media – Page 34 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Zhifei Bio’s independent product, influenza virus split vaccine, has obtained a drug registration certificate

　　Zhifei BioinfluenzaThe vaccine matrix has added another blockbuster product. The company announced on the evening of September 29 that the influenza virus split vaccine (referred to as “trivalent influenza vaccine”; registration category: preventive biological product) recently developed by its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd.) Obtain the “Drug Registration Certificate” issued by the State Food and Drug Administration. 　　Influenza is an acute respiratory infectious disease caused by the influenza virus that can cause widespread epidemics. It is highly contagious and can cause complications such as pneumonia, bronchitis, and myocarditis. It can aggravate underlying conditions in high-risk groups such as the elderly and the frail, increasing the disease burden and endangering human health. Flu vaccination is the most economical and effective measure to prevent influenza illness and influenza outbreaks. The trivalent influenza vaccine developed by Zhifei Longcoma is suitable for people aged three years and older to prevent infectious ...
- Source: drugdu
- 114
- October 8, 2025
【EXPERT Q&A】What are the key points and requirements for the product registration application materials of Class II active medical devices?

Drugdu.com expert’s response: I. Requirements for Completeness of Declaration Materials Basic Certification Documents Business License: Submit a copy of the enterprise’s valid business license (with expiration date). Personnel Qualifications: Provide identity certificates and educational/professional title certificates for the legal representative, enterprise负责人 (enterprise leader), and quality manager to verify enterprise and personnel qualifications. Contract Manufacturing: If outsourcing production, submit the contract manufacturer’s Medical Device Production License and the signed contract manufacturing agreement between both parties. Core Product Documents Medical Device Registration Application Form: Detailed description of product name, specifications, model, structure, intended use, production process, and quality control methods. Must be signed and stamped by the legal representative or responsible person. Product Instructions and Label Specimens: Include generic name, model, specifications, manufacturer information, product technical requirement number, production date, expiration date, performance, structure, intended use, contraindications, and precautions. Product Technical Requirements: Specify technical parameters, performance indicators, and testing methods in compliance with national/industry ...
- Source: drugdu
- 113
- October 8, 2025
Antihypertensive and lipid-lowering drugs show efficacy against steatotic liver disease

Metabolic dysfunction-associated steatotic liver disease is the most common liver disease in the world, affecting about one third of the adult population. This disorder is characterized by the accumulation of fat in liver cells, which has severe liver consequences and is also associated with a high mortality rate from cardiovascular disease. Now, a University of Barcelona study published in the journal Pharmacological Research shows that pemafibrate and telmisartan, two drugs already approved for other conditions, effectively reduce fat accumulation in laboratory animal models of metabolic liver disease. Furthermore, the study suggests that this combination of drugs may help to reduce both liver involvement and associated cardiovascular complications. These results open the door to the development of safer and more effective treatments for this disease, for which current therapeutic options are very limited. The study has been carried out by a team led by Marta Alegret, professor at the ...
- Source: drugdu
- 169
- October 7, 2025
Large-scale analysis offers insights into sporadic nature of chikungunya virus outbreaks

While the virus is common in tropical and subtropical regions, including Asia, Africa and South America, public health officials have been tracking reported infections in Europe and, in September, a confirmed case in Long Island, New York. Outbreaks of chikungunya have prompted the Centers for Disease Control to issue health notices to travelers bound for Bangladesh; Cuba; Guangdong Province, China; Kenya; Madagascar; Somalia; and Sri Lanka. In Guangdong Province, an”unprecedented”outbreak recently prompted government officials in China to mandate quarantines for anyone suspected of being infected by the virus, spraying individuals with mosquito repellent and spraying impacted buildings and other areas with insecticide. In a new study, published in Science Advances, researchers at the University of Notre Dame analyzed more than 80 outbreaks of chikungunya virus to improve prediction of future outbreaks and inform vaccine trial development. “Chikungunya outbreaks are unpredictable in both size and severity,”said Alex ...
- Source: drugdu
- 148
- October 7, 2025
The KOREA PHARM & BIO

Organiser: Korea Food and Drug Administration (KFDA), Korea Pharmaceutical Manufacturers Association (KPMA) Time：March 31, – April 3, 2026 address：217-60 KINTEX-ro, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Republic of Korea (Daehwa-dong) Exhibition hall：KINTEX (Korea International Exhibition Center) Product range: Pharmaceuticals: Pharmaceutical raw materials, APIs (Active Pharmaceutical Ingredients), pharmaceutical fine chemicals, intermediates, pharmaceutical additives, drug formulations, natural extracts, biotechnology, pharmaceutical outsourcing and services, laboratory equipment, pharmaceutical manufacturing equipment, etc. Chemicals: Chemical raw materials, chemical equipment, instrumentation, automation control technology, heat exchangers, crystallization, gas absorption, drying, filtration, centrifugal separators, dust removal, chemical reactors, crushers, mixers, etc. Cosmetics: Cosmetic raw materials, cosmetic additives, functional materials, natural extracts, etc. About The KOREA PHARM & BIO ： The KOREA PHARM & BIO is one of the most influential pharmaceutical and biotechnology exhibitions in Korea and across Asia. It is jointly organized by the Korea Food and Drug Administration (KFDA), the Korea Pharmaceutical Manufacturers Association (KPMA), and Kyungyon Exhibition Co., ...
- Source: drugdu
- 139
- October 7, 2025
UK health agency urges people to get vaccinated against respiratory viruses before winter

