Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, approving the company to conduct an open, multi-center Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS8807 combined with dalsylate hydroxyethanesulfonate in ER-positive, HER2-negative metastatic or locally advanced breast cancer patients. Breast cancer is the most common malignant tumor worldwide. According to the Global Cancer Epidemiology Report 2024, breast cancer ranks first among female malignant tumors in terms of incidence and mortality, with approximately 2.31 million new cases of breast cancer and 670,000 deaths per year globally, ranking first in terms of incidence and mortality of female malignant tumors. Among all breast cancer patients, about 70% are ER-positive, and the guideline-recommended standard treatment is endocrine drugs combined with CDK4/6 inhibitors. In contrast, the new generation of oral selective estrogen receptor down-regulators (SERDs) ...
Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial 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, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. 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 fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
On April 12, 2024, Shanghai Yuansong Biotechnology Co., Ltd (“Yuansong Biotechnology”) announced that its self-developed lysosomal virus Class I new drug “Recombinant L-IFN Adenovirus Injection (YSCH-01)” has received implied clinical trial approval from the Center for Drug Evaluation of the State Drug Administration (CDE) and has been approved to conduct Class I clinical trials in China. The Center for Drug Evaluation (CDE) of the State Drug Administration has granted implied consent for clinical trials and approved to conduct Phase I clinical trials in China for the indication of advanced solid tumors. The approval of this IND filing by the CDE in China is another important progress made by YuanSong Biotech in exploring the clinical study of YSCH-01, in addition to the clinical approval by the US FDA in December 2023 for two original IIT programs under development, including capsular delivery for recurrent gliomas and lysosomal viral nebulized delivery for the ...
SHENZHEN, China, April 10, 2024 /PRNewswire/ — Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and safety. As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm’s Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the ...
Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
SHANGHAI, April 2, 2024 /PRNewswire/ — YolTech Therapeutics announced that the first patient has been dosed with YOLT-101, the company’s in vivo genome editing candidate being developed as a single dose, potentially curative therapy for Familial Hypercholesterolemia(FH), marking the commencement of an Investigator-Initiated Trial (IIT). Familial Hypercholesterolemia (FH) is a genetic disorder that affects the body’s ability to remove low-density lipoprotein (LDL) cholesterol from the blood. It is characterized by high levels of LDL cholesterol, also known as “bad” cholesterol, which can lead to an increased risk of early heart disease. YOLT-101, developed independently by YolTech, aims to intervene in specific genetic mutations associated with Familial Hypercholesterolemia. Leveraging advanced gene editing technology and lipid nanoparticle (LNP) delivery, YOLT-101 promises to provide effective treatment options for patients. The preclinical data of YOLT-101 indicate that a single dose of the drug resulted in a significant reduction of LDL-C levels lasting nearly two ...
The progressive and incurable brain disorder currently affects approximately 100 patients worldwide LifeArc has announced that it has funded a pivotal clinical trial at the University of Cambridge for £750,000 to re-purpose a UK-licensed medicine to treat the ultra-rare genetic disease neuroferritinopathy. The recently launched DefINe trial aims to stop the progression of the disease with an existing drug known as Ferriprox (deferiprone), manufactured by Chiesi Global Rare Diseases. Affecting approximately 100 patients worldwide, neuroferritinopathy is a progressive and incurable brain disorder caused by changes in a gene that produces the ferritin light chain protein. This change can lead to a build-up of iron in the brain, which can cause severe symptoms such as loss of speech and swallowing. With currently no effective treatments available to treat the condition, the new randomised, placebo-controlled trial aims to reduce the iron accumulation in the brain using Ferriprox, an affordable oral tablet licensed ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
Recently, CanSinoBio’s Quadrivalent Conjugate Vaccine (QCV) initiated a Phase III clinical trial in Indonesia and completed the enrollment of the first subject. The clinical trial aims to evaluate the safety and immunogenicity of the vaccine in people aged 18-55 years. Currently, rheumatic encephalitis remains a serious challenge in global public health, and vaccination is the most cost-effective and efficient way to prevent it.2022 In June, CanSinoBio’s self-developed Mannhexin®, Asia’s first tetravalent rheumatic encephalitis conjugate vaccine, was officially approved for marketing, which fills the gap of China’s lack of high-end rheumatic encephalitis vaccines in this field. This clinical trial will expand the applicability of the quadrivalent conjugate vaccine to adults. According to the statistics, the incidence of epidemic epidemic is found in all age groups, among which the incidence rate is higher in children under 5 years old. Usually, the incidence rate of epidemic encephalitis decreases with age, but the incidence ...
Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
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