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CSPC's sirolimus injection gains breakthrough therapy designation in China

February 28, 2025 at 05:01 PM UTCBy FilingReader AI

CSPC Pharmaceutical Group Limited (HKEX: 1093) announced that its Sirolimus for Injection (albumin-bound) has been granted Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA) for the treatment of malignant perivascular epithelioid cell tumor (PEComa). Sirolimus, a specific mTOR inhibitor, uses a special technology to encapsulate sirolimus into human serum albumin, overcoming limitations of oral formulations. The product is currently undergoing multiple phase II and III clinical trials in China for solid and hematological tumors. The company is undergoing clinical trials in patients with HR+/HER2- advanced breast cancer who develop resistance to CDK4/6 inhibitors and has submitted an application for communication and exchange of pivotal phase III clinical trials to the regulatory authority.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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