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【EXPERT Q&A】What is the impact on the industry that IVD registration certificates can be bought and sold?

Drugdu.com expert’s response: The impact of the tradability of IVD (In Vitro Diagnostic) registration certificates on the industry is multifaceted, encompassing the following aspects: Ⅰ. Facilitating Industry Consolidation Rapid Acquisition of Product Lines: Companies can quickly acquire new product lines by purchasing registration certificates, without the need for research and development from scratch, significantly shortening the time to market. Accelerating the Expansion of Large Enterprises: Large enterprises may rapidly expand their market share by acquiring registration certificates from smaller enterprises, further consolidating their market position. Ⅱ. Enhancing Research and Development Efficiency Focusing on R&D and Registration: Research institutions can concentrate more on product research and development, as well as registration, without worrying about subsequent production and sales issues. Shortening Product Cycles: By selling registration certificates to manufacturing enterprises, research institutions can obtain returns faster, thereby allocating more funds and resources to new research and development projects, further shortening the time ...
- Source: drugdu
- 48
- October 30, 2024
GE Healthcare, this product is being produced for the first time in the United States

Recently, GE Healthcare is manufacturing the integrated Omni Legend PET/CT at its new production facility in Wisconsin. This marks the first time that the system has been produced domestically in the United States. 01. Innovative product Omni Legend PET/CT GE HealthCare launched its first PET/CT: Omni Legend on the fully digital Omni platform at the European Association for Nuclear Medicine (EANM) annual meeting in October 2022. The system achieved significant improvements in sensitivity, efficiency, radiation dose, and patient comfort. The system is equipped with a new digital BGO (dBGO) detector, aimed at improving examination efficiency, enhancing patient experience, and boosting diagnostic confidence. The system adopts a new category of digital BGO (dBGO) detector materials, with small crystal size and sensitivity more than twice that of existing digital scanners, which can achieve faster total scanning time and impressive small lesion detectability It aims to improve operational efficiency, enhance patient experience, and ...
- Source: drugdu
- 57
- October 30, 2024
Medtronic’s’ 2 Medical Devices’ Approved for Market by FDA

Recently, Medtronic announced that its Affera radiofrequency ablation system and Sphere-9 catheter have been approved for market by the US Food and Drug Administration (FDA). It is understood that this is an integrated electrophysiological product capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation, approved for the treatment of persistent atrial fibrillation (AFib) and tricuspid isthmus dependent atrial flutter, and previously obtained CE marking approval in March 2023. Innovative products demonstrate differentiation advantages The two medical devices approved this time originated from Affera, which Medtronic acquired for $1 billion in August 2022 and introduced these technologies. The competition in the field of electrophysiology is fierce, and Medtronic has further solidified its position with these two medical devices. The Affera radiofrequency ablation system is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible surgery, allowing doctors to accurately map and ablate using radiofrequency and electrical pulse ...
- Source: drugdu
- 59
- October 30, 2024
“Plan B” for Chinese pharmaceutical companies to go overseas

Weighing the risks is the primary issue that all pharmaceutical companies need to consider when going overseas. The cost of going overseas is not cheap. Not to mention the time cost required to build overseas clinical, promotion, and registration experience, the capital cost is the top priority. BeiGene provides a good reference: although it has seen the dawn of profitability, this is based on the total loss of nearly 50 billion yuan in the past five years; Legend Biotech’s overseas cost is not low either. It is estimated that it has spent at least 1 billion US dollars since the establishment of the Xidaqiolunsai project. Industry insiders commented that this is far more expensive than imagined. From the perspective of capital investment alone, it can be asserted that there are not many pharmaceutical companies that can play the two cards of “local + going overseas” at the same time. To ...
- Source: drugdu
- 56
- October 30, 2024
Apple’s “killer move” will change the world of diabetes?

Recently, Bloomberg reported that Apple selected some employees to conduct a blood sugar APP test. During the test, the subjects actively monitored their blood sugar through various devices on the market, and then recorded the changes in blood sugar levels caused by food intake. This study may allow Apple to more deeply integrate third-party blood sugar tracking into its own products. Apple has been planning blood sugar monitoring for a long time. In 2010, Jobs led the acquisition of RareLight, a non-invasive blood sugar monitoring company. In 2015, Apple’s frontier exploration department XDG took over the non-invasive blood sugar detection project and has invested a lot of money in recent years for concept verification. In February last year, Apple’s non-invasive blood sugar monitoring project was reported to have a major breakthrough. According to reports, Apple is developing a silicon photonic chip and a measurement process called “optical absorption spectroscopy”, which ...
- Source: drugdu
- 49
- October 30, 2024
Continuously Advancing Digital Marketing for Attenuated Live Vaccines Against Shingles

