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1st and only one! 1 Medical Device Approved by FDA

Recently, Alcon, a global leader in ophthalmic healthcare, announced its innovative product, the Direct Selective Laser Trabectomy (DSLT) device – Voyager ™ DSLT has been approved by the FDA and will be fully launched in the United States. According to Alcon, this innovative product is the world’s first and currently the only direct selective laser trabeculoplasty device, which is expected to promote laser therapy as a first-line treatment for glaucoma and benefit more patients. Glaucoma potential device heavily approved Glaucoma is a group of eye diseases characterized by progressive damage to the optic nerve, and one of its important factors is the relative increase in intraocular pressure (IOP), which is an irreversible cause of blindness. As the primary cause of irreversible blindness, many patients do not realize their condition until their vision is lost, so early intervention (from medication to surgery) is crucial for protecting vision. At present, international authoritative ...
- Source: drugdu
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- February 28, 2025
Revolutionizing Medical B2B Trade with AI-Powered Intelligence

I. How AI is Transforming the Medical B2B Industry? In the global pharmaceutical and medical device B2B trade landscape, businesses face numerous challenges, including information opacity, complex regulatory compliance, difficulty in tracking market trends, and cross-border communication barriers. As a leading B2B platform dedicated to the pharmaceutical and medical device industry, Drugdu.com (www.drugdu.com) provides global suppliers and buyers with a trusted marketplace for efficient sourcing and trade. To further enhance industry efficiency and optimize trade decision-making, Drugdu.com has officially launched Drugdu AI—a cutting-edge AI solution tailored for the pharmaceutical B2B sector. Powered by DeepSeek’s advanced AI technology, Drugdu AI leverages Drugdu.com’s extensive industry resources and global data to enable precise access to sector-specific insights, market trends, and compliance guidelines while paving the way for AI-driven trade decision-making in the future. II. What is Drugdu AI? 1. Drugdu AI is an AI-driven intelligent Q&A system developed by Drugdu.com, designed to provide pharmaceutical ...
- Source: drugdu
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- February 28, 2025
【EXPERT Q&A】What are the differences between the second class filing and the third class license of medical devices?

Drugdu.com expert’s response: The medical device Class II registration and Class III license differ significantly in various aspects, including risk level, management approach, handling authority, scope of application, approval process, and regulatory intensity. Below is a detailed elaboration on these differences in English: I. Risk Level Class II Medical Devices: Pose moderate risks and require strict control and management to ensure their safety and effectiveness. These devices are typically used for prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human extracorporeal organs, tissues, or bodily fluids, employing various technological means that may pose moderate risks to the human body. Examples include thermometers, sphygmomanometers, electronic blood pressure and pulse meters, acupuncture needles, magnetic therapy devices, hearing aids, infusion pumps, and electrocardiographs. Class III Medical Devices: Pose high risks and require special measures for strict control and management to ensure their safety and effectiveness. These devices are commonly used for diagnosing, ...
- Source: drugdu
- 39
- February 28, 2025
Aimi Vaccines has been approved by the FDA to conduct clinical trials of mRNA vaccines

On February 27, Aimi Vaccines (06660) issued an announcement announcing that its mRNA respiratory syncytial virus vaccine has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials. This is the first time that the company has obtained FDA approval for clinical trials, marking an important progress in its internationalization strategy. The announcement mentioned that in preclinical animal trials, the specific IgG antibody titer, true virus neutralizing antibody titer, and specific T cell immunity of the vaccine were significantly higher than those of the internationally marketed control vaccines, showing the competitiveness of its research and development results. Respiratory syncytial virus is an important pathogen that causes respiratory infections in infants and the elderly. At present, there is no approved antiviral specific drug for this virus in the world, so vaccination has become an effective means to prevent severe infection. As one of the earliest companies in China ...
- Source: drugdu
- 42
- February 28, 2025
Clinical data of Orelabrutinib for the treatment of MS released

On the evening of February 26, Innocare Biologics announced that the Phase II clinical data of Orelabrutinib, a new BTK inhibitor independently developed by the company, for the treatment of relapsing-remitting multiple sclerosis (RRMS) was released at the 10th Annual Forum of the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in 2025, and a live poster presentation will be held on February 27, Eastern Time. The announcement shows that Orelabrutinib has shown extremely high effectiveness in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). A dose of 80 mg of Orelabrutinib once a day showed the best efficacy and safety, so it will be used as the dose for the Phase III clinical trial of Orelabrutinib for the treatment of progressive multiple sclerosis (PMS). In a double-blind Phase II clinical trial, 158 eligible relapsing-remitting multiple sclerosis subjects were randomly assigned to four treatment groups in a ...
- Source: drugdu
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- February 28, 2025
Mabwell Biotech’s net profit loss in 2024 was 1.067 billion yuan

