media – Page 12 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】How can the stability study of in vitro diagnostic reagents under the EU IVDR be carried out efficiently?

Drugdu.com expert’s response: To efficiently conduct stability studies of in vitro diagnostic reagents within the framework of the EU’s In Vitro Diagnostic Regulation (IVDR), it is essential to systematically advance from five perspectives: regulatory compliance, study design, implementation and execution, data management and analysis, and continuous improvement. The specifics are as follows: 1. Regulatory Compliance: Precisely Align with IVDR Requirements Core Regulations and Guidelines: IVDR Regulation: As the cornerstone of EU regulations for in vitro diagnostic reagents, IVDR specifies the fundamental requirements for stability studies, including study objectives, types, and data submission. EN ISO 23640:2015: This standard provides detailed guidelines for the stability evaluation of in vitro diagnostic reagents, covering experimental design, evaluation procedures, and reporting requirements, serving as a crucial reference for stability studies. CLSI EP25-A: Targeting quantitative/qualitative reagents, CLSI EP25-A encompasses the design of stability testing plans, data analysis, transportation assessment, and the application of accelerated testing, offering specific ...
- Source: drugdu
- 96
- March 13, 2026
SHR-9803 for Injection Approved for Clinical Trials

On March 11, Hengrui Medicine (600276/01276) issued an announcement stating that the company recently received the “Drug Clinical Trial Approval Notice” for SHR-9803 for injection issued by the National Medical Products Administration, and will conduct clinical trials in the near future. This drug is a Class 1 therapeutic biological product.It can activate anti-tumor immune activity, specifically bind to and eliminate regulatory T cells within tumors, while reducing the impact on peripheral Tregs, aiming to improve the safety and efficacy of tumor treatment. To date, the cumulative R&D investment in SHR-9803 injection-related projects is approximately RMB 18.3 million (unaudited). In the first three quarters of 2025, Hengrui Medicine achieved revenue of RMB 23.188 billion and net profit attributable to the parent company of RMB 5.751 billion. https://finance.eastmoney.com/a/202603113668880571.html
- Source: drugdu
- 87
- March 12, 2026
Invests 5 million yuan to participate in the establishment of an investment fund to expand into the biopharmaceutical field

Lumay Pharmaceutical(300006) announced on March 12 that the company recently signed an agreement with Xi’an Wojie Private Equity Fund Management Co., Ltd. and Sansure Biotech.Several institutions, including a technology company, signed a partnership agreement to jointly establish Guangzhou Shengquan Baijie Venture Capital Fund Partnership (Limited Partnership). The fund aims to raise a total of RMB 150 million, of which the company, as a limited partner, will contribute RMB 5 million from its own funds, representing a 3.33% stake. The investment fund primarily invests in innovative biopharmaceuticals and medical devices .In vitro diagnosticsIn the life and health sectors, investments in these industries shall not be less than 60% of the fund’s total paid-in capital. The fund focuses on investing in Guangzhou’s strategic emerging industries and future industries, and has established a fund for seed companies in Guangzhou.Investment ratio requirements for early-stage and angel-stage projects. According to the announcement, the company’s investment ...
- Source: drugdu
- 79
- March 12, 2026
Huadong Medicine’s clinical trial application for injectable HDM2024 drug has been approved by the US FDA

March 11, Huadong Medicine…(000963) issued an announcement stating that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-American East China”), received a notification from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) that the clinical trial application for injectable HDM2024 submitted by Sino-American East China has been approved by the U.S. FDA and can be carried out in the United States for Phase I clinical trials, with the indication being advanced solid tumors. Huadong Medicine stated that the approval of the US clinical trial of injectable HDM2024 is another important step in the product’s development process and will further enhance the company’s core competitiveness in the field of oncology treatment. https://finance.eastmoney.com/a/202603113668988846.html
- Source: drugdu
- 94
- March 12, 2026
Its subsidiary’s Class 1 innovative drug TQB3205 has been approved for clinical trials, intended for the treatment of advanced malignant tumors.

On March 11, China Biopharmaceutical (01177) issued an announcement stating that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has independently developed a Class 1 innovative drug.TQB3205 has received clinical trial approval from the China National Medical Products Administration and is intended for the treatment of advanced malignant tumors. TQB3205 is an oral pan-KRAS inhibitor that effectively inhibits the proliferation of various KRAS-mutated tumor cells. The company will accelerate the clinical development of TQB3205, aiming to overcome existing treatment limitations and bring new treatment options to a wider range of patients with KRAS-mutated advanced malignancies. https://finance.eastmoney.com/a/202603113668972521.html
- Source: drugdu
- 95
- March 12, 2026
HOSPITALAR

