media – Page 40 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What are the requirements of the General Safety and Performance Requirements (GSPR) under the EU medical Device MDR and IVDR regulations?

Drugdu.com expert’s response: The General Safety and Performance Requirements (GSPR) in the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) constitute the core framework for ensuring the safety and effectiveness of medical devices and in vitro diagnostic medical devices. The GSPR requirements permeate the entire lifecycle of medical devices, encompassing design, manufacturing, clinical evaluation, labeling, and post-market surveillance. The specific content is as follows: I. Chapter Division of GSPR The GSPR requirements are detailed in Annex I of the MDR and IVDR and are divided into three chapters: Chapter 1: General Requirements for Risk-Based Management Medical devices must operate in accordance with their intended design and must not endanger the health or safety of patients, users, or third parties. Risks must be minimized as much as possible, and the degree of reduction must not negatively impact the risk-benefit ratio. Manufacturers are required to establish, ...
- Source: drugdu
- 143
- November 28, 2025
Zhifei Biological Products Co., Ltd. obtains its first US patent certificate.

Zhifei BiologicalOn the evening of November 26, the company announced that its wholly-owned subsidiary, Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd., recently obtained an invention patent certificate issued by the United States Patent and Trademark Office. The patent, titled “Combined vaccine against human respiratory syncytial virus (RSV) infections and method thereof for inducing immune response,” is patent number US12,472,243B2, with an estimated expiration date of July 29, 2042. It is understood that the aforementioned invention patent was obtained by Zhifei Green Bamboo in collaboration with Beijing Jiaotong University during the development of a respiratory syncytial virus (RSV) vaccine. Zhifei Biological Products Co., Ltd. stated that it has obtained its first patent certificate in the United States, laying the foundation for its global expansion. This patent certificate will further enhance the company’s intellectual property rights.We will establish a protection system to fully leverage our independent intellectual property rights, promote technological innovation, ...
- Source: drugdu
- 130
- November 27, 2025
How can Li Lai be called a king?

Recently, Eli Lilly became the world’s first pharmaceutical company to surpass a trillion-dollar market capitalization. This milestone not only signifies recognition from the capital market but also symbolizes the pharmaceutical industry entering a new era of value. For a long time, the pharmaceutical industry has struggled to produce true “super giants” due to the fragmented nature of disease ranges and the limited market size. However, the emergence of GLP-1 drugs has completely changed this landscape. From diabetes to weight loss, and then to the treatment of diseases that benefit multiple organs, GLP-1 is redefining the boundaries of “blockbuster drugs.” 01 GLP-1 Revolution Looking back at the development of GLP-1, it was initially just an ordinary player in the field of diabetes treatment. Insulin has always held a dominant position in the diabetes market, and GLP-1 drugs, as a latecomer, initially had a relatively limited market size. The diabetes market is ...
- Source: drugdu
- 101
- November 27, 2025
Smegglutide clinical trial failed

On November 24, Novo Nordisk announced that semaglutide failed in two Phase III clinical trials (EVOKE and EVOKE+) for Alzheimer’s disease, failing to meet the primary efficacy endpoint. EVOKE and EVOKE+ are international, multicenter, randomized, double-blind, placebo-controlled phase III clinical trials that enrolled a total of 3,808 patients aged 55-85 with early symptomatic Alzheimer’s disease (1,855 for EVOKE and 1,953 for EVOKE+), including those in the mild cognitive impairment (MCI) and mild dementia stages. The trial used an oral semaglutide 14 mg once daily dosing regimen, with the target dose achieved through 8-week dose escalation (3 mg → 7 mg → 14 mg), for a total treatment duration of 156 weeks (104 weeks of primary treatment + 52 weeks of extension treatment). The primary endpoint of the trial was the change in the Clinical Dementia Rating Scale-Sum (CDR-SB) score relative to baseline at week 104. The CDR-SB scale assesses six ...
- Source: drugdu
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- November 27, 2025
Walvax Biotech’s 13-valent Pneumococcal Conjugate Vaccine Granted Market Approval in Egypt

Beijing Business Today, Nov. 26 — Walvax Biotech announced that its subsidiary, Yuxi Walvax Biotech Co., Ltd., has received the “Biological Product Marketing Authorization” issued by the Egyptian Drug Authority (EDA) for its 13-valent Pneumococcal Polysaccharide Conjugate Vaccine, signifying that the vaccine has obtained marketing approval in Egypt. According to the announcement, the 13-valent Pneumococcal Conjugate Vaccine developed by Yuxi Walvax is primarily indicated for infants and children from 6 weeks up to 5 years of age (before their 6th birthday). It is designed to prevent infectious diseases caused by the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in the vaccine. This vaccine was initially approved for marketing in China back in 2020. Reference: https://finance.eastmoney.com/a/202511263575601059.html
- Source: drugdu
- 118
- November 27, 2025
Why Is Flu Vaccination So Hard to Promote?

