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SANTEXPO

Organiser：PG Promotion Time：May 19 – 21, 2026 Address：1, place de la Porte de Versailles, 75015 Paris, France Exhibition hall：Paris Expo Porte de Versailles Product range: Medical Technology Equipment: Anesthesia equipment, surgical instruments, sterilization equipment for surgeries, post-operative infection prevention devices, medical imaging output equipment, biological laboratory equipment, emergency equipment, etc. Ward and Nursing Room: Ward equipment, oxygen rescue equipment, patient observation room equipment, nursing products and equipment, patient call systems, patient record inquiry systems, dental clinic equipment and patient care devices, pharmacy equipment, hospital communication equipment, etc. Laboratory: Laboratory instruments and equipment, laboratory furniture, laboratory automation and accessories, medical experimental analysis and diagnostic instruments, etc. Consumables: Catheters, surgical hygiene products, disposable medical consumables, medical disposables, single-use medical items, medical dressings, etc. Hospital Logistics: Catering systems, laundry equipment, cleaning equipment, ventilation and refrigeration equipment, mortuary facilities, hospital energy supply, hospital security systems, hospital facility maintenance systems, hospital waste disposal facilities, environmental ...
- Source: drugdu
- 27
- February 24, 2026
【EXPERT Q&A】The US FDA has implemented a brand-new QMSR system regulation for medical devices. What significant changes will occur in the corresponding on-site inspections?

Drugdu.com expert’s response: The U.S. FDA’s new Quality Management System Regulation (QMSR) for medical devices marks a significant transformation in its regulatory framework and inspection logic. By integrating the ISO 13485:2016 international standard, QMSR drives a shift in quality management from “clause compliance” to “risk-driven” approaches, while strengthening lifecycle-wide compliance controls. Against this backdrop, FDA on-site inspections will undergo the following key changes: I. Evolution of Inspection Basis and Process 1. Regulatory Restructuring: QMSR incorporates ISO 13485:2016 in its entirety through “reference incorporation,” while retaining FDA-specific requirements (e.g., record retention language, certain reporting obligations). Inspections will be conducted based on “ISO 13485:2016 clauses + FDA additional requirements,” rather than the standalone clauses of the previous QSR. 2. Updated Inspection Manual: The FDA has abolished the long-standing Quality System Inspection Technique (QSIT) methodology and introduced the new Medical Device Manufacturer Inspection Compliance Program Manual (7382.850). This manual categorizes QMSR requirements into six quality ...
- Source: drugdu
- 32
- February 23, 2026
【EXPERT Q&A】How is a drug safety evaluation experiment conducted?

Drugdu.com expert’s response: Drug safety evaluation experiments require a systematic process that combines in vitro experiments, animal experiments, and clinical studies to comprehensively assess potential drug risks and ensure medication safety. Below are the specific experimental methods and procedures: I. Foundations of Experimental Design Research Objectives and Plan Clarify the drug’s intended use, target population, and core objectives (e.g., toxicity assessment, dose exploration). Develop a detailed protocol, including experimental design, animal species/quantity, and dosing duration. Conduct literature reviews to understand safety data for similar drugs and identify potential risk points. Selection of Experimental Models Animal Models: Choose mice, rats, dogs, or non-human primates based on drug characteristics. In Vitro Models: Utilize cell cultures, tissue chips, or computational simulations (e.g., PBPK models) to predict toxicity. Special Population Models: Design targeted experiments for children, pregnant women, etc. II. Core Experimental Methods 1. Acute Toxicity Experiments Objective: Evaluate toxic reactions following single or ...
- Source: drugdu
- 39
- February 20, 2026
Bulmedica

Organiser：Bulgarreklama Exhibition Group, Bulgaria Time：May 13 – 15, 2026 Address：147 Tsarigradsko Shosse 1784, Sofia Exhibition hall：Inter Expo Center Product range: Laboratory instruments, equipment, and technology; medical diagnostic technology, equipment, and products; basic medical construction supplies; hospital infrastructure; surgical instruments, equipment, and accessories; medical instruments, equipment, and devices; medical imaging equipment, etc. Internal medicine, dental equipment and materials; pharmaceuticals, pharmacology, drug and pharmaceutical sciences; orthopedic and ophthalmic equipment and materials; health and rehabilitation sciences, etc. Dental equipment and tools; dental raw materials and pharmaceuticals; dental laboratory technology, etc.; medical information technology; dental diagnostic instruments and consumables; infection control and maintenance; medical publications; medical teletherapy; medical software, etc. Ward furniture and equipment; hospital kitchen equipment; biochemical and laboratory testing equipment; hygiene materials; medical communication technology and equipment; comprehensive hospital information technology and services; electronic medical devices; hospital equipment; radiology; X-ray department; physiotherapy, etc. Biopharmaceuticals, traditional Chinese medicine, herbal medicine, etc.; pharmaceutical production ...
- Source: drugdu
- 50
- February 19, 2026
【EXPERT Q&A】What should be noted when registering medical device products for the first time?

