Akeso Biopharma Inc, a company based in National Health Technology Park, recently announced that its self-developed bispecific antibody drug for tumor immnuotherapy (R&D code: AK104) was awarded the orphan drug qualification (qualification for drugs used to prevent, treat and diagnose rare diseases) by FDA. This is the first antibody of its type.

The new drug, AK104, is mainly used to treat liver cancer, cervical cancer, lung cancer, stomach cancer, esophageal squamous cell carcinoma, nasopharynx cancer, etc.

In 1983, the United States promulgated the Orphan Drug Act, which stipulates that candidate drugs that have obtained the orphan drug qualification have the opportunity to obtain market exclusivity for 7 years, as well as a series of supporting policies provided by the FDA, such as tax reduction and exemption, declaration fee reduction for the biologic license application, cost relief for prescription drug users, R&D funding, program assistance and rapid regulatory approval channels.

In addition, Symbiox Benvitimod Cream, a new drug developed and produced by Zhonghao Pharmaceutical Co Ltd, another company within NHTP, was included in the catalog of medicines covered by national medical insurance system in December last year for the first time. The new medicine catalog will be officially implemented starting on March 1 this year. Benvitimod Cream is used for local treatment for adults with mild to moderate psoriasis vulgaris. The medicine was proved to be an effective innovative therapy application for psoriasis vulgaris, and  was approved for marketing worldwide for the first time.