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

【EXPERT Q&A】How are in vitro diagnostic kits developed?

Drugdu.com expert’s response: The R&D of in vitro diagnostic kits is a rigorous and standardized full-process system, with 5 core key stages that ultimately produce safe and effective products complying with regulatory requirements. Stage 1: Project Initiation and Preparation Clarify the target analyte to be tested, intended use and application scenarios, and complete research on market capacity, competing products and clinical demands. Confirm technical feasibility through literature review, form the project team, and prepare the project initiation assessment document for review and approval. Define core indicators such as product performance parameters and intended use, complete design input, and form the product summary materials required for registration. Stage 2: Product Development Raw material screening: Select no less than 3 qualified suppliers to ensure the quality of core raw materials (antigens, antibodies, primers, probes, etc.) is stable and traceable. Process and system optimization: Determine key parameters such as reagent formulation ratio, reaction ...
- Source: drugdu
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- September 16, 2026
the German Pharmaceutical and Pharma Exhibition

Organiser：AVOXA Time：September 15th – 17th, 2026 Address：ostfach 10 10 06, D-40001 Dusseldorf Stockum Church Street 61, D-40474, Dusseldorf, Germany – D-40001 Exhibition hall：Dusseldorf Exhibition Center Product range: Pharmaceuticals, home care products, diagnostic instruments, dietary products, hygiene products, cosmetics, pharmaceutical accessories and displays, pharmacy DP, pharmacy supplies About Expopharm： Expopharm, the German Pharmaceutical and Pharma Exhibition, is an international pharmaceutical trade fair that has established itself as a leading trade show for the European pharmaceutical industry. It alternates between Düsseldorf and Munich. Founded in 1949, Expopharm started as a pharmaceutical exhibition covering all sectors of the pharmaceutical world, including pharmaceuticals, toiletries, food supplements, naturopathy, as well as pharmaceutical equipment and technical literature. At Expopharm, you will not find key decision-makers from all other sectors of the industry gathered anywhere else like this. Leading current manufacturers will present their latest innovations in the industry, top software companies will showcase the ...
- Source: drugdu
- 42
- September 15, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: The application for a Medical Device Registration Certificate generally does not start with “preparing documents”. Instead, the first step is to confirm exactly which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while the registration certificate application process is usually required only for Class II and Class III devices. Therefore, before formally launching the application, enterprises must first complete product classification judgment, confirming the product name, structural composition, intended use, working principle and risk level, to avoid taking a wrong path in subsequent tests, clinical evaluation and declaration. After the classification is confirmed, the enterprise needs to clarify the registration applicant and the production arrangement. That is to confirm who acts as the registration applicant, who is responsible for production, whether entrusted ...
- Source: drugdu
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- September 14, 2026
Five innovative drugs approved for marketing

Recently, the National Medical Products Administration (NMPA) approved the marketing of five innovative drugs: Deuterated Aitinib Mesylate Tablets, Icosine Hydrochloride Tablets, Varigratetinib Tartrate Tablets, Veritumab Injection, and Lyconchitatumab Injection (subcutaneous). All five drugs were approved through the priority review and approval process. The NMPA conditionally approved the marketing of Deuterated Aitinib Mesylate Tablets submitted by Zhejiang Tongyuankang Pharmaceutical, indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 substitution mutation, accompanied by central nervous system metastasis. The NMPA approved the marketing of Icosine Hydrochloride Tablets submitted by Janssen-Cilag, indicated for adult patients and children aged 12 years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The NMPA conditionally approved the marketing of Varigratetinib Tartrate Tablets submitted by Hutchmed, indicated for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or ...
- Source: drugdu
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- September 11, 2026
Subsidiary’s novel coronavirus mRNA vaccine receives drug registration certificate

On September 10, Walvax Bio (300142) announced that its wholly-owned subsidiary, Yuxi Walvax, recently received the “Drug Registration Certificate” for the novel coronavirus mRNA vaccine issued by the National Medical Products Administration (NMPA). This vaccine is the company’s third-generation COVID-19 mRNA vaccine, developed iteratively based on its mRNA platform technology strategy. The marketing authorization application was submitted and accepted earlier this year. The vaccine is designed based on the JN.1 strain and is indicated for individuals aged 18 years and above for the prevention of diseases caused by novel coronavirus infection. In the first half of 2026, Walvax Bio achieved revenue of 834 million yuan and net profit attributable to the parent company of 54.19 million yuan. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870738792.html
- Source: drugdu
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- September 11, 2026
Lincomycin Hydrochloride Injection passes generic drug consistency evaluation

