Search Results for “antibody” – Page 10 – media

Global New Drug Progress and New Sharing

Progress in drug research and development 1. Anjin C5aR antagonist “Avamipram” approved for market in China On November 5th, the official website of NMPA announced that the marketing application for avacopan capsules jointly developed by Anjin and CSL Vifor has been approved, presumably for the treatment of anti neutrophil cytoplasmic antibody (ANCA) – related vasculitis (AAV). Afakepan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the allergen C5a, blocking C5a mediated neutrophil activation and migration. The drug was approved by the US FDA in October 2021 for use in combination with standard treatment regimens including glucocorticoids to treat adult active severe ANCA associated vasculitis (MPA and GPA). In July 2024, Anjin reached an agreement with CSL Vifor to acquire commercial rights to Avamipram in Asia and Latin America, including the mainland Chinese market. 2. Pfizer PARP inhibitor “Terazopanib” approved in China On November 5th, ...
- Source: drugdu
- 72
- November 8, 2024
Gan & Lee aims at the hypoglycemic drug market

Collective procurement ‘big winner’ In 1995, Gan Zhongru, who had worked as a postdoctoral fellow and senior biochemist at Merck&Co. in the United States, returned to China to start a business. Three years later, the team formed by Gan Zhongru developed China’s first genetically recombinant human insulin, becoming the third company after Eli Lilly and Novo Nordisk to produce and sell recombinant human insulin. Subsequently, under the leadership of Gan Zhongru and his R&D team, Gan Li Pharmaceutical continued to develop the first long-acting insulin analog, the first fast acting insulin analog, the first pre mixed insulin analog, and the first winter insulin in China. The products covered three insulin functional segments: long-acting, fast acting, and medium acting, becoming the “king of insulin” in China. With the acceleration of domestic insulin substitution in recent years, Ganli Pharmaceutical’s operating revenue has increased from 1.771 billion yuan in 2016 to 3.612 billion ...
- Source: drugdu
- 77
- November 8, 2024
6 innovative drugs expected to receive FDA approval in November

According to the expected target date of PDUFA, it is expected that in November, the US FDA will make regulatory decisions on the approval of six innovative drugs. This article will introduce these therapies. Active ingredient: Zenocutuzumab Indications: NRG1 positive non-small cell lung cancer (NSCLC) or pancreatic cancer Company Name: Merus Zenocutuzumab is a bispecific antibody targeting HER2 and HER3, which exhibits potential therapeutic efficacy against NRG1+cancer by uniquely binding to HER2 and effectively blocking the interaction between HER3 and NRG1 or NRG1 fusion protein. Preclinical studies have shown that zenocutuzumab can strongly inhibit the formation of HER2/HER3 heterodimers, thereby suppressing oncogenic signaling pathways, preventing tumor cell proliferation, and blocking tumor cell survival. Clinical studies have shown that it has anti-tumor activity in various types of NRG1+cancer. According to the mid-term data from the recently released Phase 1/2 clinical trial, zenocutuzumab has shown persistent efficacy in the treatment of advanced ...
- Source: drugdu
- 55
- November 7, 2024
5 innovative drugs included in breakthrough treatment varieties

Breakthrough treatment varieties refer to innovative drugs or improved new drugs used to prevent and treat diseases that seriously endanger life or seriously affect quality of life, and for which there are no effective prevention and treatment methods or sufficient evidence to show significant clinical advantages compared to existing treatment methods. After obtaining this recognition, it can accelerate the review process, accelerate the drug development process, and solve the unmet clinical needs of patients. In the past October, the CDE official website plans to include 5 breakthrough therapy varieties, including 1 therapeutic vaccine, 3 ADC drugs, and 1 monoclonal antibody drug. The following are introductions to 5 innovative drugs for reference only. 1. TVAX-008: Hepatitis B On October 14th, Nanjing Yuanda Weixin Biopharmaceutical Co., Ltd. TVAX-008 applied to be included in the breakthrough treatment category, suitable for the treatment of chronic hepatitis B virus (HBV) infection. TVAX-008 is a therapeutic ...
- Source: drugdu
- 73
- November 6, 2024
Another GLP-1 drug king, is it on the way?

Recently, the Q3 financial reports of MNCs have been released one after another, and some are happy and some are sad. When a number of MNCs began to lower their full-year EPS, Amgen’s Q3 financial report earnings gave a high score answer sheet. Among them, Amgen’s total revenue in the third quarter increased by 23%, and its GAAP net earnings per share (EPS) increased by 62% year-on-year, from US$3.22 to US$5.22. What is more imaginative is that with the data catalysis of the new macromolecular weight loss drug AMG133, this macromolecular antibody that goes against the grain and antagonizes GIPR may become Amgen’s next gold mine. According to Amgen’s Q3 2024 financial report, the most significant year-on-year growth is LUMAKRAS (AMG510) – a targeted drug for KRASG12C mutation-positive lung cancer. The sales ceiling of this gene mutation in European and American countries will be much higher than that in Asian ...
- Source: drugdu
- 60
- November 6, 2024
$1.4 billion deal highlights the future of Alzheimer’s disease therapy

