Shanghai Pharmaceutical Injection LT3001 will soon start Phase I clinical trials.

The examination and approval conclusions show that, in accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, after examination, the injection LT3001 accepted on June 15, 2020 meets the relevant requirements of drug registration and agrees to conduct clinical trials.
injection LT3001 is the world's first innovative drug project for acute stroke treatment combining targeted thrombosis and neuro-protection functions, with the potential to extend the treatment window.
, phase II clinical trials have been launched in the United States and Taiwan.
November 2019, the Company and Shuntian Pharmaceutical Technology Co., Ltd. (6535. TW) signed a cooperation agreement to obtain the project's exclusive licensing rights in Chinese mainland patents, in June 2020, the project's clinical trial application was formally accepted by the State Drug Administration, and recently, the project was approved by the State Drug Administration issued a "clinical trial approval notice", agreed to carry out clinical trials in accordance with the submitted program.
, the project has invested about Rmb37.6m (unaudited) in research and development.
in accordance with the relevant laws and regulations of China's drug registration requirements, the project after obtaining the notice of clinical trials, but also to carry out clinical trials and by the State Drug Administration review, approval and approval before production and listing.
is a major disease with a high fatality rate of disability, a high incidence rate and a large patient base.
The China Stroke Prevention and Control Report (2018) shows that the overall prevalence of stroke disease in China is 16 million/100,000, with more than 2.7 million new cases of acute ischemic stroke each year.
the number of stroke cases among people aged 40 and over in China now reached 12.42 million, and the number of people dying from stroke in China reached 1.96 million each year, and the incidence and prevalence rate increased every year.
Due to the rapid onset of stroke, the treatment time window of the existing major thrombosis drugs is only applicable to a small number of patients, making thrombosis drugs account for a lower proportion of the entire antithrombotic drug market, clinical application there is a large gap.
2019, global sales of stroke drugs totaled $15.59 billion, according to Evaluate Pharma.
PDB database of the China Pharmaceutical Industry Information Center, the market size of thrombolytic drugs in China will be about RMB 1.52 billion in 2019.
source: Shanghai Pharmaceutical Bulletin.