media – Page 162 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

The United States has suffered the worst flu in 15 years

There have been at least 24 million flu cases in the United States this flu season, including more than 13,000 deaths. This is the worst flu epidemic in the United States in 15 years. Some analysts pointed out that the main reasons for the surge in cases include the decline in the wearing rate of masks by the public, the decline in the effectiveness of flu vaccines, the poor social distance, and the inadequate public epidemic prevention measures. Flu usually occurs in winter. In the densely populated temperate regions of the northern hemisphere, the peak activity of influenza viruses is often from January to February. Since the flu season in the United States started late, it has not yet reached its peak. Most of the cases this flu season are caused by two strains, influenza A (H1N1) and influenza A (H3N2). At the same time, health department personnel are paying ...
- Source: drugdu
- 205
- February 14, 2025
【EXPERT Q&A】What regulatory requirements does the FDA have for medical device usability engineering?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) has clear regulatory requirements for the usability engineering of medical devices, primarily outlined in the “21 CFR 820” (Design Controls) and related guidance documents issued by the FDA. Below is a detailed summary of the FDA’s regulatory requirements for medical device usability engineering: I. Design Control Requirements According to “21 CFR 820.30,” the FDA requires medical device manufacturers to take appropriate measures during the design and development process to ensure that products meet safety and effectiveness requirements. These measures include, but are not limited to: Consideration of User Needs: The design team must thoroughly consider the end-users of the device, including healthcare professionals, patients, and the operating environment, to ensure that the product meets their usage needs and expectations. Risk Management: Designs must assess and mitigate potential use error risks, which is closely related to ISO 14971 (Risk Management for ...
- Source: drugdu
- 553
- February 14, 2025
成大生物拟变更为无实控人粤民投入主“成大系”公司

2月12日晚间，成大生物公告称，公司实控人拟由辽宁省国资委变更为无实际控制人，公司股票将于2月13日开市起复牌。据悉，成大生物控股股东辽宁成大已于2月12日召开相关董事会会议，审议通过董事会换届选举相关议案。换届完成后，韶关高腾通过提名并当选董事人数超过辽宁成大董事会非独立董事席位半数的方式，实现对辽宁成大经营管理产生重大影响。辽宁成大的控股股东将由辽宁省国有资产经营有限公司变更为韶关高腾，实际控制人将由辽宁国资委变更为无实际控制人。本次控制权变更后，韶关高腾将通过辽宁成大间接控制成大生物54.67%的股权。成大生物方面表示，控制权变更后，公司管理经营团队不会发生较大变化且不会对公司日常生产经营产生实质性影响。同日（2月12日）晚间，成大生物还披露了要约收购报告书。据悉，本次要约收购系韶关高腾向成大生物除辽宁成大之外的其他所有股东，发出的收购其所持有的无限售条件流通股的全面要约，不以终止成大生物上市地位为目的，但存在股权分布不具备上市条件的风险。此前，2月10日晚间，成大生物、辽宁成大同日公告称，公司实控人或将发生变动。据悉，辽宁成大第一大股东韶关高腾关于不谋求控制权的承诺已到期，提议辽宁成大董事会换届选举。公告发布次日（2月11日），辽宁成大10CM涨停。天眼查显示，韶关高腾成立于2018年，注册资本达30亿元，由广东民营投资股份有限公司（下文简称：“粤民投”）全资控股。粤民投早在2019年便开始投资并不断增持辽宁成大。次年（即：2020年），粤民投通过协议转让获得辽宁成大5.18%的股份，控股比例达12.46%，跃升为第一大股东。不过，由于彼时成大生物正在冲刺科创板IPO，粤民投并未谋求辽宁成大控制权，且于2021年2月承诺自成大生物发行上市之日起12个月内，不谋求对辽宁成大的实控权。此后该承诺期限又被延长至24个月。成大生物最终于2021年10月成功登陆科创板，但在两年后的2023年，粤民投并未采取相关动作。时至今日，粤民投终入主“成大系”公司。成大生物主营业务为人用疫苗研发、生产和销售。公司的核心产品包括人用狂犬病疫苗及乙脑灭活疫苗。据悉，该公司人用狂犬病疫苗为目前中国唯一在售的可采用Zagreb2-1-1注射法的人用狂犬病疫苗产品。该公司业绩情况不容乐观。如下图所示，成大生物业绩“上市即巅峰”，其归母净利润从上市时（即：2021年）的8.925亿元一路下跌至2023年的4.659亿元。2024年前三季度，该公司归母净利润为3.297亿元。究其原因，成大生物将其归结于国内人用狂犬病疫苗市场竞争激烈等。 https://finance.eastmoney.com/a/202502133317815088.html
- Source: drugdu
- 301
- February 14, 2025
Finolizumab Injection Obtained Drug Registration Certificate

