Organiser:CEMS-Global Time:May 7 – 9, 2026 Address:Agargaon, Sher-E-Bangla Nagar, Dhaka – 1207, Bangladesh Exhibition hall: Bangabandhu International Conference Center Product range: Hospital medical equipment, apparatus, disposable consumables, surgical equipment and accessories, surgical equipment, physiotherapy equipment, orthopedic equipment, plastic surgery equipment, prosthetic materials, restorative materials, medical and healthcare apparatus, electronic medical equipment, medical technology, testing and diagnostic equipment, therapeutic equipment, dental equipment and supplies, laboratory equipment, professional medical uniforms, first-aid equipment, hospital supplies, hospital furniture, communication equipment, control and automation systems, medical service providers and related services, technologies, and equipment, pharmaceuticals, prescription drugs, herbal preparations, nutritional health products such as supplementary minerals and vitamins, and dietary nutritional products, etc. About Meditex Bangladesh : The Dhaka Medical Equipment Exhibition in Bangladesh is the highest-caliber exhibition for medical equipment and supplies in the country. Numerous exhibitors showcase a wide variety of medical devices, enabling them to conduct business or stay informed about the latest ...
Drugdu.com expert’s response: Under the framework of the EU Medical Device Regulation (MDR), the demonstration of equivalence for medical devices is a crucial step in assessing the similarity between a new product and a marketed product in terms of technical, biological, and clinical characteristics. This directly determines whether the new product can enter the EU market in compliance with regulations. Below are the key provisions and requirements that need to be mastered for demonstrating equivalence: I. Technical Characteristics Requirements Similar Usage Conditions: The device under evaluation and the presumed equivalent device must be used under similar conditions, meaning there should be no significant clinical differences in their safety and clinical performance. This implies that in real-world medical scenarios, both devices should exhibit similar levels of patient protection and stability in treatment outcomes. Similar Software Algorithms: For medical devices incorporating software algorithms, the functional principles, clinical performance, and intended purposes of ...
On the evening of February 9, Yuandong Bio issued an announcement stating that its wholly-owned subsidiary, Chengdu Youluo Biotechnology Co., Ltd., is conducting a Phase I clinical trial of its independently developed Class 1 biological drug EP-0210 monoclonal antibody injection for the treatment of inflammatory bowel disease, and recently completed the dosing of the first subject. The announcement shows that EP-0210 monoclonal antibody injection is a humanized IgG1 monoclonal antibody drug that targets human tumor necrosis factor-like ligand 1A (TL1A). Its proposed indication is inflammatory bowel disease. Its mechanism of action is to bind to human TL1A efficiently and block the TL1A-mediated pro-inflammatory signaling pathway, thereby playing a role in the treatment of inflammatory bowel disease. Yuandong Bio stated that TL1A antibody drug development is one of the most promising emerging targets in the field of inflammatory bowel disease research, and currently there are no drugs targeting the same target ...
On February 9, Zhifei Biological Products Co., Ltd. announced that it had recently learned that the recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cell) developed by its wholly-owned subsidiary Zhifei Longcom has received a drug clinical trial approval notice from the National Medical Products Administration, agreeing to conduct clinical trials for the prevention of herpes zoster in people aged 40 and above. If the project progresses smoothly, it will further enrich Zhifei Biological’s adult vaccine portfolio and improve its product portfolio. However, it should be noted that drug development is characterized by large investments, long cycles, and high risks, and there are uncertainties regarding the progress, results, and market launch of subsequent clinical trials. This vaccine uses a novel, independently developed adjuvant that can simultaneously stimulate both cellular and humoral immune responses, potentially enhancing its protective efficacy. However, the shingles vaccine market is highly competitive, and its commercial performance remains ...
On February 10, 2026, Shanghai Heyu Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Heyu Biopharmaceutical”, HKEX code: 02256) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Heyu Biopharmaceutical’s independently developed highly selective small molecule FGFR4 inhibitor, ipraginib (Irpagratinib/ABSK-011) , for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitor (ICI) and multi-target kinase inhibitor (mTKI) therapy and have FGF19 overexpression. Currently, there is a lack of effective follow-up treatment options for patients with advanced or unresectable HCC after ICI and mTKI therapy. Studies show that approximately 30% of HCC patients overexpress FGF19, and these patients have a relatively poor prognosis after first-line targeted immunotherapy. Therefore, precise targeted therapy against the FGF19/FGFR4 signaling pathway holds promise for providing new and effective options for these patients. Ipatoloteinib is a highly selective FGFR4 inhibitor independently developed by Heyu ...
