Expert Q&A – Page 6 – media

【EXPERT Q&A】What is the effect of rukang saltuzumab on EGFR-mutated lung cancer?

Drugdu.com expert’s response: I. Clinical Research Data KL264-01 Study: In the subgroup analysis targeting EGFR-mutated non-small cell lung cancer (NSCLC) patients, the objective response rate (ORR) of sacituzumab tirumotecan as a monotherapy reached as high as 55%, with a median progression-free survival (PFS) of 11.1 months. These results were significantly superior to those in EGFR wild-type patients, who had an ORR of 24% and a median PFS of 5.3 months. SKB264-II-08 Study: Among 64 previously treated EGFR-mutated NSCLC patients, sacituzumab tirumotecan achieved an ORR of 34%, a disease control rate (DCR) of 84%, a median duration of response (DOR) of 9.6 months, a median PFS of 9.3 months, and a 1-year overall survival (OS) rate of 79%. OptiTROP-Lung03 Study: The sacituzumab tirumotecan group demonstrated a confirmed ORR of 45.1%, significantly higher than the 15.6% in the docetaxel group. The median PFS was 6.9 months, significantly longer than the 2.8 months ...
- Source: drugdu
- 151
- June 13, 2025
【EXPERT Q&A】Is midazolam effective?

Drugdu.com expert’s response: Midazolam demonstrates significant efficacy in medical settings, yet its indications, dosage, and duration of use must be strictly controlled. Its effectiveness evaluation requires comprehensive consideration based on specific applications and individual differences. Below is an analysis of its efficacy across different usage scenarios: I. Notable Effects in Anesthesia and Sedation Anesthesia Induction and Maintenance: As a short-acting benzodiazepine, midazolam has a rapid onset (2-3 minutes after intravenous injection) and a short half-life (approximately 2 hours). It effectively reduces preoperative anxiety and aids in the induction of general anesthesia. When used in combination with anesthetics like propofol, it enhances the depth of sedation, maintains hemodynamic stability, and reduces the dosage requirements of other drugs. Sedation in Intensive Care: For mechanically ventilated patients, midazolam can quickly control agitation and reduce oxygen consumption, though the risk of respiratory depression must be vigilantly monitored. Its reversibility allows for relatively rapid patient ...
- Source: drugdu
- 138
- June 11, 2025
【EXPERT Q&A】What is the difference between siRNA and shRNA? How should the grouping for regular interference detection be set?

Drugdu.com expert’s response: I. Differences Between siRNA and shRNA 1. Structure and Composition siRNA (Small Interfering RNA): siRNA is a double-stranded RNA molecule, typically 20-25 base pairs in length, with a 2-nucleotide 3′ overhang at both ends. It consists of two complementary RNA strands: a sense strand (homologous to the target mRNA) and an antisense strand (complementary to the target mRNA). siRNA is usually generated from exogenous or endogenous double-stranded RNA through cleavage by the Dicer enzyme. shRNA (Short Hairpin RNA): shRNA is a single-stranded RNA capable of forming a hairpin (stem-loop) structure, comprising a short double-stranded region (19-29 bp) and a loop region. It consists of a sense strand, a loop sequence, and an antisense strand, forming a hairpin shape. shRNA is constructed into expression vectors through genetic engineering techniques and forms a hairpin structure upon transcription. 2. Mechanism of Action siRNA: After being cleaved by the Dicer enzyme, siRNA directly binds ...
- Source: drugdu
- 153
- June 9, 2025
【EXPERT Q&A】How to apply for medical device qualifications?

Drugdu.com expert’s response: The process of obtaining medical device qualifications involves multiple stages and stringent requirements, necessitating the preparation of corresponding materials and adherence to legal procedures based on the classification of medical devices (Class I, Class II, Class III) and the specific type of business operation (manufacturing or distribution). Below is a detailed explanation: I. Clarifying the Type of Qualification to Be Obtained Medical device qualifications are primarily categorized into manufacturing qualifications and distribution qualifications. These are further classified into Class I, Class II, and Class III based on the risk level of the medical devices. The requirements and procedures for obtaining qualifications vary across different categories. Class I Medical Devices: These pose a low risk and are subject to routine management. Generally, they only require filing and do not necessitate a license. Class II Medical Devices: These carry a moderate risk and require strict control and management. Distribution ...
- Source: drugdu
- 168
- June 6, 2025
【EXPERT Q&A】Can medical devices be contracted for production?

Drugdu.com expert’s response: Medical devices can indeed be entrusted for production, but strict compliance with relevant regulatory requirements is essential. Below is a detailed analysis: I. Regulatory Basis and Fundamental Requirements According to the Regulations on the Supervision and Administration of Medical Devices and related supporting documents, medical device registrants and record-holders (hereinafter referred to as “registrants”) may entrust qualified enterprises to manufacture medical devices. The core principle of entrusted production is that registrants bear primary responsibility for the quality and safety of the products, while the entrusted party must organize production in accordance with regulations, standards, and the entrustment agreement, and accept supervision from the registrant. II. Key Restrictive Conditions Prohibited Entrusted Production Catalog: High-risk implantable medical devices (such as cardiac pacemakers, artificial joints, etc.) are not allowed to be entrusted for production. The specific catalog is formulated and dynamically adjusted by the National Medical Products Administration (NMPA). Given the direct implantation ...
- Source: drugdu
- 105
- June 4, 2025
【EXPERT Q&A】How should accelerated tests be carried out in drug stability studies?

