The application for listing of the RC48-ADC was formally accepted by the State Drug Administration.

Read: This is the first self-developed antibody-drug association (ADC) drug in China to submit a new drug for market.
, August 27, 2020, Rongchang Biopharmaceuticals (Yantai) Co., Ltd. received a notice from China's State Drug Administration (NMPA) for its self-developed injection of Virdixito monoanti (commodity name: ® , research code: RC48) for the treatment of local advanced or metastatic gastric cancer (including gastroesophageal adenocarcinoma) patients of the new drug market application was formally accepted, and was included in the priority review approval process, acceptance number: CXSS2000044 countries.
is the first self-developed antibody-drug association (ADC) drug in China to submit a new drug for market.
conducted a key clinical trial on the treatment of her2-positive localized advanced or metastatic gastric cancer patients with single-arm, open, multi-center.
the results showed that the trial reached the end of the main clinical study and showed better safety and tolerance. Professor Shen Lin, Associate Dean of Oncology Hospital, Peking University and Director of Digestive Oncology, lead researcher of the
Project, said: "The results show that the treatment of HER2-positive, including HER2 low expression (IHC 2 plus/FISH-) local late stage or metastatic stomach cancer (including gastroesophageal adenocarcinoma) has obtained the world's leading clinical data and is a major breakthrough in the field of gastric cancer treatment.
Professor Fang Jianmin, co-founder and CEO of rongchang Bio, said that China has the highest incidence of stomach cancer in the world, accounting for about 50% of the global number of patients, and the international treatment of advanced stomach cancer lack of effective treatment.
opens a new path for precision treatment of stomach cancer, has great clinical value, and is an important milestone in the history of china's independent innovation biopharmaceuses.
About Virdixito monoantigens: Wedixito monoantigens target HER2 proteins on the surface of tumors and accurately identify and bind to cancer cells, penetrating cell membranes into their internals, thereby killing cancer cells.
Wedixito monoantigen has a new molecular structure developed independently, its antibodies have HER2 high affinity, can efficiently bind to it and enter cancer cells;
.