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20-valent pneumococcal polysaccharide conjugate vaccine clinical research application accepted

Watson Bio (300142) announced on the evening of January 21 that the 20-valent pneumococcal polysaccharide conjugate vaccine jointly developed by the company and its subsidiaries Yuxi Watson Biotechnology Co., Ltd. and Yunnan Vaccine Laboratory Co., Ltd. applied to the National Medical Products Administration for clinical trials and recently obtained the “Acceptance Notice”. The 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) is independently developed by the company. It is an upgraded product developed on the basis of the company’s 13-valent pneumococcal polysaccharide conjugate vaccine that has been produced and marketed, covering more pneumococcal pathogenic serotypes. In addition, the company decided to terminate the clinical research related work of the DTaP-Hib quadruple vaccine. https://finance.eastmoney.com/a/202501213303737886.html
- Source: drugdu
- 47
- January 25, 2025
Notai Biotech’s Dry Mixed Suspension and Granule Production Lines Pass GMP Compliance Inspection

On January 21, Notai Biotech announced that the dry mixed suspension production line and granule production line in its Zhonghua Pharmaceutical Port factory (Workshop 203) recently received the “Drug GMP Compliance Inspection Notification” (Su Yao Jian Yao Sheng Gao [2025] 037 and [2025] 038) issued by the Jiangsu Provincial Drug Administration, passing the drug GMP compliance inspection. The workshop is designed according to FDA/EMA standards and has introduced first-tier international brand equipment, including Glatt’s wet granulation line, KILIAN’s double-outlet tablet press, SYNTEGON’s capsule filling machine, Glatt’s coating machine, and CAM’s automated packaging line. The designed annual production capacities are 4.5 billion tablets & hard capsules, 36 million bottles of oral dry mixed suspensions & granules, and 450 million bags of granules/powders. The workshop has passed completion acceptance. Notai Biotech stated that the successful GMP compliance inspection of the dry mixed suspension and granule production lines indicates that the production lines ...
- Source: drugdu
- 56
- January 25, 2025
The mystery behind WuXi AppTec’s “selling, selling, selling”

With the expected failure of the US Biosafety Act, just like Godot who will never show up, industry and capital participants have to think about the real role and value provided by CXO in the industry during the long wait. This experience is not only a test of patience, but also prompts everyone to think deeply. Just as people were speculating on the direction of the bill under the new government and the new Congress, WuXi AppTec (54.570, -0.92, -1.66%) unexpectedly began to sell assets frequently. First, on December 24 last year, it announced the sale of two cell gene therapy companies in the United States and the United Kingdom; then it sold part of its shares in WuXi Helian for more than 2 billion yuan; on January 18 this year, WuXi AppTec announced again that it would sell its US medical device testing platform to the US medical device ...
- Source: drugdu
- 52
- January 24, 2025
Trump signs executive order, US to withdraw from WHO

Soon after taking office for his second term, US President Donald Trump signed an executive order on Monday (January 20) directing the United States to withdraw from the World Health Organization (WHO), saying the agency had mishandled the Covid-19 pandemic and other international health crises. Trump said the WHO failed to act independently of “undue political influence from WHO member states” and also asked the United States to “unfairly pay huge fees” that were disproportionate to the amounts provided by other larger countries such as China. “The World Health Organization ripped us off, and everyone ripped off the United States. That won’t happen again,” Trump said as he signed an executive order to withdraw from the organization at the White House just hours after taking office. The WHO did not immediately respond to a request for comment. The move means the United States will withdraw from the UN health agency ...
- Source: drugdu
- 50
- January 24, 2025
Lepu Biopharma’s preclinical ADC drug goes international

On the morning of January 22, Lepu Biopharma (02157.HK) announced a global exclusive licensing agreement with ArriVent BioPharma, Inc. (AVBP.O, hereafter referred to as ArriVent) for an antibody-drug conjugate (ADC) called MRG007, aimed at gastrointestinal cancers. The company’s stock opened over 13% higher in the morning, and as of the time of publication, it rose 7.95% to HKD 2.58/share. According to the agreement, Lepu Biopharma grants ArriVent the global exclusive license to develop, manufacture, and commercialize MRG007 in regions outside Greater China (which includes mainland China, Hong Kong, Macau, and Taiwan). Lepu Biopharma will receive a total upfront payment of $47 million, with upcoming milestone payments, and up to $1.16 billion for development, registration, and sales-related milestone payments, as well as tiered royalties based on net sales outside Greater China. Lepu Biopharma announced that MRG007 showed strong anti-tumor activity in preclinical models of gastrointestinal cancers and demonstrated a high therapeutic ...
- Source: drugdu
- 49
- January 24, 2025
Sinocell turns losses into profits

