Good news came from the implementation of the policy of "Hong Kong and Macau drugs and communication": Novartis, an innovative drug Piqray (Alpelisib) for advanced breast cancer, was recently approved to introduce the Shenzhen Hospital of University of Hong Kong in Guangdong Bay Hongkong Macau Bay area. Mainland patients can benefit from innovative drugs globally. The approved Novartis Alpelisib is the world's first and only overseas oral drug approved for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative and PIK3CA mutation advanced breast cancer. Breast cancer is the highest incidence rate in Chinese women. 70% of the patients are HR+/HER2- breast cancer, and PIK3CA is one of the common mutations in HR+/HER2- subtype breast cancer. China's research data show that 49.3% of HR+/HER2- breast cancer patients are associated with PIK3CA mutation. Many basic and clinical studies suggest that PIK3CA mutation can lead to abnormal activation of PI3K / Akt / mTOR pathway, thus stimulating tumor proliferation, metastasis and invasion, and is related to poor treatment response, poor prognosis, or endocrine therapy resistance, which makes the treatment more challenging. Alpelisib is the first drug targeted at HR+/HER2- and PIK3CA mutations in advanced breast cancer. It is oral small molecule. α The specific I type phosphatidylinositol -3- kinase (PI3K) inhibitor has the ability to inhibit the PI3K pathway and inhibit cell proliferation in breast cancer cell lines carrying PIK3CA gene mutation. Data show that the earliest pan PI3K inhibitors have limited efficacy and high toxicity. Alpelisib, as a novel PI3K inhibitor, can specifically target PI3K α Subtype. The results of international multicenter randomized double-blind phase III clinical study solar-1 showed that PI3K inhibitor alpelisib combined with fluvestrant could significantly improve the progression free survival (PFS) and prolong the median overall survival (OS) by 7.9 months, especially in patients with visceral metastasis and patients with PIK3CA mutation detected by ctDNA. The reason why alpelisib and other global anti-cancer new drugs can be quickly approved and introduced into Guangdong, Hong Kong and Macao Bay area is inseparable from the implementation of the "Hong Kong and Macao drug and equipment communication" policy. The policy of "Hong Kong Macao drug and machinery communication" is a systematic, holistic and collaborative reform and innovation. It not only spans Guangdong, Hong Kong and Macao geographically, but also involves many links, such as import approval, overseas procurement, import customs clearance, storage and distribution, clinical use and so on. Among them, since August 2021, Interim Provisions on the administration of drugs and medical devices urgently needed to be imported from Hong Kong and Macao in Guangdong Province, notice of the office of Guangdong Provincial Health Commission on Approving the first batch of mainland designated medical institutions in Guangdong, Hong Kong and Macao, and measures for the administration of the use evaluation expert database of drugs and medical devices urgently needed to be imported from Hong Kong and Macao in Guangdong, Hong Kong and Macao (for Trial Implementation) The release of the policy provides institutional guarantee for the expansion and implementation of the policy in 9 mainland cities in Dawan district. At the same time, it also allows mainland cancer patients in mainland China to be in line with international standards and enjoy the latest treatment scheme in hospitals such as Shenzhen Hospital of the University of Hong Kong. Alpelisib is the only PI3K inhibitor that has been approved for breast cancer in Europe and America. It was approved in Hongkong in December 2020. Alpelisib can be used in Shenzhen Hospital of the University of Hong Kong through the policy of "Hong Kong and Macao pharmaceutical and mechanical communication". While bringing new treatment hope to the late patients with PIK3CA mutation HR + in the mainland, medical personnel can also accumulate more clinical treatment experience to provide a basis for accelerating the approval and implementation of innovative drugs. (Xinhua News Agency)