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Baili Tianheng’s HER2 ADC drug T-Bren receives Breakthrough Designation for HER2-positive gastric cancer

On November 4th, Baili Tianheng(688506) announced that its independently developed innovative biological drug T-Bren (HER2ADC) has been included in the Breakthrough Therapy List by the Center for Drug Evaluation of the National Medical Products Administration. It is indicated for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed first-line anti-HER2 therapy and first-line standard chemotherapy. The application date for this drug is September 17, 2025, registration category 1, and acceptance number CXSL2200209. T-Bren is an innovative ADC targeting HER2 with best-in-class potential. Currently, 14 clinical trials are underway both domestically and internationally, including 5 Phase III trials, 1 Phase II/III trial, 2 Phase II trials, 3 Phase I/II trials, and 3 Phase I trials, covering multiple indications. In the first three quarters of 2025, Baili Tianheng achieved revenue of 2.066 billion yuan and net profit attributable to the parent company of -495 million yuan. https://finance.eastmoney.com/a/202511043554798583.html
- Source: drugdu
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- November 5, 2025
HP515 Phase II Clinical Trial Completes First Batch of Participant Enrollment

Haichuang Pharmaceutical disclosed after trading on November 4 that the first batch of participants were recently enrolled in the Phase II clinical trial of its independently developed HP515 drug, which is intended to treat metabolic-associated steatohepatitis (MASH). Currently, there are no similar target products approved for marketing in China. The announcement indicates that HP515 tablets are an orally administered, highly selective THR-β (thyroid hormone receptor β subtype) agonist independently developed by Haichuang Pharmaceuticals. HP515 tablets directly act on THR-β to activate downstream gene transcription, thereby enhancing hepatocyte lipid metabolism activity, improving liver fat metabolism, and reducing lipotoxicity to improve metabolic-associated steatohepatitis (MASH). HP515 was approved by the China National Medical Products Administration (NMPA) for the treatment of metabolic steatohepatitis (MASH) in August 2024 and by the U.S. Food and Drug Administration (FDA) for the same purpose in September 2024. Recently, Haichuang Pharmaceuticals has completed the Phase I clinical trial of ...
- Source: drugdu
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- November 5, 2025
Low-Dose Aspirin Might Benefit Adults With Type 2 Diabetes, Study Says

By Dennis Thompson HealthDay ReporterTUESDAY, Nov. 4, 2025 (HealthDay News) — Low-dose aspirin is no longer universally recommended to prevent heart health emergencies, but it might help people with type 2 diabetes, a new study says. People with type 2 diabetes who took low-dose aspirin were less likely to have a heart attack or stroke, according to findings that will be presented Nov. 9 at the upcoming annual meeting of the American Heart Association in New Orleans. “We were somewhat surprised by the magnitude of the findings,” researcher Dr. Aleesha Kainat, a clinical assistant professor of medicine at the University of Pittsburgh Medical Center, said in a news release. “People with type 2 diabetes and a higher risk of cardiovascular disease who reported taking low-dose aspirin were much less likely to have had a heart attack, stroke or death over 10 years when compared to similar individuals ...
- Source: HealthDay
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- November 5, 2025
FDA Issues Safety Alert for Radiofrequency Microneedling

The U.S. Food and Drug Administration (FDA) is warning consumers, patients and healthcare providers about the potential risk for serious complications from radiofrequency (RF) microneedling procedures. RF microneedling devices are commonly used to improve skin appearance of the face and neck — often referred to as “resurfacing,” “tightening” or “rejuvenation” to treat issues like wrinkles. The technology works by using an array of tiny needles (microneedles) to deliver RF energy and heat into the skin. This heat is intended to cause controlled changes in the tissue, promoting new collagen growth, according to the FDA. However, the FDA has received numerous reports of serious and potentially permanent injuries related to the microneedling procedure. The adverse events reported to the agency include: Severe burns Permanent scarring Fat loss (diminishing facial volume) Physical disfigurement Nerve damage These reported injuries have occasionally required follow-up ...
- Source: HealthDay
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- November 5, 2025
【EXPERT Q&A】What requirements does the FDA have for the unique identification (UDI) of medical combination products?

Drugdu.com expert’s response: I. Which combination products does the FDA regulate? First, clarify the scope The FDA’s UDI rules primarily target medical device components, but combination products (such as drug – device combinations or device – drug co – packaged products) need to be treated differently based on their types. In simple terms: If the device is the main function in a combination product (for example, a drug – eluting stent, where the core is the stent): It must be labeled with a UDI, and the drug’s NDC code cannot be used as a substitute. If the drug is the main function (for example, a prefilled syringe, where the core is the drug inside): If it has already been labeled with an NDC code, the device part does not need to be additionally labeled with a UDI (but if the device components are sold separately, they still need to be ...
- Source: drugdu
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- November 5, 2025
to invest $3 billion in the Netherlands to build a new manufacturing facility and expand its oral drug production capacity.

