media – Page 165 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Fuhong Hanlin’s Pertuzumab Biologics License Application Accepted by FDA

On February 8, Fuhong Hanlin (02696) announced that the company’s independently developed Pertuzumab biosimilar HLX11’s Biologics License Application (BLA) has been accepted by the U.S. Food and Drug Administration (FDA). The application involves indications including combination with trastuzumab and docetaxel for the treatment of HER2-positive metastatic breast cancer patients who have not received anti-HER2 treatment or chemotherapy for metastatic disease, and as part of the overall treatment of early breast cancer for neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early breast cancer patients. HLX11 is a biosimilar independently developed by the company, intended for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, treatment of HER2-positive metastatic breast cancer, etc. According to the industry guidelines issued by the FDA, the BLA submitted this time is based on the data generated by HLX11 compared with Perjeta®, including similarity studies and phase III clinical comparison studies. According to data provided by ...
- Source: drugdu
- 320
- February 10, 2025
Merck suspends supply to China, domestic nine-valent HPV vaccine has not yet been launched

Recently, Merck announced in a earnings call after the disclosure of its financial report that it would suspend the supply of HPV vaccines to China until mid-2025 or longer. This is undoubtedly extremely explosive news. You must know that Merck’s quadrivalent and nine-valent HPV vaccine sales achieved US$8.9 billion in sales in 2023, of which 60%-70% came from the Chinese market. Its chairman and CEO Rob Davis even proposed a goal of exceeding US$11 billion in sales in 2030. Why did Merck do this, and what chain reactions will the domestic vaccine market and vaccine manufacturers have as a result? Overdrawn market, weak subsequent growth In the earnings call, Rob Davis bluntly stated that the sales dynamics of Merck’s HPV vaccine product Gardasil in China in 2025 are still challenging, and market demand has not yet returned to the company’s expectations, so the overall channel inventory is still higher than ...
- Source: drugdu
- 332
- February 10, 2025
CanSino’s Infant DTcP Vaccine Included in Priority Review

On February 7, CanSino Biologics announced that information on the website of the Center for Drug Evaluation under the National Medical Products Administration indicates that its Adsorbed Acellular Pertussis, Diphtheria, and Tetanus Combined Vaccine for Infants (hereinafter referred to as “Infant DTcP”) has been officially included in the priority review category. CanSino explained that the currently available pertussis-diphtheria-tetanus (DTP) vaccines on the domestic market use a co-purification process for pertussis antigens during manufacturing. In contrast, CanSino’s Infant DTcP is a component-based vaccine, in which each pertussis antigen is individually purified and then formulated in precise proportions. This process ensures batch-to-batch consistency and enhances the overall stability of the product’s quality. As of now, no domestically developed component-based DTP vaccines have been approved for sale in China. CanSino’s Infant DTcP is positioned as a domestic alternative to imported vaccines. Furthermore, the development of this vaccine lays the foundation for future research ...
- Source: drugdu
- 325
- February 10, 2025
Minhai Biotechnology’s Bivalent and Quadrivalent Inactivated Enterovirus Vaccines (Vero Cell) Approved for Clinical Trials

On February 7, Kangtai Biological issued an announcement stating that its wholly-owned subsidiary, Beijing Minhai Biotechnology Co., Ltd. (hereinafter referred to as “Minhai Biotechnology”), has received the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration (NMPA) for its bivalent inactivated enterovirus vaccine (Vero cell) and quadrivalent inactivated enterovirus vaccine (Vero cell). The company will promptly initiate related clinical trials in accordance with the requirements of the approval notice. The bivalent inactivated enterovirus vaccine (Vero cell) is intended for individuals aged 6 months to 71 months who are susceptible to EV-A71 and CV-A16. It stimulates the body to produce immunity against EV-A71 and CV-A16, and is used to prevent infectious diseases such as hand, foot, and mouth disease (HFMD) caused by enterovirus EV-A71 and CV-A16 infections. The quadrivalent inactivated enterovirus vaccine (Vero cell) is suitable for individuals aged 6 months to 71 months who are susceptible to EV-A71, ...
- Source: drugdu
- 318
- February 10, 2025
How DeepSeek Helps You Succeed Efficiently

In recent years, the application of artificial intelligence has been transforming industries at an unprecedented pace. As a leading AI-powered Q&A assistant, DeepSeek has quickly become a trusted partner for professionals in global trade. Particularly in the complex field of pharmaceutical trade, DeepSeek provides a range of practical tools to help businesses accurately target markets, enhance efficiency, and mitigate risks. As a global leader in cross-border pharma trade, Drugdu.com has explored ways to integrate DeepSeek’s capabilities with industry needs, delivering more efficient solutions to its users. Here’s how DeepSeek can empower your pharma trade business: Accurate Market Insights: AI as Your Detective Quickly Identify Customers and Markets Wondering which Southeast Asian country has the highest demand for raw pharmaceutical ingredients? DeepSeek uses big data analysis to provide swift, accurate answers and even generates visual reports, saving you time compared to traditional customs data checks. Monitor Competitors in Real-Time With ...
- Source: drugdu
- 576
- February 10, 2025
AI DeepSeek Drugdu Pharma Trade
【EXPERT Q&A】Why aren’t prescription drugs so tightly regulated?

