Corning Jerry PD-L1/CTLA-4 dual-specific antibodies are eligible for FDA orphan drugs.

Thymus epithelitis (TET) includes a variety of chest tumors, including thymus and thymus cancer.
7,000 to 10,000 cases in the U.S. by 2020.
Non-surgical or metastatic thymus epithym tumor prognosis, for patients who failed chemotherapy treatment with platinum-containing drugs, there is currently no approved standard treatment;
studies have shown that the thymus is an important organ for T-cell development, and that thymus epithal tumors express PD-L1 highly and may therefore benefit from immunosuppressant therapy.
KN046 is the world's first recombinant humanized PD-L1/CTLA-4 dual-specific antibody developed by CorningErry, and its innovative design includes: the use of highly safe CTLA-4 monolithic antibodies;
and clinical trial results of KN046 show that they can significantly reduce possible toxic side effects on the human exodervirus system and are expected to be breakthrough tumor immunological drugs.
KN046 Australia Phase I clinical trial in patients with thymus epithelioid tumor showed a high response rate and long-lasting response time, good safety, KN046 treatment of thymus cancer Phase II registered clinical trial has been launched recently, is expected to be in China and the United States more than 10 research centers simultaneously.
FDA's Orphan Drug Qualification Act (ODA) is an innovative FDA measure to encourage the development of diseases with less than 200,000 people in the United States.
new drugs that are eligible for orphan drug eligibility have the opportunity to gain 7 years of market exclusive rights.
addition, the FDA has a 50% tax credit for orphan drugs and clinical research costs, a BLA filing fee waiver for prescription drug users, and a range of supporting policies for FDA support for research and development grants and program assistance, and fast-track approval channels.
2019, 21 (44 percent) of the 48 new drugs approved by the FDA for the year were orphan drugs; eight of the top 10 cancer drugs were eligible for partially adaptive orphan drugs in the United States.
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