PharmaFocus Today – Page 3 – media

AD therapy suffered two major setbacks in three days

The development of Alzheimer’s disease treatments has suffered a series of setbacks in the past few days: Novo Nordisk attempted to explore the disease-modifying effects of semaglutide in early Alzheimer’s disease by leveraging its potential role in metabolic and inflammatory regulation, but both large phase 3 trials failed to show a delay in cognitive or functional decline; at almost the same time, Johnson & Johnson’s anti-tau antibody also failed to demonstrate any effect on disease progression in an interim study. 01 A Real-World Test of the GLP-1 Extension Path Novo Nordisk’s EVOKE and EVOKE+ results, announced on November 24, marked a temporary halt to the exploration of GLP-1 drugs in the field of Alzheimer’s disease. These two trials enrolled 3,808 early-stage patients aged 55 to 85, aiming to evaluate whether the oral version of semaglutide could slow the rate of cognitive and functional decline over a two-year follow-up period. Novo ...
- Source: drugdu
- 44
- December 2, 2025
Global First Drug Candidate Approved for Both China and the United States with Double New Drug Application and Double Approval – Targeting Autoimmune Diseases

Zhongzheng Intelligent Finance & Research Leads Biolabs(09887) announced on December 1st evening that the company’s independently developed candidate drug LBL-047’s new drug clinical trial (IND) application was approved by the National Medical Products Administration (NMPA) on November 25th. According to the announcement, LBL-047 is the world’s first dual-specific fusion protein to achieve dual submissions and dual approvals in China and the United States. It is composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and calcineurin binding molecule (TACI) extracellular domain. Currently, there are no drugs globally that simultaneously target plasma cell-like dendritic cells (pDC) and B cells and have been approved for clinical trials. This drug, with its unique mechanism of action, has the potential to be the first and the best among its kind. LBL-047 selectively eliminates pDC to reduce the production of type 1 interferons and inhibits the B cell ...
- Source: drugdu
- 42
- December 2, 2025
GLP-1 type weight-loss drugs mark a “new chapter” in the global fight against obesity

On Monday local time, the World Health Organization (WHO) stated that drugs such as Mounjaro have great potential in addressing the global obesity crisis, and it is estimated that 2 billion people worldwide will be affected by obesity by 2030. Given the significant efficacy of these drugs in assisting weight loss, this means that the health systems of various countries are entering a “new chapter” in treating obesity and its associated fatal diseases. This is also the first time that the WHO has recommended the use of GLP-1 drugs for the management of adult obesity, marking an important shift in the UN agency’s approach to obesity treatment. The WHO calls on countries to take measures to ensure that those in need of GLP-1 drugs can access these medications. It also points out that, typically, eligible adults should be able to use such drugs, but pregnant women should not use them. ...
- Source: drugdu
- 42
- December 2, 2025
Abbott Deploys a ‘Comprehensive Network’ with Innovative Technology

December 1, 2025, marks the 38th World AIDS Day. This year’s campaign theme, “Societal Co-governance, Integrity and Innovation, End AIDS,” aims to deepen the understanding of the importance and long-term nature of AIDS prevention and control work. Building on the review and continuation of past effective prevention and treatment experiences and exemplary practices, the theme further calls on all sectors of society to jointly shoulder the responsibility of AIDS prevention and control, strengthen exploration and innovation in HIV/AIDS intervention measures, and promote the high-quality development of AIDS prevention and control efforts. Viral testing is a critical component of AIDS prevention and control. As a leading global healthcare company, Abbott has been committed to continuously advancing and innovating in cutting-edge HIV testing technologies for the past four decades since launching the world’s first HIV antibody test kit in 1985, using accurate diagnosis to combat the threat of the disease. In 1985, ...
- Source: drugdu
- 42
- December 2, 2025
From Innovative Breakthroughs to Global Expansion

From a 300-square-meter laboratory in Shanghai’s Zhangjiang Pharma Valley to plans for expanding capacity to over 160,000 liters in Lingang Life Blue Bay, how has Top Alliance, in just 13 years, built a pipeline of over 50 innovative drugs and risen to join the ranks of mainstream international biopharmaceutical companies? “The shift from ‘single-point breakthroughs’ to ‘platform-based innovation’ has enabled Top Alliance to break through barriers continuously in R&D, commercialization, and internationalization,” said Xiong Jun, Chairman of Top Alliance, with conviction during a recent research interview with Shanghai Securities News, revealing the code to the company’s growth. Xiong Jun’s confidence stems from the global breakthrough of Top Alliance’s core product, the anti-PD-1 monoclonal antibody Toripalimab. Today, Toripalimab has long transcended its status as a mere candidate drug in the lab, becoming the first self-developed and self-produced innovative biologic from China to receive approval from the U.S. FDA and a “China ...
- Source: drugdu
- 42
- December 2, 2025
Mabwell Biopharmaceuticals’ innovative drug 9MW1911 completes Phase IIa clinical trial in COPD patients

