The Global Pharmaceutical Industry is Accelerating; Aptorum Group Has Received Orphan Drug Designation from US FDA for Its SACT-1
HONG KONG, July 26, 2022 – (ACN Newswire) – The aging of the population is accelerating, pharmaceutical technology is constantly updating, and the development of the global pharmaceutical industry continues to accelerate. The pharmaceutical market is expected to maintain a growing trend. According to Frost & Sullivan, the global pharmaceutical market is expected to reach $1,711.4 billion by 2025.
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications) and infectious diseases. The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. discovery and development of new small molecules and biologics, and systematic screening of existing approved drug molecules, etc.; and (ii) the co-development of a novel molecular-based rapid pathogen identification and detection diagnostics technology with Accelerate Technologies Pte Ltd, the commercialization arm of the Singapore’s Agency for Science, Technology and Research.
Currently, Aptorum Group’s R&D pipelines cover the ALS family of drugs and the SACT family of drugs, covering such indications as drug-resistant Staphylococcus aureus (including MRSA), Gram-positive cocci, influenza A, COVID-19, orphan disease neuroblastoma and other cancers.
Since the beginning of this year, Aptorum Group has accelerated its research and development (R&D), with major breakthroughs achieved in several pipelines under development. SACT-1, the Group’s orally administered small molecule drug for the treatment of neuroblastoma, was granted its first patent by the United States Patent and Trademark Office (US PTO) in November 2021 and Orphan Drug Designation by the US Food and Drug Administration (FDA) at the beginning of this year. Meanwhile, the Group completed the Phase I clinical trial of SACT-1 in January this year and announced the finalized data in May. The data showed that SACT-1 had impressive safety and good tolerability making the later stages of SACT-1 promising.
In addition, earlier in the year, the Group launched oncology and autoimmune discovery and development platform targeting unmet mutations and novel biomarkers, focusing on indications including non-small cell lung cancer (“NSCLC”) and autoimmune diseases such as lupus, rheumatoid arthritis and inflammatory bowel diseases. In the meantime, the Group also completed a Phase I clinical trial for ALS-4, a first-in-class anti-virulence-based small molecule drug targeting infections caused by Staphylococcus aureus including MRSA. In the second quarter of this year, the Group’s Rapid Pathogen Infectious Disease Liquid Biopsy Diagnostics (“RPIDD”) was granted a patent by the US PTO, and the Group is spearheading the efforts in the ongoing clinical validation and pre-commercialisation preparation of the technology.
Currently, the overall development prospect of the biopharmaceutical industry is promising. Aptorum Group is actively advancing its R&D projects. With its strong R&D capabilities and internal management capacity, it is expected to further enhance its business development, expand the room for enterprise development, and gain greater development opportunities in the biopharmaceutical industry.