Today, Sanofi announced that its investigational oral BTK inhibitor, Rilzabrutinib, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug designation by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of warm autoimmune hemolytic anemia (wAIHA).According to Sanofi’s announcement, both recognitions are based on clinical data from the ongoing LUMINA Phase 2b study (Clinical Study No.: NCT05002777), which aims to evaluate the efficacy and safety of rizabutinib in patients with wAIHA. In addition, the newly initiated LUMINA Phase 3 study (Clinical Study No.: NCT07086976) is evaluating the efficacy of rizabutinib versus placebo in patients with wAIHA.In addition, the drug has been approved for marketing in the United States, the European Union and the United Arab Emirates (UAE) under the brand name Wayrilz for the treatment of immune thrombocytopenic purpura (ITP) in adults. (Image source: Sanofi official website) Follow NewDrugs.com ...
On February 6, the NMPA website showed that Kelun Biotech’s TROP2 ADC, sasugamucil ( sac-TMT), has been approved for a new indication: the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have previously received endocrine therapy and other systemic therapies at an advanced or metastatic stage . This indication had previously been included in the priority review and approval process by the CDE (Center for Drug Evaluation). Screenshot source: NMPA official website Sacubituzumab is an ADC drug targeting TROP2 developed by Kelun Biotech. It is composed of a humanized monoclonal antibody, Sacituzumab, an enzymatically cleavable linker, and a novel topoisomerase I inhibitor, T030, with an average drug-to-antibody ratio (DAR) as high as 7.4. In May 2022, Kelun Biotech and Merck signed a collaboration agreement, granting the latter exclusive rights to develop, use, manufacture, ...
On February 6, the CDE website showed that Novartis’ ianalumab had applied for marketing approval in China. Ilimumab, acquired by Novartis (from MorphoSys) , is a fully human monoclonal antibody targeting B-lymphocyte activating factor receptor ( BAFF-R ). It possesses a dual mechanism of action: depleting B cells and inhibiting BAFF-R. It can be used to treat various autoimmune diseases, including Sjögren’s syndrome, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) . This drug is the first anti- BAFF-R antibody to complete Phase III trials.In the phase III NEPTUNUS-1 study , after 48 weeks of illuminumab treatment, patients with Sjögren’s syndrome had a 6.4-point reduction in the EULAR Sjögren’s Disease Activity Index (ESSDAI) score, compared to a 5.1-point reduction in the placebo group. In the phase III NEPTUNUS-2 study, patients with Sjögren’s syndrome who received irinumab treatment for 48 weeks experienced a 6.5-point reduction in their ESSDAI score, compared ...
Today (February 9), InnoCare announced that ICP-538, its internally discovered VAV1-targeted molecular glue degrader, has been officially approved by the National Medical Products Administration (NMPA) to initiate clinical trials. It is the first VAV1 molecular glue degrader to enter clinical development in China, and the second worldwide. ICP-538 is a novel, oral, potent and highly selective VAV1-targeted molecular glue degrader. Its mechanism of action is highly innovative: it selectively mediates the formation of a ternary complex between CRBN E3 ubiquitin ligase and VAV1 protein, thereby inducing rapid, dose-dependent degradation of VAV1. ICP-538 drug list Picture source: Yaozhi Data-Global Drugs Analysis System As a key protein in the downstream signaling pathways of T-cell and B-cell receptors, VAV1 plays a central role in immune cell activation, proliferation and cytokine release. By degrading VAV1, ICP-538 effectively inhibits T-cell proliferation, differentiation and activation, while suppressing B-cell activation and inflammatory cytokine secretion. These actions confer ...
On February 6, Tasly issued an announcement stating that the company had terminated its cooperation with US-based Arbor Pharmaceuticals and regained the exclusive US marketing and distribution rights for Compound Danshen Dripping Pills. This marks a potential setback for more than 20 years of efforts by Chinese patent medicines to break into the mainstream US pharmaceutical market. Compound Danshen Dripping Pills, developed by Tasly, is one of the earliest Chinese patent medicines seeking to enter the US market through formal drug registration. It first filed for FDA clinical trials in 1997, a process that has now stretched nearly 30 years — far longer than the typical approval cycle for a new drug. Following the termination of the partnership, the prospects for the product’s eventual US launch have become even more uncertain. Under the agreement, Tasly will receive a total payment of $7.5 million. Tasly told Jianshiju, a leading Chinese pharmaceutical ...
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