On July 10, SINOPHARM (01177) announced that the Group's independently developed CDK2/4/6 inhibitor Cumocillin Capsules "TQB3616" combined with Fulvestrant Injection for previously untreated HR-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer has been submitted to the Center for Drug Evaluation of the China National Medical Products Administration for new indications for marketing approval and has been accepted. The approval of the first-line indication application further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer.

In addition, the new drug application for Cumosili submitted by the Group in July 2024 has also been accepted by the CDE for use in combination with Fulvestrant for the treatment of HR+/HER2- locally advanced or metastatic breast cancer that has been previously treated with endocrine therapy.

The announcement mentioned that breast cancer is one of the most common malignant tumors in women, of which HR+/HER2- breast cancer accounts for about 65%-70% of all breast cancers. The detailed data of this study will be announced at an international authoritative academic conference in the near future, and it is expected to provide more clinical basis for related treatments.

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