media – Page 6 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Can AOC become the “next stop” for oligonucleotide therapy?

In recent years, the nucleic acid industry has developed rapidly, with many small nucleic acid drugs successfully approved for marketing, bringing revolutionary breakthroughs in the treatment of rare diseases, infectious diseases and other fields, and propelling gene therapy into a golden age of rapid development. However, traditional small nucleic acid drugs still face many bottlenecks in the delivery process. For example, therapies represented by GalNAc delivery technology are mostly limited to liver targeting, making it difficult to achieve effective delivery to extrahepatic tissues such as muscles and the central nervous system. They also have problems such as short half-life and high off-target toxicity, which greatly limit their clinical application. A few years ago, the emergence of AOC (antibody-oligonucleotide conjugate) initially solved the delivery problem that had previously hindered the development of small nucleic acid drugs. Its unique structural design and technological advantages have also made it the core direction of ...
- Source: drugdu
- 66
- December 17, 2025
A global first! Two domestically developed innovative medical devices have been approved for market launch

Recently, the National Medical Products Administration approved the registration applications of two innovative products, namely: Disposable sterile urinary catheters from Taizhou Dubomai Medical Device Co., Ltd.; Transcatheter aortic valve system from Peijia Medical Technology (Suzhou) Co., Ltd. Among them, Peijia Medical Technology (Suzhou) Co., Ltd.’s transcatheter aortic valve system is the first domestically approved integrated positioning key transfemoral approach aortic valve regurgitation (AR) dedicated interventional treatment device. Image source: Peijia Medical’s official WeChat account The product’s aortic valve positioning key design is expected to enable precise valve positioning and anchoring; the large mesh design at the outflow end is expected to reduce the difficulty of subsequent coronary re-intervention in patients with low coronary artery disease; and the high-density diamond-shaped mesh design at the inflow end is expected to provide good occlusion. Furthermore, the adjustable bend and rotatable design of the delivery system is expected to improve the accuracy of valve ...
- Source: drugdu
- 54
- December 17, 2025
MWN109 (including injection and oral tablets) is a drug independently developed by the company

Securities Daily Online News: On December 16, Lepu Medical stated in response to investor inquiries on its interactive platform that MWN109 (including injection and oral tablets) is a drug independently developed by the company. The company holds its global intellectual property rights and has already applied for patent protection for key aspects, such as the core compound structure. Furthermore, the drug has passed the Freedom to Operate (FTO) analysis. https://finance.eastmoney.com/a/202512163593263249.html
- Source: drugdu
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- December 17, 2025
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
- 53
- 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
- 46
- 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
- 60
- 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
- 53
- 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
- 48
- December 16, 2025

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