media – Page 4 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What are the document requirements and review difficulties for applying for CE in in vitro diagnostic (IVD) self-testing?

Drugdu.com expert’s response: IVD Self-testing products are classified as Class C under IVDR by default (except for urine glucose/red blood cell/white blood cell/bacteria tests, which are Class B). About 80% of IVD products require Notified Body (NB) review, and self-testing products are almost all in this category. The documentation volume is large, the review cycle is long (Class D can take 18–24 months), and the core difficulties focus on usability studies, clinical performance evidence, and IFU label compliance. I. Mandatory Documentation Checklist 1. Technical Documentation (core, approximately 20+ items) Table of contents (version status, cross-references); manufacturer name and address, product name (all models/specifications), product description (intended use, model list, photos, drawings); device sample identification, declaration of conformity; list of applicable standards, essential requirements checklist (Annex I); risk management report (EN ISO 14971); product history (sales, complaints, change records); manufacturing method (production flowchart); quality control process description (incoming/in-process/final inspection, batch release ...
- Source: drugdu
- 73
- June 8, 2026
Cinda leads the world, and Takeda’s 1.2 billion gamble is reaping the rewards.

On June 4 local time, Innovent Biologics announced that its pivotal Phase III clinical trial of IBI343 (generic name arcotatug tavatecan, Takeda code name TAK-921), a CLDN18.2-targeted ADC drug developed in deep collaboration with Takeda Pharmaceutical, has met its primary endpoint. An arrow incrementally going up stairs before pointing straight up. Blue backgroundMeanwhile, China’s National Medical Products Administration (NMPA) has formally accepted IBI343’s marketing application and included it in the priority review process , making it the world’s first CLDN18.2-targeted ADC to enter the regulatory review stage . Just one year after Takeda acquired the overseas rights to the drug for $1.2 billion last year, Innovent has once again solidified its leading position in the global ADC field with solid clinical data. I. Key results of Phase III clinical trial: Excellent efficacy and manageable safety. The Phase III clinical trial announced this time is an international multicenter study covering China ...
- Source: drugdu
- 74
- June 5, 2026
The National Medical Products Administration (NMPA) conditionally approved the marketing of Pometamethasone Alpha for injection.

Recently, the National Medical Products Administration (NMPA) conditionally approved the marketing of Pometrazyne Alpha for Injection (trade name: Bojia Ning) submitted by Jiangsu Bejitech Biotechnology Co., Ltd. through the priority review and approval procedure. It is indicated for the treatment of bleeding in adult patients with congenital hemophilia A or B who have an inhibitor of coagulation factor VIII or IX >5 Bethesda units (BU). The marketing of this product provides a new treatment option for these patients . https://mp.weixin.qq.com/s/Y059ZMm7OwCt2Y6y9d5Aqw
- Source: drugdu
- 75
- June 5, 2026
A breakthrough for domestically produced IOLs! Another innovative device approved for market launch

Recently, the National Medical Products Administration approved the registration application of the trifocal intraocular lens of Henan Saimei Vision Biotechnology Co., Ltd. (hereinafter referred to as Saimei Vision), marking a new breakthrough for domestic high-end IOLs. 01 Sino-US joint venture Focus on the research and development of high-end ophthalmic implant devices Established in 2018, CEMIVIS is a Sino-US joint venture controlled by Shanghai Haohai Biological Technology Co., Ltd. and THERAMEDICELLC. Since its inception, it has focused on the research and development and production of high-end ophthalmic implantable devices. According to CEMIVIS’ official website, its product pipeline is divided into two main categories: intraocular lenses and equipment/instruments , with a total of 7 products in the intraocular lens category . According to data from Yaozhi Medical Devices, SEM currently has five products on the market in China (excluding the products launched this time shown in the image below), all of which ...
- Source: drugdu
- 66
- June 5, 2026
A leading traditional Chinese medicine company’s Class 1 biological drug has received IND approval in the United States.

Recently, Yunnan Baiyao issued an announcement stating that its Investigational New Drug (IND) application for INB301 injection has been approved by the U.S. FDA, which agrees to conduct clinical trials for the intended indication of tumor cachexia. The press release states that this is the company’s first innovative therapeutic biological drug. Cancer cachexia is a complex metabolic disorder syndrome caused by malignant tumors, characterized by persistent skeletal muscle wasting that is difficult to reverse with conventional nutritional support. Previously, the IND for INB301 injection was included in the 30-day fast track for innovative drug review and approval in China, and was approved by the NMPA in March 2026. To date, the drug has obtained clinical trial approvals in both China and the United States, with a total R&D investment of approximately RMB 50.665 million. As a leading Chinese medicine enterprise, Yunnan Baiyao has been accelerating the research and development of ...
- Source: drugdu
- 63
- June 5, 2026
The world’s second inhaled insulin has been approved for a new indication.

