncology has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms.

Statistics:

  • Approximately 1.93 million newly diagnosed cases and about 903,900 deaths attributed to CRC globally in 2022 (International Agency for Research on Cancer, IARC).
  • CRC has the second-highest incidence after lung cancer in China, with over 500,000 new cases annually and a continuing upward trend.
  • Median progression-free survival (mPFS) of approved therapies for HER2-positive advanced CRC is only 2.0 to 3.7 months, and the median overall survival (mOS) is approximately 7 to 10 months.
  • 68.8% overall response rate (ORR) and a disease control rate (DCR) of 96.9% among 32 efficacy-evaluable patients with HER2-positive advanced CRC.
  • Median progression-free survival (mPFS) of 11.04 months and a median overall survival (mOS) of approximately 7 to 10 months among BRAF V600E wild-type patients.

Sources:

  • Alphamab Oncology (2025, October 20). Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. Announce Breakthrough Therapy Designation for JSKN003 for the Treatment of Advanced Colorectal Cancer.
  • International Agency for Research on Cancer (IARC) (2022). GLOBOCAN 2022.

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