PharmaFocus Today – Page 13 – media

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
- 93
- 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
- 100
- 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
- 93
- 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
- 105
- 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
- 104
- 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
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- July 17, 2025
GLP-1/GIP dual receptor agonist HRS9531 obtains positive top-line results in China Phase III weight loss study

On July 15, Hengrui Medicine and Kailera Therapeutics of the United States jointly announced that the Phase III clinical trial (HRS9531-301) of HRS9531 injection, a dual receptor agonist of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), for the treatment of obese or overweight subjects in China has obtained positive top-line results. Compared with placebo, all dose groups of HRS9531 (2mg, 4mg, 6mg) achieved superiority in the co-primary endpoints and all key secondary endpoints. Hengrui Medicine said that the company plans to submit a new drug application (NDA) for HRS9531 injection for long-term weight management in China in the near future, and Kailera Therapeutics is promoting the global clinical development of HRS9531 (KAI-9531). According to Hengrui Medicine , HRS9531 is aA self-developed GLP-1/GIP dual receptor agonist. To date, HRS9531 has been tested in a number of clinical trials. HRS9531-301 is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study ...
- Source: drugdu
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- July 17, 2025
Domestic marketing authorization application for Perindopril Amlodipine Tablets approved

Lisheng PharmaceuticalOn the evening of July 15, it was announced that two specifications of Perindopril Amlodipine Tablets developed by Lisheng Pharmaceutical have recently been approved for marketing by the National Medical Products Administration. Perindopril Amlodipine Tablets (I) is the second in China and Perindopril Amlodipine Tablets (III) is the fourth in China. Generic drugs approved according to the new registration classification of chemical drugs are deemed to have passed the consistency evaluation. The specification of Perindopril Amlodipine Tablets (I) is 5 mg of perindopril arginine and 5 mg of amlodipine besylate per tablet (calculated as C20H25ClN2O5). Lisheng Pharmaceutical is the first company in China to obtain approval for generic drugs of this specification. The approval of Perindopril Amlodipine Tablets will further enrich the company’s product structure and help expand the company’s business areas. In January 2024, Lisheng Pharmaceutical submitted an application for registration and marketing authorization of Perindopril Amlodipine Tablets ...
- Source: drugdu
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- July 17, 2025
New study shows that a compound containing NMN can enhance anti-cancer immunity

Recently, scientist Vollmer and his colleagues published a study in the International Journal of Molecular Sciences, proving that taking a group of anti-aging compounds can enhance immunity, which is a key protective factor against aging. The mixture of compounds tested in the study included nano-filtered colostrum, egg yolk extract, NMN, quercetin, α-ketoglutaric acid, white mushroom and celery seed extract—collectively known as AgePro. In addition, immune cell-induced cancer cell killing was enhanced in adults aged 23 to 89, indicating that these compounds are effective at all ages. Importantly, AgePro does not activate immune cells in the absence of cancer cells, indicating that it is safe to take AgePro and the risk of autoimmunity is low. These findings suggest that a mixture of these compounds can safely enhance anti-cancer immunity, that is, it does not activate immune cells against healthy cells. AgePro enhances immune cell-induced cancer cell death Since decreased immunity is ...
- Source: drugdu
- 49
- July 17, 2025
Bayer wins the “world’s first”

Recently, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom officially approved the marketing of elinzanetant, a non-hormonal drug developed by Bayer, for the treatment of moderate to severe vasomotor symptoms associated with menopause (such as hot flashes and night sweats). This approval is a milestone, and elinzanetant has become the world’s first neurokinin-1 and -3 (NK-1,3) dual receptor antagonist approved for this indication. Menopause is a natural stage in many women’s lives, but the symptoms that come with it, such as hot flashes and night sweats, bring a lot of inconvenience to their lives. Traditionally, hormone replacement therapy has been the main treatment, but many women are unable or unwilling to take this treatment due to its potential side effects. The emergence of elinzanetant brings new hope to these women. The drug effectively relieves menopausal hot flashes by inhibiting overactive KNDy neurons in the hypothalamus (which ...
- Source: drugdu
- 56
- July 17, 2025

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