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. 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. Philips and Medtronic reach cooperation It is reported that in this cooperation, Medtronic and Philips will work together to advocate for raising awareness of the potential health and ...
On October 23, with the establishment of the National Medical Products Administration Information Center in Beijing Medical Innovation Park BioPark, the six major centers of the National Medical Products Administration have been “assembled”. The six centers are the Drug Review Center of the National Medical Products Administration’s directly affiliated units, the Food and Drug Review and Inspection Center, the Drug Evaluation Center (National Drug Adverse Reaction Monitoring Center), the Medical Device Technical Review Center, the Administrative Affairs Acceptance Service and Complaint Reporting Center, and the Information Center (China Food and Drug Regulatory Data Center). Beijing Yizhuang gathers regulatory resources to provide strong guarantees for the high-quality development of biotechnology and the big health industry in terms of enterprise industry administrative approval, qualification certification, etc. In the National Bureau’s administrative affairs acceptance service hall, 10 windows are neatly arranged to handle the acceptance, consultation, charging, and certification of administrative licensing matters ...
Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
Cell, an international authoritative scientific journal, recently published a pioneering achievement from multiple research teams in China – the first time to use stem cell regeneration therapy to functionally cure type 1 diabetes. The research team used chemical reprogramming technology to induce pluripotent stem cells to prepare islet cells, and transplanted them to a type 1 diabetes patient, achieving clinical functional cure effect. So, how is it successful to induce stem cells to prepare pancreatic islet cells? Is functional cure truly a cure? Will stem cell technology be the key to conquer diabetes in the future? What is the difference between functional cure and cure Diabetes is a thorny disease, and its biggest harm to patients is that there are many clinical complications, which may lead to cardiovascular disease, nervous system damage, kidney disease, eye disease, foot disease, and so on. Diabetes ranks ninth among the world’s ten leading ...
On September 3, 2024, Circle Pharma, a biopharmaceutical company dedicated to discovering and developing cell permeable macrocycles as a clinical stage of a new therapy, announced the successful completion of $90 million in Series D funding, including the conversion of a convertible note.This round of financing is led by The Column Group, with new and old investors including Nextech Invest and Euclidean Capital participating. The funds raised from the financing will be used for the clinical development of Circle Pharma’s first and only similar cyclin A/B RxL inhibitor CID-078, and to support the development of the discovery project portfolio established by the company using its MXMO macrocycle platform. David Earp, CEO and Juris Doctor of Circle Pharma, said, “We are very grateful for the continued support of such a strong investor as we advance our pioneering work on macrocyclic therapy. This financing not only allows us to advance the clinical ...
Recently, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Lixin Pharmaceutical”) announced that it has successfully completed a C1 round of financing of RMB 300 million. This round of financing was led by China Biopharmaceutical, a well-known domestic industry party, and co-invested by Pudong Venture Capital and Zhang Jianghaoheng. Old shareholders Qiming Venture Partners and Shanghai Biomedicine Fund followed suit. Zhong Lun served as the legal advisor for this round of financing. Lixin Pharmaceuticals also mentioned that it has recently launched the C2 round of financing. The funds raised will be mainly used to accelerate the clinical progress of clinical pipelines, especially LM-302 and LM-108, and support the independently developed antibody discovery platform, next-generation ADC technology platform, and bispecific antibody technology platform, and continue to produce innovative pipelines with international competitiveness. About Lixin Pharmaceuticals Lixin Pharmaceuticals is a biopharmaceutical company based in China and facing the world. It ...
On the evening of October 24, Hengrui Medicine announced its Q3 performance report for 2024, showcasing steady growth in performance. For the first three quarters of 2024, Hengrui reported an operating revenue of 20.189 billion yuan, marking an increase of 18.67% year-on-year. The net profit attributable to shareholders reached 4.620 billion yuan, an increase of 32.98%, while the net profit after deducting non-recurring gains and losses was 4.616 billion yuan, reflecting a 37.38% increase, demonstrating robust development momentum. According to the report, Hengrui’s R&D expenditures reached 4.549 billion yuan in the first three quarters of 2024, marking a significant increase of 22% year-on-year. This ongoing high-intensity investment in R&D is providing strong momentum for the transformation of the company’s innovative achievements. As a result of these sustained investments, Hengrui is seeing a continual emergence of innovative outcomes. During the reporting period, Hengrui launched its self-developed Class 1 new drug, Fuhuanqi ...
Innovax Biological announced that its operating revenue for the first three quarters reached 1.948 billion yuan, a year-on-year decline of 60.79%. The net profit attributable to shareholders of the listed company for the same period was 267 million yuan, down 85.25% compared to last year. In the third quarter alone, the company generated revenue of 582 million yuan, down 27.72%, and reported a net profit of 6.1686 million yuan, a staggering decline of 94.18%. The company attributed the decline in performance to several market adjustments during the reporting period, including government-led centralized procurement and the extended age range for the nine-valent HPV vaccine, which have collectively led to reduced sales revenue and profits compared to the same period last year. At the market opening today, Innovax Biological’s stock price fell over 2%. In August 2022, Merck China announced an expansion of the target age group for its nine-valent HPV vaccine ...
On the evening of October 24, Boyaa Bio disclosed its Q3 2024 report, revealing that the company achieved a revenue of 1.245 billion yuan and a net profit of 413 million yuan in the first three quarters, both of which marked a decline compared to the same period last year. The company attributed this decrease primarily to its strategic decision to focus on the blood products industry, resulting in the divestment of its two major sectors, Fuda Pharmaceutical and Tianan Pharmaceutical, in the second half of 2023. During the reporting period, the company actively promoted the construction project of its smart factory for blood products (Phase 1). Currently, the main structural works, including the manufacturing center, innovation incubation center, and packaging and warehousing center, have been capped, indicating that the project has entered a new phase. According to previous plans, the factory is expected to be fully capped by the ...
Recently, the “Maidong Technology Park”, which is the global headquarters base of Mindray Animal Medical, officially started construction in Longhua, Shenzhen. It is reported that the land for the Maidong Technology Park project will be sold in September 2023, covering an area of 58600 square meters and a building area of 176000 square meters. The total planned investment is 1.774 billion yuan. After completion, it will create an intelligent manufacturing “black light” factory with high-precision automation equipment covering the entire area. Through automatic and intelligent on-site logistics scheduling, efficient, high-quality, and low-cost manufacturing will be achieved. 01. Expected annual output value exceeds 12 billion In recent years, Mindray Medical has begun to focus on four emerging businesses, namely animal medicine, minimally invasive surgery, orthopedics, and AED, on the basis of its traditional three core businesses. In 2022, Li Xiting, Chairman of Mindray Medical, made a statement Animal medicine is a ...
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