On the evening of February 26, Mabwell Biotech (688062) released its 2024 performance report, showing that the company achieved operating income of 199 million yuan, a year-on-year increase of 55.5%; attributable to -1.067 billion yuan, compared with -1.053 billion yuan in the same period last year. Mabwell Biotech said that according to the report layout, the company’s operating income increased from the same period last year. The main reason is that the company actively expanded the market, and the sales of the drug Mai Lishu increased significantly compared with the same period last year. At the same time, the drug Mabwell Health was approved for listing in March 2024. The sales revenue of drugs in the same period of this report increased; with the further expansion of commercialization, operating costs and sales expenses increased accordingly; at the same time, with the continuous advancement of new drug research and development, many ...
- Source: drugdu
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- February 28, 2025
Innovative treatments for ALS, updated progress

The “Ice Bucket Challenge” once brought the rare disease of ALS into the public eye, and Cai Lei used his personal experience and unremitting efforts to let more people understand ALS and promote the whole society’s attention to this disease. It is this indomitable spirit that inspires the scientific research team to continue exploring, and recently this rare disease treatment field has finally ushered in good news. Recently, Shize Bio announced that its independently developed universal iPSC-derived subtype neural precursor cell injection product XS-228 injection has been officially approved by the US FDA to conduct registered clinical trials for the treatment of ALS (amyotrophic lateral sclerosis, ALS). This breakthrough not only marks China’s innovative breakthrough in the field of cell therapy, but also brings new hope to ALS patients. one of the “four major incurable diseases in the world”, ALS is one of the “four major incurable diseases in the ...
- Source: drugdu
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- February 28, 2025
Technological innovation has helped Yuekang Pharmaceutical achieve breakthroughs in new drug research and development

Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the clinical trial application (IND) for the mRNA vaccine YKKYY025 injection for the prevention of respiratory syncytial virus (RSV) submitted by Hangzhou Tianlong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuekang Pharmaceutical, has been accepted. Prior to this, this vaccine had obtained clinical trial approval from the US FDA earlier this year. Understanding and meeting unmet clinical needs has always been the core direction and critical path of our research and development work, “said Yu Weishi, Chairman of Yuekang Pharmaceutical Group. It is reported that in addition to RSV vaccine, Yuekang Pharmaceutical has obtained overseas clinical approvals for multiple innovative drugs. On January 21st, the clinical trial application for YKY026 injection, an mRNA vaccine independently developed by Yuekang Pharmaceutical for the prevention of herpes zoster, was officially accepted by CDE. Due to its previous clinical ...
- Source: drugdu
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- February 27, 2025
1st domestic product! One medical device has obtained CE MDR certification

Recently, MicroPort Xintong Medical Technology Co., Ltd. (hereinafter referred to as Xintong Medical) announced that its subsidiary Shanghai Zuoxin Medical Technology Co., Ltd. has developed AnchorMan ® The left atrial appendage occlusion system has successfully obtained the EU CE MDR certification, becoming the first left atrial appendage occlusion system in China to receive this certification. In addition, the AnchorMan used in conjunction with it ® The left atrial appendage guidance system was also approved for market by the European Union during the same period. The first and only product in the country In recent years, with the further growth of the aging population, the incidence rate of atrial fibrillation has increased year by year. Among them, thromboembolism is the most common complication of atrial fibrillation, with the highest incidence and greatest harm of stroke. The stroke rate of atrial fibrillation patients is five times higher than that of the general ...
- Source: drugdu
- 45
- February 27, 2025
Overview of FDA Approval in January 2025

On January 15, 2025, Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab mrkz) for the treatment of moderate to severe active Crohn’s disease (CD) in adults. After being approved as the first treatment for moderate to severe active ulcerative colitis (UC) in adults in October 2023, Omvoh has now been approved in the United States for the treatment of two inflammatory bowel diseases (IBD). Mirikizumab mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine. By blocking the interaction with IL-23 receptors, mirikizumab inhibits the release of pro-inflammatory cytokines and chemokines. This is the first biologic therapy to provide two-year, three-year efficacy data for Crohn’s disease upon approval. This drug aims to reduce inflammation of the gastrointestinal tract, which is an important aspect of Crohn’s disease pathology. In addition, Eli Lilly has submitted listing applications for Omvoh for ...
- Source: drugdu
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- February 27, 2025

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