media – Page 18 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Akeso Biopharma’s autoimmune pipeline reaches another milestone! Mandocizumab submits application for market approval, targeting a market worth tens of billions.

February 25, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that the marketing application for Mandocizab injection, a Class 1 new drug independently developed by Akeso Biopharma, has been accepted. This novel humanized monoclonal antibody targeting IL-4Rα is used to treat moderate to severe atopic dermatitis (AD), marking another important milestone in the company’s autoimmune pipeline. Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease with the highest socioeconomic burden among dermatological diseases. According to relevant information, there are at least 230 million AD patients worldwide, with approximately 19.6 million moderate to severe AD patients in China in 2022, and this number is projected to increase to 22.8 million by 2030. With the widespread application of biologics, the market size for AD biologics is expected to grow rapidly. The application for marketing approval of mandozizumab is based on positive results ...
- Source: drugdu
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- February 28, 2026
$2.1 billion! Novo Nordisk reaches new cooperation agreement

Novo Nordisk recently announced a major collaboration agreement with Vivtex worth up to $2.1 billion to jointly develop next-generation oral biologics for the treatment of obesity, diabetes and related complications. The core of this collaboration lies in addressing a long-standing and challenging problem in the pharmaceutical industry: how to achieve effective oral administration of large-molecule biologics (such as peptides and protein drugs) . Currently, although oral versions of GLP-1 drugs are available, many biologic candidates still rely on injection for administration due to poor gastrointestinal absorption. Under the agreement, Vivtex will license its proprietary oral drug delivery technology to Novo Nordisk , while Novo Nordisk will lead the subsequent global development, manufacturing, and commercialization efforts. Vivtex will receive up to $2.1 billion in upfront payments, research funding, milestone payments, and royalties on future product sales. Founded in 2018 by three scientists from MIT, including Robert Langer, a legendary figure in ...
- Source: drugdu
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- February 28, 2026
After Eli Lilly and Novo Nordisk, who most resembles the “Third Brother of Weight Loss”?

In the global pharmaceutical industry, there is probably no sector like weight loss drug development where only two giants are competing. The number of other players entering the market is not only insufficient to form a complete game, but even a three-way competition is still a future prospect. Eli Lilly and Novo Nordisk control the most powerful brands, the most mature supply systems, and the most complete pace of indication expansion. Eli Lilly’s telposide and Novo Nordisk’s semaglutide are aggressively expanding their market share in the obesity market, which is touted as having a potential of $100 billion. Although competitors are vying for dominance in terms of drug modalities, targets, and mechanisms, products that can truly threaten telposide and semaglutide in the European and American markets remain largely untapped. Many pharmaceutical giants can only lament, “I regret that I don’t have this drug,” when looking at their own pipelines. The ...
- Source: drugdu
- 91
- February 28, 2026
Big news! The first domestic company to pass the evaluation; a blockbuster inhaler with sales exceeding one billion yuan welcomes a game-changer.

Recently, the National Medical Products Administration issued the latest drug approval certificate, and the tiotropium bromide inhalation powder submitted by Shandong Jingwei Pharmaceutical Co., Ltd. was officially approved for marketing. It also passed the consistency evaluation of generic drug quality and efficacy, becoming the first domestic company to pass the evaluation for this product , filling the industry gap of no domestically produced products that have passed the evaluation for more than ten years since the launch of this blockbuster respiratory product. As the world’s first once-daily long-acting anticholinergic drug, tiotropium bromide inhaled powder is a first-line cornerstone treatment for stable chronic obstructive pulmonary disease (COPD), recommended at the highest level by both the global GOLD COPD guidelines and domestic COPD diagnosis and treatment guidelines, indicating a strong clinical need. The original product, Spiriva by Boehringer Ingelheim, entered the Chinese market in 2005 and has long held a leading position ...
- Source: drugdu
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- February 28, 2026
Shanghai Pharmaceuticals’ Rivaroxaban Tablets Receive Singapore Drug Registration Certificate

Recently, rivaroxaban tablets produced by Changzhou Pharmaceutical Factory Co., Ltd., a subsidiary of Shanghai Pharmaceuticals, received a drug registration certificate issued by the Singapore Food and Drug Administration (HSA), and the drug has been approved for marketing. Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat and prevent deep vein thrombosis (DVT); to treat pulmonary embolism (PE); and to prevent venous thromboembolism (VTE) in patients with acute illness. In May 2025, Changzhou Pharmaceutical Factory’s rivaroxaban tablets obtained approval from the U.S. Food and Drug Administration, and in October 2025, it obtained a drug registration certificate in Malaysia. The approval of rivaroxaban tablets in three strengths (10mg, 15mg, and 20mg) by the Singapore Food and Drug Administration signifies that the drug is now qualified for sale in Singapore. This will have a positive impact on the company’s expansion ...
- Source: drugdu
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- February 27, 2026
Boehringer Ingelheim’s “Zonartinib” Receives FDA Approval for Treatment-naïve NSCLC

