The International Pharmaceutical INN Name Expert Group (INN Expert Group) decided to implement a new scheme for naming monoclonal antibody drugs at the 73rd INN Consultative Meeting in October 2021. The new scheme aims to avoid the confusion caused by the use of the “-mab” root in the old naming scheme, divides monoclonal antibody drugs into four different groups, and introduces four completely new root words. 1. Background and purpose of the new naming scheme Old naming scheme: Previously, monoclonal antibody drugs used “-mab” as the root word, but with the development of technology, this naming method can no longer accurately distinguish different types of monoclonal antibodies. New naming scheme: The new scheme divides monoclonal antibody drugs into four groups, each using a unique root word to more accurately describe the characteristics of the drug. 2. Four new root words and their meanings -tug: for “unmodified immunoglobulin” class of mAbs, ...
From May 10 to 11, high-level economic and trade talks between China and the United States were held in Geneva, Switzerland. After the talks, the two sides issued a joint statement today (May 12). The main contents are as follows: The Chinese chief negotiator for China-US economic and trade relations, Vice Premier He Lifeng, and the US chief negotiators, US Treasury Secretary Jeff Bessant and Trade Representative Greer, and other representatives of their respective governments, had candid, in-depth and constructive communication on the implementation of the important consensus reached in the phone call between the Chinese and US heads of state on January 17, and the talks made substantial progress. The United States will (i) modify the additional ad valorem tariffs on Chinese goods (including goods from the Hong Kong Special Administrative Region and the Macao Special Administrative Region) imposed by Executive Order No. 14257 of April 2, 2025, by ...
On May 13, InnoCare Pharma released its first quarter 2025 performance report, which opened with a striking cash and related account balance of 7.78 billion yuan. This figure not only lays a solid foundation for the company’s current development, but also paves a broad road for its future strategic layout. InnoCare Pharma’s performance in the first quarter was also outstanding. The company’s revenue increased by 129.9% year-on-year to 380 million yuan, and it successfully achieved a net profit of 14 million yuan, reversing the loss trend of the same period last year. Such outstanding achievements are inseparable from the outstanding contribution of its core products and the efficient promotion of market expansion. The core product Obtunib continued to perform well, with sales revenue increasing by 89.2% year-on-year to RMB 310 million, becoming the core engine of performance growth. After its three major indications, especially marginal zone lymphoma, were included in ...
Recently, according to the official website of the Shanghai Stock Exchange, the IPO application of Ningbo Jianxin Superconducting Technology Co., Ltd. (hereinafter referred to as Jianxin Superconducting) on the Science and Technology Innovation Board has been accepted. It is worth mentioning that the company has become the third company to be accepted on the Science and Technology Innovation Board in 2025. According to the prospectus, Jianxin Superconducting is mainly engaged in the research and development, production and sales of core components of medical magnetic resonance imaging (MRI) equipment. The company was founded in 2013. After years of development in the MRI industry, its main products are now widely deployed in the MRI field, including superconducting magnets, permanent magnets and gradient coils. In addition, Jianxin Superconducting has mastered a number of core technologies in the MRI field and is committed to implementing the technology. It is worth mentioning that Jianxin Superconducting ...
Recently, Element Science announced that its wearable defibrillator patch has been approved by the U.S. Food and Drug Administration (FDA) after being approved by British and European regulators early last year. This non-invasive device provides an innovative solution for patients with a temporarily increased risk of cardiac arrest. It is reported that the device is suitable for patients recovering from heart attacks and other patients with serious cardiovascular diseases. The Jewel Patch-WCD wearable cardioverter defibrillator system adopts a lightweight and waterproof design, which supports continuous wear during sleep and showering. The system includes a reusable defibrillator device, a battery pack, and a disposable electrode patch that is replaced once a week. Uday Kumar, President and CEO of Element Science, said that the Jewel patch-type external defibrillator has realized the vision of seamlessly integrating life-saving equipment into patients’ daily lives. This FDA approval not only means the achievement of a regulatory ...
