(Health Times reporter Kong Tianjiao) On February 27, a Health Times reporter found that according to the data released by the Center for Drug Evaluation of the State Food and Drug Administration, in the past week, more than 20 new categories of 1 category have been added. New drugs (excluding supplementary applications), involving innovative drugs for Alzheimer’s disease, tumors, psoriasis, etc. Among them, anti-tumor drugs are still the focus of approval. These Class 1 innovative drug companies that have been approved for clinical use include Simcere Pharmaceuticals, Xinlitai, Livzon Pharmaceuticals and other pharmaceutical companies.
New drug research and development, according to CCTV news
Health Times reporters found that at least seven anti-tumor-related drugs were clinically approved last week. Immonco’s IMM01, a SIRPα Fc fusion protein drug targeting human CD47, has been approved for Phase 1b/2 clinical trials in combination with anti-PD-1 antibody for the treatment of relapsed and refractory malignant tumors. IMM01 has a dual anti-tumor mechanism, which can simultaneously block the “don’t eat me” signal of CD47-SIRPα and activate the “eat me” signal through IgG1.
IN10018 tablet is a highly selective ATP-competitive focal adhesion kinase (FAK) inhibitor under development by Yingshi Bio, and D-1553 tablet is a highly selective inhibitor under development by Yifang Biology KRAS G12C inhibitor. The combination therapy of the two drugs has been approved for clinical treatment of advanced or metastatic solid tumors with KRAS G12C mutation.
Hibowei Pharmaceutical’s HBW-3220 for B-cell lymphoma patients with resistance or dose-intolerant to first-generation BTK inhibitors, developed by Huilun Pharmaceuticals The HTMC0435, a highly selective polyadenosine diphosphate ribose polymerase 1/2 (PARP1/2) inhibitor used as a single agent or in combination with temozolomide for solid tumors such as advanced small cell lung cancer, has also been approved for clinical use.
In addition, at least two Alzheimer’s-related drugs were approved for clinical use last week. Among them, Simcere and Vivoryon Therapeutics established a strategic regional licensing cooperation, and the developed Alzheimer’s disease treatment drug PQ912 was approved for clinical use. PQ912 is an oral small molecule glutamyl peptide targeting N3pE Cyclotransferase (QPCT) inhibitor. The clinical indication of the drug approved this time is: for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease.
SAL0114 tablets declared by Xinlitai Pharmaceuticals have been approved for clinical use and are intended to be used in patients with Alzheimer’s disease agitation. Agitation (including mania, anxiety, fear, physical and verbal aggression, etc.) is one of the most common neuropsychiatric symptoms in people with dementia.
In addition to Alzheimer’s disease and tumor drugs approved, psoriasis and stroke treatment drugs have also been approved for clinical use.
TLL-018 is a TYK2/JAK1 dual inhibitor independently developed by Gaoguang Pharmaceutical. This time, TLL-018 has two new indications approved for clinical use, namely urticaria and psoriasis. The JAK family is a class of non-receptor tyrosine kinases, including four subtypes of JAK1, JAK2, JAK3, and TYK2, and has become an important target for the treatment of autoimmune diseases such as rheumatoid arthritis and psoriasis.
PMS-001 is a new type of peptide drug developed based on the unique technology platform of protein-protein interaction interfering peptide, which is unique to Pumeisheng Pharmaceutical Co., Ltd. The clinical indications approved this time are as follows: Acute ischemic stroke.
Health Times reporters found that in addition to the above new drugs and related pharmaceutical companies, a number of Class 1 new drugs have been approved for clinical use in the past week, such as the drug that is being developed by Magpie Medicine to be used for the treatment of Alport syndrome. Nitrozine enteric-coated tablets, HE006 tablets developed by Hongyi Pharmaceutical for the treatment of relapsed/refractory acute myeloid leukemia, Novartis’ new generation of IgE antibody therapy QGE031 injection, etc.