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Targeting Chinese patent medicines, the State Food and Drug Administration has taken another action

Recently, the State Food and Drug Administration issued the “Notice on Simplifying the Registration and Approval of Traditional Oral Chinese Patent Medicines Already Marketed in Hong Kong and Macao for Market Registration in the Mainland (Draft for Comments)” (hereinafter referred to as the “Draft for Comments”). The registration and approval of traditional oral Chinese patent medicines in Hong Kong and Macao in the Mainland is expected to be further simplified, and the technical review period for qualified varieties will be shortened from the conventional 200 working days to 80 working days. ▍Key points analysis The “Draft for Comments” clearly states that the relevant applicant companies and varieties must meet three conditions at the same time: traditional oral Chinese patent medicines held by local registered manufacturers in the Hong Kong and Macao Special Administrative Regions, approved for market listing by the Hong Kong and Macao Special Administrative Regions’ drug supervision and ...
- Source: drugdu
- 46
- December 20, 2024
Can 3 cents produce a piece of aspirin?

Recently, after the announcement of the proposed winning results of the 10th national centralized drug procurement, the centralized procurement price of 3 cents a piece of aspirin attracted national attention as a “low price”. The public’s concern is largely due to the concern about whether the clinical efficacy of the drug can be guaranteed at a low price. So, can 3 cents produce a piece of qualified aspirin? ▍3 cents can produce The answer is yes. “This price can be achieved through large-scale production. Since the raw materials of aspirin itself are relatively cheap and the excipients are not particularly expensive, if the equipment conditions are good and the output is large, its cost will also be reduced. It does not mean that when the price drops to a certain level, the product quality will be low and the company will cheat. This is a commercial behavior. The company takes ...
- Source: drugdu
- 43
- December 20, 2024
Kanghua Biotech’s Recombinant Norovirus Vaccine (Pichia pastoris) Approved for Clinical Trials

On December 17, Kanghua Biotech (300841) announced that its hexavalent recombinant Norovirus vaccine (Pichia pastoris) has received a clinical trial approval notification. The vaccine developed by the company has recently been issued a “Clinical Trial Approval Notification” by the National Medical Products Administration, granting permission to conduct clinical trials. This vaccine is intended to prevent Norovirus infections and the acute gastroenteritis they cause, with the theoretical ability to prevent over 90% of related infections. The receipt of the clinical trial approval notification will not have a significant impact on the company’s short-term financial status and operating performance. The company will actively promote clinical research for this product; if successful, it will enrich the company’s product portfolio, enhance its core competitiveness and market position, thereby increasing profitability. However, the vaccine development process is lengthy and technically challenging, posing certain research risks and uncertainties that investors should consider cautiously. In the first ...
- Source: drugdu
- 44
- December 20, 2024
Can small molecule drugs achieve a breakthrough?

Wet age-related macular degeneration (Wet AMD) is the main cause of visual dysfunction and blindness in the elderly. Currently, intravitreal injection of anti-VEGF drugs has become the first-line treatment for the disease, but current anti-VEGF drugs still have many shortcomings, such as frequent injections with multiple potential risks, insensitive reactions in some patients, and low patient compliance. Therefore, it is urgent to find new therapeutic drugs. With the deepening of the understanding of pathological mechanisms, the emergence of multi-target small molecule drugs has opened up a new path for the treatment of this disease. Compared with the traditional approach of only inhibiting VEGF, these small molecules are expected to provide new opportunities for improving efficacy, reducing treatment burden and delaying drug resistance by intervening in multiple links such as angiogenesis, inflammation and oxidative stress. AMD, The third leading cause of blindness worldwide Age-related macular degeneration (AMD) is an age-related, chronically ...
- Source: drugdu
- 35
- December 20, 2024
【EXPERT Q&A】What are the content requirements of the medical device Post-marketing Supervision Plan (PMS Plan) required by the EU CE?

Drugdu.com expert’s response: The Post-Market Surveillance (PMS) Plan for medical devices required by the EU CE is a comprehensive strategic document aimed at ensuring the continued safety, effectiveness, and compliance of medical devices after they have been released to the market. The core content of this plan revolves around the following aspects, aiming to establish a comprehensive and responsive surveillance system: Firstly, defining objectives and scope. The PMS Plan must clearly outline its objectives, which are to ensure the safety and effectiveness of medical devices during use while minimizing potential risks. It should encompass all key stakeholders, including manufacturers, distributors, users, and regulatory authorities, and be applicable to various types of medical devices, both for home use and professional purposes. Secondly, establishing a data collection and analysis mechanism. The plan requires the creation of an efficient data collection system to capture information from multiple sources, such as sales data, user ...
- Source: drugdu
- 43
- December 20, 2024
China Biopharmaceuticals and Sinopharm Holdings sign strategic cooperation agreement

