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First domestically produced! Kelun Biotech’s TROP2 ADC “Lukang Satuzumab” approved for marketing

Today, Kelun Biotech announced that its TROP2-targeted ADC drug SKB264 (Lukang Satuzumab) has been approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least 2 systemic treatments (at least 1 of which is for advanced or metastatic stages). Lukang Satuzumab is the first domestically produced and the second global TROP2 ADC drug approved for marketing. This approval is based on the positive results of the Phase III OptiTROP-Breast01 study, which evaluates the efficacy and safety of Lukang Satuzumab compared with chemotherapy as a third-line treatment for patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC). The latest results published at ASCO 2024 showed that as of November 30, 2023, compared with chemotherapy, ruconazole reduced the risk of disease progression or death by 69% (HR=0.31, 95% CI: 0.22-0.45, P<0.00001). According to the results of ...
- Source: drugdu
- 101
- November 30, 2024
Big news! Promotion of Pfizer’s four star drugs has changed hands

On the evening of the 26th, Pfizer officially announced a strategic cooperation with China Resources Pharmaceutical Commercial on four varieties. The commercial operation of Pfizer’s four tumor treatment drugs AROMASIN®, IBRANCE®, Pharmorubicin RD®, and XALKORI® in China will be responsible for China Resources Pharmaceutical Commercial. Pfizer stated in an external announcement that Jean-Christophe Pointeau, President of Pfizer China, and Han Yuewei, Deputy General Manager of China Resources Group, attended and witnessed the signing of the contract between the two parties. Exemestane and epirubicin have entered multiple alliance procurement catalogs, and palbociclib and crizotinib are national negotiation varieties, and the prices are far lower than when they were first listed. It is also worth noting that looking at the drugs in the tenth batch of national procurement catalogs released a few days ago, palbociclib has been listed, and another price reduction is inevitable. The cooperation will officially start on December 1. ...
- Source: drugdu
- 126
- November 30, 2024
AnLingKe Biotechnology has completed a $42 million Series A financing to accelerate the global development of bispecific antibodies and ADC products

Allink Biotherapeutics announced today the completion of a $42 million Series A funding round. This round of financing is led by Lanchi Venture Capital, with follow-up investments from Yuansheng Venture Capital, Junlian Capital, and Jianfa Emerging Investment, as well as additional investments from existing shareholders Gao Rong Venture Capital and Mi Fang Health Fund. Gaorong Venture Capital co led the angel round of investment in AnLingKe Biotechnology in 2023. AnLingKe Biotechnology was founded in 2023 and is a biotechnology company focused on innovative drug research and development. Based on its independently developed bispecific antibody and ADC technology platform, the company has laid out a series of innovative product pipelines with the potential for first in class (FIC) and best in class (BIC). The company is committed to developing breakthrough therapies in the fields of oncology and immune diseases, bringing innovative treatment options to patients worldwide. AnLingKe Biology has established an ...
- Source: drugdu
- 143
- November 29, 2024
Kolombotai Biotechnology has obtained the TROP2 ADC drug; Two new drugs from Huadong Pharmaceutical have been approved for market | Early Reference Medicine

On November 27, Kelenbotai Biology announced that the company’s first antibody drug conjugate (ADC) targeting human trophoblast surface antigen 2 (TROP2) for unresectable local advanced or metastatic triple negative breast cancer (TNBC) adult patients who have received at least two kinds of systematic treatment in the past (at least one of which is for advanced or metastatic stage), sac-TMT (formerly SKB264/MK-2870) (Gatalay), was approved by the State Food and Drug Administration to be listed in China. This drug is the first domestically produced and the second globally approved TROP2 ADC drug. Comment: This incident has certain significance for both the company and the domestic innovative pharmaceutical industry. China has become a core participant in global ADC research and development. There are companies in China with strong ADC technology platforms, companies that have accumulated differentiated ADC clinical drugs and strong commercialization capabilities, or companies that have comprehensive and rich technical capabilities ...
- Source: drugdu
- 146
- November 29, 2024
Boston Scientific’s second acquisition this month

On November 25, 2024, Boston Scientific announced that it would acquire infusion pump manufacturer Intera Oncology for an undisclosed amount. Intera Oncology has developed the Intera 3000 hepatic artery infusion pump and chemotherapy drug fluorouridine. Both have obtained FDA approval. This pump can be used for hepatic arterial infusion (HAI) therapy to treat liver tumors mainly caused by metastatic colorectal cancer. The Intera 3000 is the only approved constant current implantable pump for HAI treatment in the United States. 01. Only approved in the United States Intera Oncology is a rapidly growing Boston life sciences company with a mission to change the course of cancer in patients with colorectal and cholangiocarcinoma. Founded by two doctors in 2019, their shared vision is to improve the survival rate of patients with colorectal cancer liver metastases and cholangiocarcinoma by ensuring access to hepatic arterial infusion (HAI) therapy. Hepatic arterial infusion (HAI) therapy is ...
- Source: drugdu
- 82
- November 29, 2024
Two innovative medical devices have been approved for market launch

