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The next hot topic of HPV vaccine is here, let men get it too!

On November 18, Wantai Bio released an announcement stating that it has obtained approval from the National Medical Products Administration to conduct clinical trials for the indications of the nine-valent HPV vaccine for males. Wantai Bio pointed out that among the male population worldwide, about 70,000 new cancer cases are related to HPV infection each year, such as penile cancer, anal cancer, oropharyngeal cancer and other head and neck cancers. Of these cancers, about 90% can be attributed to polytypes of HPV6, 11, 16, 18, etc. Wantai Bio’s nine-valent HPV vaccine covers these viruses and can prevent precancerous lesions caused by these HPV viruses. With the saturation of the female market space, coupled with several rounds of internal competition for domestic HPV vaccines, even Merck’s nine-valent HPV vaccine has shown a decline this year. In the first half of 2024, Merck’s global sales of HPV vaccines increased by only 7% ...
- Source: drugdu
- 137
- November 25, 2024
World’s first! iPSC stem cell therapy restores human vision

On November 7, 2024, researchers from Osaka University published a research paper titled: Induced pluripotent stem-cell-derived corneal epithelium for transplant surgery: a single-arm, open-label, first-in-human interventional study in Japan in the international top medical journal The Lancet. This clinical study is the first in the world to use corneal epithelial cell sheets (iCEPS) derived from human induced pluripotent stem cells (iPSCs) to repair the cornea of patients with limbal stem cell deficiency (LSCD) visual impairment. The results showed that this new regenerative therapy is safe and helped improve patients’ vision. The research team plans to conduct larger clinical trials to better understand the therapeutic effects of the therapy. In this study, ophthalmologist Kohji Nishida from Osaka University and his team used induced pluripotent stem cells (iPSCs) to treat limbal stem cell deficiency (LSCD). The research team extracted blood cells from a healthy donor, then reprogrammed them into iPSCs, which were ...
- Source: drugdu
- 98
- November 25, 2024
【EXPERT Q&A】What is the difference between CE certification and FDA certification?

Drugdu.com expert’s response: Here is a detailed comparison between CE certification and FDA certification in multiple aspects, translated into English: Ⅰ. Issuing Authority and Definition CE Certification: Issued by the European Union, CE certification represents the safety certification of products in the European Union. It signifies that the product complies with the health, safety, and environmental protection regulations within the European Economic Area (EEA), serving as a “passport” for products to enter the EU market. FDA Certification: Issued by the Food and Drug Administration (FDA) of the United States, FDA certification is the regulatory agency of the US government for products related to human health and safety, including food, drugs, cosmetics, and medical devices. FDA certification is internationally recognized as one of the highest levels of safety certification and is a necessary condition for enterprises to enter the US market and some other countries with their products. Ⅱ. Scope of ...
- Source: drugdu
- 117
- November 25, 2024
Baique Ling’s products involved have no violations, and the official flag’s daily sales have increased by 500%

On November 22nd, China Net Finance reported that in response to the recent widespread online rumors about the alleged addition of banned ingredients to cosmetics produced by Shanghai Baique Ling Daily Chemical Co., Ltd. (hereinafter referred to as “Baique Ling”), the Shanghai Food and Drug Administration issued the latest response on November 20th. After investigation, the Food and Drug Administration confirmed that there was no violation of the Regulations on the Supervision and Administration of Cosmetics and the regulations on the management of prohibited and restricted raw materials for the related product of lark, Shuinenjing essence facial cleanser (formula upgrade) (limited use date: 20241105, batch number: 3R06YV11). This conclusion has put an end to the controversy surrounding Baique Ling cosmetics. It is reported that the cause of the incident was that the Shanghai Food and Drug Administration received a report from netizens on September 27, saying that the ingredients on ...
- Source: drugdu
- 94
- November 23, 2024
750 million license in, Chinese pharmaceutical companies make money overseas and spend overseas

On November 20, Junshi Bio released an announcement and signed a License Agreement with an undisclosed licensor to obtain the exclusive license right and sub license right of the licensor to develop, manufacture, use, import, export, sell and commercialize the two dual target fusion proteins in Greater China (including Chinese Mainland, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan). The subject of this transaction is two dual target fusion proteins, mainly used for the treatment of malignant tumors. Currently, licensed product 1 is in the overseas Phase I clinical trial stage. Junshi Biotechnology has submitted its Phase I clinical trial application to the National Medical Products Administration in China, and Junshi Biotechnology has the right of first refusal for licensed product 1 outside of Greater China. Licensed product 2 is in the preclinical research stage. In addition to the exclusive license and sub license rights to develop, ...
- Source: drugdu
- 107
- November 23, 2024
Rocket material leader, 400 million bet on medical imaging

