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【EXPERT Q&A】How to apply for the quality management system verification of the registration of Class III medical devices within the territory?

Drugdu.com expert’s response: Application Process for Quality Management System Verification of Class III Medical Device Registration within China I. Submission of Registration Application and Verification Materials: The applicant must submit a quality management system verification application simultaneously with the Class III medical device registration application to the National Medical Products Administration (NMPA). Within 10 days of accepting the registration application, the NMPA will notify the corresponding provincial, autonomous regional, or municipal drug regulatory authority (provincial authority) to initiate the verification. II. Verification Notification and Material Preparation: Within 10 working days of accepting the application, the NMPA’s Center for Medical Device Evaluation (CMDE) will send the quality management system verification notification, relevant materials, and an electronic copy of the registration application form to the provincial authority. For cases involving cross-provincial contract manufacturing, the notification will only be sent to the provincial authority where the registrant is located, which shall then coordinate ...
- Source: drugdu
- 59
- January 23, 2026
Recombinant Zoster Vaccine (Shingles Vaccine) Receives Clinical Trial Approval Notice

On the evening of January 21, 2026, Hualan Vaccine announced that it recently received the “Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) for its Recombinant Zoster Vaccine (CHO Cell). Following a review conducted under the Drug Administration Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China, and other relevant regulations, the vaccine (accepted on October 30, 2025) has met the requirements for drug registration. Clinical trials for the prevention of herpes zoster (shingles) are now authorized to proceed. The announcement explains that Herpes Zoster (Shingles) is an acute cutaneous and neurological disease caused by the reactivation of the varicella-zoster virus (VZV) after years of dormancy. It primarily affects adults and the elderly with declining immune function. Characterized by clusters of vesicles along nerves and significant pain, it can severely impact quality of life. Its primary complication, postherpetic ...
- Source: drugdu
- 70
- January 22, 2026
HeartCare Medical (06609.HK) Announces NMPA Acceptance of Registration Application for Self-Expanding Intracranial Drug-Eluting Stent

On January 20, 2026, HeartCare Medical-B (06609.HK) issued an announcement stating that the registration application for its self-developed self-expanding intracranial drug-eluting stent has been formally accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China. Designed for the treatment of intracranial atherosclerotic stenosis, the stent is capable of supporting and reopening narrowed or obstructed lumens while effectively preventing in-stent restenosis. The company stated that there are currently no similar products approved for marketing worldwide, and its research and development progress remains at a leading level within the industry. However, the announcement also noted that there is no guarantee the stent will ultimately be successfully commercialized. Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares. https://finance.eastmoney.com/a/202601213625547124.html
- Source: drugdu
- 71
- January 22, 2026
Two drugs from Hengrui Medicine have received clinical trial approval

On January 21, Hengrui Medicine issued an announcement stating that its subsidiaries, Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd., received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for SHR-7787 Injection and Adebelimab Injection, and will conduct clinical trials in the near future. According to the announcement, SHR-7787 injection is a Class 1 therapeutic biological product.It works by inducing and activating T cells, enabling them to target and kill tumor cells. Adebelimab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by the company. It can block the PD-1/PD-L1 pathway that leads to tumor immune tolerance by specifically binding to PD-L1 molecules, thereby reactivating the anti-tumor activity of the immune system and achieving the purpose of treating tumors. https://finance.eastmoney.com/a/202601213626206498.html
- Source: drugdu
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- January 22, 2026
Subsidiary’s Drug Production License Changed

On January 21, Buchang Pharma’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., has obtained a renewed Drug Production License from the Shandong Provincial Drug Administration, which has approved the application for changes to the license. The issuing authority is the Shandong Provincial Drug Administration. Details of the changes: Contract manufacturing has been approved, with Yangling Buchang Pharmaceutical Co. , Ltd. and Shandong Buchang Pharmaceutical Co., Ltd. as the contract manufacturers. The products to be manufactured are loxoprofen sodium oral solution (10ml: 60mg) and melogabalin besylate tablets (2.5mg (C12H19NO2) – 5mg (C12H19NO2)). The contract manufacturing validity period is until July 16, 2028, and is limited to product registration applications. Approval information has also been added, involving ibuprofen sustained-release capsules (National Drug Approval Number H20255656). This change will help the company optimize its production structure, maintain stable production capacity, meet market demand, and have a positive impact on the company’s future operations. ...
- Source: drugdu
- 57
- January 22, 2026
Sunshine Novo’s Small Nucleic Acid Drug IND Application Accepted; Innovative Drug Pipeline Enters Harvest Phase