Drugdu.com expert’s response: The reasons for the relatively lax regulation of prescription drugs involve multiple aspects, mainly including the following points: Profit-driven: The demand for prescription drugs is large and the profits are substantial, which leads some pharmacies to take risks and illegally sell prescription drugs in pursuit of profits. In a market economy, the primary business objective of pharmacies is economic benefits, so they may overlook the strictness of prescription drug regulation. Inadequate supervision: In some regions, the supervision of pharmacies is insufficient, making it difficult to effectively curb violations. The limited availability of regulatory resources and the relatively lagging regulatory measures may create loopholes in the practical operation of prescription drug regulation. Lack of consumer awareness: Some consumers lack sufficient understanding of the definition and importance of prescription drugs, making them susceptible to诱导by pharmacies. This information asymmetry leaves consumers with inadequate judgment and vigilance when facing prescription drugs. ...
- Source: drugdu
- 481
- February 10, 2025
Analysis Report on Import and Export of Medical Devices in China

This report is based on the import and export data of China Customs, and conducts multidimensional analysis from the overall trend of medical device import and export, trade categories, trading partners, trading provinces and cities, aiming to objectively evaluate the trend and market pattern of China’s medical device import and export trade, and provide certain data references for relevant enterprise project evaluation, market research, channel expansion, etc. The relevant data are all sourced from the global medical device big data service platform – Yaozhi Medical Device Data, under the umbrella of Yaozhi Network. If you need detailed data in the report, please go to Yaozhi Medical Equipment Data for more information. Overall analysis Overall, compared to last year, China’s import and export trade volume has shown a comprehensive growth trend. From January to December 2024, overall data shows that in terms of exports, the Asian market is the largest export ...
- Source: drugdu
- 941
- February 7, 2025
Starting from February 1st, the settlement method for centralized procurement consumables has changed

Hunan will implement a new settlement method for centralized procurement consumables, with artificial crystals as the first batch of products. Starting from February 1st, the settlement method will be changed Recently, the Hunan Provincial Medical Security Bureau issued a notice on the direct settlement of medical insurance fund payments for selected medical consumables in centralized quantity procurement (hereinafter referred to as the “Notice”), requiring direct settlement of medical insurance fund payments for selected consumables products in centralized procurement to be carried out from February 1, 2025. The document on which the “Notice” is based is the “Notice on Implementing Direct Settlement of Medical Insurance Funds for Centralized Procurement of Selected Products’ Medical Payment” (Xiang Medical Insurance Fa [2023] No. 36). The Notice specifies that from February 1st, direct settlement of medical insurance funds for selected consumables products through centralized procurement will be carried out. The first batch of consumables selected ...
- Source: drugdu
- 308
- February 7, 2025
Haisike has been approved to conduct clinical trials of the innovative drug HSK39004

On February 5, Haisike (002653) issued an announcement that its subsidiaries Tibet Haisike Pharmaceutical Co., Ltd. and Sichuan Haisike Pharmaceutical Co., Ltd. recently received the “Notice of Approval for Drug Clinical Trials” issued by the State Drug Administration, approving the innovative drug HSK39004 inhalation powder spray developed by them to conduct clinical trials. The drug is mainly used to treat chronic obstructive pulmonary disease and meets the relevant requirements for drug registration. HSK39004 is a targeted small molecule inhibitor independently developed by the company. Preclinical studies have shown that it has significant effects on airway relaxation and anti-inflammation, and has good safety and great development potential. According to the drug registration classification regulations, the drug is classified as Class 1 chemical drug. Although the project has good prospects, the company also reminds investors that the research and development cycle of innovative drugs is long and the risk is high, and ...
- Source: drugdu
- 381
- February 7, 2025
Innovative drugs are expected to accelerate into hospitals, and the Class C medical insurance catalogue is about to be released

Follow the incremental policy and grasp the incremental rhythm. At this stage and for a long time in the future, innovative drugs are the most clear direction of incremental policy support. We continue to be optimistic about high-quality innovative pharmaceutical companies and transformation companies that have achieved results. Innovative drugs are expected to accelerate into hospitals, and the Class C medical insurance catalogue is about to be released. The new version of the medical insurance catalogue will be implemented from January 2025, and many newly included blockbuster innovative drugs will speed up their entry into hospitals under the promotion of the implementation details. The 2025 medical insurance negotiations will be reported in advance on April 1, and the medical insurance negotiations will end in September, which will help the newly approved products to be included in the medical insurance faster. The first version of the Class C catalog is expected ...
- Source: drugdu
- 453
- February 7, 2025

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