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【EXPERT Q&A】What requirements should be paid attention to for the EU CE registration of “medical device equivalent certificate”?

Drugdu.com expert’s response: In the process of EU CE registration, regarding the “Proof of Medical Device Equivalence,” manufacturers should pay attention to the following requirements: I. Determination of Equivalent Devices Selection of Equivalent Devices: Manufacturers can identify one or more devices that are equivalent to the device under assessment, but each equivalent device should be equivalent to the device under assessment in all listed technical, biological, and clinical characteristics. Proof of Equivalence: The equivalence of each equivalent device should be thoroughly investigated, described, and proven in the clinical evaluation report. Manufacturers cannot use different components of different devices to claim equivalence with the device under assessment. Gap Analysis: Manufacturers should conduct a gap analysis to assess all clinically significant differences and determine whether the device, in terms of its safety, technical, biological, and clinical characteristics under the Medical Device Regulation (MDR), has the same or similar clinical performance as the ...
- Source: drugdu
- 76
- January 15, 2025
Harbour Biomed Pharmaceuticals Signs Exclusive Licensing Agreement

On January 12, Harbour Biomed Pharmaceuticals (02142) announced that it has signed an exclusive licensing agreement with Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. and Windward Bio AG for HBM9378/SKB378. According to the agreement, the licensor will grant Windward Bio a global exclusive license to manufacture, develop, use, promote, sell, promise to sell, import, and otherwise commercialize HBM9378/SKB378 outside of Greater China and several Southeast Asian and Middle Eastern countries. Under the agreement, the licensor has the right to receive up to a total of $970 million in upfront and milestone payments, as well as tiered royalties ranging from single-digit to double-digit percentages of net sales. The signing of this agreement is expected to help integrate the R&D, production, and commercialization capabilities of the licensor and Windward Bio, bringing HBM9378/SKB378 to the global market. https://finance.eastmoney.com/a/202501123294354429.html
- Source: drugdu
- 52
- January 15, 2025
TopAlliances’ Dydrogesterone Tablets Approved for General Use

Beijing Business News (Reporter Ding Ning) – On the evening of January 12, TopAlliances (688180) announced that its wholly-owned subsidiary, Shanghai Wangshi Biopharmaceutical Technology Co., Ltd., has received a “Drug Supplement Application Approval Notice” issued by the National Medical Products Administration (NMPA). The hydrochloride of Dydrogesterone Tablets (brand name: Mindev) for the treatment of adult patients with mild to moderate COVID-19 infection has been approved by the NMPA, transitioning from conditional approval to general approval. https://finance.eastmoney.com/a/202501123294345292.html
- Source: drugdu
- 57
- January 15, 2025
National Center for Nanoscience and Technology has made progress in the research of universal tumor preventive nano vaccines

Recently, the team of Zhao Ruifang and Nie Guangjun from the National Center for Nanoscience and Technology, in collaboration with the team of Han Bing from Peking University School of Stomatology, have made new progress in the research of developing universal tumor preventive nano vaccines. The relevant research results were published online in Nature Biomedical Engineering (Nature Biomedical Engineering, 2024, DOI: 10.1038/s41551-024-01309-0) with the title of Potent prophylactic cancer vaccines harnessing surface antigens shared by tumour cells and induced pluripotent stem cells. By 2030, the number of new cases of malignant tumors worldwide will reach 22 million per year, and the huge population of malignant tumor patients will bring great pressure to society. In order to reduce the burden of cancer, research on tumor preventive vaccines is in full swing. In recent years, HPV and HBV vaccines have successfully reduced the incidence of cervical cancer and liver cancer related to ...
- Source: drugdu
- 53
- January 15, 2025
Kelun Biotech’s new ADC drug “Bodu Trastuzumab” has been approved for marketing with a new indication

On January 8, the CDE official website announced that the second indication application for the Class 1 new drug Bodu trastuzumab injection submitted by Kelun Biotech has been accepted for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received at least one anti-HER2 treatment. Bodu trastuzumab is an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) developed by Kelun Biotech (formerly known as A166). This is the second NDA for A166. According to Kelun Biotech’s official website, based on the results of the primary analysis, A166 has reached the primary endpoint of its key Phase 2 trial for 3L+ advanced HER2-positive breast cancer and submitted its first marketing application to NMPA in May 2023. This is the second marketing application for the product, and the indication is for 2L+ advanced HER2-positive breast cancer. In addition, A166 has also conducted Phase ...
- Source: drugdu
- 50
- January 15, 2025
Deuterium hydrobromide remdesivir tablets have received routine approval from the National Medical Products Administration

