On November 13, 2024, Lilly announced the latest follow-up data of Phase III clinical SURBOUNT-1 of Tilpolide in the treatment of pre diabetes patients with obesity or overweight. The follow-up time was up to 3 years (176 weeks), and the data were also published in the New England Medical Journal. After 176 weeks of treatment, the proportion of patients who progressed to type 2 diabetes in the Tilpodide treatment group and the placebo control group was 1.2% and 12.6% respectively, and the risk of progression to type 2 diabetes was reduced by 94%. After 17 weeks of drug withdrawal, the rates of progression to type 2 diabetes were 2.4% and 13.7%, respectively, and the risk of progression to type 2 diabetes was reduced by 88%. After drug withdrawal, the proportion of patients who progressed to type 2 diabetes increased rapidly, indicating that the disease progression was delayed but may not ...
Recently (November 7th), the official website of the China National Center for Drug Evaluation (CDE) showed that Chengdu Yuandong Biopharmaceutical Co., Ltd.’s application for the marketing of injection grade naprolimus mesylate, classified as Class 3, has been accepted. According to public information, the indications of this product are for the treatment of acute pancreatitis, chronic pancreatitis with acute exacerbation, postoperative acute pancreatitis, acute pancreatitis after pancreatography, and acute traumatic pancreatitis; Used for the treatment of disseminated intravascular coagulation (DIC); 3. Used to prevent blood clotting during extracorporeal circulation. Naprolimus mesylate is a strong and broad-spectrum serine protease inhibitor. This product was first launched in Japan for the prevention and treatment of disseminated intravascular coagulation (DIC), improvement of acute symptoms of pancreatitis, and anticoagulation during extracorporeal circulation. In March 2020, according to overseas media reports, Professor Junichiro Inoue of the Medical Research Institute of the University of Tokyo and others issued ...
Recently, according to the Mail on Sunday report in the UK, global orthopedic giant Smith&Nephew has received a stern warning from shareholders due to poor performance. Smith&Nephew’s shareholders have lost patience with CEO Deepak Nath’s strategic development speed, claiming that if the company’s performance cannot be improved, Deepak Nath will be dismissed and Smith&Nephew will also face the splitting of its orthopedic department internally. It is reported that the stock price of Xerox Hui has dropped by up to 44% in the past five years. With this year’s performance still not “clear up”, the emotions of shareholders are difficult to calm, further putting pressure on Deepak Nat. Century old enterprises face crisis Shi Lehui was founded in the UK in 1856, a well-established company with over a hundred years of history. Its main businesses include orthopedics, sports medicine and otolaryngology, and advanced wound management. Currently, Shi Lehui is at the ...
Recently, Johnson&Johnson Medical Technology has made organizational adjustments to its surgical division. Starting from January 1, 2025, the Surgery Division will be reorganized into six major departments: Minimally Invasive and Energy Surgery Division, Wound Closure Division, Biosurgery Division, Surgical Product Expansion Division (i.e. Wide Area Market Division), Strategic Marketing Division, and Robotics and Digitalization Division. 01. Adjustment of the Organizational Structure of the Surgical Division Given the rapid changes in policy environment and the new trend of market competition, Johnson&Johnson Medical Technology firmly believes that the Surgical Division’s continued leadership in the market in the new era is an important cornerstone for winning the Chinese market and the future. To this end, the company has launched the “Yaoying 2030” surgical division strategy, aiming to accelerate the transformation of the GTM model and cover more customers and patients with better and faster services. In the new stage of development, Johnson&Johnson Medical ...
M&A is a metaphysics, with heaven on one side and hell on the other, tempting prominent names to enter. The latest to enter “hell” is AbbVie. On November 11, AbbVie announced that emraclidine, the “ace project” acquired by acquiring Cerevel for $8.7 billion at the end of last year, failed to reach the expected endpoint in two Phase II studies for schizophrenia, which cast a shadow on its future. As soon as the news came out, AbbVie’s stock price plummeted 12.57%, and its market value evaporated by more than $40 billion overnight. Once, this merger and acquisition was a “model” in the industry. From the first acquisition invitation to the final acquisition of Cerevil, AbbVie took less than two months. Fast, accurate, and ruthless, it foreshadowed AbbVie’s determination to deal with the patent cliff. But now, everything is coming to nothing. This once again allows us to see the “variables” ...
