Easton Bio (688513.SH) Secures Drug Registration Certificate for Ponatinib Tablets

BEIJING — Chengdu Easton Bio Pharmaceuticals Co., Ltd. (688513.SH) has secured regulatory approval for its ponatinib tablets, the company announced Wednesday, marking a milestone in China's push to expand treatment options for patients with drug-resistant forms of leukemia.

The National Medical Products Administration issued a Drug Registration Certificate to Chengdu Shuode Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Easton Bio, for the third-generation BCR-ABL tyrosine kinase inhibitor.

Ponatinib tablets are indicated for the treatment of chronic myeloid leukemia in adult patients who are resistant to or intolerant of first- and second-generation tyrosine kinase inhibitors. The drug is also approved for adult patients with relapsed or refractory chronic myeloid leukemia in accelerated or blast phase, as well as Philadelphia chromosome-positive acute lymphoblastic leukemia, when no other tyrosine kinase inhibitor therapy is applicable.

Additionally, the approval covers adult patients with chronic myeloid leukemia — across chronic, accelerated, and blast phases — or Philadelphia chromosome-positive acute lymphoblastic leukemia who harbor the T315I mutation, as detected by validated testing methods, and who have demonstrated resistance to any tyrosine kinase inhibitor.

The T315I mutation has long been considered one of the most challenging resistance mechanisms in chronic myeloid leukemia, often rendering earlier-generation therapies ineffective. Third-generation inhibitors like ponatinib were designed specifically to overcome this hurdle, offering a critical lifeline to patients with limited therapeutic alternatives.

The approval underscores Easton Bio's strategy to strengthen its portfolio in the hematology-oncology space, a segment of China's pharmaceutical market where domestic companies are increasingly competing with imported therapies for complex, high-unmet-need indications.