Corning Jerry's double-specific antibody KN046 was awarded orphan drug status by the FDA.

Introduction: KN046 is used to treat thymus epithal tumors.
September 3, 2020, in Suzhou, China, Corning Jerry Biopharmaceuticals (stock code: 9966 HK) announced that it is owned by its wholly-owned subsidiary Jiangsu Corning Jerry Biopharmaceutical Co., Ltd. ("Jiangsu Corning Jerry") The recombinant humanized PD-L1/CTLA-4 dual-specific antibody KN046 was awarded orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of thymus epitheliote tumors.
this is CorningEry's second orphan drug qualification since the injection of PD-L1 monolithic antibody KN035 earlier this year was approved by the FDA as an orphan drug for bile pathogenic cancer.
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.
thymus epithelia (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 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 in sync.
About KN046KN046 is Corning Jerry's first recombinant humanized PD-L1/CTLA-4 dual-specific antibody, and its innovative design includes: the adoption of CTLA-4 monolithic antibodies with significantly improved safety;
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 in Australia and China has carried out nearly 20 different stages of clinical trials covering more than 10 types of tumors, such as non-small cell lung cancer, tricyste breast cancer, esophageal squamous cancer, liver cancer, pancreatic cancer, etc., the results show good safety and effectiveness.
FDA approved KN046 to go directly to Phase II clinical trials in the United States based on clinical trial results obtained in Australia and China.
the efficacy and safety of KN046 combined with platinum-containing chemotherapy for IV. stage squamous non-small cell lung cancer Phase III. Clinical trials have been launched in China.
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