Products/R&D Pipelines
Disitamab Vedotin
Trade name: Aidixi®Other Name: RC48
RC48
Disitamab vedotin is the first original antibody-drug conjugate (ADC) in China and is also the first ADC in China to receive dual recognition as a breakthrough therapy from both the US FDA and the Chinese National Medical Products Administration. It is a HER2-targeted antitumor drug. Based on its unique structural design, it demonstrates significant advantages in safety and efficacy.
Drug Instruction
Precise targeting mechanism of Disitamab Vedotin
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The antibody in RC48 selectively binds to the extracellular domain of its antigen i.e. HER2 at the surface of the tumor cell.
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RC48 is internalized into the tumor cell by endocytosis.
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The linker of RC48 is cleaved by lysosomal protease and the cytotoxin (i.e. MMAE) is released.
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The highly membrane-permeable MMAE kills the neighboring cells through bystander killing mechanism.
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MMAE kills the cell by binding to the tubulin and inducing G2/M phase arrest.
Besides the aforesaid typical action mechanism of ADC drugs, Disitamab Vedotin may also help treat cancer via antibody-dependent cell-mediated cytotoxicity (ADCC) and by blocking the HER2-activated downstream signaling pathways to disturb transcription, growth and proliferation of tumor cells.
Disitamab Vedotin has shown excellent efficacy profile across multiple tumor types
At present, disitamab vedotin has been approved for marketing for two indications in 2021, i.e., HER2-overexpressing locally advanced or metastatic gastric carcinoma (including gastroesophageal junction adenocarcinoma) previously treated with at least two lines of systemic chemotherapies and HER2-overexpressing locally advanced or metastatic urothelial carcinoma previously treated with platinum-based chemotherapies, both have been included in the National Reimbursement Drug List. Disitamab vedotin also has made breakthroughs for the indication of HER2-positive advanced breast cancer with liver metastasis previously treated with trastuzumab or its biosimilar and taxanes, with significant clinical efficacy, and has been approved for marketing in May 2025.
Treatment of urothelial carcinoma
A pooled analysis of two phase 2 clinical trials of disitamab vedotin in treatment of previously treated patients with HER2-overexpressing (IHC 2+ or 3+) locally advanced or metastatic urothelial carcinoma (a combined analysis of study no. C005 and C009) shows:
objective response rate (ORR): 50.5%;
Median PFS: 5.9 months;
Median OS: 14.2 months.
Results of a phase 1b/2 clinical trial of disitamab vedotin in combination with toripalimab in treatment of patients with locally advanced or metastatic urothelial carcinoma (study no.: C014; NCT04264936) show an ORR of 73.2%;
a median PFS of 9.2 months, and a 2-year OS rate of up to 63.2%.
Treatment of gastric cancer
The results of the phase 2 clinical trial of Disitamab Vedotin as the third-line therapy in treatment of HER2-overexpressing (IHC2+ or 3+) gastric cancer (study No.: C008) show:
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Median PFS: 4.1 months;
Median OS: 7.9 months.
In addition Disitamab vedotin has been proven effective for IHC2+/ISH- negative gastric cancer expanding the beneficial population of the anti-HER2 therapy for advanced gastric cancer.
Treatment of breast cancer
The results of the phase 3 clinical trial (Study RC48-C006) of disitamab vedotin in the treatment of HER2-positive advanced breast cancer with liver me
Compared with lapatinib plus capecitabine,disitamab vedotin significantly improved PFS and reduced the risk of disease progression or death by 44% (median PFS: 9.9 months vs. 4.9 months; HR=0.561 P=0.0143)
The overall survival (OS) data,though immature,indicated a benefit trend in favor of disitamab vedotin,with median OS of NE vs. 25.9 months (HR=0.56; 95%CI 0.25-1.29)
Cooperation with world-renowned biopharmaceutical companies
In August 2021 Seagen Inc. (Has been acquired by Pfizer) a world-renowned biopharmaceutical company and RemeGen entered into an exclusive worldwide licensing agreement for disitamab vedotin (excluding Asia-Pacific region except for Japan and Singapore). Pursuant to the agreement RemeGen will receive upfront and milestone payments of US$ 2.6 billion and tiered royalties at percentages ranging from high single digits to mid-teens on future sales by Seagen. The deal hit a then-record high in out-licensing deals of single product by Chinese pharmaceutical enterprises.
To inquire about medication details or report side effects, please reach out through:
No. 58 Beijing Middle Road, Yantai Development Zone, Shandong, China.
（+86）535-3573511
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