PharmaFocus Today – Page 16 – media

Baili Tianheng BL-B01D1 Update Progress

Recently, the world’s first dual-antibody ADC drug BL-B01D1 independently developed by Baili Tianheng has made significant progress in the Phase III clinical trial for the treatment of locally advanced or metastatic nasopharyngeal carcinoma. The analysis results show that the drug has successfully reached the primary endpoint and may bring new treatment options for nasopharyngeal carcinoma patients. Nasopharyngeal carcinoma is a highly invasive and recurrent head and neck malignant tumor. Although immunotherapy and targeted therapy have made some progress in recent years, treatment options are still limited for patients with recurrent or metastatic nasopharyngeal carcinoma, especially those who have failed multiple lines of treatment. Baili Tianheng’s BL-B01D1 came into being in this context. With its unique innovative drug mechanism, it brings new ideas to the treatment of nasopharyngeal carcinoma. BL-B01D1 is an EGFR×HER3 dual-antibody ADC drug. Its design principle is to simultaneously target two key targets, epidermal growth factor receptor (EGFR) ...
- Source: drugdu
- 83
- July 10, 2025
FDA Approves KalVista Pharmaceuticals’ Ekterly for Hereditary Angioedema

The FDA has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 years and older. According to the company, approval was based on results from the Phase III KONFIDENT trial (NCT05259917), which was the largest clinical study ever conducted in HAE. Results from the trial showed faster symptom relief and attack resolution among patients administered Ekterly compared to placebo, along with strong efficacy and a favorable safety profile.1 How does Ekterly Change the Treatment Landscape for HAE? “The FDA approval of Ekterly is a defining moment for people living with HAE,” said Ben Palleiko, CEO, KalVista, in a press release. “Ekterly enables people to treat attacks the moment symptoms begin, wherever they are. This approval affirms the strength of our science and deep commitment to the HAE community. I am profoundly grateful to the KalVista team for ...
- Source: drugdu
- 61
- July 10, 2025
The First Drug to Treat Infants Sick With Malaria Is Approved by Swiss Authority

GENEVA (AP) — Switzerland’s medical products authority has granted the first approval for a malaria medicine designed for small infants, touted as an advance against a disease that takes hundreds of thousands of lives — nearly all in Africa — each year. Swissmedic gave a green light Tuesday for the medicine from Basel-based pharmaceutical company Novartis for treatment of babies with body weights between 2 and 5 kilograms (nearly 4½ to 11 pounds), which could pave the way for hard-hit African nations to follow suit in coming months. The agency said that the decision is significant in part because it’s only the third time it has approved a treatment under a fast-track authorization process, in coordination with the World Health Organization, to help developing countries access needed treatment. The newly approved medication, Coartem Baby, is a combination of two antimalarials. It is a lower dose version of a tablet ...
- Source: drugdu
- 56
- July 10, 2025
Which Strength Training Method Is Best for You? Experts Break Down the Options

When it comes to weight-resistance exercise, you can choose free weights such as dumbbells or barbells. Or weight machines, which are often driven by cables or levers. You can use resistance bands or tubes to build strength. Or try pushups and pullups — old standbys that create muscle overload by using your own body weight. These four basic options for strength training present fitness possibilities for young or old or beginners. And they offer flexibility for use in the gym, your home or in a hotel room during travel. You’ll probably wind up using a combination of the four, and they all have their pros and cons. They are appropriate for all ages and can be augmented with aerobic exercises like walking or running — or even climbing stairs. Let’s let Dr. Rafael Escamilla, a biomechanist and physical therapist at Sacramento State University in California, and Dr. Michael Stone, a ...
- Source: drugdu
- 60
- July 9, 2025
Is One Type of Water Healthier Than Another? Here’s What Experts Say

SUNDAY, July 6, 2025 (HealthDay News) — Alkaline. Electrolyte. Flavored. Walk down the beverage aisle and you’ll find all kinds of waters promising extra health perks. But are these fancy waters really better for you? Not really, Tufts University experts say. “There’s no physiological basis that there’s some metabolic benefit to these specialty waters over just regular, plain old water,” said Roger Fielding, a senior scientist at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts in Boston. For most people, Fielding said the best thing to do is simply drink more fluids — especially since many people walk around mildly dehydrated. “If you have a preference for a beverage and that’s going to make you drink more and you’ll be more attentive to rehydrating with that beverage, and you have the resources to purchase that beverage, well have at it,” Fielding said in a news release. ...
- Source: drugdu
- 55
- July 9, 2025
Innovent Biologics’ Suvicitamab is approved for marketing, solving the dilemma in the treatment of platinum-resistant ovarian cancer

