PharmaFocus Today – Page 65 – media

Multitasking ctDNA Helps Guide Lymphoma Treatment

Circulating tumor DNA (ctDNA) is gaining ground as an important multitasking tool in the frontline treatment of diffuse large B-cell lymphoma (DLBCL), with key novel applications that include identifying genetic subtypes and guiding the escalation or de-escalation of chemotherapy, new research has shown. “We have demonstrated that a PET/ctDNA-guided approach in frontline DLBCL is feasible in a multicenter setting,” said first author Anastasios Stathis, MD, of the Clinic of Hematology, Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland, in presenting the findings at the 18th International Conference on Malignant Lymphoma (ICML) 2025 in Lugano, Switzerland. “The allocation of patients and treatment based on the combined results of PET and ctDNA is operationally successful,” he said. The findings are from the preliminary results of the phase 2 SAKK 38/19 trial, which focuses on the goal of identifying patients with key MCD genetic subtypes that are known to respond poorly to the ...
- Source: drugdu
- 220
- June 24, 2025
Healthy gut microbiome before chemo could help protect breast cancer patients against cardiotoxicity

New research suggests that a healthy microbiome before chemotherapy could help protect breast cancer patients against heart damage, or cardiotoxicity, as a result of cancer therapy. Researchers found that specific bacteria in patients’ gut microbiome correlated with heart health biomarkers that suggest they are at greater risk of heart damage during chemotherapy. “To allow cancer survivors healthier lives, we need to find new ways to protect them from the long-term side-effects of chemotherapy. This study is one of the first to ask whether the microbiome could play a role in how well patient’s hearts fare during chemotherapy,” explained Doctor Athos Antoniades, Head of Research and Development at Stremble Ventures LTD who is leading the multi-omics, including the gut microbiome DNA sequencing for this project. “We saw a clear association between some specific genus of gut bacteria and cardiac biomarkers that suggest patients are at greater risk of heart damage during ...
- Source: drugdu
- 238
- June 24, 2025
The application for the new drug for ADHD has been accepted, bringing new hope to millions of children with the disease

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the New Drug Application (NDA) of Shanghai Aike Baifa’s new drug Dexmethylphenidate Dexmethylphenidate Compound Capsules for the treatment of attention deficit hyperactivity disorder (ADHD) has been officially accepted. In April, the drug was included in the priority review by CDE. This means that this highly anticipated innovative ADHD drug is expected to significantly shorten the review cycle and enter the market ahead of schedule. ADHD is not simply “naughty and hyperactive”. As a chronic neurodevelopmental disorder, it is characterized by an imbalance in the transmission of neurotransmitters in the brain, which makes it difficult for patients to concentrate and control behavioral impulses. According to titration data, in 2021, the number of children aged 6-17 in China exceeded 24 million, with a prevalence of 1.7%. However, for a long time, clinical drug ...
- Source: drugdu
- 213
- June 24, 2025
Fierce battle for acetylcysteine tablets! Huayi Pharmaceutical’s entry accelerates market differentiation

On June 17, according to the latest announcement on the CDE official website: Huayi Pharmaceutical’s application for the listing of the Class 3 generic drug acetylcysteine tablets was accepted, making it the eighth Chinese pharmaceutical company to enter this dosage form. This move has caused new waves in the acetylcysteine market. from Tidu , the sales of acetylcysteine tablets in all terminals have been growing in recent years. In 2024, the sales of all terminals exceeded 389 million yuan, a year-on-year increase of more than 13%. In the entire expectorant market, acetylcysteine has topped the list for four consecutive years with a share of over 50%. Acetylcysteine tablets are a commonly used expectorant in clinical practice. By decomposing the disulfide bonds of mucin in sputum, it effectively reduces the viscosity of sputum and promotes the discharge of sputum. In clinical practice, it is mainly used to treat symptoms such as ...
- Source: drugdu
- 192
- June 24, 2025
Lianya Pharmaceuticals opens up a new path to accelerate the export of domestic high-end preparations and domestic supply

The quality of drug preparations is directly related to the life, health and treatment effects of hundreds of millions of patients. At present, China is the world’s second largest pharmaceutical market. It is reported that the total output value of China’s pharmaceutical industry will reach about 3.8 trillion yuan in 2022, and generic drugs will dominate the Chinese pharmaceutical market, accounting for more than 60%. However, in the field of high-end generic drugs, especially in sustained-release preparations and complex injections, there are high technical barriers, and the market accessibility of domestic high-end generic preparations is relatively low. The root cause is the weakness of the core production process, especially the precise control of the drug release mechanism, the application of complex excipient systems, and the precision quality control technology in large-scale production, which has become a key bottleneck restricting domestic high-end preparations from achieving equivalence with original research drugs and ...
- Source: drugdu
- 246
- June 24, 2025
Zhengda Tianqing’s bispecific ADC is approved for clinical trials, and the competition for EGFR/c-Met targets heats up again

