media – Page 15 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Preclinical evidence supports sotagliflozin’s superior efficacy in attenuating salt-induced kidney damage

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, initially developed to treat type 2 diabetes, have significant heart- and kidney- protective effects. In the kidney, SGLT2 reabsorbs approximately 97% offiltered glucose in the S1 and S2 segments of the proximal tubule, while SGLT1reabsorbs the remainder in the S3 segment. In research conducted in rats, investigators found that dual inhibition of SGLT1 and SGLT2 more effectively reduces salt-sensitive hypertension and kidney injury than SGLT2 inhibition alone. The findings will be presented at ASN Kidney Week 2025 November 5–9. Salt-sensitive hypertension-elevated blood pressure due to excess salt consumption- affects nearly half of individuals with high blood pressure and substantially contributes to kidney disease, cardiovascular complications, and progression to kidney failure. When researchers compared selective SGLT2 inhibition (through treatment with dapagliflozin) with dual SGLT1/2 inhibition(through treatment with sotagliflozin) in a well-established rat model of salt-induced hypertension and chronic kidney disease, they found that both drugs had ...
- Source: drugdu
- 90
- November 10, 2025
Infant Botulism in 10 US States Linked to Formula Being Recalled

Federal and state health officials are investigating 13 cases in 10 U.S. states of infant botulism linked to baby formula that is being recalled Federal and state health officials are investigating 13 cases in 10 states of infant botulism linked to baby formula that was being recalled, authorities said Saturday. ByHeart Inc. agreed to begin recalling two lots of the company’s Whole Nutrition Infant Formula, the Food and Drug Administration said in a statement. All 13 infants were hospitalized after consuming formula from two lots: 206VABP/251261P2 and 206VABP/251131P2. The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. No deaths were reported. The FDA said it was investigating how the contamination happened and whether it affected any other products. Available online and through major retailers, the product accounted for an estimated 1% of national formula sales, according to the Centers for Disease Control ...
- Source: drugdu
- 78
- November 10, 2025
【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: To apply for a Medical Device Manufacturing License, enterprises need to follow a systematic process that covers material preparation, review stages, and key compliance points, as outlined below: Pre-Application Core Condition Self-Check Qualification Foundations Medical Device Registration: Possession of a valid Medical Device Registration Certificate and product technical requirement documents for the intended medical device production. Business License Scope: The business license must explicitly include medical device manufacturing within its scope of operations. Production Conditions Facilities: Adequate production facilities matching the scale of operations, including cleanrooms (compliant with ISO 14644 standards for sterile medical devices) and storage areas. Provide property ownership certificates or lease agreements. Equipment: Equipped with primary production equipment (e.g., injection molding machines, sterilization equipment) and inspection instruments (e.g., microbiological testers, mechanical testers). A detailed equipment list should be provided. Personnel: Production, quality, and technical leaders must possess relevant professional qualifications (e.g., degrees in biomedical ...
- Source: drugdu
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- November 10, 2025
Innovative Autoimmune Drug to Make its International Academic Debut at CS2015

　China Securities Intelligent Finance News: CStone Pharmaceuticals-B (02616) announced on the morning of November 7th that it will present its pipeline drug CS2015 (OX40L/TSLP bispecific antibody) in the field of autoimmune and inflammation for the first time at the 2025 American Academy of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting through electronic posters and oral presentations. This will be the drug’s first appearance at an international academic conference. 　　According to the announcement, CS2015 employs an asymmetric molecular structure, simultaneously targeting two key inflammatory regulators, OX40L and TSLP, and utilizes a mutant Fc to prolong its circulating half-life, supporting long-term dosing intervals. Preclinical studies have shown that this molecule can potently inhibit inflammatory signaling pathways, exhibiting rapid reduction in skin lesions, decreased immune cell infiltration, and relief of itching in animal models of atopic dermatitis. 　　The announcement indicates that, in terms of drug metabolism, CS2015 exhibits excellent pharmacokinetic characteristics in ...
- Source: drugdu
- 147
- November 8, 2025
Recombinant Human Nerve Growth Factor SMR001 Eye Drops Approved for Phase III Clinical Trials

　　China Securities Intelligent Finance ST Weiming(002581) announced on November 7 that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has independently developed a Class I innovative drug.The Phase III pivotal registration clinical trial of recombinant human nerve growth factor SMR001 eye drops for the treatment of moderate to severe dry eye disease recently received approval from the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University, the lead institution, marking the official commencement of the project. 　　The announcement stated that SMR001 eye drops are a key innovative ophthalmic biological drug developed by the company. Utilizing a Chinese hamster ovary cell (CHO) expression system, it is the first domestically produced eye drop formulation with recombinant human nerve growth factor as its active ingredient. This product, by repairing damaged corneal nerves and promoting epithelial regeneration, is expected to become a novel treatment option for moderate to severe dry eye syndrome. ...
- Source: drugdu
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- November 8, 2025
Targeting Unmet Clinical Needs and Strengthening Innovation and International Development Strategies

