media – Page 21 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Nearly 97% of patients reached lipoprotein standards within 3 months! Eli Lilly announces impressive results for oral inhibitor

Eli Lilly and Company recently announced that its investigational once-daily oral lipoprotein(a)-Lp(a) inhibitor muvalaplin achieved positive results in a Phase 2 clinical trial. The study showed that the trial met the primary endpoint. Muvalaplin could significantly reduce elevated Lp(a) levels in adult patients, and the patients’ percentage change in Lp(a) levels from baseline to week 12 showed significant improvement. These data were published in the journal JAMA and released simultaneously at the 2024 American Heart Association (AHA) Annual Scientific Meeting. Muvalaplin is an orally administered small molecule that inhibits Lp(a) formation by blocking the apo(a)-apo B100 interaction while avoiding the interaction with the homologous protein plasminogen. The analysis showed that muvalaplin (10 mg, 60 mg and 240 mg) significantly reduced patients’ Lp(a) levels in the primary endpoint at week 12. Placebo-adjusted Lp(a) reductions were up to 85.8% as assessed by the intact Lp(a) assay and up to 70.0% as assessed ...
- Source: drugdu
- 82
- November 26, 2024
KIMES

Organiser：Korea E & Ex Inc., Korea Medical Device Industry Association Time：March 20th – 23rd, 2025 Address：513, Yeongdong-daero, Gangnam-gu, Seoul Exhibition hall：COEX Convention & Exhibition Center Product range: Medical Equipment: Medical technology equipment, consumables, medical electronic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical facilities, dental service equipment, disposable medical products for hospitals and households, hospital and dental medical data processing systems, dental plastic surgery, rehabilitation equipment, etc. In Vitro Diagnostics & Clinical Laboratory Equipment: Endoscopy systems, B-mode ultrasound, examination equipment, ENT treatment instruments, dynamic analysis instruments, comprehensive laboratory solutions, clinical diagnostic equipment, diagnostic reagents, precision medicine, POCT (Point of Care Testing) home diagnostic devices, clinical laboratory equipment. Rehabilitation & Nursing Products: Orthopedic devices, walkers, hearing aids, auditory warning devices for the blind, manual wheelchairs, electric wheelchairs, crutches, walking aids, massagers, health clothing, fitness equipment, training machines, wrist and ankle braces, wearable neck ...
- Source: drugdu
- 84
- November 26, 2024
16.5 billion big drug, the first domestic drug is about to be approved

Currently, there is only one Bcl-2 inhibitor in the world, venetoclax, which is jointly developed by AbbVie and Roche. AbbVie’s financial report shows that in 2023, venetoclax’s revenue will reach US$2.28 billion (approximately RMB 16.5 billion), a year-on-year increase of 13.9%. Such an attractive golden big single product, the first domestic drug is about to usher in a breakthrough. Recently, Ascent Pharmaceuticals announced that its independently developed new selective Bcl-2 inhibitor APG-2575’s new drug application (NDA) has been accepted by the CDE and recommended for inclusion in the priority review process for the treatment of refractory or relapsed (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first domestic original Bcl-2 inhibitor to submit an NDA in China, and is expected to become the second Bcl-2 inhibitor to be listed in the world. 16.5 billion big drug, the first domestic product is accelerating to the finish line. The “strongest ...
- Source: drugdu
- 69
- November 25, 2024
Domestic molecules become king bombs overseas

Recently, BionTech chose to go a step further after completing the BD transaction of Promis bispecific antibody: it completely acquired Promis, a Chinese multi-antibody biotech. The day after the announcement of the acquisition, BioNTech held the 2024 R&D Day in full swing. Most of the report was devoted to describing the cancer treatment strategy centered on the bispecific antibody PM8002 developed by Promis, and clarified that the acquisition of PM8002 is a highlight in the company’s future strategic blueprint. From 2023, we can see that BioNTech is frequently sweeping up domestic pipelines. A total of four ADC pipelines from two high-quality biotechs, Yilian and Yingen, as well as PM8002 from Promis, were all acquired by BioNTech. From the timeline, BioNTech first conducted BD transactions for several ADC pipelines in 2023, and then completed the BD of Promis bispecific antibody at the end of 2023. From today’s perspective, BioNTech regards PM8002 ...
- Source: drugdu
- 75
- November 25, 2024
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
- 75
- 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
- 67
- 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
- 86
- 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
- 82
- 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
- 77
- 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
- 72
- November 23, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.