media – Page 12 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What factors should be focused on when analyzing the benefits and risks of medical devices?

Drugdu.com expert’s response: The benefit-risk analysis of medical devices is a core component in ensuring their safety and effectiveness, requiring a comprehensive consideration of multidimensional factors encompassing science, clinical practice, ethics, and society. The following are the key factors that should be prioritized during the analysis: I. Intended Use and Performance of Medical Devices Target Patient Population Clearly define the age, gender, disease stage, or health status of patients for whom the device is suitable (e.g., children, pregnant women, elderly individuals, or patients with specific diseases). Evaluate differences in benefits and potential risks among different patient groups (e.g., children’s higher sensitivity to certain materials). Core Functions and Performance Indicators The primary therapeutic or diagnostic functions of the device (e.g., surgical robots, implantable cardiac pacemakers, in vitro diagnostic reagents). Accuracy, sensitivity, and specificity of performance parameters (e.g., false-positive/false-negative rates of diagnostic reagents). Reliability (e.g., mechanical failure rate, software stability) and durability ...
- Source: drugdu
- 84
- May 11, 2026
China Biopharmaceutical’s world-first innovative breast cancer treatment drug approved for first-line treatment indication

On May 6, Cumoxicillin Capsules (Saitanxin®), the world’s first CDK2/4/6 inhibitor independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., a subsidiary of China Biopharmaceutical (01177.HK), received approval from the National Medical Products Administration (NMPA) for its combination with fulvestrant for the initial treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This is the second indication approved for the marketing of Cumoxicillin Capsules, providing a new treatment option for first-line treatment of HR-positive advanced breast cancer patients in China. Last December, cumoxicillin was approved in combination with fulvestrant for the treatment of HR+/HER2- breast cancer patients whose disease has progressed after prior endocrine therapy, and it is estimated that it has already benefited thousands of breast cancer patients in clinical practice. This new approval is primarily based on the CULMINATE-2 clinical trial, which showed that cumoxicillin in ...
- Source: drugdu
- 105
- May 9, 2026
The Phase III monotherapy clinical trial of Lianhuan Pharmaceutical’s LH-1801 tablets has been unblinded.

On the evening of May 7th, Lianhuan Pharmaceutical…(600513) issued an announcement stating that the Phase III monotherapy clinical trial of the Class 1 new drug LH-1801 tablets organized by the company has been unblinded and preliminary analysis results of the main data have been obtained recently. The announcement indicates that LH-1801 tablets are a novel SGLT-2 inhibitor, developed by Lianhuan Pharmaceutical in collaboration with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and possessing independent intellectual property rights in China.A new antidiabetic drug, indicated for type 2 diabetes. https://finance.eastmoney.com/a/202605073730257969.html
- Source: drugdu
- 92
- May 9, 2026
Shian Biotech and GSK reach licensing collaboration worth over $1 billion on oligonucleotide drugs

Recently , GlaxoSmithKline (GSK) and SiranBio (hereinafter referred to as “SiranBio”) reached a global exclusive licensing agreement for the investigational small interfering RNA (siRNA) oligonucleotide SA030. GSK will pay Shian Biotech an upfront payment and up to US$1.005 billion in development, registration and commercialization milestone payments, as well as tiered royalties based on global net sales (excluding mainland China, Hong Kong, Macau and Taiwan). SA030 is currently in Phase I clinical trials and targets activin receptor-like kinase 7 (ALK7) for the treatment of metabolic and cardiovascular diseases. Its design target avoids the weight loss market and targets the most difficult-to-treat abdominal visceral fat. According to International Pharmaceutical Business News, this is the second time in nearly six months that GSK has acquired siRNA assets from a Chinese biotechnology company. In the previous transaction, GSK acquired two siRNA drug candidates for respiratory, immune and inflammation (RI&I) fields from Frontier Biotechnologies for ...
- Source: drugdu
- 104
- May 9, 2026
Is CAR-T cells forming bubbles in the body?

Following its $2.4 billion acquisition of Orna Therapeutics earlier this year, Eli Lilly is once again betting heavily on in vivo CAR-T therapy. Recently, Eli Lilly announced its acquisition of Kelonia Therapeutics for $7 billion, pushing the valuation of transactions in the in vivo CAR-T field to a new high. This means that by 2026, Eli Lilly will have invested nearly $10 billion in the in vivo CAR-T field alone. It’s worth noting that this acquisition doesn’t involve mature assets. Kelonia’s core drug, KLN-1010, is still in Phase I, with only early validation completed in four patients. Orna’s core asset, ORN-252, is in the clinical trial preparation stage. Clearly, Eli Lilly is not betting on a single molecule, but rather on two differentiated in vivo CAR-T technology pathways. Orna uses an LNP delivery + circular RNA system, which has advantages in in vivo stability and sustained protein expression, making it ...
- Source: drugdu
- 87
- May 9, 2026
Product revenue reached RMB 10.3 billion, a year-on-year increase of 29%.

