Vidicyto monoantigen resistance is recognized as a breakthrough treatment for CDE

Source: Pharmaceutical Rubik's Cube Info December 28, Rongchang Bio-developed antibody association drug (ADC) disitamab vedotin (RC48-ADC) was officially awarded breakthrough therapy qualification by CDE.
are patients with localized late stage or metastatic urethra cancer (including bladder, urethra, kidney and urethra sources) who have progressed after failure of chemotherapy.
for the allergy, the FDA on September 21st granted Vidicido mono-breakthrough therapy approval.
surgery and platinum-containing chemotherapy have long been important treatments for urethra skin cancer.
for patients with advanced stages that cannot be operated on, first-line therapy is usually platinum-containing chemotherapy, which is resistant to chemotherapy and can lead to tumor recurrence and disease progression with poor prognostication.
data show that the medium overall survival of patients with metastatic advanced urethroid cancer is only about 14 months, and more effective treatment is urgently needed.
Vidisitto single anti-filling HER2 positive urethring skin cancer huge clinical demand urethrial cancer is ranked ninth in the world common malignant tumor, its morbidity and mortality rate accounted for the first male genitourinary system tumor, and the trend is increasing year by year.
, the majority (90-95%) occur in the lower urinary tract (bladder and urethra) and the rest in the upper urinary tract (kidney, kidney and ureter).
bladder cancer is the most common type of urethra cancer, with Datamonitor Healthcare estimating that there will be more than 540,000 newly diagnosed cases worldwide in 2018, a number that is expected to rise to 600,000 by 2027.
is the fifth most common cancer in the United States and Europe, the sixth most fatal malignant tumor in China, with about 62,000 newly confirmed cases in 2015.
previously, Vidicido monotherapy had been identified by the FDA as a breakthrough therapy for urethroid skin cancer, based on a Phase II study led by Professor Guo Jun, vice president of Peking University Cancer Hospital.
data showed that 43 subjects with urethroid skin cancer who failed chemotherapy on the first-line and above systems received an objective remission rate (cORR) of 51.2%, a disease control rate (DCR) of 90.7%, and patients with immunotherapy orR of 62.5%.
as of April 30, 2019, the mid-year PFS 6.9 months.
, there are no drugs at home and abroad to treat HER2-positive urethra skin cancer approved.
Vidicyto monoantigen has achieved a major breakthrough in efficacy for this segment of the population, not only high efficiency, but also greatly extended the survival of patients who failed first-line treatment, can meet the huge clinical needs.
Vedisito monoantigen with the clinical data obtained by CDE awarded breakthrough therapy, the clinical development and registration process in China will undoubtedly be greatly accelerated, is expected to fill the HER2 positive urethra skin cancer clinical treatment gap.
(Communicator Wu Libo) References to advances in the treatment of late-stage urethra cancer, Journal of Practical Oncology (2020), Vol.35:292-297( Surgical progress in urethra cancer, Southeastern Defense Medicine, 2020, 22 (4): 399-402