During each flu season, the rapid surge in influenza cases within a short period can place tremendous pressure on healthcare facilities. Receiving the flu vaccination is regarded as the “first line of defense” against influenza, significantly reducing the risk of infection and severe complications among recipients. However, the influenza vaccination rate in China has long remained at an unsatisfactory level, lingering in the single digits. Compared to the market for influenza treatment drugs, sales in the flu vaccine market have consistently underperformed. Flu vaccine sales are outsold by influenza treatment drugs A Yicai reporter compiled the 2024 sales data of influenza vaccine companies listed on the A-share and Hong Kong stock markets. The main A-share influenza vaccine enterprises include Hualan Vaccine (301207.SZ), GDK Bio (688670.SH), and BCHT (688276.SH). The primary Hong Kong-listed influenza vaccine company is Zhonghui Biotech (02627.HK). From 2021 to 2024, Hualan Vaccine consistently maintained the leading position ...
- Source: drugdu
- 138
- November 27, 2025
Additional clinical trial data for pediatric patients is needed. Tian Tan Biologics has withdrawn its application for the market release of a hemophilia treatment drug.

More than 10 months after its submission, Tian Tan Biologics (SH600161, stock price 17.61 yuan, market capitalization 34.822 billion yuan) withdrew its application for listing of a hemophilia drug that cost 266 million yuan to develop. On the evening of November 19th, this leading domestic blood product company released a statement, stating that its subordinate enterprise, Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Chengdu Rongsheng), withdrew the drug registration application for “Recombinant Human Coagulation Factor VIIa for Injection”. The reason was that according to the review opinions of the CDE (National Medical Products Administration Drug Evaluation Center), supplementary information was required. It became the first domestically produced recombinant human coagulation factor VIIa biological product to be approved for market launch in China. However, from the indication perspective, Anqixin’s application scope is much smaller than Nuoqi. The products under Tian Tan Biotechnology are more similar to Nokir. On December ...
- Source: drugdu
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- November 27, 2025
CSPC Pharmaceutical Group Limited ‘s clinical trial for the recombinant fully human anti-ACTRIIA/IIB monoclonal antibody has been approved

Beijing Business News (Reporter Wang Yinhao, Song Yuying) – On November 26th, Shigao Group announced that the recombinant fully human anti-ActRIIA/IIB monoclonal antibody drug (JMT206) developed by the group has been approved by the National Medical Products Administration and can conduct clinical trials in China. The announcement shows that this product can specifically bind to both activin receptor type IIA and type IIB simultaneously, blocking the binding of activin A, myostatin, and growth differentiation factor 11 to activin receptor type II, thereby inhibiting the activation of downstream signaling pathways, reducing muscle loss, and promoting the maintenance and growth of skeletal muscles, achieving the effect of muscle gain and fat loss. At the same time, this product can also assist GLP-1 receptor agonists in achieving higher-quality weight loss efficacy. The approved clinical indication for this approval is weight management for obese or overweight individuals with at least one weight-related comorbidity. https://finance.eastmoney.com/a/202511263575661579.html
- Source: drugdu
- 110
- November 27, 2025
Seven Essential Steps for Successfully Bringing Pharmaceutical Products to the Global Market

In the process of bringing pharmaceutical products into global markets, every step from R&D to launch, from compliance to marketing, is full of challenges. Traditional approaches often rely on single channels or offline networks. However, against the backdrop of accelerating digitalization and cross-border trade, leveraging a professional platform to operate in a systematic way has become increasingly indispensable. Based on practical experience from the Drugdu.com platform, this article systematically summarizes the seven key steps that must be done well for product launch, for reference by pharmaceutical manufacturers, exporters and service providers. I. Conduct in-depth market research The launch of any pharmaceutical or medical device product should be grounded in solid market insights, including: Competitive landscape analysis: Study competitors’ pricing structures, sales channels and distribution models to support clear product positioning. Customer needs identification: Not only patients, but also medical institutions, purchasing bodies and agents. Through interviews, surveys and industry data, identify unmet ...
- Source: drugdu
- 209
- November 27, 2025
CDMEE Chengdu

Organiser：Sichuan Provincial Hospital Association, Sichuan Medical Device Industry Association, Sichuan Rehabilitation Medicine Association Time： March 17 – 19, 2026 Address：No. 198, Shijicheng Road, Chengdu, Sichuan Province Exhibition hall：Chengdu Century City New International Convention & Exhibition Center Product range: Medical Equipment Exhibition Area: Imaging equipment, in vitro diagnostic reagents and instruments, disinfection and infection control series, medical electronic equipment, medical vehicles, operating room and emergency equipment, medical consumables and surgical consumables, medical maintenance parts and consumables, etc. Medical Laboratory Exhibition Area: Medical analysis systems, gene and life science instruments, laboratory case equipment and consumables, clinical laboratory equipment and consumables, blood collection management systems and blood transfusion supplies, blood and cell analysis systems, clinical laboratory equipment parts and maintenance consumables, etc. Rehabilitation and Well-being Exhibition Area: Sensory integration training equipment, disability aids and supplies, rehabilitation and physiotherapy equipment, sensory interaction equipment, assistive devices, etc.; sensory integration training equipment, disability equipment and supplies, ...
- Source: drugdu
- 138
- November 27, 2025

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