On September 10, Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., recently received the “Drug Supplementary Application Approval Notice” for Lincomycin Hydrochloride Injection issued by the National Medical Products Administration (NMPA). The drug has passed the generic drug quality and efficacy consistency evaluation. This drug is indicated for respiratory tract infections, skin and soft tissue infections, etc., caused by susceptible bacteria such as Streptococcus, Pneumococcus, and Staphylococcus aureus. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870825889.html
- Source: drugdu
- 60
- September 11, 2026
CSPC Pharmaceutical Group’s innovative chemical drug SYH2083 eye drops approved for clinical trials in China

On September 8, CSPC Pharmaceutical Group (1093.HK) announced that its Class 1 innovative chemical drug, SYH2083 eye drops, has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China to conduct clinical trials in China. This product is a small-molecule ophthalmic formulation with a novel mechanism of action. It treats ocular surface inflammation-related diseases by reducing T lymphocyte adhesion and activation, thereby lowering pro-inflammatory signals. Preclinical studies have shown that this product demonstrates significant pharmacodynamic activity in a mouse dry eye model, with a clear mechanism of action, indicating good clinical development potential. The approved clinical trial indication is dry eye syndrome, and the product also has the potential to be extended to other inflammatory ocular surface diseases such as allergic conjunctivitis. The approval of this product’s clinical trial will further enrich the Group’s innovative drug pipeline in the ophthalmology field. Source: WeChat Official Account ...
- Source: drugdu
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- September 11, 2026
Novel influenza virus mRNA vaccine approved for clinical trials

Hualan Biological Vaccine Co., Ltd. announced that it recently received the “Drug Clinical Trial Approval Notice” for its novel influenza virus mRNA vaccine, issued and approved by the National Medical Products Administration (NMPA). Influenza is an acute respiratory infectious disease caused by the influenza virus, characterized by rapid transmission and seasonal epidemics. Influenza viruses are prone to mutation, and the general population is susceptible. Key populations such as the elderly, children, and patients with chronic underlying diseases have a higher risk of severe illness and complications after infection. Hualan Vaccine’s novel influenza virus mRNA vaccine utilizes mRNA technology, delivering mRNA encoding influenza virus-related antigens to express corresponding antigens in vivo and induce an immune response. mRNA vaccine technology features flexible antigen design and relatively short design and production cycles. As of now, no influenza virus mRNA vaccine product has been officially approved for marketing in China, and there is no ...
- Source: drugdu
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- September 11, 2026
Yuanda and Weixin’s two adsorbed acellular pertussis-diphtheria-tetanus combination vaccines simultaneously approved for clinical trials

On September 7, 2026, two combination vaccines independently developed by Yuanda Weixin Life Sciences (Nanjing) Co., Ltd. and Yuanda Weixin Life Sciences (Hangzhou) Co., Ltd. simultaneously received clinical trial approval from the National Medical Products Administration (NMPA). The adsorbed component acellular pertussis-diphtheria-tetanus (reduced dose) combination vaccine is for individuals aged 6 years and above, while the adsorbed acellular pertussis-diphtheria-tetanus (component) combination vaccine is for individuals aged 2 months and above. Both vaccines employ component purification technology, aiming to provide safer and more effective prevention against pertussis, diphtheria, and tetanus. Source: WeChat Official Account | https://mp.weixin.qq.com/s?__biz=MzkzOTI1MDk5MA==&mid=2247571964&idx=1&sn=f1d26c6d22f66fb941eae3231fb9f78a
- Source: drugdu
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- September 11, 2026
【EXPERT Q&A】How should one apply for a medical device license (Class III)?

Drugdu.com expert’s response: For trading companies and distributors that sell Class III medical devices, it is the Class III Medical Device Business License that they need to apply for. For manufacturers, the required qualifications are the Medical Device Production License and the product-specific Medical Device Registration Certificate, and these two sets of qualifications must not be confused. The general application process for the Class III Medical Device Business License is as follows: Confirm that the product falls into the Class III category: Look up the medical device classification and corresponding classification coding of the target product first. Different products correspond to different business scope entries, and this step will directly affect the subsequent requirements for personnel, business premises and warehousing conditions. Prepare the required operating conditions: The enterprise needs to have a business premises that matches its operating scale, qualified quality management personnel, complete quality management rules and a computer ...
- Source: drugdu
- 60
- September 11, 2026

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