Organiser：Informa Markets Time：May 19 – May 22, 2026 Address：Centro de Exposições Imigrantes, Rodovia dos Imigrantes, Km 1.5, São Paulo – SP Exhibition hall：São Paulo Expo Product range: Medical Equipment Pavilion: Hospital technical facilities and equipment; medical clinic technology and equipment; ward furniture and equipment; diagnostic and therapeutic equipment; biochemical and testing equipment; pharmaceutical products; sanitary materials; medical communication technology and equipment; comprehensive hospital information technology and services Rehabilitation Technology for the Disabled Pavilion: Nursing equipment; nursing products; communication technology; mobile nursing; nursing services; medical technology; orthopedic surgical technology; outpatient nursing; physiotherapy; prosthetics; services; ergonomic therapy; communication technology; wheelchairs Pharmaceutical Pavilion: Prescription drugs; traditional Chinese patent medicines; western medicines; antibiotics; powder injections; infusions; tablets; ointments; capsules; various new drugs; special drugs; national traditional Chinese medicine protected varieties; national basic medical insurance drugs; pharmaceutical raw materials; various intermediates; biochemical drug reagents and vaccines; various biological products Dental Pavilion: Dental instruments & ...
- Source: drugdu
- 117
- March 12, 2026
【EXPERT Q&A】How to apply for a medical device business license?

Drugdu.com expert’s response: Process and Required Materials for Applying for a Medical Device Operating License I. Application Process Online Application (1-2 Days) Log in to the “Food and Drug Regulatory Information Platform” of the National Medical Products Administration (NMPA) to submit the application. Register an enterprise account in advance, and clearly indicate “Third-Class Medical Device Operation” in the business scope. Material Preparation (7-15 Days) Core materials include: Enterprise business license副本 (copy, must include medical device business scope); Identity certificates and academic/professional qualification certificates (in medical-related fields) of the legal representative and quality manager; Property ownership certificate or lease contract for the business premises (warehouse area for third-class devices ≥ 15㎡); Medical device product registration certificates, manufacturer authorization letters, and business licenses; Quality management system documents (templates for 11 systems including procurement, acceptance, and warehousing). Tips to Avoid Pitfalls: Materials must be stamped with the official seal, and electronic document naming ...
- Source: drugdu
- 99
- March 11, 2026
Novogene® has been approved, making its global debut in China!

Recently, the National Medical Products Administration (NMPA) officially approved the marketing application of Novogene® (insulin smegglutide injection) in China. Novogene® is the world ‘s first and currently only approved basal insulin/glucagon-like peptide-1 receptor agonist (GLP-1RA) weekly formulation. It consists of the world’s first insulin weekly formulation, insulin smegglutide, and the globally widely used GLP-1RA weekly formulation, smegglutide[1]. It is suitable for adult patients with type 2 diabetes whose blood glucose control is poor after basal insulin or GLP-1RA treatment, and is used in combination with oral hypoglycemic drugs on the basis of diet and exercise [2] . Multidimensional blood glucose management and Patient treatment adherence remains high in type 2 diabetes. Key challenges in treatment ﹀ There are approximately 589 million adults with diabetes worldwide, of whom more than 90% have type 2 diabetes [3] . Insulin therapy is the cornerstone of diabetes management [4] , but in clinical practice, ...
- Source: drugdu
- 103
- March 10, 2026
CSPC indacaterol mometasone inhalation powder has been approved for clinical trials in China.

On March 5, CSPC Pharmaceutical Group (1093.HK) announced that…The indacaterol mometasone inhalation powder developed by our Group (hereinafter referred to as “the Product”) has been approved by the National Medical Products Administration and can be used for clinical trials in China.This product is used for maintenance treatment of asthma in adults and adolescents aged 12 years and older. Indacaterol is a long-acting β2-adrenergic agonist (LABA) with smooth muscle relaxant and bronchodilator effects. Mometasone furoate is an inhaled corticosteroid (ICS) with local anti-inflammatory effects. Indacaterol-Mometasone Inhalation Powder is the first once-daily inhaled ICS-LABA dual-combination inhaled formulation included in the National Medical Insurance Catalog (2022 Edition), providing asthma patients with a more efficient and convenient treatment option. The approval of the clinical trial for this product is another important achievement of the Group’s high-end innovative inhalation technology platform, laying a solid foundation for the development of subsequent inhalation formulations in the pipeline. ...
- Source: drugdu
- 90
- March 10, 2026
Hengrui Medicine subsidiary’s HRS9531 injection has been approved for clinical use in chronic kidney disease

On March 9, Hengrui Medicine (600276/01276) issued an announcement stating that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” for HRS9531 injection issued by the National Medical Products Administration, and will conduct clinical trials in the near future. The application for this drug was for clinical trials, with application numbers CXHL2501355 and CXHL2501356. The approval conclusion indicated that the application met the relevant requirements for drug registration and approved the commencement of clinical trials for chronic kidney disease. HRS9531 injection is a globally proprietary intellectual property.This novel dual agonist targeting both gastric inhibitory peptide receptor and glucagon-like peptide-1 receptor has the effects of regulating glucose and lipid metabolism, suppressing appetite, and enhancing insulin sensitivity. To date, the cumulative R&D investment in HRS9531-related projects is approximately RMB 632 million (unaudited). The company reminds investors that the drug development and market launch process is lengthy ...
- Source: drugdu
- 105
- March 10, 2026

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