Recently, Sirui New Materials (688102), a listed company on the Science and Technology Innovation Board, disclosed a private placement announcement, with a total fundraising amount not exceeding 600 million yuan. The project with the highest planned investment (340 million yuan) for this private placement, the construction of the Sirui New Material Technology Industrial Park, is expected to achieve an annual production capacity of 30000 sets of CT tube components, 15000 sets of DR tube components, 500 sets of linear accelerator components, 3500 sets of semiconductor product components, and 30000 sets of high-voltage VI conductive system components after reaching production capacity. It is expected to achieve sales revenue of 507 million yuan in the year of production. Among them, it is worth noting that the company will add the manufacturing of medical electronic accelerator products based on the production lines of CT tubes and DR tubes for tumor treatment. As of ...
- Source: drugdu
- 89
- November 23, 2024
Simeglutide Weight Loss Edition Officially Enters the Chinese Market

On November 17th, Novo Nordisk China held a press conference in Shanghai to announce the weight loss version of Semaglutide Injection (trade name: Novo Nordisk) ® Wegovy） Formally launched in China, this drug is the world’s first and currently the only glucagon like peptide-1 receptor agonist (GLP-1 RA) weekly formulation for long-term weight management. 01. Drug characteristics and indications Simeglutide belongs to the GLP-1 receptor agonist class of drugs. By simulating the secretion of GLP-1 hormones in the intestine, it promotes insulin secretion in a glucose concentration dependent manner, inhibits glucagon secretion, lowers blood sugar, delays gastric emptying rate, suppresses appetite, and achieves weight loss effect. Nuohe Ying ® Suitable for long-term weight management of adult patients based on controlling diet and increasing physical activity, with an initial body mass index (BMI) that meets the following conditions: ≥ 30kg/m ² (obesity), or ≥ 27kg/m ² to<30kg/m ² (overweight) and at ...
- Source: drugdu
- 141
- November 23, 2024
What signal did the National Medical Insurance Administration send out when it held a meeting with more than 40 leading enterprises?

On November 13, the National Medical Insurance Administration held a discussion in Beijing on strengthening the application of medical insurance supervision of drug traceability codes. The Health Bureau found at the scene that relevant leaders of the drug supervision department also attended. The heads of more than 40 leading companies such as Fosun Pharma, Jiuzhoutong, China Resources Pharmaceutical, Meituan Buy Medicine, Yixintang, and Yifeng Pharmacy attended the meeting. At the meeting, Gu Rong, Director of the Fund Supervision Department of the National Medical Insurance Administration, pointed out that “the medical insurance department’s strengthening of drug traceability code supervision is not only a major measure to safeguard the safety and legitimate rights and interests of the majority of insured persons, but also a major measure to support the high-quality development of enterprises. At the same time, it can also help enterprises prevent products from being counterfeited, crack down on the black ...
- Source: drugdu
- 104
- November 23, 2024
CAR-T is not selling well? Gilead lays off employees again

According to the latest news released yesterday (November 18, 2024), Gilead will lay off 104 employees at its headquarters (Foster City), effective March 14, 2025. About a few days ago (November 14, 2024), Gilead also announced that it would close its office in Seattle, and 75 employees in the office would be laid off as a result (effective January 17, 2025). In addition, Gilead will also close a Kite factory in Philadelphia by mid-2024, and the specific number of layoffs is unknown. This was a decision made shortly after Gilead released its third-quarter financial report. According to the report, the revenue for the quarter was US$7.5 billion, a year-on-year increase of 7%. The total revenue for the first three quarters was US$21.185 billion, a year-on-year increase of 6%. Its cell therapy segment seems to show a trend of weak growth, with a total sales revenue of US$485 million in Q3 ...
- Source: drugdu
- 73
- November 23, 2024
First in 30 years! Update on the progress of the “first innovative drug” for Helicobacter pylori

On November 18, Danno Pharmaceuticals announced that its world’s first innovative drug TNP-2198 for the treatment of Helicobacter pylori infection successfully completed the Phase III clinical trial and reached the primary endpoint of the study, showing multiple advantages compared with the bismuth quadruple. Dr. Ma Zhenkun, founder of Danno Pharmaceuticals, said: “TNP-2198 is the world’s first new antibacterial drug developed specifically for Helicobacter pylori infection in 30 years, with a unique multi-target synergistic mechanism.” The experimental results show that the eradication rate of Helicobacter pylori with the TNP-2198 triple regimen is still over 90%, which is also higher than the bismuth quadruple regimen, which is consistent with the results of the main analysis population, indicating that the TNP-2198 triple regimen has a good eradication effect on drug-resistant infections. TNP-2198 is a new antibacterial drug candidate with a unique multi-target synergistic mechanism. It has the advantages of overcoming antibiotic resistance, reducing ...
- Source: drugdu
- 78
- November 23, 2024

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