Expert Q&A – Page 4 – media

【EXPERT Q&A】How effective is the treatment with Masidopeptide?

Drugdu.com expert’s response: Mazdutide has demonstrated significant efficacy in weight reduction, glycemic control, and comprehensive metabolic improvement, along with favorable safety and tolerability profiles. The specific therapeutic effects are as follows: I. Weight Reduction Phase III Clinical Trial Data: In the pivotal Phase III GLORY-1 trial, after 48 weeks of treatment, the 4mg mazdutide group achieved an average weight reduction of 11.0%, while the 6mg group reached an impressive 14.0%, significantly outperforming the placebo group (0.3%). Notably, 66.7% of patients in the 6mg group lost over 10% of their body weight, and nearly half (49.5%) lost more than 15%. Real-World Cases: One patient using 6mg of mazdutide for 24 weeks saw their weight drop from 92kg to 78kg, with a 12cm reduction in waist circumference. Another female patient with a BMI of 32 experienced a weight reduction from 92kg to 76.8kg and a 12cm decrease in waist circumference after 48 ...
- Source: drugdu
- 87
- July 30, 2025
【EXPERT Q&A】Under the background of volume-based procurement, how to select high cost-performance generic drug research and development varieties?

Drugdu.com expert’s response: In the context of volume-based procurement, selecting high-cost-effectiveness generic drug R&D targets requires a comprehensive evaluation across five dimensions: market potential, competitive landscape, technical feasibility, policy orientation, and corporate resources. Priority should be given to品种 (products) that have passed consistency evaluations, address rigid clinical needs, possess moderate technical barriers, and are supported by policies. Below are detailed strategies and analyses: I. Market Potential: Focus on High-Sales, High-Profit, High-Growth Areas Absolute Sales Data Prioritize large-scale products with annual sales exceeding RMB 1 billion, such as antihypertensive drug amlodipine and antidiabetic drug metformin. Even with a 50% price reduction post-procurement, these products can maintain profitability through increased sales volume. Case Study: In the “4+7” volume-based procurement, Beijing Jialin Pharmaceutical won the bid for atorvastatin calcium at RMB 6.6 per box, achieving a gross margin exceeding 100%. With procurement across just 11 cities, projected profits reached RMB 100 million, with even ...
- Source: drugdu
- 186
- July 28, 2025
【EXPERT Q&A】What contents need to be submitted for the registration application of domestic Class II medical devices?

Drugdu.com expert’s response: The registration of Class II medical devices in China requires submission of key documents covering risk analysis, technical specifications, testing reports, clinical evaluation, labeling, quality management systems, and authenticity declarations. Detailed requirements are outlined below: I. Foundational Qualification Documents Medical Device Registration Application Form: Must include core details such as product name, model/specification, structural composition, and intended use, signed and stamped by the legal representative or responsible person. Enterprise Qualification Proof: Copy of the business license (valid within its term). Medical Device Manufacturing License (if applicable; the registered product must fall within the approved scope). Personnel Qualification Proof: Identity, educational, or professional title certificates for the legal representative, enterprise leader, and quality manager (the latter must have a medical device-related background). II. Product Technical Documentation Product Technical Report: Covers design principles, structural composition, manufacturing materials, performance indicators, and production processes. Must provide the product technical requirement number and explain the basis for key ...
- Source: drugdu
- 95
- July 25, 2025
【EXPERT Q&A】How should the clinical evaluation path for Class II active medical devices be selected?

Drugdu.com expert’s response: The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows: I. Core Pathway Selection Criteria Exemption from Clinical Trials Pathway Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue. Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence. Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids. Comparison with Predicate Devices Pathway Applicable Conditions: The product is essentially equivalent to a legally ...
- Source: drugdu
- 153
- July 23, 2025
【EXPERT Q&A】What impacts will there be if pharmaceutical enterprises export without certification?

Drugdu.com expert’s response: If a pharmaceutical enterprise fails to complete necessary certifications for export, it will face severe consequences such as blocked market access, intensified legal risks, expanded economic losses, damaged brand reputation, and decreased supply chain stability. The specific impacts are as follows: I. Blocked Market Access: Products Unable to Enter Target Markets European Union Market Lack of CE Certification: EU law mandates that medical devices, pharmaceuticals, and other products must pass CE certification. Otherwise, products will be seized or confiscated by customs, and enterprises may face hefty fines, market withdrawals, and recalls of in-use products. For example, medical devices without CE certification cannot be sold in the 27 EU member states, directly losing access to the European market. Upgraded MDR Regulations: The EU’s new Medical Device Regulation (MDR) significantly raises certification standards, requiring enterprises to invest more resources to ensure product compliance, further increasing market access difficulties for ...
- Source: drugdu
- 134
- July 21, 2025
【EXPERT Q&A】What are the document requirements for the registration of Class II medical devices in China?

