Nipocalimab Injection Approved in China as First Imported Biologic with Domestic Drug Substance Manufacturing under Cross-border Segmented Production Pilot

Beijing News (Reporter Zhang Xiulan) On May 21, Johnson & Johnson's fully human neonatal Fc receptor (FcRn) antagonist Anliwei (Nikacimab Injection) was approved by the National Medical Products Administration for use in combination with conventional therapies to treat generalized myasthenia gravis.

Myasthenia Gravis (MG) is an autoimmune disease where the patient's immune system erroneously produces antibodies that can act on the neuromuscular junction, blocking or interfering with normal nerve-to-muscle signal transmission, thereby affecting or preventing muscle contraction. This condition can occur across all age groups, genders, races, and ethnicities, but it predominantly affects young women and elderly men. Early symptoms typically manifest as ocular manifestations; however, approximately 85% of patients progress to generalized Myasthenia Gravis (gMG), which can present as severe muscle weakness and may be accompanied by symptoms such as speech and swallowing difficulties. There remains an unmet clinical need for this disease, requiring effective therapies that offer sustained and stable disease control with well-established safety profiles.

As an FcRn antagonist, Anliwei can significantly reduce immunoglobulin G (IgG) levels. These IgG antibodies are the main pathogenic factors of generalized myasthenia gravis, while not causing any detectable additional effects on other adaptive and innate immune functions. The new drug application received priority review and approval qualification from the Center for Drug Evaluation of the National Medical Products Administration. It is also the first imported biologic product approved in China to conduct a pilot program for segmented production of the bulk drug substance within the country. The bulk drug substance is produced in China, while the formulation and packaging are carried out overseas.

Proofread by Mu Xiangtong