Recently, the 13-valent pneumococcal polysaccharide conjugate vaccine of Minhai Biopharmaceuticals (hereinafter referred to as Kangtai Minhai), a wholly-owned subsidiary of Kangtai Biological, obtained the GMP certification certificate issued by the Turkish Food and Drug Administration. The acquisition of this certificate indicates that the production facilities, processes, quality control and quality management systems of Minhai Biopharmaceuticals PCV13 vaccine are in compliance with Turkey’s strict pharmaceutical production quality management standards, and also indicates that the product has the necessary conditions for access to the local Turkish market. Turkey is a “crossroads” connecting the Eurasian continent, and its geographical location has significant locational advantages. The country’s economic development is growing rapidly, and its GDP ranks among the top 20 in the world. In 2024, Turkey’s total population will be about 85.66 million, and the number of newborns in 2023 will be about 950,000. In recent years, the country’s public health level and medical ...
On the evening of July 1, the company and its wholly-owned subsidiaries, Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd. and Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., recently obtained the National Intellectual Property Rights of the People’s Republic of China.An invention patent certificate issued by the Bureau, the patent name is “A primer pair and its application in BCG-CpG-DNA adjuvant quality control method”, patent number ZL202211426011.7, patent certificate number 8029182, and the application date is November 14, 2022. The company stated that the above invention patent was applied for and obtained during the research and development of the freeze-dried recombinant tuberculosis vaccine (AEC/BC02) independently developed by the company and still in the research stage, and will be used in the company’s related products under research. The acquisition of this patent certificate will not have a significant impact on the company’s recent production and operation, but it will help to further improve ...
On June 30, Zai Lab announced that the main data of the Phase III study of bemazumab for FGFR2b-positive first-line gastric cancer achieved positive results . Zai Lab said that the detailed results of the study will be announced at a future medical conference, but this achievement is expected to redefine the standard treatment of first-line gastric cancer and bring new hope of survival to gastric cancer patients. 01 New breakthrough The FORTITUDE-101 study is a global multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of bematuzumab combined with mFOLFOX6 chemotherapy versus placebo combined with mFOLFOX6 as first-line treatment. The study was conducted in 300 research centers in 37 countries around the world, with a total of 547 patients enrolled. The study met its primary endpoint of overall survival (OS) at a pre-specified interim analysis, with bematumab plus chemotherapy demonstrating a statistically significant and clinically ...
On June 30, the official website of the National Drug Evaluation Center showed that Kanghong Pharmaceutical’s lifetilast eye drops (trade name Langyueming) were exclusively launched in China as a Class 3 new drug, which will provide a new option for dry eye treatment. With the popularization of electronic devices, the acceleration of the aging process and bad eye habits, the incidence of dry eyes in China has been increasing year by year. The number of people suffering from dry eyes or dry eye symptoms in China exceeds 300 million. According to a research report by the China Economic Industry Research Institute, the domestic dry eye drug market will reach 4.79 billion yuan in 2024, with a compound growth rate of 16.17% from 2020 to 2024, providing a huge market space for the development of dry eye drugs. Inflammatory response is the driving factor of ocular surface damage in the pathological ...
Organiser: Informa Group Time:February 9-12, 2026 address:Sheikh Zayed Road, Trade Centre – Trade Centre 2, Dubai, United Arab Emirates Exhibition hall:Dubai World Trade Centre Product range: Medical Devices and Instrumentation: Medical electronic instruments, medical ultrasonic instruments, medical X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, operating room/emergency room/consultation room equipment and appliances, disposable medical supplies, medical dressings and hygienic materials, various surgical instruments, medical wellness devices and supplies, traditional Chinese medical instruments and rehabilitation aids, hemodialysis equipment, anesthesia and respiratory equipment, etc. Home Healthcare Products and Portable Wellness Devices: Home health and wellness products, portable diagnostic, monitoring, and therapeutic instruments, rehabilitation/physical therapy devices and supplies, electronic medical instruments, dental tools, hospital office supplies, sports medicine products. Active Pharmaceutical Ingredients (APIs), Traditional Chinese Medicines, and Health Supplements: Therapeutic, rehabilitative, and wellness pharmaceuticals and products rooted in Eastern medical traditions. About Arab Health: The Arab Health ...