Recently, the official website of the Center for Drug Evaluation (CDE) of the China National Drug Administration showed that the TQB6411 injection, a Class 1 innovative drug independently developed by Zhengda Tianqing, has been approved for clinical use and is intended to be used to treat patients with advanced malignant tumors. As a dual-antibody ADC (antibody-drug conjugate) targeting EGFR/c-Met, this drug has become a “new species” that has not yet been approved for marketing in the world. The design logic of TQB6411 directly targets the key pain points of tumor treatment – drug resistance and compensatory activation of signal pathways. Epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (c-Met) are driver genes for various tumors such as lung cancer and colorectal cancer, and often form synergistic effects in signal transduction. When a drug inhibits only one of the pathways, the other pathway may be compensatorily activated, resulting in ...
- Source: drugdu
- 250
- June 23, 2025
New bispecific antibody company plans to go public in Hong Kong

In the biotechnology field, bispecific antibodies are becoming game-changing innovative therapeutics. On June 17, 2025, the Hong Kong IPO application of Innovent Biologics, a pioneer in the next-generation bispecific antibodies, was accepted and the prospectus was officially released. Founded in 2015, EpiMed Biopharma has been focused on developing bispecific antibodies using its proprietary bispecific antibody platform since its inception. Its strategic focus is on the field of T cell engagers, focusing on two major disease areas: tumors and autoimmune diseases. EpiMed has developed a proprietary technology platform designed to overcome the limitations of traditional bispecific antibody development: FIT-Ig platform: It has a unique linker-free, non-mutational and tetravalent bispecific antibody platform that can quickly generate bispecific antibody molecules while maintaining the biological function of each antibody domain, thereby achieving plug-and-play for multiple different targets. The FIT-Ig platform is the only bispecific antibody technology in the world that does not require any ...
- Source: drugdu
- 180
- June 23, 2025
Connoya sprints to become the “King of Chinese Self-immunity”

Recently, NEJM published the breakthrough data of Conoya’s BCMA/CD3 dual antibody CM336 in the treatment of refractory autoimmune hemolytic anemia (AIHA), with significant and lasting efficacy. This is not only a strong proof of its innovative strength, but also forms a synergy with the rapid commercialization of its trump card CM310, strongly supporting its sprint to become the king of autoimmune in China. BCMA/CD3 dual antibody autoimmune new blue ocean Bispecific antibody technology with T cell redirection as the core mechanism has made significant breakthroughs in the field of hematological tumors. Among them, BCMA/CD3 bispecific antibodies effectively guide cytotoxic T lymphocytes (CTL) to target and kill tumor cells through their unique dual antigen binding ability. Globally, two drugs, Teclistamab from Johnson & Johnson and Elranatamab from Pfizer, have been approved for relapsed and refractory multiple myeloma (RRMM). The former will land in the Chinese market in June 2024. Johnson & ...
- Source: drugdu
- 128
- June 23, 2025
Is It Worth Adding Chemo to ICI for NSCLC in Older Adults?

Immune checkpoint inhibitors (ICI) are a cornerstone of non-small cell lung cancer (NSCLC) treatment, but it’s not clear whether adding chemotherapy to ICI — a common practice with younger patients with NSCLC — helps older ones. No randomized trial has directly compared stand-alone ICI with chemoimmunotherapy in geriatric patients with NSCLC. Without strong data supporting the combined approach, oncologists may stay away from offering chemoimmunotherapy to older patients, especially to those with multiple comorbidities, given concerns about increased toxicity. To address the evidence gap, investigators linked Medicare and Surveillance, Epidemiology, and End Results data to compare outcomes between 14,249 older patients with NSCLC who received ICI alone (pembrolizumab or nivolumab) and 3432 treated with ICI and platinum doublet chemotherapy. Patients were aged 74 years, on average, and at least 66 years. The median follow-up duration was 211 days. The team weighed the risks and benefits of chemoimmunotherapy vs stand-alone ...
- Source: drugdu
- 98
- June 23, 2025
The World’s Only Twice-A-Year Shot to Prevent HIV Could Stop Transmission — if People Can Get It

WASHINGTON (AP) — The U.S. has approved the world’s only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it’s unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. “This really has the possibility of ending HIV transmission,” said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what’s called PrEP — regularly using preventive medicines such as the daily pills or a different shot ...
- Source: drugdu
- 155
- June 23, 2025

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