July 23, 2024, Sperogenix Therapeutics announces the NDA filling of AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) patients has been accepted by the Department of Health of Hong Kong, China.

On September 16, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced that the new drug vamorolone was included in the "breakthrough therapy" program, and the proposed indication is for Duchenne muscular dystrophy (DMD) patients who are 2 years old and above.

May 26, 2024, Sperogenix Therapeutics announced AGAMREE® (vamorolone) was introduced to the Hainan Bo’ao Lecheng International Medical Tourism Pilot Zone.

Sperogenix Therapeutics and Luca Healthcare announced a strategic partnership to develop digital therapeutics for Sperogenix’s pipeline of rare disease treatments and improve overall treatment benefits.

March 26, 2024, the NDA filling of AGAMREE (vamorolone) is indicated for the treatment of DMD in patients aged 4 years and older has been accepted by CDE of China NMPA, and been included in the “Priority Review Program.

Sperogenix will receive exclusive rights for development and commercialization of vamorolone for the treatment of Duchenne muscular dystrophy and any other rare disease.

Sperogenix will have the exclusive right to develop, manufacture and commercialize ABSK021 in mainland China, Hong Kong SAR and Macao SAR for non-oncology rare neurological diseases indications.

Presentation highlights reduction in cerebral lesion progression and the risk of developing cerebral ALD in AMN patients based on MRI and plasma biomarker data.

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition.

Mr. Yan Zhiyu was invited to attend the 9th China Rare Disease Summit held in Chengdu on 12 September and delivered a keynote speech on promoting China's participation in international multi-center clinical trials to accelerate orphan drugs access to China.