Recently, the National Medical Products Administration approved the registration applications for two innovative products, the “implantable cardiac pacing electrode lead” of Chuangling Heart Rhythm Management Medical Equipment (Shanghai) Co., Ltd. (hereinafter referred to as “Chuangling Heart Rhythm Medical”) and the “zirconia ceramic femoral head” of Beijing Ansong Technology Co., Ltd. (hereinafter referred to as “Ansong Technology”). Chuangling Heart Rhythm Medical, the first domestically produced product launched Chuangling Heart Rhythm Medical was established in 2014, dedicated to the research and development, manufacturing, and management of medical devices related to heart rhythm diseases, providing corresponding technical services and consulting, and conducting sales and import/export business of medical devices. The company strives to become the preferred brand for domestic pacemakers, providing high-quality heart rhythm management products and services for patients in China and even the world, improving their quality of life, and extending their lifespan. The BonaFire approved this time ® Implantable cardiac ...
- Source: drugdu
- 108
- November 29, 2024
【EXPERT Q&A】What is the difference between a handheld nebulizer and a humidifier for medical devices?

Drugdu.com expert’s response: The handheld nebulizer used in medical devices differs significantly from a humidifier in multiple aspects, as detailed below: Ⅰ. Primary Functions and Purposes Handheld nebulizer: Primarily used for treating respiratory diseases such as asthma and bronchitis. It atomizes medication into tiny particles, allowing patients to inhale them directly into the respiratory tract for therapeutic effect. This device typically requires use under medical guidance and in conjunction with specific medications or solutions. Humidifier: Primarily functions to increase the humidity of indoor air, reducing discomfort caused by dryness. It generally uses purified water or filtered water and does not involve the atomization of medication. Humidifiers are widely used in homes, offices, and other settings to improve the indoor environment. Ⅱ. Atomized Particle Size Handheld nebulizer: Produces very small atomized particles, usually around 0.4 to 1 micrometer in size. This particle size makes the medication easier for the human body ...
- Source: drugdu
- 100
- November 29, 2024
Amgen’s weight loss drug has a 20% weight loss effect, but the side effects are high, and the stock price once plummeted by 12.3%!

Today, Amgen announced the positive results of its weight loss therapy MariTide in a 52-week clinical phase 2 study. Analysis shows that in obese or overweight people without type 2 diabetes, MariTide achieved an average weight loss of about 20% in week 52, and there was no weight loss plateau, indicating that patients may lose weight further after treatment for more than 52 weeks. While weight loss drug companies generally rose, Amgen once plummeted by more than 12.3% because although the efficacy of Amgen’s MariTide weight loss drug met Wall Street expectations, it had high side effects and failed to beat Eli Lilly’s blockbuster drug Zepbound, and the trial results were lower than Wall Street’s high expectations for MariTide. In a one-year trial, non-diabetic patients took Amgen’s MariTide once a month or less frequently and lost up to 20% of their weight. Wegovy’s late-stage study showed a 15% weight loss ...
- Source: drugdu
- 87
- November 29, 2024
The first innovative drug failed in Phase III clinical trials, and a series of fraud and academic misconduct were behind it

On November 25, Cassava Sciences announced that the Phase III ReThink-ALZ study of Simufilam for the treatment of mild to moderate Alzheimer’s disease (AD) did not meet the pre-specified dual primary endpoints, secondary endpoints, and exploratory biomarker endpoints. Compared with the placebo group, there was no obvious improvement trend in the ADAS-COG12 and ADCS-ADL scale scores of patients in the trial group. Among them, the test results obtained by the ADCS-ADL scale showed that the situation in the trial group was even worse than that in the placebo group. After the news of the failure of the Phase III study leaked, Cassava’s stock price plummeted 85% to US$3.91, while the previous closing price was US$26.48. Since the beginning of 2021, Simufilam’s ability to reduce the toxic effects of β-amyloid protein has been questioned. Two neuroscientists, Geoffrey Pitt and David Bredt, filed a petition with the U.S. Food and Drug Administration ...
- Source: drugdu
- 78
- November 29, 2024
“Innovative Cardiac Tissue Ablation Clip” approved by CE

AtriCure, a leading company in the treatment of atrial fibrillation, announced today that its EnCompass cardiac tissue ablation clip has received the EU CE mark, meaning the device can be sold in more than 30 countries in the European Economic Area (EEA). A number of innovative products were launched AtriCure was founded in 2000 and focuses on cardiac surgery solutions. The company mainly produces and sells cardiac ablation devices, providing innovative technologies for the treatment of atrial fibrillation and related diseases. At present, AtriCure has 138 authorized patents in the United States and has served more than 300,000 patients with atrial fibrillation since 2004. It is understood that the EnCompass cardiac tissue ablation clamp is used for cardiac tissue ablation surgery, including comprehensive epicardial ablation of the left atrium during open heart surgery. This is a simpler and faster method of open-chest cardiac ablation, allowing doctors to perform comprehensive epicardial ...
- Source: drugdu
- 77
- November 29, 2024

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