Drugdu.com expert’s response: I. Regulatory Framework and Product Classification 1. Clarify Regulatory Requirements Domestic Registration: Comply with China’s Medical Device Supervision and Administration Regulations, Medical Device Registration and Filing Measures, etc. Export Compliance: Meet target country/region standards (e.g., EU CE, U.S. FDA). Key Point: Regulations are frequently updated; track changes via the NMPA website or professional agencies. 2. Accurate Product Classification Classify risk levels per China’s Medical Device Classification Catalog: Class I (low risk), Class II (moderate risk), Class III (high risk). Registration processes vary significantly by class. Recommendation: Use the NMPA’s “Medical Device Classification Determination” system for uncertain cases. For innovative products, prepare for the “Special Approval Pathway for Innovative Medical Devices.” II. Technical Documentation and Testing 1. Prepare Complete Technical Files Product Technical Requirements (CTD): Detail performance metrics (e.g., filtration efficiency for surgical masks), testing methods, and structural composition. Ensure quantifiable, verifiable metrics aligned with national standards (e.g., GB, YY series). ...
- Source: drugdu
- 73
- February 16, 2026
Rising Star in Oral Weight Loss! Hengrui’s GLP 1R/GIPR Agonist Succeeds in Phase II Study

On February 10, 2026, Hengrui Pharmaceutical and Kailera Therapeutics (US) jointly announced positive top-line results from a Phase II clinical trial (NCT06841445) of Remputeptide Tablets (HRS9531), their investigational GLP 1/GIP dual receptor agonist, in Chinese adults with obesity. Data showed that at Week 26, mean body weight reduction in the highest dose group reached 12.1%, with no weight loss plateau observed. Up to 38.6% of participants achieved at least 15% weight loss, while the incidence of gastrointestinal adverse events was maintained at a low level. This breakthrough marks important progress in the global development of oral multi target weight loss drugs. With its convenient once daily oral administration and robust efficacy data, Remputeptide Tablets is expected to offer a new therapeutic option for patients with obesity that may surpass injectable formulations. It also adds a key competitive asset to Hengrui’s global strategic layout in metabolic diseases. 1 Remputeptide: Dual pathway ...
- Source: drugdu
- 68
- February 13, 2026
The approval of telpopril monotherapy for type 2 diabetes has driven an upgrade in the management paradigm

　　According to this newspaper, in current clinical practice, the treatment of type 2 diabetes often relies heavily on the traditional approach of “gradually increasing medication.” Many patients only enter a more potent treatment phase after their blood sugar has been poorly controlled for a long time and the risk of complications has gradually accumulated. 　　However, in recent years, discussions surrounding early diabetes management have been undergoing a significant shift. A growing body of research suggests that the choice of treatment starting point not only affects short-term glycemic control but also profoundly relates to patients’ long-term complication risk and overall prognosis. Clinical management strategies for type 2 diabetes are shifting from a “late-stage reinforcement” approach to a new paradigm of “intervention at the starting point.” 　　February 11th, ReiThe innovative dual-target drug Mufengda® (Telborpeptide Injection) has been approved by the China National Medical Products Administration for monotherapy in adults with type 2 ...
- Source: drugdu
- 66
- February 13, 2026
Oral insulin launch fails; China Resources Pharmaceutical plans to sell Tianmai Biotechnology

On February 9, China Resources Pharmaceutical (03320.HK) issued an announcement on the Hong Kong Stock Exchange, stating that its wholly-owned subsidiary, China Resources Pharmaceutical Investment Co., Ltd., plans to sell its 17.87% stake in Hefei Tianmai Biotechnology Development Co., Ltd. (hereinafter referred to as “Tianmai Biotechnology”) through a public listing on the Shanghai United Assets and Equity Exchange, with a listing price of RMB 1.42 billion. Looking back at the history of cooperation between China Resources Pharmaceutical and Tianmai Biotechnology, their partnership began in 2016, when the number of diabetes patients in China continued to rise, leading to a surge in demand for insulin as a core treatment drug. At the same time, China Resources Pharmaceutical was also seeking to expand into the biopharmaceutical field. Against this backdrop, China Resources Pharmaceutical signed a strategic agreement in December 2016 to acquire a 20% stake in Tianmai Biotechnology, thus officially entering the ...
- Source: drugdu
- 57
- February 13, 2026
Hanyu Pharmaceutical’s glatiramer acetate injection receives FDA approval in the United States.

Shanghai Securities News China Securities(Reporter He Xinyi) On the evening of February 12, Hanyu Pharmaceutical…The announcement stated that the company received an abbreviated new drug application certificate for glatiramer acetate injection from the U.S. Food and Drug Administration (FDA). The announcement indicates that glatiramer acetate is an immunomodulatory drug used to treat relapsing-remitting multiple sclerosis (MS). It is a synthetic polypeptide preparation that modulates abnormal autoimmune responses by mimicking the structure of myelin basic proteins, thereby reducing the attack on the myelin sheath of the central nervous system. Hanyu Pharmaceutical stated that the approval of glatiramer acetate will further enrich the company’s overseas product pipeline and expand the company’s pharmaceutical market in the United States. The company will actively promote the sales of the drug in overseas markets, thereby positively promoting the company’s future performance growth and industry position. https://finance.eastmoney.com/a/202602123649504078.html
- Source: drugdu
- 65
- February 13, 2026
Global ADC market size $16.5 billion

20 new ADC drugs worldwide reached US$16.51 billion , a year-on-year increase of 27% , maintaining rapid growth. Six of these ADCs are blockbuster products with sales exceeding US$1 billion, including four super blockbuster products with sales exceeding US$2 billion. Enhertu continues to maintain its monopoly position, and its indications continue to expand.Datroway saw a 50% quarter-over-quarter increase and significantly raised its sales forecast.Padcev has performed exceptionally well in the US and European markets, with growth exceeding expectations.Roche’s T-DM1 has maintained steady growth, mainly due to the increase in adjuvant therapy for breast cancer.Polivy maintains rapid growth, solidifies its position as a leading DLBCL provider, and rapidly penetrates the market. Trodelvy is primarily marketed as a second-line treatment for triple-negative breast cancer, with first-line treatment expected to be approved in the second half of this year.Conclusion Chinese ADCs are playing an increasingly important role. BIC’s Trop2 ADC has been approved ...
- Source: drugdu
- 55
- February 13, 2026

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