On July 3, 2025, Innovent Biologics, an innovative drug subsidiary of Innovent Biologics (2096.HK), announced that its new generation VEGF-targeted antibody drug Enzeshu® (Suvixitamab) developed in China was approved for marketing by the National Medical Products Administration (approval number: National Medicine Standard S20250037, approval date June 30, 2025), becoming the first targeted therapy in China to cover the entire population of platinum-resistant ovarian cancer. The drug is indicated for combined chemotherapy for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed platinum-containing treatment, filling the clinical gap in targeted therapy in this field in my country. This is also the second innovative drug approved for marketing in the innovative pipeline of Innovent Biologics in 2025, following Dalireson. 01 Double survival benefit breaks through the treatment dilemma of platinum-resistant ovarian cancer The approval of Enzeshu® is based on the world’s first Phase III study ...
- Source: drugdu
- 76
- July 7, 2025
Everest Medicines’ Next-Generation BTK Inhibitor EVER001 Announces Latest Clinical Results, Continues to Demonstrate Efficacy and Safety

On July 2, Everest Medicines (1952.HK), a Hong Kong-listed innovative pharmaceutical company, announced that its new generation of covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor EVER001 (XNW1011), for which it has global rights, has obtained positive latest interim data in a Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN). The data showed that EVER001 continued to demonstrate excellent efficacy and safety during the extended follow-up period. Driven by these excellent clinical data, the development of EVER001 is expected to accelerate. Based on the current positive clinical data, experts recommend communicating directly with the U.S. Food and Drug Administration (FDA) to initiate Phase III clinical studies, and simultaneously communicate with the China Food and Drug Administration (CDE). Clinical trial data highlights frequently, with both effectiveness and safety According to reports, the Phase 1b/2a clinical trial of EVER001 for the treatment of primary membranous nephropathy conducted in China ...
- Source: drugdu
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- July 7, 2025
Jinsai Pharmaceutical’s Fuxin Qibaimab was approved, reducing the risk of gout recurrence by 87% in half a year

Recently, the official website of the National Medical Products Administration (NMPA) announced that Jinbeixin (Fuxinqibaimab), a Class 1 innovative drug independently developed by Jinsai Pharmaceutical, has been officially approved for marketing. It is suitable for patients with acute attacks of gouty arthritis in adults who are contraindicated, intolerant or ineffective to non-steroidal anti-inflammatory drugs and/or colchicine, and who are not suitable for repeated use of steroid hormones. With the three major clinical advantages of ” long-term control, rapid and effective, and safe and reliable “, Jinbeixin is expected to become the largest single product in the field of autoimmune disease treatment in China, meet huge market demand, and escort the majority of gout patients! Gout is known as the “king of pain”. According to the “2021 China Hyperuricemia and Gout Trend White Paper”, there are approximately 177 million patients with hyperuricemia in China, and more than 14.66 million patients with ...
- Source: drugdu
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- July 7, 2025
LH-1801 project enters Phase III clinical trial

On July 3, Lianhuan Pharmaceutical(600513) announced that the company has recently conducted a specific object survey with a number of investment institutions. The event was held in Beijing on July 2, 2025, and the participating units included China Asset Management, China Canada Fund and Shibei Investment. The company’s director and general manager Niu Ben and the director of the board office Ge Kai received investors and introduced the company’s development history, technical cooperation and the progress of the projects under research. The LH-1801 project mentioned in the announcement is an SGLT2 inhibitor jointly developed by the company and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. The project has now entered the Phase III clinical trial stage. It is expected that key data will be obtained in the first quarter of next year and an application for listing will be submitted to the National Medical Products Administration in ...
- Source: drugdu
- 153
- July 7, 2025
The new generation of DNA biosynthesis technology is moving towards industrialization

On May 12, 2025, Tianjin Zhonghe Gene Technology Co., Ltd. (hereinafter referred to as Zhonghe Gene) and Tianjin Tianbao Holding Co., Ltd. signed a DNA synthesis project. This marks that the new generation of DNA synthesis technology – enzymatic DNA biosynthesis technology has officially stepped into industrialization, injecting new momentum of “Intelligent Manufacturing in China” into the field of synthetic biology. It is understood that DNA synthesis technology is a key common underlying technology and core enabling technology in synthetic biology. Its synthesis principles are mainly divided into chemical methods and biological methods, and the existing commercialized DNA synthesis technologies and equipment are mainly based on chemical methods. At present, the synthesis length and cost of chemical DNA synthesis methods have reached their limits. However, this technology still has problems such as low single-step accuracy, cumbersome steps for long-fragment DNA synthesis, high synthesis cost, and environmental pollution, which restrict the ...
- Source: drugdu
- 72
- July 7, 2025

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