Drugdu.com expert’s response: Accelerated testing is a crucial method for assessing the stability changes of pharmaceuticals under short-term high-temperature and high-humidity conditions. It helps predict stability trends under long-term storage conditions and provides a basis for determining the shelf life and storage conditions of drugs. Below are the detailed steps and key points for conducting accelerated testing: I. Purpose of the Test The primary objective of accelerated testing is to accelerate the degradation or deterioration process of drugs within a relatively short period by elevating storage temperature and humidity conditions, thereby evaluating the stability of the drugs. II. Test Conditions Temperature: Typically, 40℃±2℃ is selected as the temperature condition for accelerated testing. This temperature, higher than the routine storage temperature, can expedite the degradation reactions of drugs. Humidity: The relative humidity is usually set at 75%±5%. High humidity conditions are beneficial for assessing the sensitivity of drugs to moisture. III. ...
- Source: drugdu
- 128
- June 2, 2025
【EXPERT Q&A】What is the development history and mechanism of action of mRNA drugs?

Drugdu.com expert’s response: The development of mRNA (messenger RNA) drugs has undergone a journey from early exploration to technological breakthroughs, and then to widespread application. The specific progression is as follows: I. Early Exploration (1961-1990) In 1961, scientists first discovered mRNA. In 1987, Malone found that mRNA molecules mixed with lipid droplets could enter cells and express the desired protein, marking the beginning of RNA research as a therapeutic agent. In 1990, scientists injected in vitro-transcribed messenger RNA (mRNA) into mice and discovered that it could be expressed in vivo, producing relevant proteins in a dose-dependent manner. This method of directly injecting mRNA could induce an immune response by expressing specific proteins, serving as the prototype for mRNA therapy. II. Technological Breakthroughs (Early 21st Century-2020) Entering the 21st century, mRNA synthesis, modification, and delivery technologies further advanced. In 2005, Karikó and Weissman discovered that using modified nucleotides like pseudouridine could ...
- Source: drugdu
- 108
- May 30, 2025
【EXPERT Q&A】Do domestic Class II medical devices need to be registered in the ASEAN countries where they are exported?

Drugdu.com expert’s response: Domestic Class II medical devices exported from China to ASEAN countries generally require registration in the target country, although specific requirements vary depending on each country’s regulations and the risk classification of the product. Below is a detailed analysis: I. Overview of Medical Device Registration Requirements in ASEAN Countries ASEAN countries, including Singapore, Malaysia, Thailand, Indonesia, the Philippines, Vietnam, etc., have varying regulatory requirements for medical devices. However, most countries require imported medical devices to be registered or filed in their domestic markets to ensure compliance with local regulations and standards. These requirements typically include submitting product technical documentation, quality inspection reports, clinical trial data (if applicable), etc., and may necessitate completing the registration process through a local authorized representative or importer. II. Country-Specific Requirements Examples Singapore: The regulatory authority for medical devices is the Health Sciences Authority (HSA) of Singapore. Imported medical devices must comply with HSA’s registration ...
- Source: drugdu
- 158
- May 28, 2025
【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: The process and requirements for filing Class I medical device products are as follows: I. Filing Process Determine Product Category: Confirm whether the product falls under Class I medical devices by cross-referencing with the “Class I Medical Device Product Catalog” or the “In Vitro Diagnostic Reagent Classification Catalog”. Ensure that the product name, intended use, product description, etc., align with the catalog’s scope. If the product is not listed in the catalog, an application for medical device classification determination must be submitted first. Once it is clarified as a Class I medical device, filing can proceed. Prepare Filing Materials Submit complete filing materials, including but not limited to: Filing Form: Completed and accompanied by an electronic document, requiring the filer’s signature and seal. Safety Risk Analysis Report: Prepared in accordance with the YY 0316 standard, covering the product’s intended use, hazard identification, risk control measures, and validation results. ...
- Source: drugdu
- 139
- May 26, 2025
【EXPERT Q&A】What are the standards and procedures for compliance review?

Drugdu.com expert’s response: Compliance review is an essential task undertaken by enterprises or organizations to ensure that their business activities adhere to legal and regulatory requirements, industry norms, and internal rules and regulations. The standards and procedures for compliance review vary depending on factors such as industry, region, and enterprise size, but they typically encompass the following core elements: I. Standards for Compliance Review Legal and Regulatory Requirements Applicable Laws: These include national laws, administrative regulations, and local regulations, such as the Company Law, Labor Contract Law, and Environmental Protection Law. Industry Regulations: These are specific regulatory requirements for particular industries, such as anti-money laundering regulations in the financial sector and privacy protection laws in the medical industry. International Treaties or Agreements: When engaging in cross-border business, enterprises must comply with international conventions or bilateral agreements (e.g., GDPR requirements for cross-border data flows). Internal Rules and Regulations of the Enterprise ...
- Source: drugdu
- 107
- May 23, 2025

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