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Recombinant Hepatitis B Vaccine Approved for Clinical Trials to Prevent HBsAg Rebound in Clinically Cured Chronic Hepatitis B Patients

BioKangtai (300601): Recombinant Hepatitis B Vaccine Approved for Clinical Trials to Prevent HBsAg Rebound in Clinically Cured Chronic Hepatitis B Populations PEOPLE’S FINANCE NEWS, December 17 — Shenzhen Kangtai Biological Products Co., Ltd. (BioKangtai, 300601.SZ) announced on December 17 that its self-developed Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae) (60μg) has received a “Drug Clinical Trial Approval Notice” from the National Medical Products Administration (NMPA) for a new indicated population. The notice approves clinical trials of this vaccine to prevent HBsAg seroreversion (rebound) in populations who have achieved functional (clinical) cure for chronic hepatitis B. https://finance.eastmoney.com/a/202512173594363010.html
- Source: drugdu
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- December 18, 2025
Grand Pharma’s self-developed small-molecule FAP-targeting RDC drug receives FDA IND clearance in the U.S.

Grand Pharma’s Self-Developed Global Innovative FAP-Targeting RDC Drug GPN01530 Receives FDA IND Approval for U.S. Clinical Trials SHANGHAI SECURITIES NEWS, China Securities Net (Reporter: Zhang Xue) — Grand Pharmaceutical Group Limited (“Grand Pharma”) announced on December 17 that its self-developed, global innovative Radionuclide Drug Conjugate (RDC) targeting Fibroblast Activation Protein (FAP), GPN01530, has recently received official approval from the U.S. FDA to commence Phase I/II clinical trials for the diagnosis of solid tumors. GPN01530 is Grand Pharma’s first self-developed RDC product to be approved by the FDA for clinical research. The company stated that this approval marks a significant milestone in its “Go Global” strategy and provides a vital template for the international development of its radiopharmaceutical pipeline. FAP (Fibroblast Activation Protein) is a key marker of cancer-associated fibroblasts (CAFs). It promotes tumor growth and invasion by participating in extracellular matrix remodeling, tumor cell proliferation regulation, and immunosuppression. It has ...
- Source: drugdu
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- December 18, 2025
Pharmagora Plus 2026

Organiser：CloserStill Media Ltd Time： March 14 – 15, 2026 Address：1, place de la Porte de Versailles 75015 Paris, France Exhibition hall：Paris Expo Porte de Versailles Product range: Orthopedic surgery, laboratories, shops, banks, insurance companies and IT firms, conditions related to LES (Lower Esophageal Sphincter, assuming a specific medical context; if not, please clarify), e-health, the future of pharmacies, pharmaceuticals, scientific instruments, research and development, herbal and traditional Chinese medicine industries About Pharmagora Plus 2026： The Pharmagora Plus in Paris, France, is the largest and most significant pharmaceutical exhibition within the same industry in France. Organized by the well-known French exhibition company CloserStill Media Ltd, since its inception, the exhibition has been growing in scale and influence, providing an outstanding display platform for more countries and enterprises.
- Source: drugdu
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- December 18, 2025
Subsidiary Signs Exclusive Licensing Agreement for GenSci098 Injection Project

According to the announcement, the company’s subsidiary, Shanghai Saizeng Medical Technology Co., Ltd. (hereinafter referred to as “Saizeng Medical”), recently signed an exclusive licensing agreement with Yarrow Bioscience, Inc. for the GenSci098 injection project. Under the agreement, Saizeng Medical expects to receive an upfront payment of US$120 million and near-term development milestone payments (including a non-refundable and non-deductible upfront payment of US$70 million and subsequent near-term development milestone payments of US$50 million), and will be eligible for milestone payments related to specific research, regulatory, and commercialization. Saizeng Medical will be entitled to receive up to US$1.365 billion in milestone payments for this exclusive license, and will also be entitled to royalties exceeding 10% of net sales after the product’s launch. https://finance.eastmoney.com/a/202512153591987252.html
- Source: drugdu
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- December 17, 2025
Kangfeng Biotechnology’s Anti-Gastroesophageal Reflux System Receives Approval from the Drug Administration

On December 16, Kangfeng Bio-B (06922) issued an announcement stating that its anti-gastroesophageal reflux system received approval from the National Medical Products Administration on December 15, 2025. The anti-gastroesophageal reflux system is a surgical instrument independently developed by the company. It consists of an implantable anti-gastroesophageal reflux device and an esophageal measuring tool. The working principle is to fix the device in the functional area of the lower esophageal sphincter outside the esophagus, and use the magnetic attraction generated by the magnetic beads in the device to enhance the tension of the lower esophageal sphincter, thereby restoring its anti-reflux function and treating gastroesophageal reflux disease. https://finance.eastmoney.com/a/202512163593180489.html
- Source: drugdu
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- December 17, 2025
Cell Metabolism | Efficacy of Akkermansia muciniphila Supplementation in Overweight/Obese Patients with Type 2 Diabetes

On January 28, 2025, Cell Metabolism (IF=27.7) published online a research report titled“Supplementation with Akkermansia muciniphila in Overweight/Obese Patients with Type 2 Diabetes: Efficacy Depends on Its Baseline Abundance in the Gut.” This study employed a combined approach of multicenter clinical intervention research and animal experiments to reveal for the first time that the efficacy of Akkermansia muciniphila (abbreviated as AKK) in clinical weight loss and glucose lowering largely depends on the individual’s baseline abundance of AKK bacteria in the gut. The study found that supplementation with AKK demonstrated significant metabolic improvement only in patients with low baseline AKK abundance in their intestines. This breakthrough discovery moves beyond the “one-size-fits-all” model of probiotic supplementation, proposing a “supplement only if deficient” philosophy for precise probiotic use. It provides a key example of precision probiotic intervention based on individual gut microbiota ecology and is expected to advance the development of personalized probiotic ...
- Source: drugdu
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- December 17, 2025
Major Breakthrough! China’s First Injectable Silk Fibroin Gel Enters Clinical Trials

On December 15, 2025, the clinical trial initiation meeting for the injectable silk fibroin gel, led by Director Zhao Hongyi, Chairman of the Plastic and Aesthetic Branch of the China Medical Device Industry Association, was launched at Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University. This study, initiated by Venusilk, is China’s first prospective, multicenter, randomized, positive parallel-controlled, evaluator-blinded, non-inferiority clinical trial for an injectable silk fibroin gel. It is primarily designed to validate the safety and efficacy of the filler injectable silk fibroin gel in correcting dynamic forehead wrinkles (forehead lines). The trial will be conducted simultaneously across five clinical trial centers nationwide. (Injection Silk Fibroin Gel Clinical Trial Initiation Meeting, On-site Photos) The initiation of this trial marks the entry of China’s first injectable silk fibroin gel into a new phase, bringing it closer to regulatory approval and future clinical availability, thereby accelerating patient access ...
- Source: drugdu
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- December 17, 2025
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
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- 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
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- 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
- 65
- December 17, 2025

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