HUTCHMED has received approval from the China National Medical Products Administration (NMPA) for the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib).

和黄医药已获得中国国家药品监督管理局（NMPA）批准，将ORPATHYS®（赛沃替尼）与TAGRISSO®（奥希替尼）联合疗法投入使用。

Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for 80–85% of all cases. A large proportion of NSCLC patients in Asia have EGFR mutations, and MET amplification is recognised as a common resistance mechanism following EGFR TKI therapy.

肺癌仍然是全球癌症相关死亡的主要原因，其中非小细胞肺癌（NSCLC）占所有病例的80-85%。亚洲大部分非小细胞肺癌患者存在EGFR突变，而MET扩增被认为是EGFR酪氨酸激酶抑制剂（TKI）治疗后的常见耐药机制。

ORPATHYS® has already been approved in China for adult patients with locally advanced or metastatic NSCLC harbouring MET exon 14 skipping alterations. It continues to be studied in combination therapies across other tumour types including lung, kidney, and gastric cancers.

ORPATHYS® 已在中国获批用于治疗携带MET外显子14跳跃突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。该药物仍在继续研究与其他疗法联合应用于其他肿瘤类型，包括肺癌、肾癌和胃癌。

TAGRISSO® has been widely used globally, with clinical trials supporting its effectiveness across different stages of EGFR-mutated NSCLC. It is currently being assessed in further studies, including global and China-specific Phase III trials such as SAFFRON, SANOVO, and the previously mentioned SACHI trial..

TAGRISSO® 已在全球范围内广泛使用，临床试验证明其在不同阶段的 EGFR 突变非小细胞肺癌中均有效。目前，该药物正在进一步研究中，包括全球和中国特定的 III 期试验，如 SAFFRON、SANOVO 以及前面提到的 SACHI 试验。

ORPATHYS® is a selective MET inhibitor, while TAGRISSO® is a third-generation EGFR TKI. The regulatory approval was based on positive results from the SACHI Phase III trial (NCT05015608), which showed that the combination significantly improved progression-free survival compared to chemotherapy.

ORPATHYS® 是一种选择性 MET 抑制剂，而 TAGRISSO® 是第三代 EGFR TKI。该监管批准基于 SACHI III 期试验（NCT05015608）的积极结果，该试验显示，与化疗相比，这种组合显著改善了无进展生存期。

The combination is now approved for patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) who have developed MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

该组合疗法现已获批用于在接受一线EGFR酪氨酸激酶抑制剂（TKI）治疗后出现MET扩增的局部晚期或转移性EGFR突变阳性的非鳞状非小细胞肺癌（NSCLC）患者。

The approval also triggered a milestone payment of US$11 million from AstraZeneca, which markets both medicines in China. This marks the third indication approved in China for ORPATHYS®.

该批准还触发了阿斯利康支付的1100万美元的里程碑款项，阿斯利康在中国市场销售这两种药物。这标志着 ORPATHYS® 在中国获批的第三个适应症。

The approval of this combination in China provides a chemotherapy-free treatment option for a subset of NSCLC patients who have limited alternatives following progression on initial targeted therapies.

该组合在中国的获批为一部分在接受初始靶向治疗后选择有限的非小细胞肺癌患者提供了一种无需化疗的治疗选择。