Latest ArticlesDifferent levels of genotoxic impurities 1-methyl-4-nitroso piperazine (MNP) and 1-methyl-4-nitroso piperazine (CPNP) were detected in rifampicin and rifapentine capsules. In this study, the nitrite ions in rifampicin and rifapentine capsules were determined by solid phase extraction-ion chromatography to explore the relationship between the content of nitrite ions and the formation of above genotoxic impurities.
The method of solid phase extraction-ion chromatography used for nitrite determination was established and validated.
Nitrite ion was not detected in rifampicin and rifapentine capsules with different levels of MNP and CPNP.
It is speculated that the origin of MNP and CPNP in rifampin and rifapentine capsules was not from nitrite ion, but derived from oxidative degradation of API.
Achievements have been made in the development of pharmaceutical innovation in China since the Chinese Communist Party's 18th National Congress. China is moving toward from follow-on innovation to the original innovation. This paper reviews current situation of the drug innovation, analyzes the existing problems and obstacles, and puts forward corresponding suggestions. New challenges for the future of pharmaceutical innovation include lower innovative capability, risk of dependence on foreign technological in some key chains, lack of top pharmaceutical companies in the world, etc. Several suggestions for resolving these capital, talent, technology, system, and policy problems are proposed as follows: taking advantage of the new system for mobilizing resources nationwide, improving the efficiency of innovation investment, coordination of talent attraction policies and science and technology policies, developing industry-university-institute-hospital R&D, perfecting related policy and ecosystem environment.
In recent years, with the aging of the global population and the general improvement of consumer awareness, disease prevention and early intervention have been paid more and more attention, and the traditional Chinese medicine (TCM) industry, which has the unique advantage of "preventive treatment of disease", has ushered in a huge development opportunity. Especially under the special background of the global COVID-19 pandemic, TCM has played an important role and provided a good opportunity for its industrial development. With the promulgation of a series of policies in China, the inheritance and innovative development of TCM have been accelerated. In this paper, we investigated the TCM's domestic and foreign market, research and development investment of enterprises, approval trend of innovative drugs, and internationalization and the layout of patents in the past 20 years, analyzed the current situation of TCM innovation and development, and looked forward to the future trend, with a view to provide inspiration for the future inheritance and innovation of TCM.
To understand the innovation points of drugs marketed after the implementation of the U.S. breakthrough therapy designation (BTD) program, and provide a reference basis for the development of innovative drugs and the review of breakthrough therapy drugs in China.
As of 2021, all BTD drugs approved by the U.S. FDA for marketing were collected, and the characteristics of these drugs in terms of innovative therapeutic modalities, treatment mechanisms, and technological breakthroughs were categorized and statistically analyzed.
The US FDA received 1 192 BTD drug applications and approved 242 for marketing. Among the marketed drugs, 42 (17%) were new drugs to fill clinical treatment gaps, 99 (41%) were drugs for expanded indications and new applicable populations, 27 (21%) were drug combinations for combination therapy, 16 (7%) were new drugs with more clinical treatment advantages, 31 (12.8%) were drugs with new mechanisms of action, and 12 (5%) were drugs prepared in new dosage forms or processes.
The substantial improvement of the clinical efficacy of BTD drugs is reflected in the innovation of drugs and advancement of treatment.
Zynteglo (betibeglogene autotemcel) is the world's first gene therapy approved by the U.S. Food and Drug Administration on August 17, 2022 for adults and children with β-thalassemia who require regular blood transfusions. Zynteglo is a one-time gene therapy product administered as a single dose. Each dose of Zynteglo is a customized treatment created using the patient's own $\mathrm{CD}_{34}^{+}$ bone marrow hematopoietic stem cells which are genetically modified in vitro and then autologously transplanted. The modified stem cells will differentiate into red blood cells which are capable of producing functional hemoglobin, therefore achieving the purpose of β-thalassemia treatment. This paper provides a comprehensive introduction to the gene therapy from six aspects: lentiviral vector and mechanism of action, non-clinical research, clinical efficacy research, clinical safety research, indications and methods of use, and precautions.
