media – Page 29 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Announcement on Obtaining the “Approval Letter for Drug Clinical Trial” of an Innovative Drug

Securities Daily Online News: On the evening of December 16, Haisco Pharmaceutical Group issued an announcement stating that its subsidiary, Shanghai Haisco Shennuo Pharmaceutical Technology Co., Ltd., recently received the “Approval Letter for Drug Clinical Trial” issued by the National Medical Products Administration (NMPA). Following review, the Clinical Trial Applications (CTA) for HSK45019 Tablets, HSK50042 Tablets, HSK55718 for Injection, and HSK36357 Capsules, which were accepted in October 2025, have met the relevant requirements for drug registration. Approval has been granted to proceed with clinical trials. https://finance.eastmoney.com/a/202512163593304242.html
- Source: drugdu
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- December 17, 2025
Urine-based microRNA clock predicts biological aging without a blood test

In a recent study published in the journal npj Aging, researchers developed a urinary microRNA (miRNA) aging clock that predicts chronological age from urinary miRNA profiles, with deviations used as an indirect indicator of biological age acceleration rather than a direct measurement of biological age. Aging remains the primary driver of chronic diseases, yet reliable, non-invasive biomarkers of biological age are limited. Aging clocks are biomarker-based models that estimate biological age from age-responsive characteristics, and deviations from chronological age reflect the pace of aging. These clocks are associated with morbidity and mortality risk and are used to stratify health risk and assess interventions. miRNAs have been linked to age-related disorders and aging. Aging clocks based on miRNAs in skin, blood, and plasma have been developed. Beyond skin, solid tissues exhibit reproducible age-related miRNA shifts. While tissue or blood sampling requires invasive procedures at medical facilities, urine represents a non-invasive, scalable, ...
- Source: drugdu
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- December 17, 2025
Salutogenic microbes offer new pathways to better health

Viruses and bacteria get a bad rap around the world but now Flinders University experts are identifying the positive ‘upside’ of powerful benefits that microbes have on human health. Flinders microbial ecologist Dr Jake Robinson and colleagues have presented a timely reminder of these ‘invisible friends’ in a new article published in Microbial Biotechnology, underlining the benefits of moving away from a threat-centred view of microbes and biogenic compounds. The article introduces the ‘Database of Salutogenic Potential’, a world-first prototype open-access repository that catalogues microbes and natural compounds linked to positive health outcomes. “Emerging evidence shows that exposure to diverse environmental microbiomes and natural biochemical products also promotes health and resilience,” says Dr Robinson. “Rather than viewing biodiversity as something to be eliminated, contemporary approaches recognise the vital role of diverse ecosystems in creating salutogenic, or health-promoting, environments. “By consolidating this data, we aim to rebalance the story of microbes ...
- Source: drugdu
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- December 17, 2025
【EXPERT Q&A】What are the content and regulatory requirements for the registration materials of domestic non-active medical devices?

Drugdu.com expert’s response: Domestic Registration of Non-active Medical Devices: Required Submission Materials Covering Six Core Areas Including Enterprise Qualifications, Product Technology, Quality Systems, Clinical Evaluation, Packaging and Labeling, and After-sales Service. Specific Content and Regulatory Requirements Are as Follows: I. Enterprise Qualification Documents Basic Certificates: Provide a copy of the business license (stamped with the official seal and valid), organization code certificate, and tax registration certificate (some regions have merged these into a unified social credit code). If the enterprise already holds a Medical Device Business License, this must also be submitted. Personnel Qualifications: Include identity proofs, academic or professional title certificates for the legal representative, enterprise leader, and quality supervisor, along with work resumes of quality management personnel. Additionally, provide a list of professional and technical personnel with their qualifications (e.g., copies of ID cards, academic certificates, and professional title certificates). Special Qualifications: If the product involves innovative medical ...
- Source: drugdu
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- December 17, 2025
FDA Approves Lerochol for Adults with Elevated LDL Cholesterol

FDA has announced the approval of LIB Therapeutics’ Lerochol (lerodalcibep-liga) for subcutaneous (SC) use as an adjunct to diet and exercise in reducing low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lerochol is a small protein-binding, third-generation PCSK9 inhibitor. The drug was developed as a once-monthly, single small-volume, SC injection with extended room temperature stability up to three months, making Lerochol a more convenient alternative to other PCSK9 inhibitors.1 The anti-PCSK9 binding domain of Lerochol is an 11-kDa polypeptide called adnectin, which was developed for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to improve plasma half-life. “While PCSK9 inhibitors as a class deliver powerful cholesterol lowering potential, Lerochol was designed to address the barriers that have limited their use, including ease of use features like a single small monthly injection, self-administered at home with extended room-temperature stability for home storage ...
- Source: drugdu
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- December 16, 2025
How to Head Off Tendon Trouble

