Drugdu.com expert’s response: Active medical devices refer to any medical devices that rely on electrical energy or other forms of energy (such as chemical energy, mechanical energy, etc.) to function, rather than energy directly generated by the human body or gravity. These devices typically require an external power source or built-in energy supply to fulfill their intended purposes and are widely used in various medical fields, including diagnosis, treatment, monitoring, and rehabilitation. I. Core Characteristics Energy Dependency: They must rely on external or internal energy sources (such as batteries, power adapters, chemical cells, etc.) to operate normally. Functional Complexity: They usually incorporate electronic, mechanical, or software components, enabling them to perform precise operations or data processing. Risk Level: According to the “Classification Rules for Medical Devices,” active medical devices are classified as having a higher risk level. They may involve direct electrical stimulation, energy release, or complex control mechanisms that ...
Beijing News Beike Finance (Reporter Ding Shuang) – On November 18, U.S.-listed Sinovac Biotech Ltd. announced that it received a delisting notice from Nasdaq on November 12. This was due to its failure to submit its 2024 Annual Report by the extended deadline. Unless the company requests a hearing before the Nasdaq Hearings Panel, its securities will be suspended from trading at the opening of the market on November 21 and will be delisted. On the evening of November 19, in response to the delisting notice from Nasdaq, Sinovac Biotech stated to a Beijing News Beike Finance reporter that the matter pertains to a subsequent procedure stemming from the delayed submission of its 2024 Annual Report (Form 20-F), which was caused by the previous resignation of its auditing firm. The company noted it had previously disclosed this information. Sinovac has now engaged UHY LLP as its new independent auditor and ...
According to exclusive early information obtained by vbdata.com, RocRock Biotechnology has recently completed a Series A financing round of RMB 50 million to advance its globally leading macrophage-based drug development and clinical translation. The proceeds will be primarily allocated to building the company’s world-class macrophage drug platform, accelerating IND-enabling activities and Phase I clinical progress of its proprietary third-generation CAR-M therapy targeting HER2, as well as supporting preclinical studies and investigator-initiated trials for pipelines including pancreatic cancer and lung cancer. The successful completion of this financing round not only demonstrates strong market recognition of the company’s innovative capabilities and R&D progress in the macrophage therapeutics field, but also establishes a solid foundation for subsequent clinical translation. Platform-driven approach to address key challenges in developing effective CAR-R therapies RocRock Biotechnology has fundamentally addressed the core challenges of autologous CAR-M therapy—namely difficult transduction, high costs, long production cycles, and limited anti-tumor efficacy—through ...
On November 18, 2025, Zhifei Biologics (300122) held its second interim shareholders’ meeting in Chongqing. With a high majority vote, it passed the relevant resolutions and legally abolished the board of supervisors. The meeting passed the relevant proposals by a large majority, revised the “Company Charter”, legally abolished the supervisory board, and transferred the relevant functions of the supervisory board to the audit committee of the board of directors. The director, Ms. Zhang Xinrong (former dean and professor of the Accounting College of Chongqing University of Commerce), took over these functions. It is known that Zhifei Biological has made another breakthrough in its research and development recently. The adjuvant cell-free diphtheria-tetanus-pertussis (component) combined vaccine (for adults and adolescents) (referred to as “diphtheria-tetanus-pertussis vaccine with components for adolescents and adults”) developed by the wholly-owned subsidiary Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd. has received the drug clinical trial approval notice from the ...
Shanghai Securities News · China Securities Network: After the herpes zoster mRNA vaccine and the freeze-dried varicella inactivated vaccine, Zhifei Biologics has approved another herpes vaccine for clinical trials. The company announced on November 19 evening that recently, its wholly-owned subsidiary Anhui Zhifei Longkom Bio-Pharmaceutical Co., Ltd. developed the recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cells) has received the drug clinical trial application acceptance notice from the National Medical Products Administration (Acceptance Number: CXSL2500978). Within 60 days from the acceptance date, if no negative or questioning opinions are received from the Drug Evaluation Center, Zhifei Longkom can carry out clinical trials according to the submitted plan. According to the data, herpes zoster is a common infectious skin disease caused by the reactivation of the varicella-zoster virus that has been dormant in the posterior root ganglia or cranial ganglia of the spinal cord. Vaccination is the most effective and feasible ...
