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SciTech Pharma Announces China NMPA Approval for ST-1703 for Treatment of Patients with HER2-Positive Advanced Solid Tumors

On September 10, 2021, Scitech Pharma ST-1703 clinical trial application was approved by the National Medical Products Administration (NMPA) (notification number: 2021LP01474, 2021LP01475). This is another project of Scitech Pharmaceuticals entering the clinical study stage after ST-1898 was launched in clinical trial in 2020. The clinical phase I trial will be formally launched at Shanghai Oriental Hospital very soon, with Professor GUO Ye as the principal investigator.


ST-1703 is a small molecule tyrosine kinase inhibitor with global intellectual property rights developed by Scitech Pharma, which is intended to be used for the treatment of HER2-positive advanced solid tumors (including brain metastases).


Malignant tumors are the most important public health problem in China and the world, and have become the leading cause of death in our population. According to the National Cancer Center, there will be 4.57 million new cancer cases and 3 million cancer deaths in China in 2020. The number of new cases of breast cancer is 420,000, and 20-30% of breast cancer cases are HER2-positive breast cancer, of which the incidence of brain metastasis is as high as 30%-50%. As patients with metastatic HER2-positive breast cancer live longer, the incidence of brain metastases will increase. For patients with HER2-positive advanced malignancies, especially those with brain metastases, the available therapies are limited and there is still a huge unmet medical need. ST-1703 can cross the blood-brain barrier and has a high distribution in brain tissue, which is expected to provide a new breakthrough therapy for the treatment of HER2-positive brain metastasis patients.