On the evening of November 30, Mabwell Bio announced that its independently developed innovative drug…9MW1911 has completed a Phase IIa clinical trial in patients with moderate to severe chronic obstructive pulmonary disease (COPD), demonstrating good safety and tolerability in all dose groups. Currently, the company is actively advancing a Phase IIb clinical trial of 9MW1911 for the COPD indication. The announcement indicates that 9MW1911 is an innovative monoclonal antibody independently developed based on a highly efficient B lymphocyte screening platform, and belongs to the category of therapeutic biological products.Class 1, which can bind to the ST2 receptor with high affinity, thereby blocking the IL33/ST2 signaling pathway. Currently, Mabwell Bio is rapidly advancing the Phase II clinical trial of this drug in China. The first dose was administered in the Phase IIb clinical trial targeting a larger sample size of COPD patients in July 2025, and it is expected that based ...
- Source: drugdu
- 53
- December 1, 2025
Innovent Biologics’ new psoriasis drug, Picon and Zibaimab injection, has been approved

On November 28, Innovent Biologics Inc. (hereinafter referred to as ” Innovent Biologics “), a Hong Kong-listed company, announced that its independently developed product, Xinmeiyue® (piconzimab injection), has been approved by the National Medical Products Administration (NMPA) for use in adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy. As the first IL-23p19-targeted monoclonal antibody drug independently developed by a domestic company in China, the launch of Xinmeiyue® marks a new stage in the precision treatment of psoriasis in China. Psoriasis is an immune-mediated, chronic, relapsing, inflammatory, and systemic disease induced by the interaction between the individual and the environment, characterized by recurrent flare-ups and lifelong management. Patients typically present with erythema, scales, and plaques on the skin, which may also affect the scalp, nails, palms, and soles, impacting appearance, sleep, social interactions, and emotional state. It is estimated that there are over 7 million ...
- Source: drugdu
- 50
- December 1, 2025
Selects oral triple-target agonist ASC37 for clinical development

Zhongzheng Intelligent Finance News: On November 30th evening, Ascletis Pharma Inc.-B (01672) announced that the company has selected its first oral GLP-1R/GIPR/GCGR triple-target agonist peptide ASC37 for clinical development. It is expected that the company will submit an IND application for the oral tablet of ASC37 to the US Food and Drug Administration (FDA) in the second quarter of 2026. In the head-to-head study in non-human primates, the average absolute oral bioavailability of the ASC37 oral tablet reached 4.2%, which was approximately 9 times, 30 times, and 60 times that of semaglutide, teprotide, and retatrutide using the oral SNAC formulation technology, respectively. The announcement states that the study shows that the drug exposure level of ASC37 oral tablets (measured by the area under the drug-time curve) is approximately 57 times that of retatrutide. The average apparent half-life of the oral tablet in non-human primates in the study was approximately 56 ...
- Source: drugdu
- 44
- December 1, 2025
Youcare Pharmaceutical’s subsidiary has received approval for its clinical trial from the FDA

News Report: On November 28th, Youcare Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Youcare Pharmaceutical”) released an announcement regarding the voluntary disclosure of its subsidiary YKYY018 nebulizer inhalation agent obtaining FDA approval for clinical trials. The announcement indicates that the wholly-owned subsidiary of Youcare Pharmaceutical, Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Youcare Kechuang”), recently received a notification from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) regarding the approval for the clinical trial of YKYY018 nebulized inhalation agent for the prevention and treatment of respiratory syncytial virus (RSV) infection (Study May Proceed Letter, IND number: 178457). The announcement indicates that respiratory syncytial virus (RSV) is a ubiquitous and contagious enveloped RNA virus that can cause respiratory diseases, particularly affecting susceptible groups such as children, the elderly, and individuals with compromised immune systems. As of now, there are no approved RSV infection ...
- Source: drugdu
- 45
- December 1, 2025
Vaccine makers actively expand overseas presence

November 27 – Yunnan Walvax Biotech Co., Ltd. announced that its 13-valent pneumococcal polysaccharide conjugate vaccine has recently obtained the “Biological Product Marketing Authorization” issued by the Egyptian Drug Authority (EDA), signifying the vaccine’s official approval for marketing in Egypt. Deng Zhidong, General Manager of Hainan Boao Medical Technology Co., Ltd., stated to Securities Daily that in recent years, several Chinese vaccine enterprises have leveraged their advantages of “high quality, cost-effectiveness, and flexibility” to effectively seize overseas market opportunities. Through diverse approaches such as exporting finished vaccines and providing localized production support, they are ensuring vaccine supply security in low-income countries and regions lacking independent production or procurement capabilities. According to the reporter’s research, recently multiple listed vaccine companies have announced new progress in their overseas market expansion, indicating an acceleration of their globalization strategies. On November 24, Beijing Sinovac Holdings (Group) Co., Ltd. signed two Product Development Partnership (PDP) ...
- Source: drugdu
- 45
- December 1, 2025

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