On the evening of February 11th, China Securities Network reported that Shenzhou Cell announced that its holding subsidiary Shenzhou Cell Engineering Co., Ltd. (hereinafter referred to as “Shenzhou Cell Engineering”) had recently received approval from the National Medical Products Administration for the issuance of Finolizumab Injection (trade name: Anyuping) ®） The Drug Registration Certificate is used for the treatment of head and neck squamous cell carcinoma. Finolizumab is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody injection independently developed by the company (project code: SCT-I10A）， This is approved for the treatment of head and neck squamous cell carcinoma. Finolizumab is a functional monoclonal antibody against PD-1, which can increase the supply of T cells and inflammatory cytokines at the tumor site by blocking the binding of PD-1 to its ligand, reduce the proportion of regulatory T cells and myeloid derived suppressor cells in the tumor microenvironment, alter the tumor microenvironment, restore ...
- Source: drugdu
- 541
- February 13, 2025
Novartis acquires Anthos for over $3 billion; ‘Nucleic acid king’ Zhang Hepeng restricted from high consumption due to 200000 yuan

Policy Trends The National Medical Products Administration has issued a notice regarding 26 batches of cosmetics that do not comply with regulations On February 11, the WeChat official account of the State Food and Drug Administration issued a document stating that 26 batches of cosmetics with the product label name of Yunman Bathing Lotion did not meet the requirements in the 2024 national cosmetics sampling inspection, which was inspected by Qinghai Institute for Drug Inspection and Testing and other units. Medical device approval Two first in class dual antibodies from Johnson&Johnson have been approved for market launch in China On February 11th, Johnson&Johnson announced that the marketing applications for Ruike (Evantazumab) and Tuolikuo (Taquettuzumab) have both been approved by the National Medical Products Administration. The former is the world’s first approved EGFR/c-MET bispecific antibody, while the latter is the first approved bispecific antibody drug targeting GPRC5D. GSK Mabolizumab’s new indication ...
- Source: drugdu
- 237
- February 13, 2025
Hansen Pharmaceuticals obtains drug registration certificate for empagliflozin tablets

Hansen Pharmaceuticals (002412) issued an announcement that the company recently obtained the “Drug Registration Certificate” for the chemical drug “Empagliflozin Tablets” approved and issued by the State Drug Administration. The generic name of the drug is empagliflozin tablets, the dosage form is tablets, the specification is 10mg, and the registration classification is chemical drug Class 4. According to the announcement, the drug registration standard number is YBH32972024, and the approval conclusion shows that the drug meets the registration requirements and has been approved. After obtaining the registration certificate, empagliflozin tablets can be produced and sold domestically, further enriching the company’s product line and helping to enhance market competitiveness. However, the announcement also pointed out that the future production and sales of drugs may be affected by factors such as changes in the market environment, so there is uncertainty in the profit level, and investors need to make decisions carefully. In ...
- Source: drugdu
- 235
- February 13, 2025
China tumor neoantigen mRNA vaccine LK101 has been approved by the FDA for clinical trials

