We adopted an
orphan as an heir.
我们立一个孤儿为继承人。
Mary was
orphaned in the war.
战争使玛丽成为孤儿。
The company said the new drug candidate to treat drug-resistant CML patients has been granted orphan drug and fast track designations by the United States Food and Drug Administration.
The orally taken drug has been granted orphan drug and fast track designation by the US FDA.
The orally taken drug has been granted orphan drug designation and fast track designation by the United States Food and Drug Administration.
Last year, Ascentage obtained 10 orphan drug qualifications from the US FDA, becoming the enterprise with the largest number of such qualifications in the world that year.
Altogether, four of the company's candidate drugs have been granted 12 orphan drug qualifications by the US FDA so far, allowing it to become the enterprise with the largest number of such qualifications domestically, according to the company.
The treatment was also granted Orphan Drug designation, "which provides incentives to assist and encourage the development of drugs for rare diseases", the FDA said in a statement.
“Drugs used to treat liver and gastric cancer are considered to be ‘orphan drugs’ in China because such diseases have low incidence rates in other countries and leading pharmaceutical companies would hence spend little to develop them,” she said.
In January 2020, the company inked an agreement with United Kingdom-based EUSA Pharma for development and commercialization of the latter's orphan biologic products siltuximab and dinutuximab beta in China.
Chinese biotech company Junshi Biosciences announced on Friday that the company's domestically developed drug Toripalimab (anti-PD-1 mAb), in combination with Axitinib for treatment of mucosal melanoma, has been granted orphan drug designation by the United States Food and Drug Administration.
The orphan drug designation granted by the FDA is beneficial for the continuous development of the combination therapy and the enjoyment of certain policy support in terms of registration and commercialization in the US, including but not limited to tax credits for clinical trial costs, application fee waivers for new drugs and 7 years of market exclusivity without being affected by patent.
A few days ago, 3DBio Therapeutics, a New York-based biologics and bioprinting company, announced its AuriNovo, an investigational combination product using patients' own auricular cartilage cells to 3D-bioprint living, full-sized ear construct, received Orphan Drug designation from the United States Food and Drug Administration, a status assigned to treatments developed for rare conditions.