On January 13th, Zhongzheng Intelligent Finance News Junshi Biotechnology (688180) announced that its controlling subsidiary, Shanghai Wangshi Biopharmaceutical Technology Co., Ltd., has obtained approval from the National Medical Products Administration to switch from conditional approval to routine approval for the listing of its drug, deuterium hydrobromide remdesivir tablets. Deuteromidevir hydrobromide tablet is used to treat mild to moderate novel coronavirus infection in adult patients (COVID-19 for short). The research results show that in mild to moderate COVID-19 patients, deuterium hydrobromide remdesivir tablets can significantly accelerate symptom relief and disappearance, shorten the course of the disease, accelerate virus seroconversion, reduce the incidence of severe COVID-19 or all-cause mortality, and have a more significant effect on elderly and high-risk patients. In patients with mild to moderate liver and kidney dysfunction, this drug has shown good safety and tolerability, and patients do not need or only need to adjust the dosage slightly ...
- Source: drugdu
- 67
- January 14, 2025
Konya once again authorized to go abroad; Oral Simeglutide Tablets Fully Launched | Medical Early Reference

Novo Nordisk announced that the world’s first oral glucagon like peptide-1 receptor agonist (GLP-1 RA), Novohexidine (semaglutide tablets), has been fully launched in China. Novosim helps patients benefit from GLP-1RA drugs earlier by convenient oral administration, bringing an innovative category for clinical treatment of type 2 diabetes in China. Comment: The oral administration of GLP-1RA, a biopeptide drug, has always been a technical challenge for scientists. Novohexin has broken through multiple absorption barriers in the stomach and pushed GLP-1 RA drugs into a new stage of oral administration. The launch of oral preparations in China will also make new contributions to the sales performance of Novo Nordisk’s “Smeaglutide Family”. NO.2 Conova CD38 monoclonal antibody “CM313” achieves external authorization Konya announced that its subsidiary has partnered with Timberlyne Therapeutics, Timberlyne, Inc. has reached an exclusive licensing agreement. Based on the licensing agreement, Konya grants Timberlyne exclusive rights to develop, produce, and ...
- Source: drugdu
- 77
- January 14, 2025
The first domestically produced one! Hengrui applies for another heavyweight drug to be listed on the market

On January 9th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the application for the listing of SHR4640 tablets, a Class 1 new drug of Hengrui Pharmaceutical, has been accepted. SHR4640 tablets are a highly selective small molecule inhibitor developed by Hengrui Pharmaceutical for the specific expression of UraT1 (urate transporter) in renal tubular epithelial cells. It is a class 1 anti gout drug independently innovated by Hengrui Pharmaceutical and the first UraT1 inhibitor to be applied for market in China. As of now, a total of approximately 279.87 million yuan has been invested in research and development projects related to SHR4640 tablets. 01. Breaking the monopoly of imported drugs? Since the 1970s, the development of URAT1 inhibitors has been quite bumpy. In the nearly 50 years since its first appearance on the historical stage, multiple products have repeatedly gone ...
- Source: drugdu
- 74
- January 14, 2025
One innovative medical device approved for market launch

Recently, the National Medical Products Administration approved the registration application for the innovative product “intraocular lens with crystalline lens” of Abonod (Beijing) Medical Technology Co., Ltd. (hereinafter referred to as Abonod). Heavy product, breakthrough innovation Established in 2010, iBonod is an innovation driven manufacturer of ophthalmic medical devices, covering three major areas: ophthalmic surgical treatment, myopia prevention and control, and vision health care. We strive to provide one-stop solutions for cataract surgery, refractive error correction, and optical consumption. It is worth mentioning that iBonod successfully listed on the Science and Technology Innovation Board on July 29, 2020, becoming the first ophthalmic medical device company in China to complete the listing on the board. The company is based on three core products: artificial intraocular lenses, corneal reshaping lenses, and contact lenses. The company has strategically expanded its coverage of the entire lifecycle product pipeline for eye health. After years of development, ...
- Source: drugdu
- 60
- January 14, 2025
Sansure Biotech Plans to Acquire 100% Equity of Zhongshan Haiji

Beijing Business News (Reporter Ding Ning) – On January 11, Sansure Biotech (688289) announced that the company intends to acquire 100% equity of Zhongshan Weiming Haiji Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhongshan Haiji”) for 807.5 million yuan. Sansure Biotech stated that Zhongshan Haiji has certain production capacity in the areas of recombinant proteins, peptide technology platforms, as well as overall industrial microbiology and synthetic biology, which can create a synergistic development with the company in the field of functional biomedicine products. In the future, the company will continue to leverage the strengths of both parties to provide technical support and collaborative innovation for the research projects related to growth hormones. Additionally, the expertise in diagnostics can offer necessary validation and feedback support for the ongoing optimization and iteration of growth hormone products. https://finance.eastmoney.com/a/202501123294309388.html
- Source: drugdu
- 59
- January 14, 2025

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