　　China Securities Journal (Reporter Li Mengyang) – Recently, Henlius Biotech officially announced key updated data on its PD-L1 ADC (antibody-drug conjugate) HLX43 for the treatment of non-small cell lung cancer (NSCLC). This release integrates for the first time the results of the product’s international multicenter Phase II clinical trial, further validating its global clinical value. Simultaneously, the company also announced the latest follow-up data from a Phase II dose-finding study of its independently developed recombinant anti-EGFR monoclonal antibody HLX07, in combination with the anti-PD-1 monoclonal antibody H, slulimab, for first-line treatment of EGFR-high expressing advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). 　　”Currently, we invest most of our commercial revenue into the research and development of innovative pipeline products. The company is continuously advancing the development of core innovative products such as H-drug Hanseo and PD-L1 ADC HLX43,” said Zhu Jun, Executive Director and CEO of Henlius Biotech, in ...
- Source: drugdu
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- November 8, 2025
GSK calls for the establishment of a standardized national systemic lupus erythematosus (SLE) diagnosis and treatment system to help improve the prognosis of lupus patients.

　　At the 8th China International Import ExpoAt the China International Import Expo (hereinafter referred to as “CIIE”), GlaxoSmithKlineGSK successfully invited several senior experts, scholars, and non-profit partners in the field of rheumatology and immunology to gather together to exchange ideas on topics such as disease awareness, patient support, and chronic disease management of systemic lupus erythematosus (SLE). The aim was to improve public scientific understanding, improve the living environment of patients, and help patients regain confidence in life. Leveraging the powerful enabling effect of the China International Import Expo 　　Data shows that systemic lupus erythematosus (SLE) is a chronic autoimmune connective tissue disease that can cause damage to multiple organs and tissues, including the kidneys, cardiovascular system, lungs, digestive system, blood system, and eyes, and significantly increases the risk of death. Currently, there are over one million lupus patients in China, primarily women of childbearing age. With the continuous improvement ...
- Source: drugdu
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- November 8, 2025
Sanofi’s two innovative cardiovascular drugs make their global debut

　　The 8th China International Import ExpoDuring the China International Import Expo (hereinafter referred to as the “CIIE”), SanofiThe opening ceremony of the China International Import Expo (CIIE) and the global debut ceremony of cardiovascular innovations were officially held. Sanofi brought two innovative drugs in the cardiovascular field to the expo.—The global debut of Avketate tablets and Pleuselan sodium injection. 　　Oxana Monge, General Manager of Sanofi 　　”Plesulan sodium injection is the world’s first siRNA drug targeting the innovative APOC3 mRNA, bringing new hope for the treatment of patients with familial chylomicronemia syndrome and severe hypertriglyceridemia.””We hope that these two innovative products can leverage the CIIE as an innovation accelerator and its powerful spillover effect to quickly transform from exhibits into commodities, benefiting Chinese patients more rapidly,” said Oxana Monge. 　　Hypertrophic cardiomyopathy (HCM), the most common inherited heart disease, can lead to fatal risks such as sudden death, heart failure, and thromboembolism. ...
- Source: drugdu
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- November 8, 2025
Sanofi’s innovative targeted nanobody drug, Kebeli, has been approved in China.

　　On November 5th, SanofiAnnouncement of its innovative drugCablivi (caracizumab for injection) has been officially approved by the National Medical Products Administration (NMPA) for use in combination with plasma exchange and immunosuppressive therapy.Acquired thrombotic thrombocytopenic purpura (aTTP, also known as immune-mediated thrombotic thrombocytopenic purpura) in adults and adolescents aged 12 years and older weighing at least 40 kg. https://finance.eastmoney.com/a/202511053556137255.html
- Source: drugdu
- 134
- November 8, 2025
Metsera’s weight loss drug performance is outstanding, leading to a surge in the company’s valuation amid bidding wars among industry giants.

　　The next-generation weight loss drug developed by Metsera, Inc. in the United States has shown good tolerability in an interim clinical trial, with only a very small number of participants dropping out midway, a result that has increased the attractiveness of the pharmaceutical company. 　　Studies show that the drug’s weight loss effect is comparable to that of current market leader Eli Lilly.It is comparable to Zepbound, and only about 3% of participants dropped out of the trial. In contrast, some other weight-loss drugs…The dropout rate in the trial was high, with participants often discontinuing the medication due to side effects. 　　John Buse, a professor at the University of North Carolina at Chapel Hill School of Medicine, said while introducing the trial at the Obesity Society Annual Meeting in Atlanta, “The tolerability (of the drug) is excellent.” 　　Metsera first disclosed trial data at the end of September. The results showed that ...
- Source: drugdu
- 58
- November 8, 2025

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