PharmaFocus Today – Page 83 – media

An IIT study based on an engineered extracellular vesicle mRNA platform to deliver full-length dystrophin for the treatment of Duchenne muscular dystrophy (DMD) has been initiated, opening a new paradigm for gene therapy

Researchers from Shenzhen Bay Laboratory, Shenzhen Academy of Medical Sciences, Peking University Shenzhen Graduate School, and Shanghai Spinoin Biotechnology Co., Ltd. recently collaborated with Shanghai Children’s Medical Center affiliated to Shanghai Jiao Tong University School of Medicine and obtained approval to conduct the world’s first clinical trial using a non-viral vector full-length dystrophin (FL-dystrophin) gene therapy to treat Duchenne muscular dystrophy (DMD) . This is also the first international clinical trial initiated by researchers (IIT) to introduce gene therapy drugs into humans using an extracellular vesicle delivery platform. The project, titled ” A novel mRNA platform based on engineered extracellular vesicles (EVs) to treat Duchenne muscular dystrophy “, aims to deliver FL-dystrophin mRNA through engineered extracellular vesicles, evaluate its safety, tolerability and preliminary efficacy in DMD patients, and provide patients with safer and more efficient gene therapy options. 01 Research background and scientific basis Duchenne muscular dystrophy is a fatal ...
- Source: drugdu
- 241
- July 16, 2025
Sinovent’s new drug application for marketing approval has been accepted, the nemesis of drug-resistant bacteria is here

On July 9, the CDE official website showed that Sinovent’s application for the marketing approval of imipenem-cilastatin sodium fonobactam for injection (hereinafter referred to as imipenem-cilastatin sodium fonobactam for injection) was officially accepted. This world-first new antibacterial drug is intended to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), directly addressing the most difficult problem of drug-resistant bacterial infection in clinical practice. Compared with other new β-lactamase inhibitors (such as avibactam, relebactam, etc.), this product has a wider and stronger inhibitory activity, and can comprehensively and effectively inhibit the common A, C, and D enzyme activities of Gram-negative bacteria. Behind this breakthrough is a key breakthrough in the field of drug-resistant bacteria by a Chinese pharmaceutical company that was established only 8 years ago. In the intensive care unit, hospital-acquired pneumonia and ventilator-associated pneumonia are common life-threatening infections. What is more worrying is that the detection rate of carbapenem-resistant ...
- Source: drugdu
- 165
- July 16, 2025
Lepu Medical’s Sodium Hyaluronate Solution for Injection is Approved for Registration to Expand Business in the Consumer Healthcare Field

On the evening of July 11, Lepu MedicalDisclosure of a suggestive announcement regarding the registration approval of sodium hyaluronate solution for injection by NMPA. The company learned today that the sodium hyaluronate solution for injection independently developed by its subsidiary Sichuan Xingtai Pule Medical Technology Co., Ltd. has been approved for registration by the National Medical Products Administration (NMPA), with the registration certificate number of National Medical Device Registration No. 20253131324. The product is used in medical institutions for injection into the superficial dermis of the face to temporarily improve dry skin and dull complexion in adults. The announcement pointed out that the sodium hyaluronate solution for injection is a water light injection product. By accurately injecting nutrients into the superficial or middle layers of the dermis, it effectively solves the problem of skin care products being difficult to absorb through the skin. The successful approval of the sodium hyaluronate ...
- Source: drugdu
- 182
- July 15, 2025
Digene Pharmaceuticals’ Suvotinib Tablets are included in the latest version of the NCCN guidelines to create a new paradigm for the internationalization of China’s “original” new drugs

July 12, Digene (Jiangsu) Pharmaceutical Co., Ltd. (hereinafter referred to as “Digene Pharmaceutical”) held a press conference in Beijing on the approval of Shuvozal® in the United States. Reporters learned that ZEGFROVY® (generic name: Suvotinib tablets) of Digene Pharmaceuticals has been included in the National Comprehensive Cancer Network (NCCN) non-small cell lung cancer guidelines for the treatment of previously treated epidermal growth factor receptor (EGFR) exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC). ZEGFROVY® has become the only EGFR exon20ins NSCLC small molecule targeted drug in the world that has been included in the international authoritative lung cancer guidelines. Earlier, Shuwozhe® was approved for marketing by the U.S. Food and Drug Administration (FDA) through priority review on July 3, becoming the world’s first and only EGFRexon20ins NSCLC innovative drug approved in the United States.It is also China’s first independently developed global innovative . Professor Wang Mengzhao of Peking ...
- Source: drugdu
- 146
- July 15, 2025
Ascentage Pharmaceuticals is out with its powerful weapon

On July 10, according to the official website of NMPA, Ascentage Pharma’s highly anticipated pipeline product, lisatoclase tablets (APG-2575), has been conditionally approved for marketing for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously received at least one systemic treatment including a Bruton’s tyrosine kinase (BTK) inhibitor. You should know that before this, there was only one Bcl-2 inhibitor in the world – venetoclax. Since then, the research and development boom of Bcl-2 drugs can be said to have lasted for ten years. Now, it has finally borne fruit in the biotech company Ascentage Pharmaceuticals. A major target for crossing the cycle Bcl-2 is the founding member of the Bcl-2 regulatory protein family, the most notable feature of which is its regulatory role in mitochondrial apoptosis. The Bcl-2 family of proteins consists of members that promote or inhibit apoptosis, and controls apoptosis by controlling mitochondrial outer membrane ...
- Source: drugdu
- 164
- July 15, 2025
$10 billion! Merck bets on respiratory drugs

