On November 7, 2024, Shanghai, China – Today, Vantiv, a kidney care company that Baite Medical plans to spin off, held a launch ceremony for its new generation continuous blood purification equipment PrisMax at the 7th China International Import Expo. Mr. Wang Xiaoyu, Vice President of Emergency and Critical Care Business in China, and Ms. Liu Ying, Senior Director of Regulatory Affairs and Quality Department in Asia Pacific and China, delivered speeches on behalf of Baite Medical, which plans to spin off its kidney care company. They unveiled the company’s leadership team and strategic partners on site, and explained the insights of this locally implemented initiative in upgrading diagnosis and treatment services, responding to national policies, and enhancing clinical value. As one of the advocates and industry leaders of the global concept of continuous blood purification, Vantiv has advanced emergency and critical care therapies that can support both kidney and ...
“This is our third time participating in the China International Import Expo. Over the past few years, we have leveraged the platform of the expo to share our R&D achievements and business progress, while accelerating the launch of our innovative products in China to benefit more groups as soon as possible. Ultimately, through the expo, we have carried out various collaborations and signed agreements with different partners, thereby speeding up our development process in China,” said Jin Fangqian, Gilead Sciences’ Global Vice President and General Manager for China, during an interview with media outlets like Times Finance during the 7th China International Import Expo. At this year’s expo, Gilead Sciences announced significant progress regarding its core product, Lenacapavir, in the field of HIV prevention. Lenacapavir is the world’s first approved HIV capsid inhibitor and offers a long-acting treatment regimen needing administration only twice a year. The drug has been approved ...
On November 4, according to the official website of CDE, Suzhou Ascentage Pharmaceuticals Co., Ltd. (hereinafter referred to as “Ascentage Pharmaceuticals”) proposed a priority review for the Class 1 new drug APG-2575 tablets, which is intended for patients with refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. APG-2575 is a Bcl-2 selective inhibitor independently developed by Ascentage Pharmaceuticals. It can restore the normal apoptosis process of cancer cells by selectively inhibiting Bcl-2 protein, thereby achieving the purpose of treating tumors. It is understood that APG-2575 is the first locally developed Bcl-2 inhibitor to enter the clinical stage in China. It is also the second in the world and the first in China to see clear efficacy and enter the key registration clinical stage. At present, the drug has broad potential for single-drug and combination therapy in the treatment of various blood tumors and solid tumors. To date, APG-2575 has received ...
On November 6, Novo Nordisk released its third-quarter report for 2024. In the first nine months of this year, sales increased by 23% to 204.7 billion Danish kroner, of which sales of diabetes and obesity treatment drugs increased by 25% to 191.8 billion Danish kroner. The star product Semaglutide continued to advance by leaps and bounds, with sales of three brands (sugar-lowering injection Ozempic, sugar-lowering tablets Rybelsus, and weight-loss injection Wegovy) reaching 141.213 billion Danish kroner, or about 20.3 billion US dollars, in the first nine months of this year. Not long ago, Eli Lilly also announced its performance, among which the sales of two brands of GIPR/GLP-1R dual agonist Tirzepatide (Mounjaro, a hypoglycemic injection, and Zepbound, a weight loss injection) reached US$11.0284 billion in the first three quarters of this year. Specifically, Mounjaro’s sales revenue was US$8.010 billion, and Zepbound’s sales revenue was US$3.018 billion. Zepbound has been rapidly ...
In front of the old domestic eye medicine leaders such as Yisheng Bio and Xingqi Eye Medicine, Zhaoke Ophthalmology is a young upstart. In 2021, Zhaoke Ophthalmology successfully landed on the Hong Kong Stock Exchange as the second eye medicine biotechnology company with 25 ophthalmic drug candidates. Three years later, although it has not yet gotten out of the quagmire of losses, Zhaoke Ophthalmology is still working hard in the eye medicine track and finally ushered in the opportunity to overtake on the curve. Two years of rapid growth, fierce attack on the “first billion drug” Recently, Zhaoke Ophthalmology announced that the Phase III clinical trial (China CHAMP) of its eye medicine candidate NVK002 has achieved positive top-line results. NVK002 is an experimental new topical ocular solution for controlling the deepening of myopia in children and adolescents (using 0.01% and 0.02% low-dose atropine). This is the most popular atropine myopia ...
