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This is Corning Jerry's third orphan drug qualification.
previously, the FDA has awarded the under-skin injection PD-L1 monolithic antibody KN035 bile duct cancer orphan drug qualification and PD-L1/CTLA-4 dual specific monolithic antibody KN046 thymus cancer orphan drug qualification.
KN026 and KN046 have shown good safety, toerability and anti-tumor efficacy in single-drug clinical trials, and a KN026 joint KN046 clinical trial initiated by researchers has achieved excellent results.
previous studies showed that KN046 combined with KN026 had an objective remission rate of 64.3% (9/14) in HER2-positive solid tumors and a disease control rate of 92.9% (13/14), the results were published this year in the SITC.
Conninger is conducting A Critical Clinical Study (SEARCH-01) on KN026 Joint KN046II, which is planned to be conducted in 20-30 Chinese and 10-20 U.S. clinical research centers to assess the effectiveness, safety, and tolerance of KN026 Joint KN046 in the treatment of HER2-positive solid tumors, including key clinical studies for the treatment of advanced gastric and gastroesophageal concomitant cancer.
is known to be the fifth most common cancer in the world and the third leading cause of cancer death worldwide.
about 950,000 new cases and 720,000 deaths worldwide each year.
1975-2017 SEER cancer statistics, the annual number of GC/GEJ cases in the United States is about 116,525.
fluorouracil and platinum chemotherapy drugs are commonly used as first-line treatments.
available second- and back-line treatments include yew alcohol combination remolu monoanti, yew alcohol, dositasi, ilidacon and optimal support therapy, with an objective remission rate of approximately 15-25%.
second-tier mid-survival is only 8-9 months, and the back-line mid-survival is only 4-6 months.
note: There are deletions in the original text