November 3rd, ReiThe company announced plans to acquire Caterpillar in the Netherlands.Vic is investing $3 billion to build a new manufacturing facility to expand its oral drug production capacity and improve its global supply chain. Eli Lilly stated that the facility will be responsible for producing its first oral small-molecule GLP-1 receptor agonist, orforglipron. The company plans to submit applications for the drug’s use in obesity treatment to regulatory agencies worldwide by the end of this year. Eli Lilly also stated that the investment plan will create 500 high-paying jobs in South Holland, targeting highly skilled engineers, scientists, operations specialists, and laboratory technicians. In addition, approximately 1,500 new jobs are expected during construction. The project is scheduled to begin next year, with final implementation depending on the completion of government permits and local approvals. https://finance.eastmoney.com/a/202511033553774014.html
- Source: drugdu
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- November 4, 2025
Pfizer files antitrust lawsuit to block Novo Nordisk’s acquisition of Metsera.

American pharmaceutical company PfizerFor Metsera and Novo NordiskA lawsuit has been filed against the two weight-loss drug companies .The latest merger agreement reached with the property developer violates U.S. federal antitrust laws. This is Pfizer ‘s second lawsuit in four days, aimed at preserving its acquisition agreement that was unexpectedly disrupted by Novo Nordisk . According to a complaint filed by Pfizer in the U.S. District Court for the District of Delaware on Monday, Pfizer alleges that Novo Nordisk, the maker of Ozempic , is planning a proposed acquisition of U.S. biopharmaceutical company Metsera, which would further solidify its leadership in the field of obesity treatments by killing a smaller competitor. The background to this event is that in September of this year, Pfizer announced that it had agreed to acquire Metera for $47.50 per share in cash, corresponding to an enterprise value of approximately $4.9 billion. If certain research and development targets are met, Pfizer will pay an additional $22.50 ...
- Source: drugdu
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- November 4, 2025
Livzon Pharmaceutical’s innovative quadrivalent recombinant protein influenza vaccine completes Phase I clinical trial with first cohort vaccination

Shanghai Securities News China Securities(Reporter Zhang Xue) On October 30, Livzon Pharmaceutical Group announced that its developed quadrivalent recombinant protein…influenzaThe LZSN2401 vaccine recently completed vaccination of the first cohort of subjects in its Phase I clinical trial, and subsequent cohort enrollment has successfully commenced. This vaccine is the world’s first adjuvanted quadrivalent recombinant protein influenza vaccine, and its development deeply integrated artificial intelligence.The technology, along with a significant breakthrough in adjuvant systems, promises to provide better protection for influenza prevention and control, especially for the elderly. According to the company, in the development of LZSN2401, Livzon Pharmaceutical applied artificial intelligence technology systems to process development and analysis method optimization, which greatly improved R&D efficiency and product quality, fully demonstrating the company’s strategic direction of using artificial intelligence to promote R&D efficiency in recent years. Qualcomm utilizes AI algorithms to analyze key process parameters.Through quantitative simulation and intelligent screening, the team optimized a process route that would have taken more than six months under the traditional model ...
- Source: drugdu
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- November 4, 2025
A recent study published in the international academic journal *Vaccines* shows that Sinovac’s varicella vaccine has a better safety profile than the control vaccine.

Reporters have learned that the internationally renowned academic journal *Vaccines* recently published a research paper entitled “Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Healthy Children Aged 12 to 15 Months.” This study is the first to use Beijing Sinovac Biotech…Sinovac Biotech’s (hereinafter referred to as “Sinovac”) varicella live attenuated vaccine was compared head-to-head with another control vaccine that has passed WHO prequalification. The results showed that Sinovac’s varicella live attenuated vaccine met the non-inferiority standard for immunogenicity and had better safety than the control vaccine. This study was a randomized, double-blind, positive-control, non-inferiority phase III clinical trial conducted at San Juan de Dios Hospital in the Philippines. A total of 484 healthy children aged 12 to 15 months were enrolled and randomly assigned to receive either one dose of Sinovac varicella attenuated live vaccine (239 cases) or control vaccine (245 cases). The primary evaluation factor was the varicella-zoster ...
- Source: drugdu
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- November 4, 2025
BIO-Europe Autumn

Organiser：EBD Group Inc. Time：November 3 – November 5, 2025 Address：Messeplatz 1, Postfach 277, A-1021 Wien, Vienna, Austria Exhibition hall：MESSE WIEN Exhibition Congress Centre Product range: Animal and plant pharmaceuticals, gene/cell therapy, bioinformatics, genomics/genetics, medical devices, nanotechnology, clinical research and laboratory services, platform technologies, chemistry, stem cell research, drug delivery, technology transfer, and pharmaceutical R&D. About BIO-Europe Autumn： The BIO-Europe Autumn in Austria is Europe’s most professional exhibition focusing on biotechnology, pharmaceuticals, and nutraceuticals. Held in different cities each autumn, the BIO conference brings together thousands of leaders from the biotechnology industry across multiple countries. The event aims to make every connection meaningful and targeted, fostering activities dedicated to achieving breakthroughs in biotechnology. The exhibitors at BIO-Europe Autumn in Austria span a wide range of sectors, including analytical services, the bioinformatics industry, cloud computing, software and hardware development, clinical research reporting/clinical data management, imaging software, and information technology. These ...
- Source: drugdu
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- November 4, 2025

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