Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
INNOCARE Pharmaceuticals Limited (the “Company” or “INNOCARE”) is currently in the clinical phase of registration of its innovative drug zurletrectinib (ICP-723). zurletrectinib (ICP-723) has shown favorable safety and efficacy in adult and adolescent (12 to 18 years old) patients. zurletrectinib (ICP-723) has demonstrated a favorable safety and efficacy profile in adults and adolescents (12 to 18 years of age), and has recently completed the first case of administration in a pediatric patient (2 to 12 years of age), initiating the first clinical study in a pediatric patient. The main information is announced as follows: I. Introduction of ICP-723 Zurletrectinib (ICP-723) is INNOCARE’s proprietary second-generation pan TRK small molecule inhibitor for the treatment of patients with advanced or metastatic solid tumors harboring NTRK fusion genes who have not received TRK inhibitor therapy and who are resistant to first-generation TRK inhibitors. Zurletrectinib (ICP-723) can effectively inhibit not only TRKA, TRKB, and TRKC ...
SinoCellTech (hereinafter referred to as the “Company”) has received the Notice of Approval for Drug Clinical Trial issued by the State Drug Administration (hereinafter referred to as the “SDA”), agreeing that the Company’s self-developed product, SCTC21C Injection, could be used in clinical trials for the treatment of CD38+ hematologic malignancies. (hereinafter referred to as the “Company”) received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial of the Company’s self-developed product, SCTC21C Injection, for the treatment of CD38+ hematologic malignancies. As there are many unpredictable factors in the process of clinical trial of drugs, the results of clinical trial, review and approval as well as the timing are subject to a certain degree of uncertainty, we respectfully request investors to make decisions cautiously and pay attention to the prevention of investment ...
Tonghua Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd (“Dongbao Zixing”), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceuticals Co., Ltd. (“Tonghua Dongbao”), has completed a pivotal Phase IIa clinical trial and obtained the summary report of the trial. The results of the study showed that the primary endpoints were achieved. The relevant information is announced as follows: I. Basic information of the drug 1、Name: THDBH130 Tablets 2、Indications:Hyperuricemia and gout 3、Dosage form: Tablet 4、Specification:2.5mg、20mg 5、Registration Classification: Chemical 1 6、Applicant: Dongbao Zixing (Hangzhou) Biomedical Co. 7, drug clinical trial approval: State Drug Administration approved the issuance of drug clinical trial approval notice (2021LP02020). The State Drug Administration approved the issuance of a notice of approval for clinical trial of the drug (2021LP02022; 2021LP02023), agreeing to carry out clinical trials. II. R&D Investment As at the date of this announcement, the Company has invested approximately RMB79.39 million in research and development in the Project. III. ...
Shanghai Shengdi Pharmaceuticals Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Company Limited (hereinafter referred to as the “Company”), has received the Notice of Approval for Clinical Trial of Adebenosumab Injection approved by the State Drug Administration (hereinafter referred to as the “State Drug Administration”). Ltd. has received the “Notice of Approval for Clinical Trial” from the State Drug Administration (hereinafter referred to as “SDA”) for Adebenosumab Injection, which will be launched in the near future. The relevant information is announced as follows: I. Basic information of the drug Drug Name: Adebelizumab Injection Formulation: Injection Application: Clinical Trial Acceptance No.: CXSL2300746 Conclusion of Approval: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the application for clinical trial of Adebelizumab Injection accepted on October 31, 2023 complies with the relevant requirements for drug registration, and approval is granted for the product to ...
Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
Important Note: Recently, Beijing Shenzhou Cell Biotechnology Group Co. (hereinafter referred to as the “Company”) has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing that the Company’s self-developed product, SCTC21C Injection, can be used for the treatment of CD38+. (the “Company”) received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (the “SDA”), agreeing to carry out clinical trials for the treatment of CD38+ hematologic malignancies for the Company’s self-developed product SCTC21C Injection. As there are many unpredictable factors in the process of clinical trials of pharmaceutical products, the results and timing of clinical trials, review and approval are subject to certain uncertainties, investors are advised to make decisions with caution and take precautions against investment risks. The relevant information is announced as follows: I. Basic Product Information 1. Product name: SCTC21C ...
Recently, the latest clinical data of two Henlius products were released online and will be presented in poster sessions at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI), namely, the phase 2/3 study (HLX10-015-CRC301) of Henlius’ NMPA approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in metastatic colorectal cancer (mCRC) with Professor Rui-Hua Xu of Sun Yat-Sen University Cancer Center as the leading principal investigator, and the phase 2 study (HLX22-GC-201) of Henlius’ novel anti-HER2 mAb, HLX22, combined with HANQUYOU (trastuzumab for injection, HLX02, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer with Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University as the leading principal investigator of this study. Colorectal cancer (CRC) is one of the most common malignancies globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths ...
Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the “Company”) has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows: The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.