CSPC Pharmaceutical (01093.HK): NDA for Sirolimus Albumin-Bound Injection Accepted by NMPA with Breakthrough Therapy and Priority Review Status

NewTimeSpace News: CSPC Pharmaceutical Group Limited (stock code: 1093) announced that the new drug application for its self-developed Sirolimus for Injection (Albumin-Bound), submitted by the group, has been accepted by the National Medical Products Administration (NMPA). Following review by the Center for Drug Evaluation of the NMPA, the product has been simultaneously included in the Breakthrough Therapy Drug Program and granted priority review and approval qualification.

According to the announcement, the product is a macrolide immunosuppressant and a highly selective inhibitor of the mammalian target of rapamycin (mTOR). It was submitted as a Category 2.2 improved new chemical drug, with the proposed indication for unresectable locally advanced or metastatic malignant perivascular epithelioid cell tumor (PEComa).

The announcement stated that the core basis for this marketing application is a pivotal Phase Ib/III clinical trial enrolling patients with histologically confirmed, locally advanced and metastatic malignant PEComa who had not previously received mTOR inhibitor treatment. The pivotal Phase III clinical trial successfully met its pre-specified primary endpoint. Compared with the conventional treatment selected by investigators in the control arm, the product demonstrated significant efficacy advantages, with data showing both statistical significance and clinical meaning, enabling rapid and deep tumor remission.

The group noted that, given the current absence of a unified standard treatment regimen for malignant PEComa, the product is expected to establish a new standard in this therapeutic area based on its excellent efficacy. The product also showed an overall favorable safety profile, with generally manageable adverse reactions and a broad safety window.

The announcement also disclosed that the Sirolimus for Injection (Albumin-Bound) is the first intravenous sirolimus formulation approved for clinical research in China. The group is currently advancing a pivotal Phase III clinical study of the product in combination with fulvestrant for the treatment of HR+/HER2- breast cancer, and continues to explore the efficacy and safety of the product as monotherapy and in combination regimens across multiple solid tumor types.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.