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New drug JSKN027 accepted for clinical trials

On December 17th, CorningJereh Pharmaceutical (09966) announced that its Investigational New Drug (IND) application for its independently developed programmed death-ligand 1 (PD-L1)/vascular endothelial growth factor receptor 2 (VEGFR2) bispecific antibody-drug conjugate (ADC) JSKN027 has been formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). 　　The company plans to conduct a Phase I clinical study of JSKN027 for the treatment of advanced malignant solid tumors, aiming to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity in this patient population, and to determine the maximum tolerated dose and/or recommended Phase II dose. 　　JSKN027 is the world’s first PD-L1/VEGFR2 bispecific antibody ADC to enter clinical trials. Preclinical data show that JSKN027 exhibits significant tumor-suppressive activity in both in vitro and in vivo models, and GLP toxicology studies demonstrate good tolerability at the highest dose. Based on its multiple mechanisms of ...
- Source: drugdu
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- December 18, 2025
WHO Warns Europe’s Influenza Peak May Arrive by Year-End

The World Health Organization (WHO) stated on the 17th that influenza is spreading across Europe approximately four weeks earlier than in previous years. Among the 38 countries reporting data, at least 27 have reached high or very high levels of influenza activity. In countries such as Ireland, Montenegro, Serbia, Slovenia, and the United Kingdom, more than half of the influenza-like illness samples tested have been confirmed as influenza virus infections. Dr. Hans Kluge, WHO Regional Director for Europe, noted that the influenza A(H3N2) subtype has become the predominant circulating strain, accounting for about 90% of confirmed cases, but there is no evidence of increased pathogenicity. Early data from the United Kingdom show that the current seasonal influenza vaccine effectively reduces the risk of severe illness caused by this strain. The WHO emphasized that older adults, individuals with underlying health conditions, pregnant women, children, and healthcare workers should be prioritized for ...
- Source: drugdu
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- December 18, 2025
Clinical Trial Application for Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine Accepted for Review

Shanghai Securities News, China Securities Network – Zhifei Biological announced on the evening of December 17 that its wholly-owned subsidiary, Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., recently received the “Drug Clinical Trial Application Acceptance Notice” (Acceptance No.: CXSL2501083) from the National Medical Products Administration (NMPA) for its “Modified Vaccinia Ankara (MVA) Monkeypox Attenuated Live Vaccine.” If no negative feedback or queries are received from the Center for Drug Evaluation within 60 days from the acceptance date, clinical trials may proceed according to the submitted plan. Background information indicates that monkeypox is a zoonotic disease caused by the monkeypox virus. Its clinical course typically consists of two phases: the invasive phase and the rash phase. The invasive phase lasts 0–5 days and is characterized by fever, intense headache, lymphadenopathy, back pain, myalgia, and profound asthenia. Lymphadenopathy is a distinctive feature of monkeypox. The virus primarily spreads through close skin contact (particularly ...
- Source: drugdu
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- December 18, 2025
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

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