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Zhonghui Bio-B recombinant RSV vaccine approved by FDA and CDE

On August 17, Zhonghui Bio-B (02627) announced that its independently developed recombinant respiratory syncytial virus vaccine (CHO cells) (adjuvanted) had received approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration and the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This vaccine was developed to target respiratory syncytial virus (RSV), a significant cause of respiratory infections in infants, the elderly, and immunocompromised individuals. According to the announcement, the company’s vaccine demonstrated higher pre-F protein expression levels (approximately 1,000 to 1,500 mg/L) in preclinical studies than the marketed recombinant RSV vaccine (approximately 600 to 800 mg/L for the marketed product). Furthermore, after 14 days at 40°C, the company’s pre-F protein activity remained above 95%, while the marketed product’s activity decreased to approximately 50%. This demonstrates that the company’s vaccine is more stable and immunogenic than similar products. While the company ...
- Source: drugdu
- 39
- August 18, 2025
【EXPERT Q&A】How can one query the natural medicines approved in the past decade and their sources through the FDA drug approval database?

Drugdu.com expert’s response: To query FDA-approved natural drugs and their sources over the past decade through the FDA drug approval databases, the following systematic workflow can be followed, integrating FDA official resources with natural product classification logic for efficient retrieval: I. Define Search Objectives and Natural Drug Categories Natural drugs typically refer to active ingredients directly derived from plants, microorganisms, marine organisms, or minerals, as well as their structurally modified derivatives. Key focus areas include: Plant-derived: Examples include paclitaxel (from Pacific yew) and artemisinin (from sweet wormwood). Microorganism-derived: Examples include erythromycin (from actinomycetes) and cyclosporine (from fungi). Marine-derived: Examples include trabectedin (from sea squirts) and eribulin (from sponges). II. Leverage FDA Core Databases for Screening Drugs@FDA Database Steps: Access the database and select “Advanced Search”. Set the “Approval Date Range” to the past decade (e.g., January 1, 2015, to December 31, 2025). Enter natural product-related keywords in the “Active Ingredient” ...
- Source: drugdu
- 58
- August 18, 2025
Quanguo Fund conducts research on Shenlian Biotechnology, and Shizhiyuan is conducting a phase II clinical trial of chronic spontaneous urticaria in China

According to the disclosed institutional research information, Quanguo Fund conducted research on listed company Shenlian Biotechnology from August 6, 2025 to August 8, 2025. Attached research content: 1、 An introduction was given on the recent business situation of the company, the research and development progress of new products such as multi valent vaccines, the company’s layout and positioning in the field of human biological products, and the future coordinated development strategy of animal protection and human drug use. 2、 Main communication Q&A Quan Guo Fund Q1. Please introduce the basic situation of Yangzhou Shizhiyuan Biotechnology Co., Ltd. Answer: Yangzhou Shizhiyuan Biotechnology Co., Ltd. is a high-tech biopharmaceutical enterprise established in October 2020. At the beginning of its establishment, it was an important biopharmaceutical development base set up by the United Biomedical, Inc. (UBI) group in mainland China, focusing on innovative drug development, clinical approval, project management, and promoting clinical trial ...
- Source: drugdu
- 51
- August 15, 2025
Respiratory viruses awaken dormant breast cancer cells and raise relapse risk

In a recent study published in Nature, an international team of researchers showed that respiratory viral infections awaken dormant breast cancer cells in the lungs. Breast cancer is the most prevalent cancer in females and the second leading cause of cancer-related deaths in the United States (US). Disseminated cancer cells (DCCs) can remain dormant for years after initial remission before metastatic relapse. The tumor microenvironment and cell-intrinsic factors determine whether metastatic cells progress or remain dormant. Notably, microenvironmental disturbances can be sufficient to increase metastasis. Respiratory viral infections are common, with seasonal flu affecting over one billion people yearly. These infections are usually associated with pulmonary inflammation along with an increase in inflammatory cytokines (interferons [IFNs] and interleukin 6 [IL-6]) and expansion of immune cells, such as macrophages, T cells, and neutrophils. Such inflammatory mechanisms have been reported as regulators of metastatic processes. The study and findings In the present ...
- Source: drugdu
- 50
- August 15, 2025
Got the Sniffles? Here’s What to Know About Summer Colds and the COVID-19 Variant Called Stratus

Summer heat, outdoor fun … and cold and flu symptoms? The three may not go together in many people’s minds: partly owing to common myths about germs and partly because many viruses really do have lower activity levels in the summer. But it is possible to get the sniffles — or worse — in the summer. Federal data released Friday, for example, shows COVID-19 is trending up in most states, with emergency department visits up among people of all ages. Here’s what to know about summer viruses. How much are colds and flu circulating right now? The number of people seeking medical care for three key illnesses — COVID-19, flu and respiratory syncytial virus, or RSV — is currently very low, according to data from the Centers for Disease Control and Prevention. Flu is trending down and RSV has been steady. But COVID-19 is trending up in most U.S. states. ...
- Source: drugdu
- 49
- August 15, 2025
The biochemical raw material of Vonola fumarate has been approved for marketing