By Carole Tanzer Miller HealthDay ReporterSUNDAY, Dec. 14, 2025 (HealthDay News) — Injure a tendon and you might not notice right away, but beware: These injuries often fail to heal properly, putting everyday activities at risk. “No matter how strong your muscle is, you’re not going to be able to have the functionality and the stability you need if a tendon is impaired,” Nelly Andarawis-Puri, a bioengineering researcher at Cornell University in Ithaca, N.Y., told NIH News in Health. Tendons connect your muscles and your bones. Your ability to move your body is at risk when tendon tissue becomes inflamed, ruptures or breaks down. You might experience pain or stiffness, swelling and weakness. A sudden awkward movement is sometimes to blame — but everyday activities that require repetitive movements pose particular risks. (Think: Typing long hours at the office, which may make your hands hurt, or doing repeated jumping exercises ...
- Source: drugdu
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- December 16, 2025
Ascletis Pharma’s ASC50 Phase I clinical trial in the United States yielded positive topline results

On December 15, Ascletis Pharma-B (01672) announced positive top-line results from its independently developed oral small molecule IL-17 inhibitor, ASC50, in a Phase I clinical trial in the United States. The primary objective of the trial was to evaluate the safety, tolerability, and pharmacokinetic characteristics of ASC50. Forty-six healthy subjects received different doses of ASC50 (10 mg to 600 mg). The results showed that the elimination half-lives of ASC50 at each dose were 43, 89, 91, 87, 104, and 85 hours, supporting once-daily or potentially weekly oral administration. Furthermore, ASC50 demonstrated significant targeted binding efficacy after administration, with IL-17A levels remaining elevated up to day 7 at higher doses. Safety and tolerability were good at all dose levels, with all adverse events being mild and no serious adverse events reported. Based on these positive results, ASC50 will advance to the next phase of clinical development, conducting multi-dose escalation studies for ...
- Source: drugdu
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- December 16, 2025
Hualan Biological’s application for clinical trial of pembrolizumab injection has been accepted

Hualan BiologicalOn December 16, the company announced at noon that its investee company, Hualan Gene Engineering Co., Ltd., received the “Acceptance Notice” from the National Medical Products Administration for its application for clinical trial registration of pembrolizumab injection for domestic production. Hualan Biological stated that its pembrolizumab injection is a biosimilar. The original pembrolizumab product (trade name: Keytruda®) is manufactured by Merck.The company developed one of the world’s first approved PD-1 inhibitors, which has been approved globally for dozens of important oncology indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer. Its clinical value has been widely recognized. https://finance.eastmoney.com/a/202512163592877572.html
- Source: drugdu
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- December 16, 2025
Another Phase 3 clinical trial failed.

Recently, biotechnology company Arcus Biosciences and its partner Gilead announced the formal termination of the Phase III clinical trial STAR-221 , which combines PD-1, TIGIT, and chemotherapy as first-line treatment for gastric cancer , because the study showed no efficacy in the interim analysis . STAR-221 is a global, randomized, open-label phase III clinical trial that enrolled approximately 1040 patients with locally advanced, unresectable, or metastatic HER-2-negative gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The study aimed to evaluate the efficacy and safety of Arcus’ anti-TIGIT monoclonal antibody domvanalimab in combination with its PD-1 inhibitor zimberelimab and chemotherapy regimens (FOLFOX or CAPOX) as first-line treatment, compared to the standard therapy nivolumab (Opdivo) in combination with chemotherapy. The primary endpoint of the study was to assess overall survival (OS) in tumors with high PD-L1 expression (TAP ≥ 5%), PD-L1-positive tumors (TAP ≥ 1%), and the intention-to-treat population (all PD-L1 levels) ...
- Source: drugdu
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- December 16, 2025
Ascletis Investors surges fourfold! A quiet turnaround for Ascletis!

Recently, Ascletis Pharma released Phase II study data for its oral small molecule GLP-1 drug ASC30. In 125 obese or overweight subjects, the 60 mg dose group experienced a weight loss of up to 7.7%, and no weight loss plateau was observed. Following the announcement, Ascletis Pharma’s stock price surged by more than 20% intraday on December 9. In fact, Ascletis Pharma’s stock price has increased approximately fourfold this year, ranking among the top performers in the pharmaceutical industry. 01 The data is amazing. small molecule GLP-1R completely biased agonist developed by Ascletis Pharma . According to publicly available information from Ascletis Pharma, this drug possesses unique and differentiated properties, and can be taken orally once daily or subcutaneously once monthly to quarterly as a treatment or maintenance therapy for long-term weight management. Furthermore, it is not subject to dietary restrictions and can be taken at any time of day. ...
- Source: drugdu
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- December 16, 2025

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