Search Results for “Clinical Trial” – media

Sinocell’s “RSV vaccine 1.2 category new drug” approved for clinical trials

According to the official website of CDE, SCTV02 injection, a Class 1.2 new drug for preventive biological use developed by Sinocell Engineering Co., Ltd. (hereinafter referred to as “Sinocell”), has obtained implicit approval for clinical trials. Its indication is to prevent diseases caused by respiratory syncytial virus (RSV) infection. Respiratory syncytial virus (RSV) is an infectious virus belonging to the genus Pneumovirus of the family Paramyxoviridae. It mainly causes lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. According to statistics, almost all children have been infected with respiratory syncytial virus before the age of 2. Due to the large population base in China, the number of children with lower respiratory tract infections caused by RSV infection ranks relatively high in the world. RSV has always been called the ...
- Source: drugdu
- 38
- October 29, 2024
【EXPERT Q&A】Do I need a registered clinical trial for 3D endoscopy?

Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
- Source: drugdu
- 42
- October 28, 2024
Johnson & Johnson’s “Class 1 new drug for prostate cancer” approved for clinical trials in China

On October 12, according to the official website of CDE, Johnson & Johnson’s Class 1 new drug JNJ-78278343 injection obtained implicit approval for clinical trials and is suitable for the treatment of adult male patients with advanced prostate cancer. According to public information, JNJ-78278343 is a KLK2-CD3 bispecific antibody and T cell redirection product, which is designed to target KLK2 and induce T cell activation by binding to CD3 on T cells. This product has potential immunomodulatory and anti-tumor activity. After administration, it can bind to CD3 on T cells and KLK2 on tumor cells expressing KLK2, thereby redirecting T cells to tumor cells expressing KLK2, resulting in T cell-mediated lysis of KLK2-expressing tumor cells. At present, Johnson & Johnson has conducted a number of studies on JNJ-78278343 for prostate cancer internationally. Among them, the Phase 1 study of JNJ-78278343 monotherapy for advanced prostate cancer is expected to be initially ...
- Source: drugdu
- 52
- October 18, 2024
Jacobs’ Pan-KRAS inhibitor approved for clinical trial in the US

September 23, 2024 – The clinical trial application (IND) for Pan-KRAS inhibitor JAB-23E73 independently developed by JACOBIO was approved in the United States, and a Phase I/IIa clinical trial for advanced solid tumors will be conducted in the United States. The IND application for China has been submitted, and clinical trials will be conducted in China simultaneously after approval. KRAS is widely present in a variety of tumor mutations. 23%-25% of cancer patients have KRAS mutations. About 2.7 million new tumor patients with KRAS-related mutations each year are expected to benefit from Pan-KRAS inhibitors. JAB-23E73 can inhibit both active and inactive KRAS, and has no significant inhibition on HRAS and NRAS. As an oral KRAS inhibitor, JAB-23E73’s preclinical data showed good pharmacokinetic properties. JACOBIO is committed to providing patients with breakthrough treatment options. The company’s research projects are based on the six major tumor signaling pathways of KRAS, tumor immunity, ...
- Source: drugdu
- 62
- September 27, 2024
Yingsi Intelligent’s world’s first TNIK inhibitor ISM001-055 has achieved positive results in phase IIa clinical trials

·ISM001-055 is an innovative drug driven by generative artificial intelligence and fully developed independently by Insilicon Intelligence. It targets TNIK (Traf2/NCK interacting kinase) and has completed phase IIa clinical trials for the treatment of patients with idiopathic pulmonary fibrosis (IPF); ·This study lasted for 12 weeks, and its preliminary results showed that ISM001-055 exhibited good safety in IPF patients and showed a dose-dependent pharmacological trend in improving lung function indicators in patients; ·The positive clinical trial results of ISM001-055 also provide the first conceptual validation for AI driven drug development. Hong Kong, China, September 18, 2024- Yingsi Intelligent, a clinical stage biotechnology company driven by generative artificial intelligence (AI), announced that its pipeline ISM001-055 has achieved positive preliminary research results in a phase IIa clinical trial. ISM001-055 is a “first in class” small molecule inhibitor driven by generative AI for drug discovery and design, targeting TNIK (Traf2/NCK interacting kinase) for ...
- Source: drugdu
- 66
- September 23, 2024
AstraZeneca’s “Class 1 Anti-heart Failure Chemical Drug” has applied for clinical trials in China

