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Sinovac’s Trivalent Influenza Vaccine Age Indication Expanded to Cover All Individuals Aged 6 Months and Older

Beijing Sinovac Biotech Co., Ltd. announced that the expanded age indication for its trivalent influenza vaccine An’er Lifu® (0.5ml/dose) has recently been approved by the National Medical Products Administration (NMPA). With this approval, the target population has been broadened to include children from 6 to 35 months old, making the vaccine suitable for all individuals aged 6 months and above. Reported as China’s first preservative-free trivalent influenza vaccine since its 2006 launch, An’er Lifu® serves a critical population. Children aged 6-35 months face high risks of flu complications, making vaccination the most effective and affordable prevention method. Following expanded age approvals for both Sinovac’s quadrivalent and trivalent flu vaccines (0.5ml/dose), the company has now standardized its seasonal vaccine dosages for everyone aged 6 months and above. This milestone will ensure immunization protection for all eligible groups including young children, significantly improving influenza vaccine accessibility across China. In terms of virus ...
- Source: drugdu
- 86
- November 19, 2025
Subsidiary’s Methylprednisolone Sodium Succinate for Injection Obtains Registration Certificate in Panama

Tianjin Pharmaceutical Group announced on the evening of November 18 that its subsidiary, Tianjin Pharmaceutical Group Co., Ltd., has obtained a registration certificate from the Ministry of Health of the Republic of Panama for Methylprednisolone Sodium Succinate for Injection. This milestone signifies that the drug is approved for manufacturing and marketing in the Republic of Panama. Following the product’s registration certificate from the Ministry of Health of the Dominican Republic in April this year, this latest approval marks another significant achievement in the company’s expanding international presence. Methylprednisolone Sodium Succinate for Injection is a corticosteroid medication primarily used for anti-inflammatory therapy, immunosuppressive treatment, managing hematological diseases and cancers, and treating shock.Tianjin Pharmaceutical Group Co., Ltd. submitted its registration application to the Ministry of Health of the Republic of Panama in 2024 and received approval, securing the registration certificate in November 2025. According to the IQVIA database, the global sales of ...
- Source: drugdu
- 74
- November 19, 2025
New antibody strategy shows promise for halting cyst growth in polycystic kidney disease

Polycystic kidney disease (PKD) is a debilitating hereditary condition in which fluid-filled sacs form and proliferate in the kidneys. Over time, the painful, growing cysts rob the organs of their function, often leading to dialysis in advanced cases. There is currently no cure. Researchers at UC Santa Barbara, however, have proposed a cyst-targeted therapy that could interrupt the runaway growth of these sacs by leveraging the target specificity of the right monoclonal antibodies – lab-made proteins that are used in immunotherapy. “The cysts just keep growing endlessly,” said UCSB biologist Thomas Weimbs, senior author of the study published in the journal Cell Reports Medicine. “And we want to stop them. So we need to get a drug into these cysts that will make them stop.” This research was funded in part by the National Institutes of Health and the U.S. Department of Defense. Interrupting a runaway process There are a ...
- Source: drugdu
- 75
- November 19, 2025
New AI Might Boost Liver Donations By Highlighting Best Potential Donors

By Dennis Thompson HealthDay ReporterTUESDAY, Nov. 18, 2025 (HealthDay News) — Artificial intelligence (AI) might help more donated livers reach recipients in a usable state by predicting how soon an organ donor will die after being taken off of life support, a new study says. The time between removal of life support and death can’t exceed 30 to 45 minutes, or transplant surgeons will reject a donated liver because it’s less likely to work effectively in a recipient, researchers said. A trained AI model reduced the rate of futile organ procurements by 60% by predicting better than doctors whether a donor is likely to die within that time frame, researchers recently reported in The Lancet Digital Health. “By identifying when an organ is likely to be useful before any preparations for surgery have started, this model could make the transplant process more efficient,” senior researcher Dr. Kazunari Sasaki, a clinical ...
- Source: drugdu
- 58
- November 19, 2025
【EXPERT Q&A】What are the requirements for the registration of Class III in vitro diagnostic reagents?