On July 9, Merck announced that it had reached a final agreement with Verona Pharma (VRNA), a biopharmaceutical company focusing on respiratory diseases. According to the agreement, Merck will acquire Verona’s American Depositary Shares (ADS) through a subsidiary at a price of US$107 per share, with a total transaction value of approximately US$10 billion. Through this acquisition, Merck will acquire Ohtuvayre, a first-in-class new COPD drug, expanding its R&D pipeline and product portfolio for the treatment of cardiopulmonary diseases, which is expected to drive growth over the next decade. This is not the first time Merck has made a big investment. According to public data, the patent for PD-1 inhibitor Keytruda, which accounts for nearly half of Merck’s revenue, is about to expire, and the US government is expected to negotiate for Keytruda under the IRA in 2026. Another best-selling drug of Merck, HPV vaccine Gardasil, is facing severe challenges ...
- Source: drugdu
- 246
- July 15, 2025
Kanghua Biotechnology plans to change ownership! Before the suspension, there was a significant increase in trading volume and a three-year consecutive decline in net profit. Shareholders are reducing their holdings and leaving the market

On the evening of July 13th, Kanghua Biotechnology (300841) announced that its controlling shareholder and actual controller, Wang Zhentao, is planning to change the company’s control rights, which may lead to a change in the company’s controlling shareholder and actual controller. Upon application to the Shenzhen Stock Exchange, the company’s stock will be suspended from trading starting from Monday, July 14th, with an expected suspension period of no more than 2 trading days. It should be noted that before the suspension, Kanghua Biotechnology saw a significant increase in trading volume on July 11th, with the latest stock price reaching 72.01 yuan per share. According to the data, Kanghua Biotechnology is mainly engaged in the research and development, production, and sales of human vaccines. The company has obtained drug registration certificates for vaccines such as freeze-dried human rabies vaccine (human diploid cell) and ACYW135 meningococcal polysaccharide vaccine. Kanghua Biotechnology’s net profit ...
- Source: drugdu
- 168
- July 15, 2025
Why Too Much May Harm Your Patients’ Weight Loss Efforts

Although many of your patients may think that increasing protein is the key to fat loss and successful weight management, there’s a consensus in the medical community that patients should be aware that there can, indeed, be too much of a good thing. “I feel like protein intake, although important, is grossly overemphasized in weight loss, and a strong focus on protein can miss other critical goals necessary for weight loss — chief among them [being] caloric restriction but also fiber intake and adequate nutrients,” said Matthew Badgett, MD, internal medicine physician at Cleveland Clinic in Ohio. “I discuss protein but advise to not overdo it.” While protein is one of the key macronutrients our bodies need to build muscle and repair tissue, patients should know of varying sources. “Lean proteins are a great option and can come from both animal and plant-based sources like lentils, peas, and other high-protein ...
- Source: drugdu
- 124
- July 15, 2025
Exposure to endocrine-disrupting chemicals in early life linked to cravings for sugary and fatty foods

Exposure to endocrine-disrupting chemicals in early life, including during gestation and infancy, results in a higher preference for sugary and fatty foods later in life, according to an animal study being presented Sunday at ENDO 2025, the Endocrine Society’s annual meeting in San Francisco, Calif. Endocrine-disrupting chemicals are substances in the environment (air, soil or water supply), food sources, personal care products and manufactured products that interfere with the normal function of the body’s endocrine system. To determine if early-life exposure to these chemicals affects eating behaviors and preferences, researchers from the University of Texas at Austin conducted a study of 15 male and 15 female rats exposed to a common mixture of these chemicals during gestation or infancy. “Our research indicates that endocrine-disrupting chemicals can physically alter the brain’s pathways that control reward preference and eating behavior. These results may partially explain increasing rates of obesity around the world,” ...
- Source: drugdu
- 129
- July 15, 2025
Is Drug Working? Still Needed?

A new allergy medication is prompting clinicians to adjust their approach to oral food challenges — medically supervised tests in which clinicians give increasing doses of an allergen like peanut or milk to see how a patient reacts. The FDA in 2024 approved omalizumab (Xolair) to help reduce allergic reactions in adults and children aged 1 year or older with immunoglobulin E-mediated food allergy. Patients receiving the injections are supposed to avoid foods to which they are allergic. In the event of an accidental exposure, the medication can afford protection against a serious reaction. The approval opened a new frontier in allergy therapy but also raised questions without clear answers, like: How can patients be sure the medication is working? And how will they know if they “outgrow” an allergy, as some people do? After the approval, clinicians wrote to the American Academy of Allergy, Asthma & Immunology seeking advice. ...
- Source: drugdu
- 153
- July 14, 2025

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