On November 11, the National Medical Insurance Administration and the Ministry of Finance jointly issued the “Notice on Doing a Good Job in Prepayment of Medical Insurance Funds”, which clearly stated that a prepayment system should be established, which will be used specifically for medical expenses such as the purchase of drugs and medical consumables. The prepayment scale of medical insurance prepayments is about 1 month, and it shall not be used for non-medical expenses such as medical institution infrastructure investment, daily operation, and debt repayment. For a long time, the “difficulty in collecting payments” in hospitals has been a “long-standing” problem that pharmaceutical companies have to face. Especially after the epidemic, the income of some medical institutions has been affected, and the problem of capital shortage is obvious. After receiving local financial subsidies, they often choose to ensure the core operating funds first and delay the payment of procurement ...
On November 12, ST Jiuzhi issued a “Notice on the Transfer of Equity by the Controlling Shareholder and the Proposed Change of Control and Equity”. On November 10, Li Zhenguo, the controlling shareholder and actual controller of Jiuzhitang, signed the “Share Transfer Agreement on Jiuzhitang Co., Ltd.” with Heilongjiang Chenneng University of Technology Venture Capital, stipulating that Li Zhenguo will transfer his 6.25% stake in Jiuzhitang to Chenneng Venture Capital, and the total transfer amount of the target shares is about 385 million yuan. After the transfer is completed, Chenneng Venture Capital will become the controlling shareholder of ST Jiuzhi, with a controlling proportion of 24.04%, and the Heilongjiang Provincial State-owned Assets Supervision and Administration Commission will become the actual controller of ST Jiuzhi. Li Zhenguo holds 18.19% of ST Jiuzhi’s shares, making him the second largest shareholder. Specific changes in equity: It is worth mentioning that there were early ...
AstraZeneca disclosed its financial report for the first three quarters of 2024 on November 12. The company’s revenue was 39.182 billion US dollars, a year-on-year increase of 19%; of which product revenue was 37.576 billion US dollars, a year-on-year increase of 19%. AstraZeneca raised its full-year performance guidance for 2024 in the announcement, and it is expected that both full-year revenue and core earnings per share will achieve high-ten-digit percentage growth, which was previously expected to be in the mid-ten digits. From the perspective of regional distribution, the Chinese market has undoubtedly become an important engine for AstraZeneca’s performance growth. In the first three quarters of 2024, AstraZeneca’s revenue in China reached more than 5 billion US dollars (equivalent to more than 35 billion yuan in RMB), accounting for about 13% of its global market share, becoming an important part of AstraZeneca’s global business. Many people may have no idea ...
Drugdu.com expert’s response: When using overseas clinical trial data for IVD (In Vitro Diagnostic) products, attention should be paid to the following aspects: Ⅰ. Data Quality and Integrity Ensuring Data Accuracy: Utilize validated data collection tools and methods, such as Electronic Data Capture (EDC) systems. Implement a double-entry and verification mechanism to reduce human entry errors. Conduct regular data consistency checks and logical checks to identify and correct abnormal values and errors. Ensuring Data Integrity: Maintain detailed records and traceability from trial design to data collection, processing, and analysis. Ensure that all relevant data is collected completely without omissions. Ⅱ. Data Compliance Adhering to Relevant Regulations and Guidelines: Understand and comply with the regulations and guidelines for in vitro diagnostic reagents in the target market (e.g., the European Union, the United States, etc.). For instance, the IVDR (In Vitro Diagnostic Medical Devices Regulation) of the European Union has specific requirements for clinical trial data. Ethical Review: Ensure that ...
On November 11th, according to the latest announcement on the NMPA official website, Sichuan Kelun Pharmaceutical Co., Ltd. approved the submission of avatranipal maleate tablets. Since the beginning of this year, 24 varieties of Kelun Pharmaceutical (including its subsidiaries) have been evaluated. The original research and development company of Avastin Maleate Tablets is AkaRx, a company based in the United States. It is the world’s first oral thrombopoietin receptor agonist (TPO-RA) approved by the US Food and Drug Administration (FDA) for chronic liver disease-related thrombocytopenia, mainly suitable for adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery. According to the database, the sales revenue of Avastin Maleate Tablets in the national in-hospital market exceeded 500 million yuan in 2023, with a year-on-year growth of 40.97%. Previously, there were 8 pharmaceutical companies in China, including Qilu Pharmaceutical, Chengdu Beite Pharmaceutical, and Nanjing Zhengda Tianqing Pharmaceutical, that had ...
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