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2024-03-26 18:26:37
Company
NDA of AGAMREE was Accepted and Granted Priority Review by China’s CDE
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.
2024-03-26 18:23:34
Company
Sperogenix and Santhera Entered into Exclusive License Agreement for Vamorolone in Rare Diseases in the Greater China Region
Sperogenix will receive exclusive rights for development and commercialization of vamorolone for the treatment of Duchenne muscular dystrophy and any other rare disease.
2023-12-19 09:10:54
Company
Vamorolone was included in the "Breakthrough Therapy" program by the Center for Drug Evaluation of China NMPA
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.
2023-12-19 09:10:46
Company
Abbisko and Sperogenix Announce An Exclusive Agreement to Develop ABSK021 for ALS and Other Rare Neurological Diseases in Greater China
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.
2022-03-1 10:21:41
Company
Sperogenix Therapeutics and Luca Healthcare Announce a Strategic Collaboration to Develop Digital Therapeutics for Rare Diseases
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.
2022-03-1 10:16:09
Company
Additional data from leriglitazone Phase 2/3 ADVANCE clinical trial presented at ANA 2021
Presentation highlights reduction in cerebral lesion progression and the risk of developing cerebral ALD in AMN patients based on MRI and plasma biomarker data.
2022-01-4 14:14:18
Company
Minoryx and Sperogenix ink an exclusive license agreement to develop and commercialize leriglitazone in China
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.
2021-11-9 14:14:43
Company
Mr. Ziyu YAN delivered a keynote speech at the 9th China Rare Disease Summit
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.