Recently, Beijing Likang Life Science and Technology Co., Ltd. (hereinafter referred to as “Likang Life Science”) independently developed a tumor neoantigen mRNA vaccine product, LK101 injection, which successfully obtained IND (clinical trial application) approval from the U.S. Food and Drug Administration (FDA). This is my country’s first tumor neoantigen mRNA vaccine product approved by the FDA, marking that my country’s innovative strength in the field of tumor immunotherapy has been internationally recognized. Based on the patient’s individual tumor-specific mutations, LK101 injection selects highly immunogenic neoantigens through high-throughput sequencing and artificial intelligence-driven antigen prediction platforms, and uses mRNA technology to encode target antigens, aiming to induce a directional immune response in the body. Compared with traditional treatments, this technology has higher accuracy and safety, and provides new ideas for the treatment of solid tumors. Two years ago, LK101 injection was approved for clinical trials in China and conducted Phase I clinical ...
- Source: drugdu
- 835
- February 13, 2025
Aimi Vaccines Apply for Clinical Trial of mRNA Herpes Zoster Vaccine

On February 11, Aimi Vaccines (06660) issued an announcement that the company recently applied to the Drug Review Center of the China Food and Drug Administration for clinical trials of mRNA herpes zoster vaccines. According to the announcement, the company’s mRNA herpes zoster vaccine showed that specific T cell immunity, IgG antibody titers and membrane antigen fluorescent antibody titers were significantly higher than the commercially available recombinant subunit control vaccine in preclinical animal trials. This shows that the vaccine has obvious advantages in immune protection. In addition, the announcement mentioned that the particularity of the herpes zoster virus makes it latent for life after the initial infection, and T cell-mediated immune protection is the key to controlling viral reactivation. At present, the vaccination rate of herpes zoster vaccine in the target population is only about 0.1%, and the market potential is huge. According to industry consultants, the market size of ...
- Source: drugdu
- 246
- February 13, 2025
The world’s first! Bio-Thera’s “Secukinumab Biosimilar” marketing application has been accepted

On February 8, according to the official website of NMPA, the drug marketing application for “Secukinumab Injection” (BAT2306) submitted by BioAtla was accepted. This is the first secukinumab biosimilar to be submitted for marketing. According to data, the original research secukinumab is a fully human IgG1 monoclonal antibody developed by Novartis that can selectively bind to the cytokine interleukin 17A (IL-17A) and inhibit its interaction with the IL-17 receptor. In December 2014, Secukinumab (trade name: Cosentyx) was first approved for marketing for the treatment of psoriatic arthritis. In March 2019, Secukinumab was approved for marketing in China under the trade name Cosentyx. So far, Novartis’ Secukinumab has been approved for marketing in many countries and regions around the world, including Japan, the European Union, the United States, and China, involving multiple indications such as psoriatic arthritis, psoriasis vulgaris, plaque psoriasis, ankylosing spondylitis, and pustular psoriasis, and all indications have been ...
- Source: drugdu
- 399
- February 13, 2025
Asia Health

Organiser：Informa Markets Time：July 16th – 18th, 2025 Address：8, Jalan Dutamas 2, Kompleks Kerajaan, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Exhibition hall：Malaysia International Trade and Exhibition Product range: Medical Devices: Laboratory equipment and configurations, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc. Medical Technology: Orthopedic and rehabilitation technology, medical architectural facilities and technology, medical information and communication technology, etc. Pharmaceuticals: Various types of finished pharmaceuticals, medications, medical excipients, etc. Hospital Consumables: Disposable medical supplies, medical disinfectants, etc. Medical Supplies: Medical clothing and laundering technology, nutritional meal preparation equipment, medical furniture, etc. About Asia Health： The Malaysia Kuala Lumpur Medical Device Exhibition (Asia Health) is the most authoritative medical device exhibition in Southeast Asia. The market it radiates primarily includes Southeast Asian countries such as India, Malaysia, Indonesia, Vietnam, and the Philippines. Asia Health has achieved continuous success for exhibitors and visitors from all over ...
- Source: drugdu
- 415
- February 13, 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.