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【EXPERT Q&A】What are the main materials required for the registration and application of Class II medical devices in China?

Drugdu.com expert’s response: The registration application for Class II medical devices in China requires a range of materials covering multiple aspects to ensure the safety, effectiveness, and quality controllability of the products. Below are the main materials and their detailed descriptions: I. Basic Application Documents Medical Device Registration Application Form: It must be signed by the legal representative or person in charge and stamped with the official seal. All items filled in should be complete and accurate, consistent with the subsequent materials submitted. Usually, two copies are required, with one copy not bound and provided separately. Medical Device Manufacturer Qualification Certificate: Includes a copy of the “Medical Device Manufacturing License” and a copy of the “Business License”. The product applying for registration should fall within the production scope specified in the “Medical Device Manufacturing License”. Both the “Medical Device Manufacturing License” and the “Business License” must be valid. II. Product ...
- Source: drugdu
- 25
- January 19, 2026
【EXPERT Q&A】In vitro diagnostic reagents, if there are changes to matters not stated in the registration certificate and its attachments, is it necessary to apply for a change of registration?

Drugdu.com expert’s response: In the case of in vitro diagnostic reagents, if changes occur to matters not specified in the registration certificate and its attachments, there is no need to apply for a variation of registration. According to the “Measures for the Registration and Filing of In Vitro Diagnostic Reagents” and relevant regulations, when changes occur to matters not specified in the registration certificate and its attachments for in vitro diagnostic reagents, enterprises are not required to apply for a variation of registration with the original registration authority. However, they must control the changed content through their internal quality management systems, with the specific requirements as follows: I. Scope of Changes Not Involving the Registration Certificate Changes to matters not specified in the registration certificate and its attachments typically include, but are not limited to: Adjustments to packaging formats or specifications (e.g., changing from bulk packaging to single-dose packaging); Changes ...
- Source: drugdu
- 42
- January 16, 2026
1.2 Billion Yuan! Sino Biopharm Acquires Another Pharmaceutical Company

Sino Biopharm fully acquires Hegenia, a dark horse in siRNA Space, to enrich its pipeline in Chronic Disease Therapy. 01 Sino Biopharm Scores Another Major Win with the Acquisition Sino Biopharmaceutical Limited (“Sino Biopharm”) has just announced via an official filing that it will acquire Hangzhou Hegenia Biopharmaceuticals Co., Ltd. (“Hegenia”), a small interfering RNA (siRNA) drug developer, for a total consideration of CNY 1.2 billion. Upon completion of the transaction, Hegenia will become an indirect wholly-owned subsidiary of Sino Biopharm. This acquisition marks the first takeover of a domestic siRNA-focused biotech by a large-scale pharmaceutical enterprise in China, and also represents a key strategic move by Sino Biopharm in expanding its innovative drug portfolio. Sino Biopharm stated that the acquisition is aimed at building a next-generation innovative pipeline for cardiovascular therapy, optimizing its strategic layout in the weight management and metabolic disease sector, and further tapping into the ...
- Source: drugdu
- 78
- January 15, 2026
Breakthrough! Changshan Pharmaceutical’s enoxaparin sodium injection receives FDA approval in the United States, marking a new chapter in its overseas market journey!

Recently, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (stock abbreviation: Changshan Pharmaceutical, stock code: 300255 ) reached a significant milestone – the ANDA application for the generic version of its core drug, enoxaparin sodium injection , was officially approved by the U.S. Food and Drug Administration ( FDA ), with ANDA number 218775. This marks the first time Changshan Pharmaceutical’s heparin preparations have passed FDA certification in the United States, signifying that the company’s product quality has aligned with international standards and successfully obtained its “ticket” to enter the U.S. market. As a commonly used antithrombotic drug in clinical practice, enoxaparin sodium injection has indications covering multiple key scenarios: prevention of venous thromboembolic diseases associated with orthopedic and general surgery, reducing the risk of postoperative thrombosis; treatment of existing deep vein thrombosis (including cases with non-severe pulmonary embolism, excluding pulmonary embolism requiring surgery or thrombolytic therapy); treatment of unstable angina and ...
- Source: drugdu
- 80
- January 15, 2026
Kelun and Grand Pharmaceuticals compete for the first generic version of a blockbuster heart failure drug!

