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The 11th batch of centralized drug procurement has officially started, with 55 varieties initiating a competition for positions

On July 15th, the National Organization Drug Joint Procurement Office issued a notice to launch the 11th batch of national organization drug centralized procurement related drug information reporting work. The reporting time for enterprises is from July 16th, 2025 to July 31st, 2025 at 4:00 pm. According to relevant information, in the initial stage of variety selection, the eleventh batch of centralized procurement will end on March 31, 2025, and the selection criteria will continue to use the “number of reference preparations and generic drug companies that have passed consistency evaluation reaches 7 or more” from the tenth batch of centralized procurement. A total of 122 varieties meet the entry threshold. After three stages of screening, 55 varieties were finally included in the 11th batch of centralized procurement reporting. The drugs included in the scope of centralized procurement are mainly oral sustained-release forms and injections, accounting for over 80% ...
- Source: drugdu
- 77
- July 18, 2025
FDA Widens Indication of Finerenone for Heart Failure Patients

The FDA has expanded the indications of finerenone to include patients with heart failure with a left ventricular ejection fraction (LVEF) of at least 40%. The expanded approval for finerenone, a nonsteroidal mineralocorticoid receptor antagonist developed by Bayer, comes on the strength of the phase 3 FINEARTS-HF trial, published last year in the New England Journal of Medicine. The study demonstrated that, alongside standard medical care, patients who received the drug achieved a 16% reduction in the risk of cardiovascular death and unplanned or urgent hospitalization due to heart failure. The benefit was driven by a reduction in worsening heart failure events; no significant effect was seen on cardiovascular death. The FDA initially approved finerenone in 2021 to reduce the risk for cardiovascular death, hospitalization for heart failure, nonfatal myocardial infarction, and kidney complications in adults with chronic kidney disease associated with type 2 diabetes. The latest decision expands treatment ...
- Source: drugdu
- 81
- July 18, 2025
Researchers Try New Ways of Preserving More Hearts for Transplants

WASHINGTON (AP) — Two university hospitals are pioneering new ways to expand lifesaving heart transplants for adults and babies — advances that could help recover would-be heart donations that too often go unused. The new research aims to overcome barriers for using organs from someone who dies when their heart stops. Called DCD, or donation after circulatory death, it involves a controversial recovery technique or the use of expensive machines. Surgeons at Duke and Vanderbilt universities reported Wednesday that they’ve separately devised simpler approaches to retrieve those hearts. In the New England Journal of Medicine, they described successfully transplanting hearts to a 3-month-old infant at Duke and three men at Vanderbilt. “These DCD hearts work just as well as hearts from brain-dead donors,” said Vanderbilt lead author Dr. Aaron M. Williams. How hearts are saved for donation Most transplanted hearts come from donors who are brain dead. In those situations, ...
- Source: drugdu
- 74
- July 18, 2025
CanSino Biologics receives approval from the Food and Drug Administration to conduct clinical trials of recombinant trivalent polio vaccine

July 16, CanSino (688185/06185) announced that it had recently received the “Drug Clinical Trial Approval Notice” for the recombinant trivalent polio vaccine (Sf-RVN cells) approved and issued by the National Medical Products Administration. The registration classification of this vaccine is a preventive biological product in category 1.2: The application is for registration of clinical trials of domestically produced drugs. The approval conclusion is to agree to conduct clinical trials for the prevention of poliomyelitis caused by polio virus infection type I, type II, and type III. The recombinant polio vaccine is prepared through protein structure design and VLP assembly technology, has good safety and immunogenicity, and does not contain viral genetic material. The vaccine is currently undergoing Phase I/II clinical trials in Indonesia. In the first quarter of 2025, CanSino Biologics achieved revenue of 137 million yuan and a net profit attributable to shareholders of the parent company of -11.55 ...
- Source: drugdu
- 76
- July 18, 2025
Bio-Thera’s BAT2506 (golimumab) injection marketing authorization application accepted by the U.S. FDA

On July 16, Bio-TheraThe company announced that it had recently received the BAT2506 (golimumab) injection biologicThe drug licensing application (BLA) has been accepted by the U.S. Food and Drug Administration (FDA). Its indications include active ankylosing spondylitis (AS), combined with methotrexate for the treatment of moderately to severely active rheumatoid arthritis (RA), moderately to severely active ulcerative colitis (UC) that is dependent on corticosteroids or has insufficient response or intolerance to other treatment options, etc. The announcement shows that BAT2506 (golimumab) injection is a golimumab biosimilar developed by Bio -Thera in accordance with the relevant guidelines of the National Medical Products Administration, the US FDA, and the European EMA for biosimilars. Golimumab is an antibody targeting TNF-α, which can specifically bind to soluble and transmembrane human TNF-α with high affinity, blocking the binding of TNF-α to its receptor TNFR, thereby inhibiting the activity of TNF-α. It is reported that the ...
- Source: drugdu
- 72
- July 18, 2025
When FDA made 200 rejection letters public

