Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®, Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
On September 14, according to the official website of CDE, AstraZeneca’s clinical trial application for the Class 1.1 chemical drug AZD5462 tablets was accepted. According to public information, the drug is a relaxin RXFP1 receptor agonist. Relaxin, as an agonist of the relaxin 1 receptor (RXFP1), produces unique and diverse biological effects, including pulmonary and systemic vasodilation, tissue remodeling/fibrosis reversal, and reduced inflammation, and therefore also has potential in cardiopulmonary diseases. significant curative effect. In addition, this substance is also known as the “pregnancy hormone” and is regulated during pregnancy to help the expectant mother’s cardiovascular system meet the increased demands of the developing fetus and remodel tissue and musculoskeletal structure. . AZD5462 is a relaxin RXFP1 receptor agonist developed by AstraZeneca. Preclinical studies on monkey models of heart failure with reduced ejection fraction (HFrEF) showed that cardiac systolic function was improved after 8 weeks of treatment. There was no ...
Domestic companies have created a new situation in the TAVR market and created a new market engine. On August 14, 2024, the State Food and Drug Administration officially approved the domestic Prizvalve transcatheter aortic valve system developed by New Pulse Medical. As the first self-developed balloon-expandable valve launched in China, the Prizvalve valve system is expected to be the first to break the import monopoly, effectively improve the quality of life, and quickly capture market share. Aortic valve disease mainly includes aortic valve stenosis and aortic valve regurgitation. With the deepening of aging, the prevalence of cardiovascular diseases (including aortic valve stenosis) continues to rise, and the number of patients with aortic valve disease in the world and China has increased year by year. This change has not only had a serious impact on the quality of life of patients, but also posed severe challenges to the medical system. Traditional ...
Original Medical Overview Medical Overview September 19, 2024 08:54 Shanghai Multiple myeloma (MM) is a blood cancer that, despite advances in treatment methods in recent years, remains an incurable disease. The traditional treatment options for MM include the combination of proteasome inhibitors (PIs), immunomodulators (IMiDs), and monoclonal antibodies (Mo Abs). Although these methods improve patient survival and progression free survival (PFS), with the emergence of treatment resistant clones, patients will eventually develop resistance to these treatments. Therefore, researchers are exploring new treatment strategies such as CAR-T cell therapy and bispecific antibodies, which activate immune T cells to kill tumor cells. Based on the review of bispecific antibodies and multiple myeloma published in the Blood Cancer Journal this month, let’s talk about the design, mechanism of action, current clinical trials, and future development directions of bispecific antibodies. 01 Bispecific antibodies and therapeutic targets Bispecific antibodies (BsAbs) are antibody constructs with two ...
BioArt September 19, 2024 08:45 Shanghai Bile acids are metabolites produced by the synergistic effect between the host and its gut microbiota. They can regulate various biological functions and affect the host’s susceptibility to viral infections, especially enteroviruses and hepatitis viruses, by activating specific receptors and cellular signaling pathways in intestinal and liver tissues. A small fraction (<10%) of total bile acids can enter the systemic circulation and may play a critical role in antiviral immunity during systemic infections. However, the function and mechanism of bile acids in regulating the host’s immune response to viral systemic infections are still poorly understood, and the association between bile acid metabolism and disease outcomes of viral systemic infections is also unclear. Viral hemorrhagic fever is usually caused by highly pathogenic RNA viruses, which can lead to severe systemic infections, multiple organ failure, and even death. Severe fever with thrombocytopenia syndrome (SFTS) is a ...
Recently, Fosun Pharma (stock code: 600196.SH; 02196.HK) announced that its subsidiary, Fosun Pharma Industry, plans to invest $27 million in cash to acquire 50% of the equity of Fosun Kite held by Kite Pharma. Once this equity transfer is completed, Fosun Pharma will wholly own Fosun Kite and plans to invest an additional $10 million or its equivalent in renminbi as a capital increase for Fosun Kite. On the same day the equity transfer agreement was signed, Fosun Kite and Kite Pharma comprehensively revised and restated their original licensing agreement, signing a “Revised and Restated Licensing Agreement.” According to this agreement, Fosun Kite has obtained exclusive rights to develop, produce, and commercialize Yescarta® and Brexu-Cel (Fosun Kite’s research project FKC889) in mainland China, Hong Kong, and Macau, and within the field of cancer treatment. Additionally, Fosun Kite plans to change its name to Fosun Kairui and will function as Fosun ...
Innovative drugs are a gamble, a big gamble. Once the research and development fails, the stock price collapses and financing is unavailable. On the contrary, if the gamble is won, it is not impossible for the stock price to soar. Especially in the US stock market, it has always been so violent. For the losers, there are only two options: disband on the spot or fight back. The so-called fight back means finding a way to start the next round of innovation gambling. This requires both money and the courage to gamble. Summit is an old “gambler” who plans to gamble again. After its establishment in 2003, Summit focused on the anti-infection field, and its core product was benchmarked against vancomycin, the “last line of defense for antibiotics.” It landed on Nasdaq in 2015, but because the core product ridinilazole did not perform well in the final clinical data, the ...
To this day, liver cancer is still the top killer on my country’s cancer “killer list”. According to the latest data on cancer in China in 2022 released by the National Cancer Center (NCC) in February 2024, liver cancer ranked second with 316,500 deaths. The core reason is that despite the continuous progress in first-line treatment, the existence of drug resistance has made the current second-line treatment of liver cancer face great challenges. First of all, for patients whose disease progresses after TKIs treatment, the clinical needs are far from being met. Whether it is changing TKIs or using immunotherapy, the degree of clinical benefit needs to be improved. Specifically, the key trials of multikinase inhibitors regorafenib and cabozantinib in patients whose disease progressed after sorafenib treatment showed that the objective response rate (ORR) was only 11% and 4%, respectively, and the proportion of patients who achieved remission was extremely ...
Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services. In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease ...
The following article is from the biological world, authored by the author Transforming growth factor beta (TGF – β) is a multifunctional cytokine that plays a critical role in processes such as development, immunity, cancer, and fibrosis. TGF – β has three different gene expression products (TGF – β 1, TGF – β 2, and TGF – β 3), all of which are expressed in an inactive (latent) form, namely L-TGF – β, and “activation” is crucial for its function. Most therapeutic strategies targeting TGF – β do not target specific latent and/or activation mechanisms, but rather inhibit the overall TGF – β signaling pathway and exhibit significant toxicity. A deeper understanding of latency and activation may contribute to the development of better TGF – β targeted therapeutic strategies. Traditionally, it is believed that mature TGF – β must physically dissociate from L-TGF – β 1 before signal transduction can ...
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