On October 16, 2025, Hubei Yuanda Tianming Pharmaceutical, a wholly-owned subsidiary of Grand Pharmaceutical Group, had its marketing application for ivabradine hydrochloride oral solution, submitted as a Class 3 chemical drug, accepted. Less than three months later, on January 9, 2026, Hunan Kelun Pharmaceutical also submitted a marketing application for the same product, becoming the second company to enter the market. This signifies the official start of the battle for the first generic version of ivabradine hydrochloride oral solution . Currently, only regular tablets of ivabradine hydrochloride are available on the Chinese market ; the oral solution formulation has not yet been approved. 01 Peak revenue within the hospital exceeded 300 million yuan, and the original drug led the market with a 57.43% market share. Ivabradine hydrochloride was originally developed by Servier in France . Its tablets were first approved for marketing in France in October 2005, in the United ...
- Source: drugdu
- 76
- January 15, 2026
Xuesaitong soft capsules are the company’s exclusive core dosage form

January 14th – Kunming Pharmaceutical GroupIn response to investor inquiries on the interactive platform, the company stated that Xuesaitong soft capsules are its exclusive core dosage form. As a liquid dosage form, soft capsules offer faster absorption rates, and the simplified formulation and single excipient composition help optimize product safety from the source, creating a differentiated advantage. The company continues to explore the application of Xuesaitong soft capsules in precise indications and in combination with other drugs. Among these, the core product “Lixuwang” Xuesaitong soft capsules combined with aspirin in the integrated traditional Chinese and Western medicine treatment plan “Ali Therapy” has achieved good academic results. Simultaneously, leveraging its comprehensive R&D pipeline and technological reserves, the company continuously iterates and upgrades existing products to meet the medication needs of different patient groups and consolidate and enhance its long-term competitiveness. Furthermore, the company highly values the medication experience and needs of ...
- Source: drugdu
- 63
- January 15, 2026
Hualan Biological’s investee company’s application for marketing authorization of adalimumab injection has been accepted

On January 13, Hualan Biological Engineering Co., Ltd.The company issued an announcement regarding its investee company, Hualan Ankang Biotechnology Co., Ltd.The company (formerly known as Hualan Gene Engineering Co., Ltd.) has received the Acceptance Notice (Acceptance No.: CXSS2600006) from the National Medical Products Administration for its application for registration and marketing authorization of adalimumab injection for domestic production. This drug is a biosimilar used to treat various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, and Crohn’s disease. The announcement stated that, as of now, Shenzhou Cell　　has [a certain number of] [products/services] in China.Adalimumab injection from eight companies, including an engineering company, has been approved for marketing. If Hualan Ankang’s product is ultimately approved for marketing, it will enrich its product portfolio and is expected to add a new profit growth point. https://finance.eastmoney.com/a/202601133616721398.html
- Source: drugdu
- 64
- January 15, 2026
Gan & Lee Pharmaceuticals’ glargine insulin injection receives marketing authorization from the European Commission

January 14th that Gan & Lee Pharmaceuticals…(603087) announced that the company and its wholly-owned European subsidiary, Gan & Lee Pharmaceuticals Europe Ltd., recently received a notification from the European Commission that the company’s product, insulin glargine injection (trade name: Ondibta), has obtained marketing authorization in the European Union, Iceland, Liechtenstein and Norway for the treatment of diabetes in adults, adolescents and children aged 2 years and older. https://finance.eastmoney.com/a/202601143619110685.html
- Source: drugdu
- 61
- January 15, 2026
Application for registration of erythromycin lactobionate for injection accepted

Fosun Pharma (600196) announced on January 14 that its subsidiary, Suzhou Erye Pharmaceutical Co., Ltd., has recently had its drug registration application for injectable erythromycin lactobionate accepted by the National Medical Products Administration. This drug is a chemical drug intended for use in treating infections caused by specific susceptible strains of microorganisms when oral administration is not feasible or the severity of the infection requires rapid attainment of high erythromycin serum concentrations; for the prevention of initial rheumatic fever; for the prevention of recurrence of rheumatic fever; and for the prevention of bacterial endocarditis. https://finance.eastmoney.com/a/202601143619173587.html
- Source: drugdu
- 69
- January 15, 2026
High-potency rabies vaccine completes Phase III clinical trials

On January 15, Aim Vaccine (06660) issued an announcement stating that its iterative process high-titer human diploid rabies vaccine has successfully completed Phase III clinical field work. This product demonstrated high levels of protective antibodies in animal trials, with a significantly higher potency than existing human diploid rabies vaccines. Compared to traditional first-generation human diploid rabies vaccines, the company’s vaccine has overcome technical bottlenecks such as low viral titer and low yield, optimized purification processes, and significantly improved product quality and safety. According to Frost & Sullivan, China’s rabies vaccine market is projected to reach RMB 14.8 billion by 2030. This vaccine offers flexible administration methods and has the capacity for large-scale production, making it expected to become the preferred choice for vaccination institutions, further solidifying the company’s market position and promoting sustainable development. https://finance.eastmoney.com/a/202601153619836997.html
- Source: drugdu
- 67
- January 15, 2026

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