Recently, the U.S. FDA published for the first time about 200 Complete Response Letters (CRLs), covering new and generic drugs. This move marks a major institutional breakthrough in the FDA’s transparency process and also reveals the information blind spots that have been kept secret in the pharmaceutical regulatory system for many years. A CRL is a non-approval response from the FDA after evaluating a drug application (NDA or BLA), detailing the reasons for the rejection, the reviewers’ concerns, and possible remedial measures that the applicant may need to take in the future. However, for a long time, these letters were only sent to pharmaceutical companies, and the FDA was not allowed to proactively disclose them unless the pharmaceutical company chose to disclose them. This often makes the real reasons for the failure of drug development unclear, and the outside world can only speculate based on the vague wording released by ...
- Source: drugdu
- 73
- July 18, 2025
【EXPERT Q&A】What are the document requirements for the registration of Class II medical devices in China?

Drugdu.com expert’s response: I. Enterprise Qualifications and Basic Documents Medical Device Registration Application Form Must include detailed information such as product name, model, specifications, intended use, manufacturing process, and quality control methods, accompanied by product photographs. Enterprise Qualification Certificates Business license. Medical Device Manufacturing License (if already obtained). Identity certificates and educational/professional qualification certificates of the legal representative, enterprise person in charge, and quality manager. Power of Attorney Required if the registration is handled by someone other than the legal representative or enterprise person in charge, with an authorized signature and official seal. II. Technical Documentation and Product Information Product Technical Files Design principles, structural features, and performance specifications: Detailed descriptions of technical parameters, functional characteristics, and testing methods. Bill of materials: Includes specifications, models, quality standards, and supplier qualification documents for raw materials, components, and assemblies. Manufacturing process flowchart: Must annotate key and special processes, accompanied by process descriptions. ...
- Source: drugdu
- 75
- July 18, 2025
Yoga, Tai Chi, walking and jogging found to improve sleep and ease insomnia

Yoga, Tai Chi, walking and jogging may be the best forms of exercise to improve sleep quality and ease insomnia, suggest the findings of a comparative pooled data analysis published in the online journal BMJ Evidence Based Medicine. The findings back the use of exercise as a primary treatment strategy for poor sleep patterns, say the researchers. Characterized by difficulties falling and staying asleep, and early morning awakening, the prevalence of insomnia ranges from 4-22%, note the researchers. It is associated with heightened risks of various mental and physical health conditions, including dementia and cardiovascular disease. Drug treatments for insomnia are not without their side effects, and cognitive behavioural therapy (CBT), while effective, isn’t always available due to the shortage of trained therapists, explain the researchers. An emerging body of research suggests that exercise is helpful, but current guidelines don’t specify which types of exercise might be most beneficial. The ...
- Source: drugdu
- 83
- July 17, 2025
Study Finds No Link Between Vaccine Aluminum and Health Problems

TUESDAY, July 15, 2025 (HealthDay News) — A new study of more than 1.2 million people found no link between aluminum in childhood vaccines and long-term health problems, including autism, asthma or autoimmune diseases. The research, published July 14 in the Annals of Internal Medicine, looked at 50 chronic conditions. They included 36 autoimmune diseases, nine types of allergies and asthma, and five neurodevelopmental disorders, such as autism and ADHD, NBC News reported. Aluminum has long been added to vaccines to help the body build a stronger immune response. But the additive has also become a target for vaccine skeptics, including some public figures who have called it harmful. “Our study addresses many of these concerns and provides clear and robust evidence for the safety of childhood vaccines,” senior author Anders Hviid, head of epidemiology research at Statens Serum Institute in Denmark, said. “This is evidence that parents need to ...
- Source: drugdu
- 84
- July 17, 2025
The 11th batch of centralized drug procurement has been launched; Zhongsheng Pharmaceutical acquires Lixin | 21 Health Daily

The 11th batch of centralized drug procurement work has been launched On July 15th, the National Healthcare Security Administration announced that the 11th batch of national organized drug centralized procurement work has been launched recently. After three-stage screening, 55 varieties have been included in the scope of the 11th batch of centralized procurement reporting. The person in charge of the relevant department of the National Medical Insurance Administration introduced that the 11th batch of centralized procurement of drugs organized by the state has completed the selection of the intended procurement varieties, and the reporting work for medical institutions will soon be carried out. The overall procurement rules will adhere to the principles of “stabilizing clinical practice, ensuring quality, preventing bid rigging, and combating internal competition”. Adhere to the principle of “centralized procurement of non new drugs and non centralized procurement of new drugs”, and scientifically determine the procurement varieties. ...
- Source: drugdu
- 80
- July 17, 2025

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