Santhera Pharmaceuticals (SIX: SANN) has announced that Sperogenix Therapeutics, its partner, has started a paid Early Access Program (EAP) in China for AGAMREE® (vamorolone), intended for patients with Duchenne muscular dystrophy (DMD).In April 2024, the Hainan Medical Products Administration (HMPA) granted approval for the EAP, following local regulations and recognizing the drug's existing approvals in the US, EU, and UK.

Santhera Pharmaceuticals（SIX:SANN）宣布，其合作伙伴Sperogenix Therapeutics已在中国为AGAMREE®（vamorolone）启动了一项付费早期获取计划（EAP），该计划旨在为杜兴氏肌营养不良症（DMD）患者提供服务。2024年4月，海南省医疗产品管理局（HMPA）根据当地法规批准了EAP，并承认该药物在美国，欧盟和英国的现有批准。

This approval highlights the critical need for treatment options in China, where there are currently no approved therapies for DMD. The EAP commenced in mid-May at the Bo'ao Lecheng Pilot Zone in Hainan Province, where the first patients have begun receiving AGAMREE.Additionally, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for AGAMREE in DMD for patients aged 4 years and older in March 2024, categorizing it for Priority Review and Breakthrough Therapy designations.

这一批准突显了中国对治疗方案的迫切需求，目前尚无经批准的DMD治疗方法。EAP于5月中旬在海南省博鳌乐城试验区开始，首批患者已开始接受AGAMREE治疗。此外，中国国家医药产品管理局（NMPA）于2024年3月接受了针对4岁及以上患者的DMD中AGAMREE新药申请，将其分类为优先审查和突破性治疗指定。

If the regulatory review is successful, approval could be granted by the first quarter of 2025.Duchenne muscular dystrophy affects approximately 70,000 people in China, where there is currently no approved drug, pointing to a significant unmet need. The increasing rates of diagnoses further emphasize the demand for effective treatment options.As per their licensing agreement, Sperogenix holds exclusive rights for the development and commercialization of AGAMREE in DMD and other rare diseases within China.

如果监管审查成功，可能会在2025年第一季度获得批准。杜兴氏肌营养不良症影响了中国约70000人，目前中国尚无批准的药物，这表明需求尚未得到满足。诊断率的提高进一步强调了对有效治疗选择的需求。根据他们的许可协议，Sperogenix拥有在中国DMD和其他罕见疾病中开发和商业化AGAMREE的专有权。

Santhera will provide the drug for both the EAP and future commercialization, while Sperogenix will compensate Santhera with royalties on net sales and additional milestones based on sales performance.AGAMREE® (vamorolone) operates by interacting with the same receptors as glucocorticoids but alters their downstream effects.

Santhera将为EAP和未来的商业化提供药物，而Sperogenix将根据净销售额和基于销售业绩的其他里程碑向Santhera支付版税。AGAMREE®（vamorolone）通过与糖皮质激素相同的受体相互作用而起作用，但会改变其下游作用。

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