Search Results for “EC” – Page 199 – media

【EXPERT Q&A】Which countries’ certificates can be converted after CB certification?

Drugdu.com expert’s response: After obtaining CB certification, manufacturers can convert it into certification for multiple countries. The CB Scheme is based on International Electrotechnical Commission (IEC) standards, through which manufacturers can use a CB Test Certificate issued by a National Certification Body (NCB) to obtain national certifications from other member countries of the CB Scheme. Here are some of the national certifications that can be converted from CB certification: Ⅰ. Countries Where CB Certification Can Be Converted Europe: Germany (VDE, GS, etc.) / France / United Kingdom / Netherlands / Spain / Italy / Austria / Sweden / Switzerland, etc. Americas: United States (UL, ETL, etc.) / Canada (CSA, ULC, etc.) / Mexico / Brazil. Asia-Pacific: Australia (RCM, SAA, etc.) / New Zealand / Japan / South Korea (KC Mark) / Singapore / India / Thailand. Other Regions: South Africa / Turkey / Russia / Ukraine / Argentina / Brazil (Note: Listed twice as Brazil is mentioned in both Americas and Other ...
- Source: drugdu
- 69
- September 11, 2024
Plant intervention at the forefront, terminate IPO!

On September 4th, the Shanghai Stock Exchange terminated one IPO company: Shandong Branden Medical Equipment Co., Ltd. (hereinafter referred to as “Branden”). According to information, this was Branden’s voluntary withdrawal of its listing application, and the listing on the Science and Technology Innovation Board was terminated. Two major products support the banner of revenue Founded in 2003, Baibai An is a national high-tech enterprise dedicated to applying medical material modification technology to implantable medical devices, focusing on the research and development, production, and sales of biological and medical products. Through independent research and continuous innovation, Branden has formed a technology platform centered on medical material modification, precision machining, and digital diagnosis and treatment of vascular pathways. According to the prospectus, Branden is the first domestic enterprise to obtain the registration certificate for Class III medical device products of domestically produced Peripherally Inserted Central Catheters (PICCs), breaking the monopoly of imported ...
- Source: drugdu
- 93
- September 9, 2024
Up to 1 billion US dollars! An RNA pharmaceutical company has reached a cooperation agreement with Eli Lilly

On September 4, 2024, HAYA Therapeutics, a pioneering biotechnology company that uses precise RNA guidance to regulate genome targeting therapy for chronic diseases, announced the signing of a multi-year cooperation agreement with Eli Lilly. Both parties will utilize HAYA’s advanced RNA guided regulatory genome platform to support preclinical drug discovery for obesity and related metabolic diseases. The partner will identify multiple RNA targets derived from the regulatory genome to treat these chronic diseases. According to the terms of the cooperation agreement, HAYA will receive a down payment, including equity investment, and is eligible to receive up to $1 billion in preclinical, clinical, and commercial milestone payments, as well as royalties for product sales. HAYA’s proprietary regulatory genome discovery platform can identify long non coding RNA (lncRNA) targets specific to tissues, diseases, and cells, and develop treatment methods targeting RNA, which may have better efficacy and lower toxicity compared to current ...
- Source: drugdu
- 55
- September 9, 2024
Vaxcyte’s stock price soared after achieving a ‘stunning’ victory in the competition against Pfizer’s 31 valent pneumococcal conjugate vaccine (PCV)

Editor’s Bio Products Circle Vaxcyte has released Phase 1/2 data for its 31 valent pneumococcal vaccine candidate, which analysts have described as “astonishing”. If these data can be replicated in large-scale critical studies, it could pose a serious threat to Pfizer’s Prevnar 20. Vaxcyte’s half period data for VAX-31 in adults aged 50 and above against Prevnar 20 is “extraordinary” and suggests a “killer product in the pneumococcal conjugate vaccine category,” said analysts at Leerink Partners in a report on Tuesday. Leerink analyst said, “We believe that these data support VAX-31’s potential to gain a significant market share in the pneumococcal conjugate vaccine market expected to exceed $10 billion by 2030+ Due to this positive reading, Mizuho analysts referred to it as the “best case scenario,” and Vaxcyte’s stock price jumped about 44% at the release time on Tuesday morning.Today, we are opening a new chapter for Vaxcyte as we ...
- Source: drugdu
- 72
- September 9, 2024
Spending 1.3 billion, Sinopharm Group strikes again

Recently, Tiantan Biological announced that its holding subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. intends to acquire 100% equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd., a wholly-owned subsidiary of CSL BEHRING ASIA PACIFIC LIMITED (Jetbehring (Asia Pacific) Co., Ltd.) for a total amount of US$185 million (nearly RMB 1.33 billion). Among them, the equity acquisition price is US$138 million, and the remaining amount is provided by Chengdu Rongsheng to Zhongyuan Ruide to repay the shareholder loan of CSL Asia Pacific to Zhongyuan Ruide (hereinafter referred to as “CSL”, “Zhongyuan Ruide” and “this acquisition”). After the completion of this transaction, Zhongyuan Ruide will become a holding subsidiary of Tiantan Biological, and its financial statements will be consolidated. For Tiantan Biological, this is a deal that adds icing on the cake. Blood products are a rigid demand track with extremely high barriers, and “whoever gets the plasma station will win the ...
- Source: drugdu
- 71
- September 9, 2024
Chinese neurological device giant rushes for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed the listing guidance registration and planned IPO at the Beijing Securities Regulatory Bureau, and the guidance institution is CICC. According to the counseling work arrangement, CICC plans to complete the counseling plan for Pinchi Medical in November and December this year, and apply to the Beijing Securities Regulatory Bureau for counseling acceptance. After the counseling is completed and accepted, Pinchi Medical may apply for an IPO. This is another brain pacemaker company that plans to go public through an IPO in 2023 after Jingyu Medical started filing for listing counseling. According to Smart Medical Equipment, so far, the only two local companies that mass-produce brain pacemakers have embarked on the road to IPO. Founded in 2008, Pinchi Medical is a high-tech enterprise specializing in the research and development, production and sales of a series of neuromodulatory ...
- Source: drugdu
- 62
- September 9, 2024
【EXPERT Q&A】Why domestic medical device bidding needs CE certification?

Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
- Source: drugdu
- 56
- September 9, 2024
Novo Nordisk applies for listing of growth hormone in China once a week

Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone deficiency (AGHD) patients. ...
- Source: drugdu
- 102
- September 7, 2024
Domestic neural device giant sprints for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed its IPO counseling and registration with the Beijing Securities Regulatory Bureau, with the counseling agency being China International Capital Corporation (CICC). According to the coaching work arrangement, CICC plans to complete the coaching plan for Pinchi Medical in November December this year and apply for coaching acceptance from the Beijing Securities Regulatory Bureau. After completing the coaching acceptance, Pinchi Medical may apply for IPO. This is another brain pacemaker company planning to go public in 2023, following Jingyu Medical’s IPO guidance filing. According to reports from Smart Medical Devices, the only two local companies that mass produce brain pacemakers have now embarked on the path of IPO and planned to go public. Tsinghua endorsement, Pinchi Medical is aiming for IPO Pinchi Medical was founded in 2008 and is a high-tech enterprise specializing in the research, development, ...
- Source: drugdu
- 70
- September 7, 2024
Novo Nordisk applies for listing of growth hormone in China once a week

Original Medicine Guanlan Medicine Guanlan September 5, 2024 08:35 Shanghai Reported by WuXi AppTec Content Team Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once ...
- Source: drugdu
- 64
- September 7, 2024

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