The UK Health and Safety Agency (UKHSA) announced on the 26th that as winter approaches, influenzaThe number of cases of COVID-19, COVID-19 and respiratory syncytial virus (RSV) is on the rise, and the public is urged to make appointments for relevant vaccines as soon as possible. 　　The latest UK national influenza and COVID-19 surveillance report shows that related cases have been steadily increasing over the past few weeks. The COVID-19 positive rate has risen from 7.6% to 8.4% in one week, and the number of COVID-19 hospitalizations per 100,000 people has also increased from 2 to 2.73. UKHSA emphasizes that before the peak season of respiratory diseases arrives, people should receive timely medical treatment from the UK National Health Service.The free vaccinations are provided by the National Health Service (NHS). Pregnant women and millions of children are already eligible for the vaccine, and most eligible groups can make an appointment from October 1. This ...
- Source: https://finance.eastmoney.com/a/202509263525102518.html
- 147
- October 6, 2025
Beike Bio responded to the inquiry letter regarding its semi-annual report and detailed the reasons for the decline in herpes zoster vaccine sales.

Beike BioA response was made to the regulatory inquiry letter regarding information disclosure in the 2025 semi-annual report, mentioning the reasons for the decline in sales of shingles vaccine. 　　In the first half of 2025, the company’s operating income was 285 million yuan, a year-on-year decrease of 53.93%; the net profit was -73.5734 million yuan, turning from profit to loss year-on-year. The company disclosed that the decline in performance was mainly due to the decline in sales of shingles vaccine. 　　The announcement showed that during the reporting period, the company’s sales volume of shingles vaccine was -17,300 doses, with sales revenue of -65.2266 million yuan. 　　Beike Bio believes that factors such as product price structure, vaccination demand, low disease awareness, insufficient consumption willingness of the applicable group, and vaccine hesitation affect the product revenue. 　　The company stated in its response that during the reporting period, sales of herpes zoster vaccines decreased ...
- Source: https://finance.eastmoney.com/a/202509303526642756.html
- 151
- October 6, 2025
【EXPERT Q&A】What are the requirements for clinical evaluation of medical devices under the EU MDR ?

Drugdu.com expert’s response: The EU Medical Device Regulation (MDR) aims to ensure the safety and efficacy of medical devices through its requirements for clinical evaluation. The specific requirements are as follows: I. Clinical Evaluation Plan Purpose and Scope: The clinical evaluation plan should clearly outline the objectives, scope, methods, and timeline of the evaluation, taking into account the intended use, risks, and expected clinical outcomes of the medical device. Clinical Data Collection and Analysis: It should describe how clinical data related to the medical device will be collected, analyzed, and evaluated, including the selection of patient populations, data collection methods and time points, and statistical methods for data analysis. Design and Management of Clinical Trials: If clinical trials are required, the plan should detail the design and management of the trials, including participant selection criteria, trial arrangements, duration, supervision, and management. Reporting of Clinical Evaluation Results: It should specify how ...
- Source: drugdu
- 161
- October 6, 2025
Dongcheng Pharmaceutical’s subsidiary’s new prostate cancer drug approved for clinical trials

Dongcheng Pharmaceutical recently announced that its controlling subsidiary, Lannacheng, has received approval from the National Medical Products Administration (NMPA) for the clinical trial of 225Ac-LNC1011 injection, authorizing it to conduct clinical trials for prostate cancer. This drug, an alpha-particle radioactive in vivo therapeutic targeting prostate-specific membrane antigen (PSMA), is intended for the treatment of patients with advanced prostate cancer who are PSMA-positive. Currently, no similar product is marketed outside of China , and no sales data is available. The project has invested approximately 14.53 million yuan in R&D. In completed animal and human trials, 225Ac-LNC1011 injection has demonstrated therapeutic potential for prostate cancer. However, the drug development cycle, clinical trial approval, and production are long and involve many steps. Investors need to be aware of the risk of drug development failure.
- Source: https://www.stcn.com/article/detail/3353547.html
- 153
- October 5, 2025
Rectal bleeding increases the odds of colorectal cancer diagnosis by 8.5 times

Adults under 50 undergoing colonoscopy were found to have a dramatically higher risk of having colorectal cancer when the procedure was done for rectal bleeding. Researchers found that rectal bleeding increased the odds of a colorectal cancer diagnosis by 8.5 times, underscoring the need to take the symptom seriously even in the absence of a family history in a population who may not otherwise meet screening age criteria. The research will be presented at the American College of Surgeons (ACS) Clinical Congress 2025 in Chicago, October 4-7. The retrospective study analyzed 443 patients under 50 who underwent a colonoscopy at the University of Louisville Health System between 2021 and 2023. Of them, 195 (44%) were diagnosed with early-onset colorectal cancer, while 248 (56%) had normal results. “Many of the early-onset colorectal cancers that I see have no family history. This research lends support to the question of ...
- Source: drugdu
- 144
- October 5, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.