media – Page 39 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Sino Biopharmaceutical’s Zonaptinib Receives CDE Breakthrough Therapy Designation

On August 20, Sino Biopharmaceutical (01177) announced that its selective HER2 tyrosine kinase inhibitor, Zonectinib, has again received Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CFDA). Zonectinib is indicated for the first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring activating mutations in the HER2 tyrosine kinase domain (TKD). This Breakthrough Therapy designation was based on data from the BeamionLUNG-1 clinical trial. Studies have shown that the 5-year survival rate of patients with advanced non-small cell lung cancer is less than 30%. Among them, about 2%-4% of non-small cell lung cancer is driven by HER2 gene mutations. Currently, the first-line treatment for patients with advanced HER2 mutation NSCLC is still chemotherapy ± immunotherapy.No new drugs have been officially approved in China. Zonectinib, a covalently bound, oral, selective HER2 small molecule inhibitor developed by Boehringer ...
- Source: drugdu
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- August 26, 2025
Nasal Spray Live Attenuated Influenza Vaccine Obtains Drug Registration Certificate

On August 25, BCHT(688276) issued an announcement that the company received the nasal spray influenzaDrug registration certificate for live attenuated vaccine. The company’s approved nasal spray live attenuated influenza vaccine can simulate natural influenza virus infection through nasal inoculation , forming the first immune barrier in the respiratory tract to prevent influenza virus invasion. In the first quarter of 2025, BCHT achieved revenue of 162 million yuan and net profit attributable to shareholders of the parent company of 1.06 million yuan. https://finance.eastmoney.com/a/202508253493526324.html
- Source: drugdu
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- August 26, 2025
Xinjiang Medical Exposition

Organiser: Xinjiang Medical Exhibition Organizing Committee Time：September 5-7, 2025 address：No. 3 Hongguangshan Road, Shuimogou District, Urumqi, Xinjiang Uygur Autonomous Region Exhibition hall：Xinjiang International Convention and Exhibition Center Product range: Medical Exhibition Area: Medical imaging equipment, intelligent monitoring, diagnostic, and treatment devices, testing equipment, in vitro diagnostic reagents, surgical instruments and consumables, patient bed care equipment and appliances. Health and Wellness Exhibition Area: Rehabilitation medicine, rehabilitation equipment, assistive devices, physiotherapy equipment and supplies, travel and residential care for the elderly, health and wellness industry image project displays, health and wellness insurance industry. Dental and Ophthalmology Exhibition Area: Dental diagnostic equipment, dental treatment equipment, dental auxiliary equipment, eye health diagnosis and treatment, ophthalmic medical equipment, vision testing instruments and equipment. Traditional Chinese Medicine Exhibition Area: Chinese herbal medicines, Chinese medicine decoction pieces, traditional Chinese medicine diagnostic instruments, moxibustion products, traditional Chinese medicine physiotherapy + Internet products, traditional Chinese medicine equipment, packaging. Epidemic ...
- Source: drugdu
- 234
- August 26, 2025
How a single gene reshapes pain perception through polyamine signaling

In a recent study published in the journal Nature, an international team of researchers showed that solute carrier family 45 member 4 (SLC45A4) is a pain gene that encodes a neuronal polyamine transporter. Chronic pain affects one in five adults and has an adverse effect on the quality of life. Unfortunately, available treatments are often inadequate, with poor tolerability and efficacy. Polyamines, such as spermidine, spermine, and putrescine, are regulatory metabolites reported to contribute to chronic pain. They play crucial roles in nucleic acid synthesis and stability, cell signaling, and growth. Polyamines are implicated in neurological disorders, such as stroke and epilepsy. They can regulate neuronal excitability through ion channel interactions and have been linked to pain. Polyamines exhibit altered levels in pain states in humans and modulate pain behavior in animal models. Nevertheless, the systems influencing polyamine transport in the nervous system remain unclear. The study and findings In ...
- Source: drugdu
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- August 25, 2025
Flu Shot Season is At Hand

By Carole Tanzer Miller HealthDay ReporterSATURDAY, Aug. 23, 2025 (HealthDay News) — With a longtime vaccine critic leading the nation’s health departments, you might be wondering whether there’s a new flu shot this fall. There is — and Health and Human Services Secretary Robert F. Kennedy Jr. says most Americans should get it. He’s basing that recommendation on the advice of a board he appointed to advise the federal government on vaccines. The U.S. Centers for Disease Control and Prevention (CDC) says people 6 months old and up should get a flu shot. That’s pretty much the same advice the CDC has given in the past. This year’s version of the flu vaccine should be widely available soon, according to KFF Health News. No shortages are anticipated. So when should you roll up your sleeve? The best time to take the jab is September, October or early November, doctors say. ...
- Source: drugdu
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- August 25, 2025
Betta Pharmaceuticals discloses clinical research progress on ensartinib for postoperative adjuvant indications

