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 ...
Recently, optical giant Zeiss announced that it has reached a cooperation agreement with Swiss AR/VR company Creal to jointly develop a new digital vision healthcare platform based on light field display technology, planning to completely revolutionize existing vision diagnosis and treatment procedures. Light field display is a method that utilizes ray tracing to reconstruct 3D scenes in space, and is currently the most likely practical 3D display technology. Compared with holographic display technology, which is also a true 3D display technology, light field display has smaller data volume, lower cost, and smaller volume. Zeiss will introduce CREAL’s light field display technology to create a device that can digitally reproduce real refractive testing. The new device will be able to virtually simulate traditional glasses and contact lenses, eliminating the need to switch lenses repeatedly. Objects in front of us will be displayed at different focal lengths, and through precise digital imaging, ...
Recently, the US FDA updated the list of authorized artificial intelligence and machine learning (AI/ML) medical devices. This list is a barometer of the health status of the artificial intelligence industry, and updates show that the FDA is maintaining a rapid pace of authorization. In the past few years, the FDA’s AI authorization has maintained double-digit growth, which reflects the increasing number of submissions received by the FDA from AI developers. AI/ML medical equipment explosion In the past, the FDA usually updated the list of approved AI/ML devices once a year, but with the frequent changes and approvals of artificial intelligence technology, the FDA has increased the frequency of updating the list. This list update includes 61 new approvals, including products approved between March 31st and June 25th. Similar to previous updates, applications targeting radiology accounted for the majority of the new licenses, with 44 products on the list since ...
On September 8, 2024, Kangfang Biotechnology announced at the 2024 World Lung Cancer Congress the heavyweight research data of the registered Phase III clinical trial (HARMONI-2/AK112-303) of the company’s independently developed global first PD-1/VEGF bispecific antibody new drug, Ivoxidan, compared to pembrolizumab monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression positive (PD-L1 TPS ≥ 1%). Ivoxidan became the world’s first drug to demonstrate significantly better efficacy than pembrolizumab in a single drug head to head Phase III clinical trial. Affected by this news, the stock price of Kangfang Biotechnology has risen by 14%. AK112-303/HARMONI-2 (CTR20222137) is a registered phase III randomized, double-blind clinical trial conducted in China to evaluate the first-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression positive (PD-L1TPS ≥ 1%) compared to Ibuprofen (PD-1/VEGF) monotherapy. The primary endpoint was PFS assessed by IRRC according to ...
Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China. This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market. Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above. Referring to the progress of Pfizer’s application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the ...
September 10, 2011 – The State Council Information Office held a series of press conferences on the theme of “promoting high-quality development” on the morning of the 10th, Yan Qinghui, deputy director of the State Medical Insurance Bureau, said at the meeting that the medical insurance sector will vigorously promote the expansion of the quality of the collection of medicine and mining. Continuously expand the coverage of collection, carry out a new batch of national organization drugs and high-value medical supplies collection, will be cochlear implants and other high-value medical supplies into the collection. Yan Qinghui introduced, the effectiveness of the collection work can be recognized from three aspects: First, the burden of drug use by the public has been reduced, and the accessibility and quality of drugs have been improved. For example, hepatitis B antiviral drugs entecavir and tenofovir, etc., the annual cost of patients before the ...
Today, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Screenshot source: CDE official website Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone ...
On September 4th, the Shanghai Stock Exchange terminated one IPO company: Shandong Branden Medical Equipment Co., Ltd. (hereinafter referred to as “Branden”). According to information, this was Branden’s voluntary withdrawal of its listing application, and the listing on the Science and Technology Innovation Board was terminated. Two major products support the banner of revenue Founded in 2003, Baibai An is a national high-tech enterprise dedicated to applying medical material modification technology to implantable medical devices, focusing on the research and development, production, and sales of biological and medical products. Through independent research and continuous innovation, Branden has formed a technology platform centered on medical material modification, precision machining, and digital diagnosis and treatment of vascular pathways. According to the prospectus, Branden is the first domestic enterprise to obtain the registration certificate for Class III medical device products of domestically produced Peripherally Inserted Central Catheters (PICCs), breaking the monopoly of imported ...
Lionco Pharmaceuticals (603669) September 5 evening announcement, recently, the company’s subsidiary Lionco Pharmaceuticals received the State Drug Administration issued “Cefzodoxime Sodium for Injection” supplemental application for approval of the notice of the drug, the drug through the generic quality and efficacy consistency evaluation. As of the date of the announcement, the Company has invested RMB5.72 million in research and development for Cefozoxime Sodium for Injection. The drug is mainly used for lower respiratory tract infections, urinary tract infections, abdominal infections, pelvic infections, sepsis, skin and soft tissue infections, bone and joint infections, meningitis caused by Streptococcus pneumoniae or Haemophilus influenzae, and simple gonorrhea caused by sensitive bacteria. According to IMS data, the China market sales of cefazoxime sodium for injection is 2,740 million yuan in 2023. According to the State Drug Administration (SDA), a total of 34 companies (including Lingkang Pharmaceuticals) have been approved to market cefzodoxime sodium for injection ...
Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed the listing guidance registration and planned IPO at the Beijing Securities Regulatory Bureau, and the guidance institution is CICC. According to the counseling work arrangement, CICC plans to complete the counseling plan for Pinchi Medical in November and December this year, and apply to the Beijing Securities Regulatory Bureau for counseling acceptance. After the counseling is completed and accepted, Pinchi Medical may apply for an IPO. This is another brain pacemaker company that plans to go public through an IPO in 2023 after Jingyu Medical started filing for listing counseling. According to Smart Medical Equipment, so far, the only two local companies that mass-produce brain pacemakers have embarked on the road to IPO. Founded in 2008, Pinchi Medical is a high-tech enterprise specializing in the research and development, production and sales of a series of neuromodulatory ...
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