People’s Finance News, August 13th: China National Pharmaceutical Group (600056) announced on the evening of August 13th that its wholly-owned subsidiary, Tianfang Pharmaceutical, has received the “Notice of Approval for the Marketing Application of Vonoprazan fumarate” issued by the National Medical Products Administration. This medicine is mainly used to treat reflux esophagitis. Combined with appropriate antibiotics to eradicate Helicobacter pylori. In addition, Tianfang Pharmaceutical has recently received the “European Pharmacopoeia Applicability” certificate for clindamycin phosphate approved and issued by the European Agency for the Quality of Medicines. This medicine is a lincomycin antibiotic, mainly used for infections caused by Gram-positive bacteria and anaerobic bacteria.
- Source: drugdu
- 49
- August 15, 2025
The SHR-7782 injection of Hengrui Medicine’s subsidiary has been approved for clinical trials of the drug

Beijing Business Today (Reporter Wang Yinhao, Intern Reporter Song Yuying) On August 14th, Hengrui Medicine announced that its subsidiary, Suzhou Shengdiya Biomedical Co., LTD., has received the “Notice of Approval for Clinical Trials of SHR-7782 Injection” issued by the National Medical Products Administration and will commence clinical trials in the near future. The announcement shows that SHR-7782 injection is a therapeutic biological product independently developed by the company. It can specifically bind to the surface antigens of tumor cells and kill tumor cells, and is intended for the treatment of advanced solid tumors. At present, no similar drugs have been approved for marketing either at home or abroad. https://finance.eastmoney.com/a/202508143484248589.html
- Source: drugdu
- 57
- August 15, 2025
Jiuzhou Pharmaceutical’s subsidiary Ruibo successfully passed the FDA cGMP on-site inspection

On August 12, Jiuzhou Pharmaceutical(603456) announced that its subsidiary, Ruibo (Suzhou) Pharmaceutical Co., Ltd., successfully passed a cGMP on-site inspection by the U.S. Food and Drug Administration (FDA) from May 19 to May 22, 2025, with a NAI (No Action Indicated) result. The inspection covered six major systems: quality systems, materials, production, packaging and labeling, equipment and facilities, and laboratory controls. The inspection involved the production of active pharmaceutical ingredients (APIs) Entresto, Kisqali, and Pyrenamine 07. This FDA on-site inspection demonstrates that Ribo Suzhou complies with US FDA requirements for its pharmaceutical cGMP quality management system and production environment and facilities. This provides assurance for the company’s continued international expansion and has a positive impact on its expansion into regulated markets globally. Furthermore, the company has established a hierarchical cGMP quality management system for R&D, production, quality control, and project management that meets leading global industry standards, which is expected ...
- Source: drugdu
- 40
- August 15, 2025
Boan Bio’s “Dulaglutide” biosimilar, a world first, has been approved, providing a new option for long-term glucose control for diabetic patients.

Recently (August 8), Luye Pharma’s subsidiary, Boan Bio, officially received marketing approval from the National Medical Products Administration for its independently developed dulaglutide injection (trade name: Boyuping®), specifically for blood sugar control in adults with type 2 diabetes. As the world’s first and currently the only approved biosimilar to Trulicity®, Boyuping® fills a gap in the domestic market – previously, no other domestically produced similar product had entered the marketing authorization application stage. This marks a major breakthrough for Chinese companies in the GLP-1 biosimilar field. As a long-acting GLP-1 receptor agonist, dulaglutide regulates insulin secretion by mimicking glucagon-like peptide-1, achieving stable blood sugar control. Its core advantage lies in its high compliance design, requiring only a once-weekly dosing regimen. It also offers multiple clinical benefits: in addition to lowering blood sugar, it can significantly reduce the risk of cardiovascular events, reduce weight, protect renal function, and has a low ...
- Source: drugdu
- 41
- August 15, 2025
【EXPERT Q&A】What does the release of the management regulations for the filing of Internet drugs and medical devices mean?

Drugdu.com expert’s response: The issuance of the Administrative Provisions on the Filing of Internet Information Services for Drugs and Medical Devices marks a new phase in China’s regulatory efforts to standardize and strengthen oversight of internet-based information services for drugs and medical devices. Its core significance is reflected in the following aspects: I. Regulatory Framework Upgrade: Decentralized Management Enhances Efficiency Clarified Division of Responsibilities National Medical Products Administration (NMPA): Oversees nationwide filing guidance and supervision, establishing unified standards. Provincial Medical Products Regulatory Authorities: Responsible for specific filings and local supervision, creating a “national coordination + local implementation” model that ensures policy consistency while enhancing regional regulatory flexibility. Refined Filing Units: Filings are conducted on a per-website or per-app basis to ensure traceability of information on each platform and prevent regulatory gaps caused by “one license for multiple uses.” Strengthened Dynamic Oversight Real-Time Updates for Filing Changes: Key information, such as the host ...
- Source: drugdu
- 68
- August 15, 2025

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