SSE News / China Securities Online (Reporter: Li Yanzheng) — Sunshine Novo announced on January 21, 2026, that its investigational small nucleic acid drug, ABA001, has formally received Clinical Trial Application (IND) acceptance from the National Medical Products Administration (NMPA). The drug is targeting hypertension, marking a pivotal step forward for the company’s nucleic acid drug platform. ABA001 utilizes GalNAc covalent conjugation technology to precisely deliver siRNA into hepatocytes, specifically degrading AGT mRNA to effectively “shut off” the pressor switch of the Renin-Angiotensin-Aldosterone System (RAAS). Non-clinical data demonstrate that a single subcutaneous injection can produce rapid and sustained blood-pressure-lowering effects in animal models, accompanied by a favorable safety profile. Classified as a Category 1 innovative chemical drug, ABA001 is intended for the treatment of primary hypertension. It offers the potential for quarterly or even semi-annual dosing, a significant improvement over existing daily medications. According to the regulatory review process, if ...
- Source: drugdu
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- January 22, 2026
Big news! Chia Tai Tianqing’s oral GLP-1 has been approved for clinical trials! Can its differentiated “biased” mechanism break through the red ocean market?

On January 20, the CDE (Center for Drug Evaluation) announced the implicit approval for clinical trials, showing that TQF3250 capsules, an oral weight-loss product submitted by Chia Tai Tianqing Pharmaceutical Group in November last year, has been approved for clinical trials. Unlike the more familiar GLP-1 receptor agonists on the market, TQF3250 is an “orally administered small molecule-biased GLP-1 receptor agonist.” It preferentially activates cAMP-related pathways, reducing β-arrestin recruitment and receptor endocytosis, aiming to achieve a better balance between duration of action and tolerability. From a mechanistic research perspective, the signal bias of the GLP-1 receptor is indeed considered a potential direction for optimization by the academic community. Rewinding to a month ago, a landmark event occurred in the global narrative of oral weight-loss drugs. Novo Nordisk’s oral weight-loss drug received FDA approval in December 2025, seizing a crucial position in the oral weight-loss drug market. Subsequently, Eli Lilly’s oral ...
- Source: drugdu
- 51
- January 22, 2026
Industry News | Roche’s Class 1 Oral GLP-1 Receptor Agonist Approved for Clinical Trials in China

On January 20, the website of the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that Roche’s Class 1 new drug RO7795081 has been approved for clinical trials in China, intended for long-term weight management in overweight or obese patients. Public information shows that RO7795081 (CT-996) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist . Roche previously entered into a merger agreement with Carmot Therapeutics, acquiring the company for approximately $3.1 billion, thereby gaining access to three GLP-1 investigational therapies, one of which is CT-996. Publicly available information shows that, unlike endogenous GLP-1 hormones, CT-996 is specifically designed as a biased GLP-1 receptor agonist that activates cAMP signaling with minimal recruitment of β-arrestin. These precisely modulated signaling properties promise to lead to robust glycemic control, resulting in significant weight loss and good tolerability. In July 2024, Roche announced positive results from a Phase 1 clinical ...
- Source: drugdu
- 57
- January 22, 2026
Analytica Anacon

Organiser：Messe München GmbH (Germany) Time：April 22 -24, 2026 Address：NESCO, Goregaon East, Mumbai, Maharashtra 400063 (Note: The original text seems to be missing the last digit of the postal code, here I’ve added a commonly used one for Mumbai area for reference; you may need to verify it.) Exhibition hall： Bombay Exhibition Center Product range: Analytical Technology: Analytical instruments and equipment, microscopes and optical imaging processing, spectral and chromatographic products Testing, Measurement, and Quality Control: Industrial quality control, material property identification technologies, material testing, pharmaceutical and industrial quality control Laboratory Equipment: Laboratory apparatus and equipment, laboratory data and archiving management equipment, chemicals, reagents, and consumables Life Sciences and Testing & Measurement Technology: Bioanalysis, biochemical agents and bioinformatics technologies, laboratory testing and measurement supplies About Analytica Anacon ： Analytica Anacon India, the India Laboratory Instrument and Analytical Biotechnology Exhibition, is the most influential exhibition in the laboratory, analytical, and biochemical technology sectors ...
- Source: drugdu
- 70
- January 22, 2026
Phase III Clinical Trial of Recombinant Staphylococcus Aureus Vaccine Progressing Normality

Securities Daily Online, Jan 20 (Reporter) — Olymvax Biopharmaceuticals stated during an investor survey that the Phase III clinical trial of the company’s recombinant Staphylococcus aureus vaccine is proceeding as planned. As of now, the study remains blinded, and no efficacy data has been generated yet. The company expects to complete the initial and confirmatory testing of all serum samples in the first quarter of this year (2026). Meanwhile, data cleaning is currently underway. It is anticipated that after completing data cleaning and obtaining the serum test reports in the first half of this year, the company will be able to perform a periodic database lock and the first unblinding for protective efficacy analysis. As vaccine clinical trials are susceptible to various factors, the final progress and results of the clinical trials shall be subject to the company’s official public disclosures. https://finance.eastmoney.com/a/202601203624958315.html
- Source: drugdu
- 62
- January 21, 2026

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