The development of therapies for Alzheimer’s disease has always caused many developers to feel exhausted, and now AbbVie has also increased its investment in neurodegenerative diseases. AbbVie has agreed to spend $1.4 billion to acquire Aliada Therapeutics, whose main acquisition asset is Aliada’s authorized Alzheimer’s disease candidate drug ALIA-1758 from Johnson&Johnson. Its mechanism of action is still an anti beta amyloid protein (3pE-A β) antibody, but the unique feature of ALIA-1758 is that it can cross the blood-brain barrier, greatly improving the brain’s absorption rate. Aliada started a phase 1 trial among healthy volunteers in May, but AbbVie believes the timing is ripe for acquisition. Previously, AbbVie made the decision to abandon its internal Alzheimer’s disease asset ABBV-916. This anti beta amyloid antibody has no significant difference in safety and efficacy compared to the already marketed monoclonal antibody therapy for Alzheimer’s disease. Therefore, AbbVie decided to terminate the development ...
- Source: drugdu
- 59
- November 5, 2024
Domestic PD-L1 was approved in the UK for the first time

CStone Pharmaceuticals announced today (October 31) that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab combined with platinum-containing chemotherapy for patients without EGFR sensitive mutations, or without ALK, ROS1, First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with RET genomic tumor variants. This is the second marketing authorization application approval for sugalimab in overseas markets, following the approval by the European Commission. The approval was mainly based on the results of a multi-center, randomized, double-blind Phase III clinical study – GEMSTONE-302. Sugemalimab combined with chemotherapy can significantly extend the progression-free survival and overall survival of patients with newly treated metastatic NSCLC compared with placebo combined with chemotherapy. The research data has been published in The Lancet Oncology and Nature Cancer, and has been presented in oral and poster presentations at many international academic conferences. CStone Pharmaceuticals has reached a strategic cooperation with ...
- Source: drugdu
- 47
- November 4, 2024
Domestic TCE polyclonal antibodies are “surging”

MNCs are hunting for domestic molecules and have already involved the field of TCE polyclonal antibodies. On October 29, GlaxoSmithKline announced the acquisition of Enmu Bio’s CD19 and CD20 targeted T cell engager CMG1A46, including a $300 million advance payment and $550 million in potential milestone payments. Not long ago in August, Merck also bought Tongrun Bio’s CD3xCD19 bispecific antibody CN201 with a down payment of $700 million and a milestone payment of $600 million. The direction of the giants is also relatively consistent: betting on the autoimmune market. At present, the core “battlefield” of TCE polyclonal antibodies is tumors. TCE polyclonal antibodies are relatively special. One end (or two ends) is connected to TAA (tumor-associated antigen) to locate tumor cells, and the other end is connected to the CD3 epitope of T cells to activate T cells and exert the tumor-killing effect of T cells. In the field of ...
- Source: drugdu
- 53
- November 2, 2024
Medici Globalization Strategy Accelerates, Overseas Business Reaches New Heights

On the evening of October 30, Medici released its Q3 2024 report. In the third quarter, the company achieved operating revenue of 280 million yuan, a year-on-year decrease of 9.83%, and a net profit loss attributable to shareholders of approximately 58.44 million yuan. The company attributed this primarily to changes in the investment and financing environment for biomedicine during the reporting period, intensified industry competition, declining order prices, delays in executing some orders, and a decrease in gross profit margins. Domestic and international laboratory progress is promising, deepening the global strategic layout. As a pioneer of China’s Contract Research Organizations (CRO), Medici has maintained a forward-looking approach since its inception, adhering to a dual-market development strategy that encompasses both domestic and international markets. Its overseas operations span many regions, including the United States, Europe, Japan, and South Korea, and the company has established deep cooperative relationships with internationally renowned pharmaceutical ...
- Source: drugdu
- 55
- November 2, 2024
The first patient enrolled in the Phase III clinical trial of first-line treatment for biliary tract tumors using the head to head valumab regimen and the Ivo Western regimen

Recently, Kangfang Biotechnology (9926. HK) announced the completion of the first patient enrollment in a randomized, controlled, multicenter, registered Phase III clinical trial (HARMONI-GI-01/AK112-309) of its independently developed PD-1/VEGF bispecific antibody combination regimen with Ivexil and a comparison with Valiumab (PD-L1) combination regimen for first-line treatment of advanced biliary malignancies (BTC). Research on AK112-309 The HARMONI-GI-01/AK112-309 study was conducted by renowned domestic liver and gallbladder tumor experts, Professor Zhou Jian from Zhongshan Hospital affiliated with Fudan University and Professor Zheng Tongsen from Harbin Medical University Cancer Hospital, as co principal investigators. The endpoint of the study was overall survival (OS). The HARMONI-GI-01/AK112-309 study is the sixth registered phase III clinical trial conducted by Ecovaci, using PD-1/L1 monoclonal antibodies as control drugs. It reflects the company’s determination and confidence in iterating the current tumor immunotherapy landscape and establishing better global cancer standard treatments. It also demonstrates the ability of Kangfang Biotech ...
- Source: drugdu
- 47
- November 2, 2024

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