On December 13th, China Biopharmaceutical and Sinopharm Group signed a deep strategic cooperation agreement in Chengdu. The two sides will fully integrate the resources of Sinopharm Group’s National University Pharmacy, SPS+professional pharmacy, and China Biopharmaceutical’s rich product resources, and carry out deep cooperation in the off hospital market to jointly build a nationwide retail network and improve the convenience of patients’ drug purchases. President Lian Wanyong and Vice President Wu Yijian of China National Pharmaceutical Group, CEO of China Biopharmaceutical and Chairman of CP Tianqing Xie Chengrun, Vice President of CP Tianqing Chen Hui, and others attended the signing ceremony. Liu Tianyao, General Manager of the Global Procurement and Supply Chain Service Center of China National Pharmaceutical Group, and Qi Tianze, Special Assistant to the Chairman of CP Tianqing, signed the agreement on behalf of both parties. The heads of various business units of China Biopharmaceutical and some subsidiaries of ...
- Source: drugdu
- 43
- December 19, 2024
Ed Biotech forges a precise medical “compass”

Ed Biotech has always focused on research and innovation, steadily moving forward on the path of precise diagnosis of tumors, allowing precision medical products to better play the role of a “compass” and alleviate patients’ pain. Recently, a reporter from Shanghai Securities News came to the Xiamen headquarters of Ed Biotech to listen to their stories of forging ahead and helping China’s precision medicine industry rise to new heights. Take the difficult yet correct path Xiamen Haicang District, Aide Biological Dust free Production Workshop. We can produce 30 types of Class III diagnostic products here, with a daily production capacity of over 100000 people. These products cover various types of cancer with precision medical conditions, and most of them are domestically approved, some of which are even internationally pioneering. When the reporter met with the company’s general manager Luo Jiemin, this “post-80s” PhD had just returned from the academic annual ...
- Source: drugdu
- 71
- December 19, 2024
InterPharma

Organiser：Jakarta International Expo (JI EXPO) Time：October 21st – 24th, 2025 Address：Jl. Gatot Subroto No.1, RT.1/RW.3, Gelora, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270, Indonesia Exhibition hall：Balai Sidang Jakarta Convention Center Product range: Active Pharmaceutical Ingredients (APIs), intermediates, natural extracts; excipients, formulations, custom manufacturing; biopharmaceuticals, fine chemicals; laboratory equipment, instruments, laboratory supplies, water treatment; environmental and quality control, technical publications; pharmaceutical products, medicines; pharmaceutical engineering, materials, and packaging; pharmaceutical machinery and equipment. About InterPharma： InterPharma, the Pharmaceutical Exhibition in Jakarta, Indonesia, is the largest and most influential pharmaceutical exhibition in Indonesia. It is one of the significant professional exhibitions for pharmaceuticals, medicines, and packaging careers in the Southeast Asian region. The exhibition covers a wide range of products, including APIs, intermediates, biopharmaceuticals, medical supplies, materials and packaging, pharmaceutical machinery and equipment, etc.
- Source: drugdu
- 67
- December 19, 2024
Two innovative medical devices have been approved for market launch

Recently, the National Medical Products Administration approved the registration applications for two innovative products, the “Proton Therapy System” of Maisheng Medical System Company (hereinafter referred to as Maisheng Medical) and the “Cardiac Pulse Electric Field Ablation Device” of Shanghai Hongtong Industrial Co., Ltd. (hereinafter referred to as Shanghai Hongtong). Maisheng Medical, the first product to be launched in China Maisheng Medical was founded in 2004 and is headquartered in Littleton, Greater Boston, Massachusetts, USA. We specialize in the research, development, production, installation, and service of miniaturized proton therapy equipment for cancer treatment, with branch structures in Europe and Asia. We are a leader in the field of miniaturized proton therapy. The miniaturized proton radiotherapy system developed based on its own core technology has unique advantages such as good clinical efficacy, high integration level, small footprint, and low overall customer ownership cost. At present, Maisheng Medical has advanced proprietary intellectual property ...
- Source: drugdu
- 69
- December 19, 2024
5 innovative medical devices enter special review process

On December 16th, the National Medical Products Administration’s Device Review Center released the results of the special review application for innovative medical devices (No. 11 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Hot steam ablation system: Shanghai Lixiao Medical Technology Co., Ltd Lixiao Medical was founded in January 2019 by Dr. Cheng Lifei, Global Vice President of Business Development at Medtronic. It is an innovative medical technology platform that focuses on the introduction of advanced medical technologies from overseas, local research and development, and industrialization. It specializes in the research and development of medical devices for the treatment of chronic diseases such as cardiovascular, urinary, and respiratory diseases. As of now, Lixiao Medical has completed two rounds of financing of nearly one billion US dollars, led by well-known investment institutions such as Eli Lilly Asia, Sequoia Capital, and WuXi AppTec. ...
- Source: drugdu
- 73
- December 19, 2024

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