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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
- 118
- 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
- 172
- 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
- 156
- 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
- 185
- 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
- 155
- 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
- 144
- 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
- 155
- 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
- 158
- February 19, 2026
【EXPERT Q&A】How should we view the consistency between generic drugs and original research drugs?

Drugdu.com expert’s response: The consistency between generic drugs and originator drugs is a crucial issue in the pharmaceutical field, with its core lying in assessing whether generic drugs achieve equivalent levels in terms of quality, efficacy, and safety compared to originator drugs. This issue not only concerns patients’ rights to medication but also affects the balance between innovation and accessibility in the pharmaceutical industry. The following analysis unfolds from four dimensions: science, policy, economy, and society. I. Scientific Foundation: Technical Standards for Consistency Evaluation Pharmaceutical Equivalence：Generic drugs must be identical to originator drugs in terms of active ingredients, dosage forms, strengths, and routes of administration, and demonstrate consistency in physical and chemical properties through tests such as dissolution rate and content uniformity. This serves as the fundamental threshold for generic drug development. Bioequivalence (BE)：It is necessary to prove through human clinical trials or alternative methods (e.g., in vitro models) that ...
- Source: drugdu
- 572
- February 18, 2026
CPHI Middle East

Organiser：Informa Markets Time：May 11 – 13, 2026 Address：King Abdullah Rd, King Abdullah Dt., Riyadh 11564, Saudi Arabia Exhibition hall：Riyadh International Convention & Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracyclines, amino acids and their derivatives, chloramphenicols, digestive system drugs, other anti-infective agents, penicillins, aminoglycosides, lincomycins, cardiovascular system drugs, antiparasitic drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, and other Western medicine raw materials. Pharmaceutical Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, production equipment and technology for pharmaceuticals, pharmaceutical packaging equipment, pharmaceutical packaging materials, systems for pharmaceutical production, cleaning, disinfection, and laboratory instrumentation. Pharmaceutical Products: Various traditional Chinese patent medicines, Western medicines, new drugs,特效 drugs (special-effect drugs), various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal and plant extracts, veterinary drugs, food ingredients and additives, etc. About CPHI Middle East： The CPhI Middle East in Riyadh, ...
- Source: drugdu
- 306
- February 17, 2026

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