RemeGen Secures Regulatory Milestone: Disitamab Vedotin Approved for HER2-Low Breast Cancer with Liver Metastases in China

RemeGen Co., Ltd. (Stock Code: 9995) has announced a significant regulatory development: the company has received official approval from the National Medical Products Administration (NMPA) of China for a new indication of its flagship drug, Disitamab Vedotin (Code: RC48, Trade Name: 愛®). This new indication allows for the treatment of adult patients with HER2-low expressing breast cancer with liver metastases, marking the fourth approved indication for this innovative therapy in China.

Key Highlights of the Announcement

• Regulatory Approval: The NMPA has granted approval (Approval No.: S20210017, Certificate No.: 2026S00808) for Disitamab Vedotin to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer with liver metastases in adult patients. Eligible patients are those who have already received at least one prior systemic therapy in the metastatic setting, or whose disease recurred during or within 12 months of completing adjuvant chemotherapy.
• Clinical Evidence: Approval is based on robust data from the randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China. The study demonstrated favorable efficacy and safety for Disitamab Vedotin in this specific patient population.
• Market Expansion: This approval further extends Disitamab Vedotin’s reach, making it now authorized in China for four distinct indications:
  • HER2-overexpressing locally advanced or metastatic gastric cancer
  • HER2-overexpressing locally advanced or metastatic urothelial carcinoma
  • HER2-positive advanced breast cancer with liver metastases
  • HER2-low expressing breast cancer with liver metastases (newest approval)
• First-in-Class Achievement: Disitamab Vedotin is China’s first original antibody-drug conjugate (ADC) developed independently by RemeGen. It is also the first ADC in China to receive Breakthrough Therapy designations from both the U.S. Food and Drug Administration (FDA) and China’s NMPA.
• Significant Unmet Need: Breast cancer is the most common malignant tumor among women globally, with approximately 2.3 million new cases and 670,000 deaths each year worldwide. In China alone, there are 357,000 new cases and 75,000 deaths annually. Liver metastasis is present in 17.8% to 35% of metastatic breast cancer patients and is linked to a poor prognosis (5-year survival rate of about 20%). Approximately 45% to 55% of breast cancer cases are HER2-low, with these patients having few treatment options and poor survival rates, especially when visceral metastases are involved.

Strategic and Share Price Implications for Investors

• Market Competitiveness: The additional approved indication significantly enhances the commercial potential and market competitiveness of Disitamab Vedotin in China’s large and growing oncology market.
• Price Sensitivity: Expansion into the HER2-low breast cancer segment with liver metastases—an area of high unmet clinical need—could drive sales growth and potentially have a material impact on RemeGen’s revenues and share value.
• Commercialization Risks: The company notes that, as with any pharmaceutical product, successful commercialization post-approval is subject to factors such as policy environment, market demand, and competitive dynamics, which may introduce uncertainties.
• Investor Advisory: Shareholders and potential investors are urged to exercise caution when trading the company’s shares, in light of both the positive regulatory news and the inherent uncertainties in drug commercialization.

Board and Management Update

This announcement was authorized by Mr. Wang Weidong, Chairman and Executive Director of RemeGen Co., Ltd. The board comprises a mix of executive, non-executive, and independent non-executive directors, reflecting strong corporate governance.

Conclusion

The approval of Disitamab Vedotin’s new indication represents a major milestone for RemeGen, positioning the company as a leader in next-generation cancer therapies in China and enhancing its profile in the global oncology market. The news is potentially share price moving given the therapeutic and commercial significance of the new approval.

Disclaimer: The information provided in this article is for informational purposes only and does not constitute investment advice. Investors should perform their own due diligence and consider their own financial circumstances before making any investment decisions. The company’s future performance is subject to various risks and uncertainties, including but not limited to regulatory, market, and competitive factors.

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