Drugdu.com expert’s response: I. How to Determine if a Software is Medical Device Software? In simple terms, for the European Union (EU), a software is considered medical device software (MDSW) when it meets three conditions simultaneously: It Performs Medical Tasks For example, diagnosing diseases, monitoring conditions, treating patients, or assisting in surgeries. If it merely records exercise steps, reminds users to drink water, or sends notifications to doctors (without involving medical decision-making), it doesn’t qualify. Examples: A software that analyzes electrocardiogram (ECG) data to assess heart disease risk is medical device software; a fitness app that records daily step counts is not. It Processes Data The software should not just store or display data (such as an electronic medical record system). It must analyze, calculate, modify the data, and then generate medical-related results. Examples: A software that automatically marks tumor locations based on computed tomography (CT) images is medical device ...
NO.1 Apple may abandon self-developed AI models According to foreign media sources, Apple is considering abandoning its self-developed internal model and using Anthropic or OpenAI’s artificial intelligence (AI) technology to drive the new version of Siri. Insiders revealed that Apple has contacted these two companies to discuss deploying their Large Language Model (LLM) on Apple’s own cloud infrastructure for testing. Comment: This collaboration may indicate that Apple’s self-developed progress in the AI field is not as expected and requires external forces to accelerate development. NO.2 Moderna Influenza Vaccine Phase III Clinical Trial Successfully Completed On Monday, US vaccine manufacturer Moderna announced that its experimental influenza vaccine based on mRNA had a stronger immune response than the existing vaccine in a phase III trial, which paved the way for the approval of its COVID-19/influenza combined vaccine. Comment: This achievement not only brings new hope to the influenza vaccine market, but ...
NO.1 Hang Seng Hong Kong Stock Connect Innovative Drug Index is about to be revised, explicitly excluding CXO companies On June 30th, the Hang Seng Hong Kong Stock Connect Innovation Drug Index announced a revised compilation plan, adding a rule to exclude CXO (pharmaceutical outsourcing) companies. According to the new compilation plan, all the constituent stocks of the revised index are innovative pharmaceutical companies, making it one of the first innovative pharmaceutical indices tracked by ETFs to achieve a purity of 100%. Pang Yaping, General Manager of the Index Research Department of E Fund, stated that CXO mainly provides services and does not directly acquire the core intellectual property rights of innovative drugs. Generally, CXO does not participate in the patent development and commercialization of innovative drugs and does not obtain patent authorization benefits. Therefore, after excluding CXO, the Hang Seng Hong Kong Stock Connect Innovative Drug Index can focus ...
By Lori Solomon HealthDay ReporterMONDAY, June 30, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy. Benlysta (200 mg/mL), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, is the first and only approved biologic for both systemic lupus erythematosus and lupus nephritis. It is not recommended in patients with severe active central nervous system lupus. The most common major adverse reactions seen with Benlysta were serious infections, some of which were fatal. The most common adverse reactions (≥5 percent) were nausea, diarrhea, fever, inflammation of the nasal passages and throat, bronchitis, insomnia, pain in extremity, depression, migraine, and injection site reactions. “In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease ...
By Dennis Thompson HealthDay ReporterMONDAY, June 30, 2025 (HealthDay News) — The thought of swallowing a pill on a thread isn’t the most pleasant notion, but it could be a vastly better alternative for people at increased risk of throat cancer, a new study says. For nearly 20 years, U.K. resident Duncan Cook has had regular endoscopies to monitor his case of Barrett’s esophagus, a condition in which acid reflux damages cells and can lead to throat cancer. Then researchers offered him another option: Swallow a capsule that dissolves in the stomach to release a small sponge. Using an attached string, health care professionals draw the sponge back up the throat, lightly scraping cells off the esophagus along the way. “The first time I had the sponge, I was a bit nervous. It’s quite a big pill to swallow, but it’s much better than going for endoscopies,” Cook, 57, ...
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