Recently, the CDE (Center for Drug Evaluation) website announced that the new indication for Vidistovimab injection in combination with trastuzumab and toripalimab as first-line treatment of HER2-high expressing advanced gastric/gastroesophageal junction adenocarcinoma is proposed for inclusion in the Breakthrough Therapy designation. If successfully approved, this will be the fourth Breakthrough Therapy designation received by this drug since its launch in 2021, setting a new record for regulatory approval of domestically produced ADC (anti-adrenergic cellular carcinoma) drugs.
HER2 is an important therapeutic target for gastric cancer, accounting for approximately 12%-23% of all gastric cancers. If low-to-medium HER2 expression is included, then about 40%-45% of gastric cancer patients express HER2. These tumors are more aggressive and prone to recurrence and metastasis. Vidicetumab (trade name: Aidixi® ) is China's first original ADC drug developed by Rongchang Biotechnology. Targeting the HER2 protein on the tumor surface, it can precisely identify and kill tumor cells. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Professor Shen Lin from Peking University Cancer Hospital gave an oral presentation announcing the results of a study on vidicetumab in combination with toripalimab and chemotherapy/trastuzumab as first-line treatment for HER2-expressing locally advanced or metastatic gastric cancer. This study covered patients with high, medium, and low HER2 expression, significantly improving the efficacy of first-line treatment for advanced gastric cancer compared to standard treatment in the control group, and expanding the beneficiary population to those who had previously failed targeted therapies. In patients with HER2-overexpressing gastric cancer, vedicetumab combined with toripalimab and chemotherapy, and vedicetumab combined with toripalimab plus trastuzumab, showed significant efficacy advantages compared to toripalimab plus trastuzumab plus CAPOX chemotherapy, with manageable safety. Vidicetumab not only boasts excellent clinical data but has also achieved remarkable commercial success. Its most notable achievement is setting a record for the highest overseas licensing transaction for a single product by a Chinese pharmaceutical company. In August 2021, Rongchang Biotechnology reached a global exclusive licensing agreement with the internationally renowned biopharmaceutical company Seattle Genetics Inc., worth up to $2.6 billion. According to data from PharmNet, vedicetumab's sales reached nearly 800 million yuan in 2024, with cumulative revenue reaching 1.56 billion yuan by the end of 2024.
Rongchang Bio currently has two core products: Telitacicept (RC18) and Vidicetumab (RC48). Telitacicept is the world's first and first-in-class injectable recombinant B lymphocyte stimulating factor (BLyS)/proliferation inducing ligand (APRIL) dual-target novel fusion protein product, with eight indications in the field of autoimmune diseases currently in commercialization or late-stage clinical trials.

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