The FDA has approved AbbVie and GenMab’s Epkinly (epcoritamab-bysp) in combination with rituximab and lenalidomide (Epkinly + R2) for adults with relapsed or refractory (R/R) follicular lymphoma (FL). Epkinly combination becomes first bispecific antibody regimen for relapsed or refractory follicular lymphoma With this regulatory action, Epkinly becomes the first and only bispecific antibody combination therapy indicated for this patient population.1 “Recurrent [FL] can be an incurable, complex and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey,” Lorenzo Falchi, MD, lymphoma specialist, department of medicine, Memorial Sloan Kettering Cancer Center, said in a press release. “The results shown with Epkinly + R2 in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R2 alone. These data, delivered by a regimen that’s chemotherapy-free and can be administered in the outpatient setting, suggest that Epkinly + ...
WEDNESDAY, Nov. 19, 2025 (HealthDay News) — People paying out of pocket for Ozempic or Wegovy may soon see lower costs, as Novo Nordisk rolls out new price discounts for its popular GLP-1 medications. The company announced that through the end of March, patients with prescriptions can buy the two lowest doses of Ozempic and Wegovy for $199 a month for two months. After that, the monthly cost rises to $349. The discounts can be accessed through the drugs’ websites and used at pharmacies or through telehealth. The $199 offer only applies to 0.25 mg and 0.5 mg injections. The higher $349 price covers the 1 mg dose of Ozempic and all Wegovy doses. The 2 mg dose of Ozempic is not included. “The US healthcare system is complex, with different types of insurance and various ways for patients to obtain their medicines,” Dave Moore, Novo Nordisk’s executive vice president ...
Organiser:Taiwan External Trade Development Council (TAITRA) Time:June 25 – June 27, 2026 Address:No.1, Jingmao 2nd Road, Nangang District Exhibition hall:Taiwan Taipei World Trade Center Nangang Exhibition Hall Product range: Laboratory instruments and biotechnology testing equipment, various assistive devices (including wheelchairs, electric scooters, and their parts), dressings and consumables, healthcare and rehabilitation products (physical therapy, personal healthcare products, and equipment), etc. Diagnostic instruments and equipment, disinfection and sterilization instruments and equipment, dental and orthopedic equipment, surgical instruments, emergency equipment, etc. Medical services, medical books, and teaching equipment, etc. Biomedical products, hospital construction materials, traditional Chinese medicine, raw Chinese herbal materials, scientific Chinese medicine, etc. About Medical Taiwan: Medical Taiwan, the Taiwan Taipei Medical Equipment and Rehabilitation Exhibition, is Taiwan’s sole professional business platform for the export of the medical equipment industry. This year, the exhibition will introduce a dedicated zone for pet medical supplies for the first time, bringing ...
Shanghai Securities News (Reporter He Xinyi) – On November 19th, Lianhuan Pharmaceutical announced that the company intends to collaborate with Nanjing University to jointly develop “anti-thrombotic small nucleic acid drugs”, with an investment amount of 15 million yuan. It is known that this cooperation aims to leverage Nanjing University’s strong research capabilities and preliminary research foundation in nucleic acid drugs, combined with the company’s industrialization and clinical development capabilities, to jointly promote the research and commercialization of innovative drugs. https://finance.eastmoney.com/a/202511193568677315.html
According to NBD AI news, an investor asked on the investor interaction platform: As the flu season approaches, does your company have sales of flu-related medications? Xidian Pharmaceutical (301130.SZ) stated on the platform on November 19th that regarding its existing marketed products, our company has a mature anti-influenza drug– Compound Paracetamol and Analgin Capsule, and an antiviral tablet that will be approved for market in 2025 and is clinically used for treating upper respiratory tract infections and influenza. The company’s ongoing research project “Study on the Intervention Effect of daphnetin on Mice Models of Human Diseases ” has sub-project “Research on the Intervention Effect of daphnetin on Mouse Virus Pneumonia Models”, in which the experimental results showing the safety and effectiveness of rixinzhi in treating viral pneumonia have been obtained. We have also obtained the invention patent “Application of daphnetin in the Preparation of Drugs for Treating Viral Pneumonia”. If ...
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