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【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
- 68
- 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
- 76
- 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
- 69
- 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
- 66
- March 10, 2026
Junshi Biosciences’ marketing application for toripalimab injection (subcutaneous injection) has been accepted

On the evening of March 9 that Junshi Biosciences (688180) issued an announcement stating that the company received an “Acceptance Notice” issued by the National Medical Products Administration, and the marketing application for 12 indications of the company’s product, toripalimab injection (subcutaneous injection), for the treatment of tumors has been accepted. Junshi Biosciences stated that JS001sc is a subcutaneous injection formulation developed by the company based on its already marketed product, toripalimab injection. It is the first domestically produced anti-PD-1 monoclonal antibody subcutaneous injection formulation to enter the marketing application stage, and is expected to bring convenience to patients. The 12 indications listed in this marketing application for JS001sc are all the indications currently approved for toripalimab injection in mainland China. https://finance.eastmoney.com/a/202603093666384241.html
- Source: drugdu
- 66
- March 10, 2026
ATTC Platform Shines

On March 5, Hutchison MediPharma announced its financial results for 2025. The market sales of four oncology products (fruquintinib, surufatinib, cevotinib, and tazestat) reached $524.7 million, a 5% increase. Sales in the second half of the year were up 24% compared to the first half of 2025. the core product , fruquintinib (FRUZAQLA), increased by 26% to $366.2 million overseas , primarily driven by strong growth following approval in 38 countries, including approval in more than 15 countries by 2025. Further reimbursement coverage is also progressing steadily, with the product currently included in health insurance programs in nearly 20 countries. of fruquintinib were $100.1 million , down from $115 million in 2024. Other oncology/immunology revenue (including upfront payments, regulatory milestone payments, R&D services, and licensing revenue) was $71.1 million. Other revenue (primarily from prescription drug distribution) remained stable at $263 million. Total consolidated revenue was $548.5 million. In addition, Hutchison ...
- Source: drugdu
- 66
- March 10, 2026
Are the problems with OX40 more serious than we thought?

The OX40 monoclonal antibody has had a troubled history. On March 3, Kylin Pharmaceutical announced that due to the addition of a new case of Kaposi’s sarcoma in clinical trials, the company decided to discontinue all clinical studies of its OX40 monoclonal antibody Rocatinlimab. This breaking news has once again thrust the OX40 monoclonal antibody into the spotlight. Once, this was a promising new area of autoimmune medicine that industry giants had high hopes for. However, the results were less than satisfactory, forcing the market to re-evaluate the competitiveness of OX40 monoclonal antibody. However, with the exposure of the risk of tumorigenesis, OX40 monoclonal antibodies may face more challenges in the field of autoimmune diseases. 01 Cancer Controversy On March 3, a news release from Peking Union Medical College Hospital brought the OX40 monoclonal antibody into the spotlight. Hsieh Ho Kirin stated that a recent safety review of Rocatinlimab revealed ...
- Source: drugdu
- 58
- March 10, 2026
Up to $690 Million! GSK Sells Liver Disease Drug

On March 9, 2026, GSK and Alfasigma S.p.A. announced a licensing agreement, under which Alfasigma will obtain global exclusive rights to linerixibat for the development, manufacture and commercialization of the drug. According to reports, linerixibat is an investigational ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC). Linerixibat has been granted Orphan Drug Designation in the United States, the European Union and Japan, as well as Priority Review in China for the treatment of cholestatic pruritus in PBC patients. Based on positive data from the Phase III GLISTEN trial, marketing applications for linerixibat are currently under regulatory review in the United States, the European Union, the United Kingdom, China and Canada. The GLISTEN trial met its primary endpoint and key secondary endpoints, demonstrating rapid, significant and sustained improvements in cholestatic pruritus and pruritus-related sleep disturbance compared with placebo. ...
- Source: drugdu
- 63
- March 10, 2026
PharmaLab Japan

Organiser：Reed Exhibitions Time：May 20 – 22, 2026 Address：3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: General Exhibition Area: Products related to cell biology, drug research, various equipment, consumables, reagents, products related to biological omics, biological imaging equipment, software, databases, biological resources, biological materials, biological industry clusters, investment, industrial upgrading, etc. Regenerative Medicine Research Exhibition Area: Cell culture, cell production products/services, regenerative medicine, cellular medicine, etc. Contract Services Exhibition Area: Contract research and development, testing, analysis, contract expression, synthesis, refinement, clinical research CMO, CRO, SMO, technology transfer TLO, IP consulting, etc. Precision Processing Exhibition Area: Precision/fine processing technologies, microfluidics (microTAS, Bio MEMS, biochips, biosensors), microchannels, microsystems, etc. About PharmaLab Japan： PharmaLab Japan is one of Asia’s leading pharmaceutical laboratory exhibitions. The highly anticipated 250 conference/seminar events will provide attendees with the best venue to learn about life sciences knowledge. As a comprehensive biotechnology ...
- Source: drugdu
- 79
- March 10, 2026
Marketing application for HSK39297 tablets, an innovative drug for paroxysmal nocturnal hemoglobinuria, has been accepted

Harsco Pharmaceutical(002653) announced on the evening of March 8 that its subsidiary, Sichuan Haisco Pharmaceutical Co., Ltd., recently received an Acceptance Notice from the National Medical Products Administration (NMPA) for its independently developed HSK39297 tablets for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This drug is classified as a Class 1 chemical drug under China’s new chemical drug registration classification and is a leading domestic CFB inhibitor targeting PNH. According to the announcement, HSK39297 is a highly potent and selective small molecule inhibitor of complement factor B. It inhibits FB activity, blocking the activation of the alternative pathway and complement amplification circulation, thereby suppressing the activity of the entire complement pathway. It is designed to treat various diseases mediated by abnormal complement activation. In PNH patients, this drug acts at the proximal end of the complement cascade alternative pathway, simultaneously controlling C3b-mediated extravascular hemolysis and terminal complement-mediated ...
- Source: drugdu
- 71
- March 9, 2026

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