Betta PharmaceuticalsOn the morning of August 25th, the company announced that in April 2022, the National Medical Products Administration (NMPA) approved the clinical trial of Ensartinib Hydrochloride Capsules (Bemena®, hereinafter referred to as “Ensartinib”) for the adjuvant treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) after surgery. Recently, an interim analysis of the clinical trial, as assessed by the Independent Data Monitoring Committee (IDMC), demonstrated positive results, meeting the study’s pre-specified primary endpoint and demonstrating statistically significant and clinically important benefits. Detailed data from this study will be presented at a major international academic conference this year. The company’s team is actively preparing application materials and aiming to submit the NDA for this new indication as soon as possible. https://finance.eastmoney.com/a/202508253492884316.html
- Source: drugdu
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- August 25, 2025
How NMN Helps Longevity Enzymes Fight Aging

Sirtuin enzymes are a family of NAD+-dependent deacetylase proteins, also known as sirtuins, which mediate many of the beneficial effects of NMN on the brain and intestines of aged mice. Left: Sirtuin 1 bound to the sirtuin activator resveratrol (magenta). Right: Sirtuin 6 bound to the sirtuin activator (yellow) and NAD+ (red). Sirtuins act like molecular switches, orchestrating the countless processes necessary for cellular health and longevity. These specialized proteins function as NAD+-dependent deacetylases—enzymes that remove acetyl groups from other proteins, effectively altering their function. They regulate processes ranging from DNA repair and energy metabolism to inflammation and cellular stress responses. However, sirtuin activity naturally declines with aging. Sirtuins are particularly intriguing because of their dependence on NAD+ (nicotinamide adenine dinucleotide). This crucial coenzyme serves as the “fuel” for sirtuin activity. Unfortunately, NAD+ levels naturally decline with age, dropping by up to 50% in mammals during the transition from youth ...
- Source: drugdu
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- August 25, 2025
Obtained U.S. FDA Drug Registration Approval for Nicardipine Hydrochloride Injection

SecuritiesDaily News Network reported on the evening of August 21 that Jianyou SharesThe company recently received an approval letter from the U.S. Food and Drug Administration (FDA) for nicardipine hydrochloride injection, 25mg/10mL (2.5mg/mL), according to an announcement. https://finance.eastmoney.com/a/202508213490940546.html
- Source: drugdu
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- August 25, 2025
The world’s first hexavalent rotavirus vaccine is approved for marketing

Recently, Sinopharm Group China National Biotec Group Wuhan Biological ProductsThe Institute’s oral hexavalent, reassortant, live attenuated rotavirus vaccine (Vero cell-based) (trade name: Wushengerlunbao®) has been officially approved for marketing by the National Medical Products Administration. This product, the world’s first and most expensive rotavirus vaccine, is a Class 1 new biological drug for preventive use in China and is primarily used to prevent acute gastroenteritis in infants and young children caused by rotavirus https://finance.eastmoney.com/a/202508223492196812.html
- Source: drugdu
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- August 25, 2025
【EXPERT Q&A】Are quality management systems in the medical device industry effective?

Drugdu.com expert’s response: The quality management system (QMS) in the medical device industry is not only valuable but also a core element in ensuring product safety and effectiveness, meeting regulatory requirements, enhancing corporate competitiveness, and promoting the healthy development of the industry. Its importance is reflected in the following aspects: Ensuring Patient Safety and Product Effectiveness Risk Control: Medical devices directly interact with the human body, and quality defects can lead to severe health risks (e.g., surgical instrument fractures, implant failures, diagnostic device misdiagnoses). The QMS reduces risks to acceptable levels through systematic risk assessments (e.g., Failure Mode and Effects Analysis, or FMEA), design controls, and production process monitoring. Performance Verification: Rigorous testing and validation (e.g., biocompatibility testing, electrical safety testing, performance stability testing) ensure that products meet their intended purposes and prevent medical accidents caused by functional failures. Meeting Global Regulatory and Compliance Requirements International Standard Mandates: Major global ...
- Source: drugdu
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- August 25, 2025

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