media – Page 33 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

34 million patients no longer rely on imported drugs

In China, the number of people suffering from attention deficit hyperactivity disorder (ADHD) has exceeded 34 million. For a long time, the clinical treatment of this group has been heavily reliant on imported drugs. With the launch of the first generic drug by Lifang Pharmaceutical, the approval of multiple dosage forms of improved new drugs by Youer Pharmaceutical, and the successful approval of innovative compound preparations by Aikebaifa, several domestically produced ADHD treatment drugs have been launched, and the reliance on imported drugs is gradually being broken. In the ADHD sector, a breakthrough battle for domestic substitution and upgrading has officially begun. 01 Market potential awaits release Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder characterized by disproportionate attention deficits and hyperactivity, manifesting as poor concentration, impulsivity, hyperactivity, and learning difficulties. According to the “Pediatric Expert Consensus on Early Identification, Standardized Diagnosis and Treatment of Attention Deficit ...
- Source: drugdu
- 144
- February 25, 2026
How far can GLP-1 go in the weight loss race?

At the start of 2026, a business development (BD) deal between CSPC Pharmaceutical Group and AstraZeneca set a new record for the highest amount of foreign licensing for Chinese biopharmaceutical companies, with a potential value of over US$18.5 billion. This record-breaking business development deal has once again propelled the research and development of weight-loss drugs to a new level . According to the agreement, AstraZeneca has acquired the global exclusive rights to CSPC Pharmaceutical Group’s once-monthly injectable weight management product portfolio outside of Greater China, including one clinical-ready project SYH2082, three preclinical projects, and four new collaborative projects based on CSPC Pharmaceutical Group’s platform. It is worth mentioning that SYH2082 is a GLP1R/GIPR agonist, which means that GLP-1 will continue to be popular in the weight loss field. 01 Blood sugar reduction has been unknown for many years One day of weight loss produced a medicine king With the release ...
- Source: drugdu
- 114
- February 25, 2026
【EXPERT Q&A】How to apply for the classification and definition of medical devices?

Drugdu.com expert’s response: To ensure the authenticity and completeness of application materials, the following procedures and requirements must be followed when applying for classification determination of medical devices: I. Application Methods and Channels 1. Online Registration and Application Visit the official website of the National Institutes for Food and Drug Control (NIFDC, under the National Medical Products Administration) at https://www.nifdc.org.cn. Navigate to the “Medical Device Standards and Classification Management” section and click on the “Medical Device Classification Determination Information System.” Register an account, complete the Application Form for Classification Determination of Medical Devices, and upload other required materials. Starting from February 19, 2024, paper submissions are no longer required; the entire process is conducted electronically. 2. Paper Submission (Backup Option) If paper materials are required, print the Application Form for Classification Determination online, affix the enterprise’s paging seal to all documents, and mail them to the following addresses based on product type: Domestic Products: ...
- Source: drugdu
- 111
- February 25, 2026
Aohong Pharmaceutical | Drug registration application for Motomidyl Hydrochloride Injection accepted by CDE

Recently, the National Medical Products Administration accepted the drug registration application of Motomidate Hydrochloride Injection (Project Code: ET-26, Application Registration Category: Class 1 Chemical Drug; hereinafter referred to as “the new drug”) by Jinzhou Aohong Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharma (stock code: 600196.SH; 02196.HK). The proposed indication for this application is for anesthesia induction and short-term surgical anesthesia. This new drug is a Class 1 new drug for intravenous general anesthesia and was included in the “Major New Drug Development” science and technology major project in 2014.According to the latest data from IQVIA CHPA1 , in 2024, sales of similar drugs (such as etomidate) used for anesthesia induction and short-term surgical anesthesia in mainland China (excluding Hong Kong, Macao and Taiwan) amounted to approximately RMB 4.238 billion.As a wholly-owned subsidiary of Fosun Pharma, Aohong Pharmaceutical has always regarded innovation as the core driving force for its sustainable ...
- Source: drugdu
- 100
- February 24, 2026
Hansoh Pharmaceutical’s blockbuster new drug has been approved for marketing in the European Union!

Just now, Hansoh Pharmaceutical announced that its innovative drug, Ametinib Mesylate Tablets (Chinese trade name: Ameile® , overseas trade name: Aumseqa® ) , has been officially approved by the European Commission ( EC ) for marketing in the European Union for the treatment of: First-line treatment for adult patients with advanced non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR ) exon 19 deletion or exon 21 ( L858R ) substitution mutation ; Treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC . This approval came after the European Medicines Agency ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) issued a positive opinion. Ametinib thus becomes the first Chinese-developed EGFR-TKI drug to receive EU approval, marking another breakthrough for domestically produced targeted innovative lung cancer drugs in the European market. Ametinib mesylate tablets (Aumseqa® ) are China’s first original ...
- Source: drugdu
- 129
- February 24, 2026
Jinsai Pharmaceutical’s new drug officially approved for clinical trials to improve micropenis in children!

On February 24, the CDE website showed that GenSci141 ointment , submitted by Jinsai Pharmaceutical , was approved for clinical trials. It is indicated for improving micropenis in children caused by hypergonadotropic hypogonadism, 5α-reductase 2 deficiency, congenital adrenal hyperplasia with reduced androgen synthesis, and idiopathic causes. The registration categories are 2.2 and 2.4. GenSci141 ointment is a dihydrotestosterone ointment developed by Jinsai Pharmaceutical . It mainly works by paracrine secretion within target tissues, targeting and promoting penile tissue growth and development. According to publicly available information, there are currently no approved drugs worldwide specifically for micropenis in children, indicating a significant unmet clinical need. If successful, GenSci141 ointment could become the world’s first drug specifically for micropenis in children. https://mp.weixin.qq.com/s/lKYLBl1EyMWSjlHehOE0Kw
- Source: drugdu
- 123
- February 24, 2026
Frontier Biotechnologies Enters Global Licensing Collaboration with GlaxoSmithKline for Small Nucleic Acid Drugs

Recently, Frontier Biotechnologies (Nanjing) Co., Ltd. (hereinafter referred to as “Frontier Biotechnologies” or the “Company”) has officially entered into an exclusive license agreement with GlaxoSmithKline (hereinafter referred to as “GSK”), a global biopharmaceutical company. Pursuant to the agreement, GSK will obtain the global exclusive rights to develop, manufacture and commercialize two small interfering RNA (siRNA) pipeline products. One of the drug candidates has entered the Investigational New Drug (IND) application stage, and the other is a preclinical candidate. This agreement demonstrates the Company’s expertise in the early-stage discovery and development of siRNA drugs, representing an important milestone in advancing the Company’s global development strategy. Under the agreement, the Company will receive an upfront payment of USD 40 million, and up to an aggregate of USD 963 million in development, regulatory and commercialization milestone payments across the two programs, as well as tiered royalties on the global net sales of both ...
- Source: drugdu
- 147
- February 24, 2026
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
- 132
- 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
- 124
- 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
- 114
- February 20, 2026

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