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On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
On-site launch ceremony
The Kangle Guard nine-valent HPV vaccine was approved by the Indonesian Food and Drug Administration (Kepala Badan Pengawas Obat dan Makanan, or BPOM) at the end of September 2023. Kangle Guard has also become the first domestic enterprise to independently launch phase III clinical trials of nine-valent HPV vaccine overseas. This trial was a randomized, blind, positive-controlled Phase III clinical study in Indonesia. Shanghai SDM trained the CRA locally, participated in the process exercise of the research center, and checked the staffing of researchers and monitors to ensure that the trial was carried out in strict accordance with the protocol and the law.
HPV is the main cause of cervical cancer, vaginal cancer and other cancers, and the nine-valent HPV vaccine is one of the effective means to prevent human papillomavirus (HPV) infection. For Indonesia, a country where cervical cancer has become a high incidence of new cases of female cancer, the phase III clinical trial of the Kangle Guard nine-valent HPV vaccine in Indonesia is a milestone.
Project site photo
Shanghai SDM is deeply engaged in the field of clinical trials and provides full-chain services for vaccine research and development customers. Since its establishment, the International Vaccine Project Department has undertaken overseas clinical trials of HPV, COVID-19 and other products, and successfully operated several efficacy clinical trials, with rich experience in overseas clinical trials and solid strategic partners. To provide the sponsor with national research, strategy formulation, overseas registration, project management, quality control, data management, statistical analysis, medical writing and medical supervision and other full process services.
On October 24-25 2024, Dr. Yuwen, CBO and SVP of SDM Bioservices, was invited to attend the 2024 International Biomedical Industry Innovation Beijing Forum co-sponsored by DIA and Beijing Advanced Medical Equipment Industry Innovation Alliance. The forum brings together representatives of global regulators, leading experts in biomedicine, industry leaders and academics to discuss the latest trends and industry innovations in global drug development.
August 1, China, Beijing, Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical Industry Base to investigate the development and construction of pharmaceutical research and development service platform enterprises.
On July 24, SDM Bioserices and Australia JP Medical Consulting Pty Ltd (hereinafter referred to as "JP Medical Consulting") announced a strategic cooperation. The cooperation aims to make full use of the clinical resources and professional advantages of the two sides in the field of medicine in China and Australia, promote the internationalization of clinical trials and new drug research and development, and provide one-stop services for Chinese biopharmaceutical enterprises in Australian clinical trials.
On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
On July 11-12, 2024, MedDRA MSSO successfully held the fourth offline face-to-face training of 2024 at the Shenyang office of SDM. As the organizer of this event, SM gathered together with more than 40 experts from various fields such as CRO, pharmaceutical companies and partners, including medical coders, data management and statistics, drug safety/pharmacovigilance, medical writers and other modules.
On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
