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On November 3, 2022, Tianjin Suntech Pharmaceutical Technology Co.
, Ltd.
announced that its core product ACT001 has been granted orphan drug designation by the FDA for diffuse midline glioma DMG, and its pipeline product ACT004 has also passed ethical approval in Australia, and its potential indication is renal fibrosis
.
Up to now, ACT001 has successively obtained four overseas heavy qualification certifications, and the designation of DMG orphan drugs is also the first variety in China to obtain FDA "rare pediatric disease designation (RPD)" and "orphan drug designation (ODD)" for the same indication
.
ACT001 is currently one of the few immunomodulators in the world that can cross the blood-brain barrier, and drug research and development focuses on brain tumors and brain inflammation, and has been approved for 12 clinical trials in China, the United States and Australia, including 4 phase 1 clinical trials, 7 1b/2a or phase 2 clinical trials, and 1 2b/3 phase clinic
.
At present, we are fully promoting the launch of two key indications, namely diffuse pontine glioma (DIPG) in children and the combination of radiotherapy for the treatment of patients
with lung cancer brain metastases.
.
The proportion of patients with DIPG diagnosed according to traditional methods with H3 K27 mutations is as high as 85%.
ACT001 has been approved as an orphan drug by the US FDA, and its application data includes safety and efficacy data
from children with DMG (the vast majority of whom have H3 K27 mutations) in Australian trials.
Another pipeline key variety, ACT004, has completed standardized preclinical studies and passed the review of the Australian Ethics Committee, and is about to launch a phase 1 clinical trial, and its clinical indication is renal fibrosis
.
Other indications for preclinical pipeline drugs include pancreatic cancer, liver cancer, acute lung injury and inflammatory bowel disease
.
Suntech's success in the drug industry is inseparable from the team's down-to-earth and rigorous style, as well as the unique blood-brain barrier penetration drug screening platform and cancer stem cell drug development platform, and the continuous output of small molecule drug candidates with new structures
.
The drug research and development strategy for rare diseases in children also fully reflects the clinical value orientation and social responsibility orientation of its project establishment, and it is a practitioner of "integrity and innovation, going to the world" in
China's pharmaceutical research and development.
Up to now, Suntech has completed hundreds of millions of yuan of financing in angel rounds, Series A, Series B and Series C, and since 2017, it has introduced government industry guidance funds and professional investment institutions such as Tianjin Binhai Venture Capital, Shenzhen Guozhong Capital, Guangdong Hengjian Asset Management Group, Anhui Chuanggu Capital, Anyuan Fund, Amphora Capital, Tianjin Qingda Investment Group, and Ordos Transformation and Development Investment, and is preparing for listing
on the Science and Technology Innovation Board.