On September 14, according to the official website of CDE, AstraZeneca’s clinical trial application for the Class 1.1 chemical drug AZD5462 tablets was accepted. According to public information, the drug is a relaxin RXFP1 receptor agonist. Relaxin, as an agonist of the relaxin 1 receptor (RXFP1), produces unique and diverse biological effects, including pulmonary and systemic vasodilation, tissue remodeling/fibrosis reversal, and reduced inflammation, and therefore also has potential in cardiopulmonary diseases. significant curative effect. In addition, this substance is also known as the “pregnancy hormone” and is regulated during pregnancy to help the expectant mother’s cardiovascular system meet the increased demands of the developing fetus and remodel tissue and musculoskeletal structure. . AZD5462 is a relaxin RXFP1 receptor agonist developed by AstraZeneca. Preclinical studies on monkey models of heart failure with reduced ejection fraction (HFrEF) showed that cardiac systolic function was improved after 8 weeks of treatment. There was no ...
- Source: drugdu
- 73
- September 23, 2024
myTomorrows and Pancreatic Cancer Europe partner on clinical trials

The partnership will improve care for patients with pancreatic cancer myTomorrows, a global health technology company connecting patients with all possible treatment options, has announced a new partnership with Pancreatic Cancer Europe, a multi-stakeholder platform that brings together experts from all over Europe to improve care for patients with pancreatic cancer. Through the new partnership, Pancreatic Cancer Europe (PCE) will utilise myTomorrows’ database of ongoing clinical trials to equip patients, caregivers and healthcare professionals (HCPs) with up-to-date, accessible information about pre-approval treatments that may be relevant to them. The partnership with the European patient advocacy group and myTomorrows will help to expand access to all possible treatment options for patients suffering from a variety of life-threatening illnesses. For pancreatic cancer patients and HCPs, the partnership will help make the process of identifying and understanding the existing clinical trial options easier. Pancreatic cancer is the fourth leading cause of cancer deaths, ...
- Source: drugdu
- 71
- August 30, 2024
Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson’s Disease

HANGZHOU, China, Aug. 15, 2024 /PRNewswire/ — Vimgreen Pharmaceuticals, a science-driven pharmaceutical company focused on the modulation of adenosine signaling, announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC, a novel adenosine A2A receptor (A2AR) antagonist that also functions as an inverse A2AR agonist, for the treatment of early-to-mid stage Parkinson’s disease. A total of 150 participants have been enrolled and randomized into one of three cohorts, a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group at a ratio of 1:1:1. The 12-week Phase 2 trial is a multicenter, randomized, placebo-controlled, double-blind study to investigate the safety and efficacy of VG081821 as monotherapy in early-to-mid stage PD patients. The primary endpoint was the difference of change from baseline in movement disorder society-unified Parkinson’s disease rating scale (MDS-UPDRS) part III (motor symptoms) score between VG081821 and placebo over the 12 weeks of administration. ...
- Source: drugdu
- 78
- August 17, 2024
First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
- Source: drugdu
- 111
- August 12, 2024
Hengrui Pharmaceuticals’ Innovative Drug Fronachizumab Approved for Clinical Trials for the Treatment of Moderate to Severe Plaque Psoriasis in Children and Adolescents

Recently, Hengrui Pharmaceuticals’ subsidiary, Suzhou Shengdia Bio-pharmaceutical Co., Ltd. has received a Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration, agreeing to conduct a clinical trial for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to less than 18 years old, who are suitable for systemic therapy or phototherapy. Psoriasis is a chronic, relapsing, immune-mediated inflammatory skin disease that most often involves the scalp, knees, elbows, hands and feet. The prevalence of psoriasis ranges from 0.09% to 11.4% of the global population [1][2], and the prevalence of psoriasis in our country is about 0.5% [3]. About 80%-90% of psoriasis cases are of the common type of psoriasis (plaque psoriasis) and 10%-20% of cases are of moderate to severe psoriasis involving more than 5% of the body surface area (BSA) [4]. It is estimated that approximately 1/3 of adults with psoriasis ...
- Source: drugdu
- 74
- August 12, 2024

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