Antengene has announced that the Thailand Food and Drug Administration has approved a New Drug Application (NDA) for XPOVIO® (selinexor).XPOVIO® is the first approved oral selective inhibitor of the nuclear export protein XPO1. It has a unique mechanism of action, providing synergistic benefits in combination therapies, with a rapid onset and sustained effects. By inhibiting XPO1, XPOVIO® supports the accumulation of tumour suppressor proteins in the nucleus, reduces oncogenic protein levels, and restores hormone sensitivity through the glucocorticoid receptor pathway. This approval covers two indications: the combination of XPOVIO® with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have undergone at least one prior treatment, and the combination of XPOVIO® with dexamethasone for patients who have received at least four previous treatments and whose disease has become resistant to multiple therapies.XPOVIO® is the first orally available selective XPO1 inhibitor, already approved in nine APAC markets.

Antengene宣布，泰国食品和药物管理局已批准XPOVIO®（selinexor）的新药申请（NDA）。XPOVIO®是第一种经批准的核输出蛋白XPO1口服选择性抑制剂。。通过抑制XPO1，XPOVIO®支持肿瘤抑制蛋白在细胞核中的积累，降低致癌蛋白水平，并通过糖皮质激素受体途径恢复激素敏感性。该批准涵盖两个适应症：XPOVIO®联合硼替佐米和地塞米松治疗至少接受过一次治疗的成人多发性骨髓瘤（MM）患者，以及XPOVIO®联合地塞米松治疗至少接受过四次治疗且疾病对多种疗法产生耐药性的患者。XPOVIO®是第一种口服选择性XPO1抑制剂，已在九个亚太市场获得批准。

This latest approval in Thailand introduces a novel therapeutic option for MM patients, offering new hope to many in the country. The drug has also been included in national health insurance or reimbursement schemes in China, Australia, Singapore, and South Korea.The ASEAN region, with its growing population and increasing healthcare demands, represents an important market for biopharmaceutical innovation.

泰国的最新批准为MM患者引入了一种新的治疗选择，为国内许多人带来了新的希望。该药物还被纳入中国、澳大利亚、新加坡和韩国的国家健康保险或报销计划。东盟地区人口不断增长，医疗保健需求不断增加，是生物制药创新的重要市场。

Antengene recently secured approval for XPOVIO® in Malaysia and expects approval in Indonesia by the end of 2024. The company continues to focus on bringing innovative treatments to the ASEAN market, aiming to improve patient outcomes across the region.In addition to expanding XPOVIO® into new markets, Antengene is working on broadening it.

Antengene最近在马来西亚获得了XPOVIO®的批准，预计2024年底在印度尼西亚获得批准。该公司继续专注于将创新疗法引入东盟市场，旨在改善整个地区的患者预后。除了将XPOVIO®扩展到新市场之外，Antengene还致力于扩大其范围。