Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®, Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
Johnson & Johnson has had frequent executive changes in recent years, not only in the innovative pharmaceutical industry, but also in the medical technology department. At least nine executive changes have been reported since 2023. Recently, Enovis, a global orthopedic giant, announced the appointment of Tim Czartoski as president of its U.S. surgical and global products and supporting technologies business. Tim Czartoski previously worked in the DePuy Synthes orthopedic business unit of Johnson & Johnson Medical Technology. Tim Czartoski is a very experienced veteran in the medical field. He has more than 20 years of experience in the medical technology industry, especially in the orthopedic business. Tim Czartoski has held several key positions at Johnson & Johnson, leading the growth of Johnson & Johnson’s business. Looking back at Tim Czartoski’s career at Johnson & Johnson, he has held several positions in the DePuy Synthes orthopedic business unit of Johnson & ...
Recently, Merit Medical announced that it has agreed to acquire Cook Medical’s lead management business for $210 million (approximately RMB 1.5 billion). Merit expects to provide funding for the transaction through a combination of cash on hand and borrowing under its long-term credit line. The proposed transaction is expected to be completed in the fourth quarter of 2024, subject to obtaining or waiving (in accordance with the provisions of the asset purchase agreement) approval for certain closing conditions, including antitrust laws and other customary closing conditions. It is understood that Cook Medical’s lead management business has a 34 year operating history, providing a comprehensive end-to-end medical device and accessory product portfolio for patients who need to remove or replace pacemaker or implantable cardioverter defibrillator (ICD) leads for lead management procedures. 01. Breaking through industry difficulties Cook Medical’s lead management business provides medical equipment and accessories for potential customer management programs. ...
Vice Minister Huang Guo of the National Drug Administration recently revealed that the agency is leading the modernization of drug regulation through information technology. The administration continues to implement the Smart Drug Regulation Action Plan, focusing on building an integrated system for the registration and approval of drugs, medical devices, and cosmetics. This initiative aims to fulfill the “efficient handling of single transactions” requirement, achieving seamless cooperation throughout the entire process from acceptance and review to approval and certification. As a result, the volume of online acceptance and the rate of timely conclusions have steadily increased, significantly enhancing the quality and efficiency of reviews and approvals. Currently, all government service matters handled by the National Drug Administration have been transitioned to 100% online processing, and all enterprise-related certificates at the bureau level have been fully digitized. The total number of electronic certificates issued has exceeded 170,000, allowing enterprises to access ...
The announcement of the complete closure of Shenzhen Zhonglian Pharmacy also announced that this once top 100 chain in the country could not withstand the economic downturn and collapsed. It also brought back the author’s memories of developing a new OTC market in Shenzhen many years ago. Shenzhen, the forefront of China’s reform and opening up, the first special economic zone, is not only the “holy land” in the hearts of countless businessmen, but also the place where miracles are born. In August 2001, I was sent to Shenzhen by the company to develop the market due to my outstanding performance at the age of 25. At that time, the company where the author worked was mainly engaged in women’s products (sanitary napkins, panty liners), and its business scope was mainly in the southwest region. Based on the concept of increasing the added value of women’s care products, it developed ...
Drugdu.com expert’s response: The registration requirements for Active Pharmaceutical Ingredients (APIs) in Mexico typically involve a separate registration process, rather than simply being associated with the registration of the final dosage form. This is because APIs, as the essential components of dosage forms, have a direct impact on the quality, safety, and efficacy of the final product. Registration Requirements for APIs in Mexico Approval from the Mexican Ministry of Health: The export of APIs to Mexico requires approval from the Mexican Ministry of Health. This signifies that APIs must comply with Mexico’s local pharmaceutical regulations and standards. COFEPRIS Registration: Manufacturers of APIs need to register with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is the primary agency under the Mexican Ministry of Health responsible for regulating drugs, medical devices, cosmetics, and hygiene products. During the registration process, companies must submit a range of documents, including but not limited ...
Imaging equipment is an indispensable medical product for building a clinical diagnosis and treatment system. Medical imaging equipment interacts with the human body through a certain medium (such as X-rays, electromagnetic fields, ultrasound, etc.), and presents the structure and density of internal tissues and organs of the human body in the form of images for diagnostic physicians to judge and evaluate the health status of the human body. Commonly used medical imaging equipment in clinical practice includes computed tomography (CT), magnetic resonance imaging (MR), X-ray imaging equipment, nuclear medicine diagnostic equipment, and ultrasound equipment (US). Medical imaging of different modalities has different working principles, imaging characteristics, application scenarios, and advantages and disadvantages, but the functions are relatively consistent: Medical imaging equipment is one of the basic diagnostic options before most diseases are currently intervened, especially in the context of aging in China. Most aging-related diseases such as cardiovascular and cerebrovascular ...
On September 3, 2024, the Shenzhen Public Resource Trading Center once again publicly solicited opinions on the “Continuation of Procurement Documents for Centralized Volume Purchase Agreement of Ultrasonic Knife Heads and Pre filled Catheter Flushers (Draft for Comments)”. Enterprises can provide feedback before 17:00 on September 10. The variety of this procurement is ultrasonic blade head (disposable/reusable/integrated handle ultrasonic blade head). After two years, this market is once again experiencing a tense moment. The Guangdong Alliance’s centralized procurement of ultrasonic knives will be launched, and market competition has entered a white hot stage Since the first centralized procurement of ultrasonic cutting heads in Fujian Province in 2020, as of 2024, the centralized procurement areas for ultrasonic cutting heads have spread throughout the country. After this launch, the Guangdong Alliance will become the largest alliance for centralized procurement of ultrasonic knives. At the end of 2021, Guangdong led a 16 province ...
In September, the 2024 semi-annual reports of various companies have basically been disclosed. According to statistics from Cyber Blue, among the 493 A-share listed pharmaceutical companies (according to the industry classification of Tonghuashun, the same below), the number of companies with year-on-year decline and growth is close to “50-50” – 242 pharmaceutical companies have a year-on-year decline in revenue, accounting for 49% of the total; 252 have an increase in revenue, accounting for 51% of the total. Among the 242 pharmaceutical companies whose revenue decreased compared with the same period last year, 40% of them fell by less than 10%; there were 12 companies with a decline of more than 50%, of which the company with the largest decline had a year-on-year revenue decline of more than 97%. Among the 252 pharmaceutical companies with year-on-year revenue growth, 183 had an increase of less than 20%, accounting for ...
Recently, global orthopedic giant Xerox announced that Mr. Hu Hai, Managing Director of Xerox Greater China, has decided to leave Xerox on September 26th to seek external development opportunities. At present, Hu Hai has not announced where his next destination will be, and Shi Lehui has not yet announced a new successor. Retired veteran resigns In September 2021, Xerox announced the departure of its Managing Director for Greater China, Alaeddin Ahram, and the new Managing Director for Greater China, Hu Hai, took office on September 27th. Hu Hai is a veteran in the field of medical devices, with over 30 years of experience in the field, especially in orthopedics. Prior to joining Xerox, he had extensive work experience in several giant companies, including serving as Vice President of the Joint Division in China at Johnson&Johnson Medical, Vice President of Depuy Synthes in China at Johnson&Johnson Orthopedics, the first CEO and ...
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