Scientists have identified mutated immune cell clones that could point to improved treatment for refractory celiac disease. Researchers at the Garvan Institute of Medical Research and UNSW Sydney have discovered why some people with celiac disease continue to suffer debilitating symptoms despite strictly avoiding gluten. The study, published in Science Translational Medicine, used cutting-edge single-cell sequencing techniques to reveal that certain immune cells in the gut of these patients carry genetic mutations. The team’s findings suggest these abnormal immune cells are driving ongoing intestinal inflammation that causes symptoms like diarrhoea, pain and malnutrition – pointing to a new way to diagnose and potentially treat the most severe form of celiac disease. Rogue immune cells emerge as hidden culprits celiac disease is a chronic autoimmune condition where the body mistakenly attacks the small intestine in response to gluten, a protein found in wheat, barley and rye. While most people with ...
The U.S. Department of Health and Human Services and U.S. Food and Drug Administration have begun to comprehensively review the nutritional value of infant formula, a program the agencies have dubbed Operation Stork Speed. Operation Stork Speed aims to review the nutrient content of infant formula, increase testing for heavy metals and contaminants, encourage companies to develop new formulas, and clarify ways to better inform consumers about formula ingredients. Individual nutrient requirements for infant formula are already reviewed at regular intervals; however, this will be the first comprehensive review since 1998. The FDA has initiated Operation Stork Speed with a Request for Information (RFI) to gather public input. This input will be used to evaluate whether current nutrient requirements need to be updated based on the most recent scientific findings, including international data. The agency is also interested in receiving input regarding potential adjustments to the current minimum or maximum ...
NO.1 Shiyao Group enters into exclusive license agreement for irinotecan liposome injection On May 15th, Shiyao Group announced that it has entered into an exclusive license agreement with Cipla USA, Inc. for the commercialization of irinotecan liposome injection in the United States. According to the terms, the group will receive a down payment of $15 million and is also entitled to receive up to $25 million in potential initial commercial sales and regulatory milestone payments, as well as up to $1.025 billion in potential additional commercial sales milestone payments, and a double-digit gradient sales commission calculated based on the annual net sales of the product in the region. Comment: This event is an important breakthrough in the company’s internationalization strategy. The potential transaction volume of over 1 billion US dollars demonstrates the huge commercial potential of Irinotecan Liposome Injection in the US market, and also reflects the strong strength of ...
BeiGene Limited (referred to as “BeiGene”, 688235. SH) recently released its Q1 2025 financial report, which showed that the company’s operating revenue reached 8.048 billion yuan, an increase of 50.2% compared to the same period last year’s 5.359 billion yuan. In terms of net profit, the company still faces certain pressure to incur losses, but the losses have significantly narrowed. The net profit attributable to the parent company was a loss of 94.503 million yuan, a significant reduction from the loss of 1.908 billion yuan in the same period last year. From the perspective of cost structure, BeiGene continues to increase its research and development investment. Data shows that BeiGene’s research and development expenses in 2024 amounted to 14.14 billion yuan, an increase of 10.35% compared to the same period last year. Research and development investment is used for preclinical studies, clinical trials, collaborative research and development of the company’s ...
Drugdu.com expert’s response: Imported drugs are not absolutely more effective than domestic drugs. The difference in their efficacy is influenced by multiple factors, including drug type, research and development (R&D) technology, formulation processes, and individual patient variations. A comprehensive assessment based on specific circumstances is necessary. Below is a detailed analysis: I. The Difference in Drug Efficacy is Not Absolute Common Diseases: For common illnesses such as colds and coughs, there is little difference in efficacy between domestic and imported drugs. For example, domestic paracetamol has been widely recognized for its antipyretic and analgesic effects and is more cost-effective. Chronic Diseases: In the treatment of chronic diseases requiring long-term medication, such as hypertension and diabetes, imported drugs may offer better patient compliance due to their precise formulations and superior side effect management. However, domestic drugs that have passed consistency evaluations are equally reliable in terms of efficacy and safety. Complex ...
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