On May 6, 2026, BeiGene (NASDAQ: ONC; HKEX: 06160; SSE: 688235.SH) released its first quarter 2026 financial results. During the reporting period, the company’s total revenue was RMB 10.544 billion, representing a year-on-year increase of 31.0%. Product revenue accounted for 98% of total revenue, reaching RMB 10.321 billion, a year-on-year increase of 29.3%, mainly driven by sales growth of Brukinsa® (zanubrutinib), as well as Amgen’s licensed products and Tislelizumab®. The announcement shows that thanks to increased product revenue and improved cost management, the company’s operating efficiency has been further improved, with net profit attributable to the parent company reaching RMB 1.608 billion in the first quarter. In addition, BeiGene has adjusted its operating performance forecast for 2026, with total revenue now expected to be between RMB 43.6 billion and RMB 45.2 billion, up from between RMB 43.6 billion and RMB 45 billion. Full-year operating profit (i.e., operating revenue minus operating ...
- Source: drugdu
- 278
- May 9, 2026
Domestically produced autoimmune drugs are beginning to show their potential.

The emergence of domestically produced autoimmune drugs has come faster than expected. In 2024, four domestically produced autoimmune biological agents were approved, ending the previous “frozen” state of having no drugs and ushering in the first watershed moment. Hengrui Medicine, Connoya, Zhixiang Jintai… the names of domestic pharmaceutical companies began to appear on the autoimmune drug landscape. Accompanying this is a collective start for China to avoid “target differentiation and starting on the same track”. Globally, the autoimmune field is a breeding ground for blockbuster drugs, catalyzing the emergence of numerous multinational pharmaceutical companies (MNCs) with market capitalizations exceeding $100 billion. Currently, the performance of major pharmaceutical companies such as AbbVie, Sanofi, and UCB is still dominated by autoimmune single products. Just a few days ago, Sanofi’s Q1 2026 financial report showed that its flagship product, dupilumab, generated $4.874 billion in sales in a single quarter, representing a year-on-year increase ...
- Source: drugdu
- 85
- May 9, 2026
New breast cancer drug successfully completed Phase 3 trials.

Recently, Celcuity announced that its self-developed pan-PI3K/mTOR inhibitor gedatolisib achieved a clinically meaningful improvement in progression-free survival (PFS) in the Phase 3 clinical trial codenamed Viktoria-1 for advanced breast cancer. This Viktoria-1 clinical trial focused on patients with PIK3CA wild-type advanced breast cancer and employed a highly compelling head-to-head controlled design. The experimental group received triple therapy consisting of gedatolisib, AstraZeneca’s fulvestrant (Faslodex), and Pfizer’s palbociclib (Ibrance), while the control group received the current clinical standard of care—Novartis’ Piqray in combination with fulvestrant. had a statistically and clinically significant improvement in progression-free survival (PFS) . Furthermore, the dual therapy regimen of gedatolisib and fulvestrant also performed well in the key secondary endpoint compared to Piqray plus fulvestrant, validating its therapeutic advantage in this patient population. The release of this significant data quickly generated a positive response in the capital market. Following the announcement, Celcuity’s stock price surged nearly 40% in ...
- Source: drugdu
- 85
- May 8, 2026
This tech giant is spending a whopping 2 billion yuan to accelerate its “AI transformation.”

Recently, Sanofi officially announced that it will invest US$294 million (approximately RMB 2 billion) to expand its global AI Center of Excellence in Toronto. According to the official announcement, this expansion also received a matching grant of up to $5 million from the Ontario Investment Fund . The project is expected to create 50 new high-end professional positions in artificial intelligence, machine learning, and data science by 2028. Prior to this, the center already had more than 150 positions, covering multiple professional fields such as cloud computing, data engineering, software development, bioinformatics, and pharmaceutical data science . The newly recruited talent will be responsible for designing and implementing various AI tools within Sanofi, applying them comprehensively to all aspects of the business, including drug development, manufacturing, and commercial operations. Sanofi’s Chief Digital Officer, Emmanuel Frenehard, publicly stated that artificial intelligence has been deeply integrated into the entire process of research, ...
- Source: drugdu
- 87
- May 8, 2026
Yuandong Bio takes the lead! China’s first acetaminophen-oxycodone extended-release tablets approved

Recently, according to the NMPA website, Chengdu Yuandong Biopharmaceutical Co., Ltd.’s improved new drug, acetaminophen oxycodone extended-release tablets , submitted under the Class 2.2 chemical drug category , has been approved for marketing, making it the first company in China to obtain approval for this dosage form. Acetaminophen/oxycodone extended-release tablets are a potent, centrally acting analgesic composed of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug acetaminophen. The two work synergistically to ensure analgesic efficacy while optimizing medication safety. Compared to domestically marketed acetaminophen/oxycodone immediate-release tablets, its core innovation lies in its dual-layer tablet design —one immediate-release layer and one extended-release layer —achieving long-lasting and stable analgesia, effectively reducing dosing frequency, and significantly improving patient adherence .According to the “China Pain Medicine Development Report,” there are over 300 million chronic pain patients in China, and this number continues to grow by 10-20 million annually, indicating a huge and rigid ...
- Source: drugdu
- 75
- May 8, 2026

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.