On February 26, the FDA granted zongertinib through a special approval pathway for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) tyrosine kinase domain activating mutations . Zonatitinib, developed by Boehringer Ingelheim, is the world’s first and currently only approved oral HER2 tyrosine kinase inhibitor (TKI). It selectively inhibits HER2 (ERBB2) while avoiding inhibition of wild-type EGFR, thereby minimizing related toxicities. In August 2025, Zonatitinib received approval from both the FDA and the NMPA for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC who have HER2 (ERBB2) tyrosine kinase domain activating mutations and have previously received systemic therapy.With this approval, the target population for zotinib has been further expanded to include individuals who have not received systemic therapy.This approval is based on data from the Phase I Beamion LUNG-1 study. Results showed that the confirmed objective response ...
- Source: drugdu
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- February 27, 2026
Marketing application for recombinant anti-IL-4Rα humanized monoclonal antibody injection accepted

Sansheng Guojian(688336) announced on February 26 that the company recently received an “Acceptance Notice” issued by the National Medical Products Administration, and the new drug application for its independently developed recombinant anti-IL-4Rα humanized monoclonal antibody injection (research code: SSGJ-611) has been accepted. According to the announcement, SSGJ-611 is a monoclonal antibody against IL-4Rα independently developed by the company. It has a novel amino acid sequence and can specifically bind to IL-4Rα, blocking IL-4 and IL-13 signaling, thereby alleviating diseases such as atopic dermatitis. Atopic dermatitis is a chronic, relapsing, inflammatory skin disease. Moderate to severe cases often present with generalized rashes, accompanied by intense itching, dry skin, and crusting. Treatment options are limited, severely impacting quality of life. The global prevalence has gradually increased over the past 30 years, with a prevalence rate of 6.1% among adults in my country. The announcement stated that the Phase III clinical trial conducted ...
- Source: drugdu
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- February 27, 2026
Genrix Bio’s marketing application for talicibazine injection for the treatment of adult seasonal allergic rhinitis has been accepted.

Genrix Bio announced on the evening of February 26 that its Phase III clinical trial of “Telicibaimab Injection (GR1802 Injection)” for the indication of adult seasonal allergic rhinitis has met the primary endpoint. The company has submitted a new drug application for this indication to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and it has been accepted (acceptance number: CXSS2600031). According to available information, telithiasismab injection is a recombinant fully human anti-IL-4Rα monoclonal antibody independently developed by the company, targeting IL-4Rα. This drug specifically binds to human IL-4Rα on the cell surface, blocking the binding of IL-4 and IL-13 to IL-4Rα, inhibiting downstream STAT6 phosphorylation, and suppressing CD23 upregulation, thereby inhibiting Th2-type inflammatory responses mediated by IL-4 or IL-13. According to reports, the new drug application for telixirizabab injection for the treatment of moderate to severe atopic dermatitis in adults was accepted in September ...
- Source: drugdu
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- February 27, 2026
13.8 billion! Leading domestic imaging equipment manufacturer sees significant revenue growth.

Today, United Imaging Healthcare released its preliminary financial results for 2025. The core indicators in the 2025 financial report are all positive, with revenue, net profit and other key indicators increasing by more than 30% . 01 Core Driver Significant performance growth Specifically, in 2025, United Imaging Healthcare’s total revenue reached RMB 13.821 billion, a year-on-year increase of 34.18%, and its net profit attributable to the parent company was RMB 1.888 billion, a year-on-year increase of 49.60%. In addition, many indicators showed significant growth, among which the net profit excluding non-recurring items was RMB 1.788 billion, a substantial year-on-year increase of 77.01%. Based on its outstanding performance in 2025, United Imaging Healthcare’s stock price soared today, with trading volume and turnover skyrocketing. As of 9:40 a.m. today, the highest stock price reached 133.53 yuan, with a single-day increase of up to 5.64%, and a total market value of 108.5 billion ...
- Source: drugdu
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- February 27, 2026
IL-4R antibody submitted for market approval

On February 25, the marketing application of Akeso Biopharma’s IL-4R antibody mandocimab injection was accepted by the NMPA. In August 2025, Akeso announced that its IL-4R antibody, mandocizumab, had achieved all efficacy endpoints in a Phase III clinical trial for the treatment of moderate to severe atopic dermatitis and planned to apply for market approval. Based on inter-study comparisons (non-head-to-head), the efficacy data of mandocizumab is superior to that of the marketed product Dupixent, and it is being further expanded to adolescents. Sanofi’s IL-4R antibody, Dupixent, is the world’s best-selling autoimmune drug, with sales of $18.5 billion in 2025. Image source: Medical Notes Conclusion In the field of autoimmune diseases, Akeso Biopharma will focus on developing dual-target iterative products. The IL-4R/ST2 bispecific antibody AK139 is actively advancing its clinical development and has now reached the Phase II clinical trial stage. https://news.yaozh.com/archive/47273.html
- Source: drugdu
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- February 27, 2026

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