Drugdu.com expert’s response: I. Enterprise Qualifications and Basic Documents Medical Device Registration Application Form Must include detailed information such as product name, model, specifications, intended use, manufacturing process, and quality control methods, accompanied by product photographs. Enterprise Qualification Certificates Business license. Medical Device Manufacturing License (if already obtained). Identity certificates and educational/professional qualification certificates of the legal representative, enterprise person in charge, and quality manager. Power of Attorney Required if the registration is handled by someone other than the legal representative or enterprise person in charge, with an authorized signature and official seal. II. Technical Documentation and Product Information Product Technical Files Design principles, structural features, and performance specifications: Detailed descriptions of technical parameters, functional characteristics, and testing methods. Bill of materials: Includes specifications, models, quality standards, and supplier qualification documents for raw materials, components, and assemblies. Manufacturing process flowchart: Must annotate key and special processes, accompanied by process descriptions. ...
- Source: drugdu
- 126
- July 18, 2025
【EXPERT Q&A】How many types of EU CE certification are there?

Drugdu.com expert’s response: The EU CE certification is primarily classified into three types based on certification modes (COC, AOC, DOC) and multiple types based on product directives, while the certification path also involves different module combinations. Here is a detailed classification and explanation: I. Three Types Based on Certification Modes COC (Certificate of Compliance) Issuing Authority: Third-party organizations (e.g., intermediaries or testing and certification bodies). Content: Typically accompanied by technical documentation (TCF) such as test reports, and enterprises are also required to sign a Declaration of Conformity. Applicable Scenarios: Applicable to a variety of situations, whether for AOC or other products requiring certification under specific modes (e.g., B+D, B+E, H, etc.), a COC certificate may ultimately be obtained. AOC (EC Attestation of Conformity) Issuing Authority: EU Notified Bodies (NB). Content: According to EU regulations, only NB organizations are qualified to issue such certificates. Applicable Scenarios: Typically arises when product certification ...
- Source: drugdu
- 129
- July 16, 2025
【EXPERT Q&A】How to standardize drug information?

Drugdu.com expert’s response: Standardizing drug information is a critical step in enhancing medical data quality, facilitating information sharing, and ensuring medication safety. Below are the specific methods and steps to achieve drug information standardization: I. Clarify Standardization Objectives and Scope Define Core Objectives Improve Data Consistency: Ensure consistent naming and dosage representations of the same drug across different systems. Support Cross-System Interoperability: Enable data exchange among hospitals, pharmacies, and regulatory agencies. Ensure Medication Safety: Avoid medication errors caused by information confusion. Meet Regulatory Requirements: Comply with national drug coding standards, electronic health record (EHR) specifications, etc. II. Define Standardization Scope Basic Information: Drug names, ingredients, dosage forms, specifications, manufacturers, etc. Clinical Information: Indications, usage and dosage, contraindications, adverse reactions, etc. Administrative Information: Drug codes, classifications, prices, inventory, etc. Research Information: Pharmacokinetic parameters, clinical trial data, etc. Establish a Unified Drug Information Standard System Adopt International/National Standards Drug Coding: Utilize internationally ...
- Source: drugdu
- 143
- July 14, 2025
【EXPERT Q&A】What are the standards and procedures for compliance review?

Drugdu.com expert’s response: I. Standards for Compliance Review The standards for compliance review serve as benchmarks to ensure that the actions of enterprises or organizations are lawful and compliant, primarily covering the following three aspects: Legal and Regulatory Requirements National Laws and Regulations: These include the Constitution, laws, administrative regulations, departmental rules, and local regulations, such as the Company Law, Labor Law, and Cybersecurity Law. International Treaties and Regulatory Provisions: For foreign-involved enterprises, compliance with the laws and regulations of the host country where investments are made, international conventions (e.g., GDPR), and bilateral treaty agreements is required. Industry Regulatory Requirements: Examples include capital adequacy ratios and risk management regulations in the financial sector, as well as medical device approval processes in the healthcare industry. Industry Standards and Best Practices Industry Codes: Examples include the Basel Accords in the financial sector and ISO 13485, the quality management system standard for medical devices. Social Responsibility ...
- Source: drugdu
- 148
- July 11, 2025
【EXPERT Q&A】How effective is Dula peptide in lowering blood sugar?

Drugdu.com expert’s response: Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with significant glucose-lowering effects, particularly suitable for patients with type 2 diabetes mellitus. Its specific manifestations are as follows: I. Core Glucose-Lowering Mechanisms Promotion of Insulin Secretion: By mimicking the body’s natural GLP-1, dulaglutide activates GLP-1 receptors, increasing cyclic adenosine monophosphate (cAMP) levels in pancreatic β-cells. This precisely stimulates insulin secretion when blood glucose levels rise (e.g., after meals), thereby lowering blood glucose. Inhibition of Glucagon Release: Glucagon is a hormone that raises blood glucose. Dulaglutide suppresses its secretion, further reducing hepatic glucose output and aiding in glycemic control. Delay of Gastric Emptying: By slowing the passage of gastric contents into the small intestine, dulaglutide prolongs carbohydrate absorption time, preventing sharp postprandial blood glucose spikes and achieving stable glycemic control. II. Clinical Efficacy Data Significant Reduction in Glycated Hemoglobin (HbA1c): Multiple studies demonstrate that after 24 weeks of dulaglutide treatment, HbA1c levels decrease by ...
- Source: drugdu
- 131
- July 9, 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.