Progress in drug research and development 1. Anjin C5aR antagonist “Avamipram” approved for market in China On November 5th, the official website of NMPA announced that the marketing application for avacopan capsules jointly developed by Anjin and CSL Vifor has been approved, presumably for the treatment of anti neutrophil cytoplasmic antibody (ANCA) – related vasculitis (AAV). Afakepan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the allergen C5a, blocking C5a mediated neutrophil activation and migration. The drug was approved by the US FDA in October 2021 for use in combination with standard treatment regimens including glucocorticoids to treat adult active severe ANCA associated vasculitis (MPA and GPA). In July 2024, Anjin reached an agreement with CSL Vifor to acquire commercial rights to Avamipram in Asia and Latin America, including the mainland Chinese market. 2. Pfizer PARP inhibitor “Terazopanib” approved in China On November 5th, ...
Collective procurement ‘big winner’ In 1995, Gan Zhongru, who had worked as a postdoctoral fellow and senior biochemist at Merck&Co. in the United States, returned to China to start a business. Three years later, the team formed by Gan Zhongru developed China’s first genetically recombinant human insulin, becoming the third company after Eli Lilly and Novo Nordisk to produce and sell recombinant human insulin. Subsequently, under the leadership of Gan Zhongru and his R&D team, Gan Li Pharmaceutical continued to develop the first long-acting insulin analog, the first fast acting insulin analog, the first pre mixed insulin analog, and the first winter insulin in China. The products covered three insulin functional segments: long-acting, fast acting, and medium acting, becoming the “king of insulin” in China. With the acceleration of domestic insulin substitution in recent years, Ganli Pharmaceutical’s operating revenue has increased from 1.771 billion yuan in 2016 to 3.612 billion ...
On October 31, Merck was the first to release its third-quarter financial report. In the first three quarters, K drug performed as well as ever, with sales of US$21.646 billion, a year-on-year increase of 18%, and annual sales are expected to exceed US$29 billion. According to this trend, K drug is likely to defend the title of King of Medicine in 2024. However, on November 6, after Novo Nordisk released its third-quarter report, the competition for the King of Medicine caused a stir. In the first three quarters, the total sales of multiple versions of semaglutide reached US$20.3 billion, approaching K drug. Such a limited gap also indicates the fierceness of the competition for the King of Medicine. Before the results of the fourth quarter are announced, no one knows the final answer. Will K drug become the “shortest-lived King of Medicine” in history? On February 1, 2024, with the ...
Drugdu.com expert’s response: When applying for the CE certification for IVD self-test products in the EU, attention should be paid to the following aspects: Ⅰ. Understanding the IVDR Regulatory Requirements Regulatory Content: IVD self-test products need to comply with the regulations of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the IVDR, IVD products are classified into four risk categories: A, B, C, and D. Self-test products, which typically involve patients performing their own tests, may fall into higher risk categories, requiring special attention to relevant audit requirements. Ⅱ. Preparing Technical Documentation Completeness: Technical documentation should include product instructions, technical specifications, validation reports, quality control manuals, etc., and should be organized and numbered according to the order specified in Appendix II of the IVDR. Accuracy: The content of the documentation should be accurate and reflect the true performance and safety of the product. ...
Today, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Roche Diagnostics China announced that its new molecular detection platform LightCycler® PRO System real-time fluorescence quantitative PCR instrument* (hereinafter referred to as “LightCycler® PRO”) was officially launched in China. Wang Feng, Senior Director of Roche Diagnostics China – Life Sciences Department, Marcus Droege, CEO of TIB Molbiol, James Lee, Global Senior Product Manager of Roche Diagnostics, and other guests attended the LightCycler® PRO launch conference. “As a global leader in in vitro diagnostics, Roche Diagnostics has always empowered scientific research with cutting-edge innovative technologies and led the development of the industry. LightCycler® PRO is another breakthrough innovation in the field of molecular testing. It can achieve 7-channel multiplex testing and has powerful advantages such as accuracy, high efficiency, flexibility, and ease of use. We hope that this time, with the help of the CIIE, it will officially ...
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