On October 28, Baike Biology (688276) held a performance briefing for the third quarter of 2024. The company’s board members, including General Manager Kong Wei, Executive Deputy General Manager Jiang Chunlai, and Board Secretary Zhang Zhe, communicated with investors regarding the operating results and financial status for the third quarter of 2024. Baike Biology is an innovative biopharmaceutical company mainly focused on infectious disease prevention and control. Since its establishment, it has primarily engaged in the research, development, production, and sale of human vaccines. The company currently has approved vaccines, including chickenpox vaccines, intranasal flu vaccines, and shingles vaccines. Among these, the chickenpox vaccine has maintained a leading market share for many years, making it one of the company’s primary sources of revenue. The intranasal flu vaccine is a part of the World Health Organization’s (WHO) Global Influenza Action Plan (GAP) and is the only attenuated live influenza vaccine administered ...
- Source: drugdu
- 43
- October 30, 2024
Endoscopic equipment company completes over 100 million yuan Series B financing

Recently, Shenzhen Xingchen Sea Medical Technology Co., Ltd. (hereinafter referred to as “Xingchen Sea Medical”) announced the completion of a Series B financing of over 100 million yuan, led by Yuansheng Venture Capital, with continued investment from old shareholders Junlian Capital and Daotong Investment, and Haoyue Capital serving as the exclusive financial advisor. It is reported that this round of financing will help Xingchen Hai Medical further expand its production capacity, accelerate new product research and development, and expand its global market, promoting its rapid development in the field of disposable endoscopes. Complete 4 rounds of financing Xingchen Sea Medical was established in October 2020, with a founding team from domestic and foreign head medical device companies. With over ten years of experience in minimally invasive surgical product research and development, global marketing, and production management, we are committed to becoming an innovative leader in endoscopic intervention diagnosis and treatment. ...
- Source: drugdu
- 56
- October 29, 2024
Significant Collaboration with Philips

On October 25, 2024, Medtronic and Philips announced the establishment of a strategic advocacy partnership centered on stroke care. The two companies will work together to raise awareness of the potential health and economic benefits that timely diagnosis and treatment of stroke can bring to patients, families, and society, and further expand and strengthen their partnership with the World Stroke Organization (WSO). It is reported that this cooperation has three key focus areas, including raising public awareness of stroke symptoms and the importance of timely medical treatment, improving treatment accessibility by increasing the number of hospitals with stroke treatment capabilities and providing training, and using advanced technology to create a comprehensive stroke care system to support early diagnosis, effective treatment, and postoperative monitoring. 01. Focus on stroke care, Philips and Medtronic reach cooperation It is reported that in this collaboration, Medtronic and Philips will work together to promote awareness of ...
- Source: drugdu
- 58
- October 29, 2024
High level introduction of anti-tumor adjuvant drugs! Sinopharm International negotiates and signs contracts with Korean and American pharmaceutical companies

The neutropenia caused by tumor chemotherapy can easily lead to potentially life-threatening complications. The Rolontis product treatment plan can effectively prevent and treat chemotherapy-induced neutropenia, helping cancer patients with treatment and recovery. Sinopharm International adheres to the functional mission of serving the national strategy and promoting people’s health and well-being. It leverages the role of Sinopharm Group’s international business strategy platform for pharmaceutical and health, introduces Rolontis products from South Korea, improves the safety and effectiveness of cancer patient treatment, and promotes the optimization and upgrading of the pharmaceutical and health supply chain industry chain.On October 24th, China Pharmaceutical Foreign Trade Co., Ltd., a subsidiary of Sinopharm International, and Hanmei Pharmaceutical Co., Ltd. signed a Rolontis product cooperation agreement, marking a new chapter of cooperation in the field of biomedicine based on pharmacy equipment cooperation between the two parties. Zhou Song, Secretary of the Party Committee and Chairman of Sinopharm ...
- Source: drugdu
- 44
- October 29, 2024
BeiGene PD-1 issues first prescription in the United States, opens new chapter with its own international solid tumor commercialization team

In late October, BeiGene’s self-developed PD-1 inhibitor, Trastuzumab (English trade name: TEVIMBRA), was launched ®， Chinese product name: Baize An ®） The first prescription was issued in the United States, officially entering the American market and bringing new treatment options to local patients. This milestone also marks the beginning of a new chapter for BeiGene’s own commercialization team for solid tumors in the United States.Teralizumab was approved by the US Food and Drug Administration (FDA) in March 2024 for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). In October 2024, BeiGene announced the commercial launch of Trastuzumab in the United States, benefiting this patient population at a price 10% lower than other PD-1 therapies approved for this indication. The first prescription of Trastuzumab in the United States has become another important milestone in the company’s ...
- Source: drugdu
- 48
- October 29, 2024

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