Drugdu.com expert’s response: As high-risk medical devices, Class III in vitro diagnostic reagents have registration requirements covering multiple aspects, as detailed below: I. Management Category and Registration Pathway Management Category: Class III in vitro diagnostic reagents are subject to registration management and are directly approved by the National Medical Products Administration (NMPA). Registration Pathway: For newly developed products not yet listed in the classification catalog of in vitro diagnostic reagents, applicants may directly apply for the registration of Class III in vitro diagnostic reagents or determine the product category in accordance with classification rules, apply to the NMPA for category confirmation, and then apply for product registration or handle product filing. For direct applications for the registration of Class III in vitro diagnostic reagents, the NMPA will determine the category based on the risk level. II. Product Technical Requirements and Registration Inspection Product Technical Requirements: Applicants or filers should formulate ...
- Source: drugdu
- 102
- November 19, 2025
Biosimilar drug pertuzumab approved for market in the United States can cover all indications of the original product

On November 17th, Shanghai Fuhong Hanlin Biotechnology Co., Ltd. (hereinafter referred to as “Fuhong Hanlin”) announced that its HLX11 (Pertuzumab, US trade name: POHERDY) ®） Approved by the US Food and Drug Administration (FDA), it can be used interchangeably with the original product PERJETA (pertuzumab), becoming the first and only PERJETA biosimilar drug in the United States, covering all indications approved for the original product in the United States. As of now, 7 products of Fosun Pharma have been approved for overseas market, including 4 products approved for market in the United States. The reporter also learned from Fosun Pharma that this is the first pertuzumab biosimilar drug in the United States and the first FDA approved interchangeable biosimilar drug for the treatment of cancer. HLX11 has also submitted listing applications and been accepted in China, Europe, and Canada. Partoluzumab is a monoclonal antibody against HER2 receptor, which is applicable ...
- Source: drugdu
- 94
- November 18, 2025
NIH Funding Cuts Have Affected Over 74,000 People Enrolled in Experiments, a New Report Says

A new report finds over 74,000 people enrolled in experiments have been affected by the National Institutes of Health’s funding cuts Nov. 17, 2025, at 11:00 a.m Source: Associated Press NEW YORK (AP) — Over 74,000 people enrolled in experiments have been affected by the National Institutes of Health’s funding cuts, according to a new report. Between the end of February and mid-August, funding ceased for 383 studies that were testing treatments for conditions including cancer, heart disease and brain disease. The cuts disproportionately impacted efforts to tackle infectious diseases like the flu, pneumonia and COVID-19, researchers found. The funding cuts likely disrupted patients’ lives in different ways. Some may have signed up for trials that never began or got delayed as institutions scrambled for alternate funding. Others could have lost access to medication or been left with an unmonitored device implant. More still could have participated in trials only ...
- Source: drugdu
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- November 18, 2025
FDA Limits Duchenne Gene Therapy After Two Teens Die of Liver Failure

MONDAY, Nov. 17, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is tightening restrictions on a gene therapy used to treat Duchenne muscular dystrophy after two teenagers died from liver failure linked to the medication. The FDA decision limits the use of Elevidys, made by Sarepta Therapeutics, to boys who are 4 years and older who can still walk, the agency said. It will no longer be allowed for boys who have already lost mobility, something that typically happens around age 12 for patients with Duchenne. Officials said a safety review confirmed that the two teens developed severe liver damage after receiving the infusion. Both later died. The FDA is also adding its strictest boxed warning to highlight the risks of serious liver injury, acute liver failure and death. Sarepta, based in Cambridge, Massachusetts with offices worldwide, told regulators earlier this year that it had already stopped ...
- Source: drugdu
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- November 18, 2025
Nine drugs, including HRS-4642 injection, received approval notices for clinical trials.

　　Nanfang Finance News, November 17th – Jiangsu Hengrui Medicine Co., Ltd. ( 01276.HK) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., recently received approvals from the National Medical Products Administration for HRS-4642 injection, SHR-1701 injection, SHR-7367 injection, SHR-8068 injection, adebecilimab injection, bevacizumab injection, SHR-A2102 for injection, and apple .The Clinical Trial Approval Notices for Famitinib Malate Capsules and Dalcilide Ethylhex … https://finance.eastmoney.com/a/202511173566406150.html
- Source: drugdu
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- November 18, 2025
China’s First FRα-ADC Drug Receives Routine Approval

　　On the evening of November 17th, Huadong Medicine(000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration (NMPA) for its supplemental application to change from conditional approval to regular approval for somituximab injection (ELAHERE®). 　　The announcement indicates that somituximab is the first and currently only FRα-targeting ADC drug approved in China, the United States, and the European Union for the treatment of platinum-resistant ovarian cancer (PROC). Hangzhou Sino-American East China Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, holds exclusive clinical development and commercialization rights for this product in Greater China. 　　It is understood that somituximab is an innovative ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer), developed in collaboration between Sino-American Huadong and Immuno Gen, Inc. (now acquired by AbbVie).It consists of an FRα-binding antibody, a cleavable linker, ...
- Source: drugdu
- 86
- November 18, 2025

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