Roflumilast is a selective phosphodiesterase-4 inhibitor. Roflumilast 0.3% cream was approved by the U.S. FDA on July 29, 2022 (trade name Zoryve) for the treatment of plaque psoriasis in patients of 12 years or older, including intertriginous areas. Unlike other topical medicines, roflumilast has a higher safety profile, it is non-irritating to the skin, can be used continuously in long-term, and does not thin the skin. This article reviews its mechanism of action, pharmacokinetics, safety, clinical efficacy and precautions for use.
The U.S. Food and Drug Administration (FDA) has issued a series of policy documents in recent years to accelerate the approval and marketing of generic drugs. This article briefly introduced the relevant contents of one of these documents, i.e., "Good Abbreviated New Drug Application Assessment Practices", to explain how the US FDA tries to find a way, from the agency's perspective, to standardize the review process of generic drugs, and improve the review efficiency and effectiveness to promote generic drug marketing without quality compromising. Also, some thoughts were put forward respecting the relevant policies for the reform of China's drug review and approval system.
Non-alcoholic steatohepatitis (NASH) has a global prevalnce of about 3%~5%, and lifestyle interventions are the main prevention and treatment methods of NASH. The diet pill orlistat, antioxidant vitamin E, and insulin sensitizer pioglitazone have certain therapeutic effects on NASH. In recent years, many therapeutic drugs for NASH of different mechanisms have entered clinical trials at different stages, such as the double agonist lanifibranor of peroxisome proliferator activated receptor α/δ, glucagon-like peptide-1 receptor agonist liraglutide, acetyl CoA carboxylase inhibitor firsocostat, thyroid hormone receptor agonist resmetirom, stearyl-CoA desaturase-1 inhibitor aramchol, sodium-glucose cotransporter 2 inhibitor dapagliflozin, fibroblast growth factor-21 analogue efruxifermin, Fani-X receptor agonist obeticholic acid, etc. In this paper, the current status of NASH treatment and clinical research of new drugs are systematically summarized.
To study the distribution of expanded activated lymphocytes in severe immunodeficient mice.
Ninety-six NPG mice were used and randomly divided into vehicle control group and administration group. The animals in the vehicle control group were given vehicle by tail vein injection once; the animals in the administration group were given DiR-labeled EAL cells by tail vein injection once. Blood was collected at different time points after administration, and EAL cells were detected by in vivo imaging system. At 1 h, 3 h, 2 d, 7 d, 14 d, 28 d, 42 d, and 56 d after administration, the mice were anesthetized, and blood, heart, liver, spleen, lung, kidney, brain, testis, epididymis, uterus, ovary, stomach, duodenum, colon, bone marrow, fat, and skeletal muscle were taken for cryopreservation. The distribution of EAL cells in peripheral blood and the above-mentioned tissues was studied by flow cytometry, in vivo imaging method and qPCR method.
The numbers of CD3+ T cells, CD3+CD4+ T cells and CD3+CD8+ T cells in peripheral blood were higher at 2 d after administration, and then showed a downward trend, reaching the lowest at 14 d, and maintained a low level thereafter. The results of in vivo imaging showed that the cells were mainly distributed in the lungs, liver, spleen and bilateral leg bones, and were mainly distributed in the lungs and liver within 1 d after administration. The results of gene copy number detection showed that the cells were mainly distributed in the lungs and blood, followed by the spleen, liver and bone marrow, and only a little in other tissues. At 1 h after administration, the gene copy number of cells in the lungs was relatively high. At 2 d, the number of gene copies in the blood and spleen was relatively high, and then gradually decreased, reaching the lowest at 14 d, and at 56 d cells were only detected in individual organs of one mice.
EAL cells were administered to NPG mice, the cells were mainly distributed in lung, blood and spleen. At 56d after administration, the cells were basically eliminated from the mice.
Ergosterol peroxide, a derivative of ergosterol, is widely found in a variety of medicinal fungi and plants and has various biological activities because of its 5α, 8α-peroxide bridge structure, such as anti-tumor, anti-virus, immune regulation, bacteriostasis and anti-inflammation. It is worth noting that the anti-tumor activity of ergosterol peroxide is significantly higher than ergosterol. At present, the preparation processes of ergosterol peroxide mainly include biological extraction and chemical synthesis. Biological extraction fails to acquire a large amount of ergosterol peroxide because of its low content in natural resources. However, chemical synthesis is convenient, and may realizes the industrialization of ergosterol peroxide. Here, the progress in study on biological activities and preparation of ergosterol peroxide was reviewed to provide direction for its application.
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