In the tide of the capital market, the performance of enterprises is like a beacon, guiding the direction of investors. The 2024 annual performance profit forecast announcement of Sinocell undoubtedly brought a touch of light to many followers. Recently, Sinocell officially released the 2024 annual performance profit forecast announcement. As a leading company in China’s biopharmaceutical industry, Sinocell has achieved significant performance growth in the past year: the company expects to achieve revenue of 2.48 billion yuan to 2.54 billion yuan during the reporting period, a year-on-year increase of more than 30%; net profit attributable to the owners of the parent company is expected to be 0.9 billion yuan to 1.3 billion yuan; net profit attributable to the owners of listed companies after deducting non-recurring gains and losses is expected to be 450 million yuan to 490 million yuan. So far, all three major performance indicators of Sinocell are expected ...
- Source: drugdu
- 48
- January 24, 2025
The results of the selection of over 70 types of consumables for centralized procurement are about to be implemented

In 2024, the improvement of quality and expansion of consumables through centralized procurement will accelerate, and multiple high-value consumables will achieve significant price reductions; At the same time, the coverage of centralized procurement of in vitro diagnostic reagents is expanding, and the IVD industry is undergoing a comprehensive transformation. According to the statistics of Yaozhi Medical Equipment, about 10 large-scale consumables procurement projects were carried out in 2024, involving various types of consumables such as cochlear implants, peripheral interventions, IVD reagents, etc., and many varieties have not experienced centralized procurement and price reduction before. High value consumables, centralized procurement acceleration In 2024, the storm of centralized procurement in the high-value consumables field has not stopped, and multiple consumables have achieved significant price reductions. Among them, the results of centralized procurement of consumables in the intervention field are particularly significant. In the fifth batch of high-value consumables for national procurement, the ...
- Source: drugdu
- 51
- January 24, 2025
Two innovative medical devices have been approved for market launch

On January 20th, the National Medical Products Administration approved the registration applications for Xinuopu Medical Technology (Beijing) Co., Ltd.’s “Cryoablation Device” and Wuhan Kaidewis Biotechnology Co., Ltd.’s “Human CDO1/AJAP1/GALR1 Gene Methylation Detection Kit (Fluorescent PCR Method)”, two innovative products. Xinnopu Medical specializes in the field of electrophysiology Xinnopu Medical, founded in 2005, has been focusing on the field of cardiac electrophysiology for nearly 20 years and continues to lead industry technological innovation. It is a leader in the Chinese atrial septal puncture market. At present, Xinnopu Medical’s existing products cover dozens of categories including atrial septal puncture instruments, diagnostic instruments, and therapeutic instruments, and have established a complete business system covering research and development, manufacturing, and sales. Xinnopu Medical is actively promoting revolutionary innovation projects such as cryoablation system (Nordica), 3D mapping system (Meridian), intracardiac ultrasound (ICE) diagnostic catheter and equipment (enVision) with the innovation research and development center in ...
- Source: drugdu
- 41
- January 24, 2025
【EXPERT Q&A】What are the requirements for conducting clinical trials of medical devices?

Drugdu.com expert’s response: Here is the English translation of the provided text: Conducting medical device clinical trials must meet a series of stringent requirements to ensure the scientific, ethical, and safe conduct of the trials. Based on relevant regulations and norms, the following are the key requirements: Ethical Committee Approval Medical device clinical trials must obtain approval from an ethical committee. The ethical committee evaluates the ethical and moral aspects of the trial to ensure that it does not pose unnecessary risks to participants. Planning and Design The trial should have a detailed plan and design, including research objectives, methods, recruitment and inclusion criteria, exclusion criteria, etc., to ensure the scientific and reliable conduct of the trial. Participant Recruitment and Informed Consent The recruitment process for trial participants must be clearly defined, including the source of participants, recruitment methods, and how to obtain their informed consent. Participants must fully understand the ...
- Source: drugdu
- 54
- January 24, 2025
4 types of “peripheral vascular intervention consumables” centralized procurement quotation completed

Hebei Province has launched the four types of peripheral vascular interventional medical consumables alliance centralized procurement rules four quotation work, and the quotation has been completed recently. 4 types of interventional consumables, recently completed quotation On January 16th, the Hebei Provincial Medical Drug and Equipment Centralized Procurement Center issued a notice on the implementation of the four pricing rules for the centralized and quantity based procurement of four types of medical consumables, including peripheral vascular intervention guidance pathways, in the inter provincial alliance. The notice also includes a list of companies that provide pricing for rule four, and requires them to complete the pricing for rule four. (Read the original text to obtain the list and original file) According to the previously released procurement documents, Rule Four is as follows: (1) After executing the selected rule three, enable the selected rule four, and the selected enterprise in rule four will ...
- Source: drugdu
- 64
- January 23, 2025

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