On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center’s official website, announcing that Lepu Biotech’s injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies. This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations. In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the ...
Recently, the State Council Information Office held a series of themed press conferences on “Promoting High-quality Development”. Yan Qinghui, deputy director of the National Medical Insurance Administration, said that so far, a total of 432 designated medical institutions in 30 provinces have been inspected. It is expected that the number of inspected institutions this year will exceed the total of the past five years, and the expansion is relatively large. According to incomplete statistics from Cyber Blue, as of September 18, the national flight inspection team has landed in Hebei, Shanxi, Liaoning, Jilin, Heilongjiang, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Hainan, Sichuan, Guizhou, Yunnan, Shaanxi, Gansu, Qinghai, Inner Mongolia, Guangxi, Tibet, Ningxia, Xinjiang, Beijing, Shanghai and other places (see the attachment at the end of the article for details). According to the work arrangements of the National Medical Insurance Administration, all provinces across the country will complete ...
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 ...
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 ...
Recently, Merit Medical announced that it has agreed to acquire Cook Medical’s lead management business for $210 million (approximately RMB 1.5 billion). Merit expects to provide funding for the transaction through a combination of cash on hand and borrowing under its long-term credit line. The proposed transaction is expected to be completed in the fourth quarter of 2024, subject to obtaining or waiving (in accordance with the provisions of the asset purchase agreement) approval for certain closing conditions, including antitrust laws and other customary closing conditions. It is understood that Cook Medical’s lead management business has a 34 year operating history, providing a comprehensive end-to-end medical device and accessory product portfolio for patients who need to remove or replace pacemaker or implantable cardioverter defibrillator (ICD) leads for lead management procedures. 01. Breaking through industry difficulties Cook Medical’s lead management business provides medical equipment and accessories for potential customer management programs. ...
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 ...
Over the past decade, the cross-border medical intermediary industry has experienced a boom, followed by a sharp decline during the pandemic. It has only been after the pandemic that the industry began to recover, but very few companies have managed to endure to this point. Recently, the company Shengnuo Yijia announced a partnership with the Hong Kong Yanghe Medical Group, launching a patient service center in the Yanghe facility to assist critically ill patients from mainland China in seeking medical treatment in Hong Kong. Previously, Shengnuo Yijia focused on bringing patients to the U.S., U.K., Japan, and other overseas regions for treatment. Now, they are increasing efforts to explore the Hong Kong medical market. How should we view this change? According to Shengnuo Yijia Chairman Cai Qiang, cross-border medical services have entered their next phase. The key question remains: Where are the new opportunities in this industry? Seeking Treatment in ...
The “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” built this time aims at the difficulties and pain points of key technologies and results transformation in the process of antibody drug research and development and industrialization. It will build and improve the two key platforms of “core technology breakthrough” and “innovation results transformation” to conduct independent localization research on materials and consumables required for the production of biological products, including cell culture medium, protein chromatography medium and virus removal nanofiltration membrane, and carry out results transformation and industrialization development for key innovative antibodies, antibody-drug conjugates and recombinant humanized proteins. Next, the “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” will further promote the development of biological products and the joint development of upstream and downstream industrial chains, complete the transformation from biosimilars to innovative biological products, develop new antibody drugs with independent intellectual property rights, and ensure the ...
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