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 ...
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. ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
The layout of bispecific antibodies in the field of tumors has become mature, but in the field of autoimmune diseases, the layout of bispecific antibodies is relatively small. The first batch of enlightened MNCs have begun to take action. Recently, autoimmune bispecific antibody therapy has increasingly become the focus of new drug research and development. Many pharmaceutical giants such as Johnson & Johnson, Sanofi, and Roche have chosen to deploy in the field of autoimmune bispecific antibodies, with a total of more than US$8.15 billion (approximately RMB 59.1 billion) in mergers and acquisitions and related drug transactions. The track of autoimmune bispecific antibody therapy has changed. Sanofi, Merck, and Roche: Grabbing the beachhead of CD3 bispecific antibodiesCD3 is closely related to the activation of T cells. By combining CD3 and tumor-associated antigens, it can guide and activate T cells to approach and kill tumor cells. At present, most of the ...
Due to some chronic and common diseases, patients come to township health centers and community health service centers for treatment, but are told that ‘there is no medicine’. In response to the problem of difficult medication at the grassroots level, the National Health Commission and six other departments recently jointly issued the “Opinions on Reforming and Improving the Grassroots Drug Linkage Management Mechanism to Expand the Types of Grassroots Drugs”, striving to smooth the channels for drug connection between urban and rural areas, counties and townships, enhance the ability of grassroots drug allocation and use, and meet the basic medication needs of the masses. Expand types Make the medicine at the doorstep more comprehensive The proportion of grassroots diagnosis and treatment in China has reached 52% by 2023. However, some medical staff have previously reported that there are few types of drugs available at the grassroots level, limited space for ...
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