PharmaFocus Today – 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
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- 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
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- November 8, 2024
Let’s look at the suspense of the King of Medicine

On October 31, Merck was the first to release its third-quarter financial report. In the first three quarters, K drug performed as well as ever, with sales of US$21.646 billion, a year-on-year increase of 18%, and annual sales are expected to exceed US$29 billion. According to this trend, K drug is likely to defend the title of King of Medicine in 2024. However, on November 6, after Novo Nordisk released its third-quarter report, the competition for the King of Medicine caused a stir. In the first three quarters, the total sales of multiple versions of semaglutide reached US$20.3 billion, approaching K drug. Such a limited gap also indicates the fierceness of the competition for the King of Medicine. Before the results of the fourth quarter are announced, no one knows the final answer. Will K drug become the “shortest-lived King of Medicine” in history? On February 1, 2024, with the ...
- Source: drugdu
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- November 8, 2024
PCR new legend debuts at CIIE! Roche Diagnostics releases LightCycler® PRO

Today, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Roche Diagnostics China announced that its new molecular detection platform LightCycler® PRO System real-time fluorescence quantitative PCR instrument* (hereinafter referred to as “LightCycler® PRO”) was officially launched in China. Wang Feng, Senior Director of Roche Diagnostics China – Life Sciences Department, Marcus Droege, CEO of TIB Molbiol, James Lee, Global Senior Product Manager of Roche Diagnostics, and other guests attended the LightCycler® PRO launch conference. “As a global leader in in vitro diagnostics, Roche Diagnostics has always empowered scientific research with cutting-edge innovative technologies and led the development of the industry. LightCycler® PRO is another breakthrough innovation in the field of molecular testing. It can achieve 7-channel multiplex testing and has powerful advantages such as accuracy, high efficiency, flexibility, and ease of use. We hope that this time, with the help of the CIIE, it will officially ...
- Source: drugdu
- 36
- November 8, 2024
Haichen Pharmaceutical Approved for Additional Injection Specification of Labetalol Hydrochloride 150mg

On November 6, Haichen Pharmaceutical (300584) announced that it has received approval for the addition of a new specification for injection of Labetalol Hydrochloride 150mg through a supplemental drug application. The company recently received a notification from the National Medical Products Administration, approving the addition of the 150mg specification based on the already approved 50mg specification, and is considered to have passed the consistency evaluation. The registration classification of this approval is for chemical drugs, with the manufacturing enterprise being the company itself. The approval number is H20247263. The addition of the new specification will involve changes to the production process, which must be implemented within six months from the date of approval. Labetalol Hydrochloride injection is a novel ultra-short-acting beta-blocker, clinically suitable for the emergency treatment of various rapid cardiac arrhythmias. In 2023, this product generated sales revenue of 267 million yuan, accounting for 51.59% of the company’s total ...
- Source: drugdu
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- November 8, 2024
The world’s first, created in China! Weekly insulin preparation Novozyme® debuts at CIIE, to be launched at the end of the month

On November 6, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Novo Nordisk held a press conference and announced that the world’s first weekly insulin formulation, Novozymes® (insulin Efficacy Injection), which was exhibited for the first time at this CIIE, will be commercially launched in China at the end of November 2024 for the treatment of type 2 diabetes in adults, ushering in the era of weekly insulin treatment. Professor Peng Yongde, head of the Department of Endocrinology and Metabolism at the First People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said: “Insulin therapy is still an indispensable and important cornerstone in the diabetes management pathway. As a key component, basal insulin strives to better meet clinical treatment needs to help patients start treatment in a timely manner, improve treatment compliance, increase treatment continuity, and improve patient satisfaction.” Insulin “from day to week” ...
- Source: drugdu
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- November 8, 2024
Cell Drug Conjugates – An Innovative Drug Delivery System

In recent years, cell drug conjugates (CDCs) have gradually become a hot topic in medical research as an emerging drug delivery system. On July 1, 2024, Professor Gu Zhen and others from Zhejiang University published a review paper titled “Cell Drug Conjugates” in the Nature Journal of Biomedical Engineering. The article deeply explores the principles, preparation methods, and applications of this technology in cancer and immune diseases. This article will explain the content of the literature in detail, taking you to understand the core and prospects of this innovative technology. 01 What are cell drug conjugates (CDCs)? Cell drug conjugates are a complex that combines live cells and therapeutic drugs, capable of simultaneously exerting the functions of both, particularly suitable for the treatment of complex diseases such as cancer and autoimmune disorders. Unlike traditional drug delivery systems such as liposomes, nanoparticles, etc., CDCs utilize the physiological characteristics of cells, ...
- Source: drugdu
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- November 7, 2024
Cytokines

Preface B cells are the only cell type capable of differentiating into antibody secreting cells (plasma cells), and they can also present antigens to T cells and produce cytokines. By producing cytokines, B cells affect multiple aspects of immunity: cytokines derived from B cells, including lymphotoxins, are crucial for the individual development, homeostasis, and activation of secondary lymphoid organs, as well as the development of tertiary lymphoid tissue in ectopic sites; Other cytokines derived from B cells, such as interleukin-6 (IL-6), interferon – γ, and tumor necrosis factor, can affect the development of effector cells and memory CD4+T cell responses; Finally, B cells can regulate inflammatory immune responses by secreting IL-10 and IL-35, and “regulatory B cells” are the main source of inhibitory cytokines derived from these B cells in the body. The role of B cells in tissue development and repair Lymphatic organogenesis is mainly regulated by lymphoid tissue ...
- Source: drugdu
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- November 7, 2024
Siemens Healthineers plans to sell some of its shares

Recently, according to Reuters, Ralf Thomas, Chief Financial Officer of Siemens (SIEGn. DE), stated that Siemens may sell some of its shares in Siemens Healthineers (SHLG. DE), Siemens Energy (ENR1n. DE), and Fluence (FLNC. O) to help raise funds for its acquisition of Altair. On October 30th, Siemens signed the final acquisition agreement with AI software leader Altair, with a transaction amount of up to 10.6 billion US dollars (approximately 75 billion yuan), setting a record for the largest merger and acquisition transaction in Siemens Group’s history (excluding the merger of the spin off business Siemens Healthineers). The combination of Altair’s capabilities in simulation, high-performance computing, data science, and artificial intelligence with Siemens Xcelerator (industrial software) will create the world’s most complete portfolio of artificial intelligence design and simulation products, “said Siemens President and CEO Boren 01. Siemens official response Siemens, a century old manufacturing giant originating from Europe, was ...
- Source: drugdu
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- November 7, 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
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- November 7, 2024

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