In the field of diabetes treatment, the exploration of non-injectable drug delivery routes has never stopped. Recently, the U.S. FDA officially approved the expanded pediatric indication for inhaled insulin Afrezza , making it the first and only mealtime inhaled insulin approved for use in children and adolescents aged 6 years and older. As the second inhaled insulin approved for marketing globally after Exubera, Afrezza’s successful entry into the pediatric nursing field not only fills the market gap for needle-free blood sugar control in children, but also marks a milestone in pediatric endocrine therapy. 01 Inhaled insulin can be used for children aged 6 years and older. The approval of Afrezza’s new indication makes it the world’s first non-invasive insulin for pediatric use in nearly a century , reshaping the landscape of injectable insulin administration for adolescent diabetes. This drug is rapidly absorbed through the alveoli and takes effect by mimicking ...
- Source: drugdu
- 63
- June 5, 2026
【EXPERT Q&A】What is the process for obtaining a medical device business license?

Drugdu.com expert’s response: Key Point: Only Class III medical devices require a Medical Device Business License. Class I needs no license, Class II only requires filing. Here is the complete process: Step 1: Confirm which class you need Class I (low risk): No license needed, e.g., surgical scalpels, gauze, stethoscopes Class II (medium risk): Business filing only, e.g., thermometers, blood pressure monitors, nebulizers Class III (high risk): License required, e.g., cardiac stents, contact lenses, syringes, CT scanners Note: Starting April 2026, new regulations: individual businesses can no longer apply for Class II or Class III licenses/filings. Applications must be made under a corporate entity (except for individual businesses dealing with 13 specific low-risk Class II products). Step 2: Corporate qualification preparation Register a company. The business scope of the business license must include “Class III medical device distribution.” Statutory processing time: 45 working days; in practice, most regions take 15–20 ...
- Source: drugdu
- 68
- June 5, 2026
Hansoh Pharmaceutical’s GLP-1/GIP Dual-Target Reduction New Drug Application for Market Launch | Industry News

On June 4, Hansoh Pharmaceutical announced that its New Drug Application (NDA) for once-weekly subcutaneous injection of GLP-1/GIP receptor dual agonist ollipopeptide injection has been accepted by the National Medical Products Administration (NMPA) of China. The drug is indicated for long-term weight management in obese or overweight adults. Olepoeptide (HS-20094) is a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) dual receptor agonist independently developed by Hansoh Pharmaceutical . It selectively activates GLP-1/GIP receptors to regulate metabolic pathways related to appetite control, glucose metabolism and energy balance, producing biological effects such as blood sugar control and weight loss. It is administered once a week via subcutaneous injection. According to a press release from Hansoh Pharmaceutical, in March 2026, the first Phase 3 clinical trial (HS-20094-301) of olepiropeptide in overweight or obese adults in China met its primary endpoint. After 48 weeks of treatment with olepiropeptide, the highest average weight loss from baseline ...
- Source: drugdu
- 73
- June 4, 2026
Shijiazhuang Pharmaceutical Group’s Class 2.2 new drug accelerates its domestic market launch

Malignant perivascular epithelioid cell tumor (PEComa) is a relatively rare mesenchymal tumor composed of perivascular epithelioid cells with distinctive histological and immunohistochemical features . This tumor is typically large, with marked nuclear atypia, frequent mitotic figures , tumor necrosis, and invasive growth, exhibiting an aggressive clinical course. Approximately 50% of patients with malignant PEComa are diagnosed at an advanced stage, often with metastasis, resulting in a poor prognosis.On June 3, 2026, according to the latest , the sirolimus for injection (albumin-bound) submitted by CSPC Ouyi Pharmaceutical Co., Ltd. is proposed to be included in the priority review list for the treatment of malignant perivascular epithelioid cell tumor (PEComa). According to a press release from CSPC Pharmaceutical Group, Sirolimus for Injection ( Albumin -Bound ) (HB1901) is a sirolimus albumin-bound nanoparticle suspension for injection. Its active pharmaceutical ingredient (API) is sirolimus, and it is a modified new drug that has not ...
- Source: drugdu
- 75
- June 4, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Sri Lanka.

Recently , Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Ningte® isoflurane inhalation issued by the National Medicines Agency ( NMRA ) of Sri Lanka . This signifies that the product can be exported to Sri Lanka for commercial sale. Obtaining this approval is an international recognition of the completeness and compliance of the company’s quality system, technical standards, and registration documents. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia . With its advantages of rapid induction, rapid recovery, and low metabolic rate, it is widely used in various surgeries. Currently, this product is available in China, the United States, and Japan, and registration applications have been submitted in several countries, including Tanzania and Pakistan . The company is accelerating its global supply expansion to provide patients with a safe and effective anesthetic option. During the ...
- Source: drugdu
- 64
- June 4, 2026

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