Event Recap | Dr. Xue Ming Qian Attends the 5th East-West Biopharma Summit, Focusing on Accelerating Clinical Data in Asia

From March 9 to 11, the 5th BioCentury–BayHelix East-West Biopharma Summit was held in Seoul, South Korea. The conference brought together innovative companies, investment firms, and industry leaders from the global biopharmaceutical sector to discuss cross-regional cooperation and development opportunities for biopharmaceutical innovation.

Dr. Xue Ming Qian, Chairman of the Board and CEO of Transcenta Holding, was invited to participate in a panel discussion on March 10, focusing on the theme 'Generating Faster Data via Asia.' He shared insights and practices on how to fully leverage Asian resources to accelerate clinical data generation with industry experts.

Panel guests

Dr. Qian Xueming stated that in recent years, China has continuously promoted the reform of clinical trial-related policies to enhance the efficiency of innovative drug development. In terms of ethical review, for multi-center clinical trials, the results of the lead unit's ethics review can be recognized by other member units, avoiding duplicate reviews. At the same time, clinical trials can undergo ethical evaluation simultaneously during the application phase without waiting for formal approval, significantly shortening the start-up cycle. Regarding genetic resource management, eligible clinical trials can adopt a filing method instead of an approval process, greatly simplifying procedures and providing efficient support for conducting innovative drug clinical trials.

In addition, Transcenta’s high-quality CMC capabilities can also accelerate the acquisition of clinical data. The company has helped partners solve complex CMC problems, allowing them to quickly launch clinical research in both China and the United States and successfully obtain financing support.

Regarding the data itself, Dr. Qian Xueming emphasized that Fast data isn't fast unless it's portable. In other words, clinical data obtained in China needs to be acceptable to other countries and regulatory systems to support global drug development. Taking osemitamab (TST001) as an example, during its Phase II clinical design stage, Transcenta fully considered FDA regulatory requirements, conducting research simultaneously in China and the United States to collect key data on the safety, efficacy, and pharmacokinetics/pharmacodynamics of patients from both countries, ensuring the data is globally applicable. In the early clinical research stages, Transcenta utilized biomarkers to screen subgroups of highly responsive patients and selected high-quality CROs to participate in the study, advancing CDx development and providing strong support for global clinical research, ensuring reliable and transferable data. This strategy enabled osemitamab (TST001) to rapidly obtain Phase III clinical approvals in China, the United States, and South Korea.

This roundtable discussion focused on how to make full use of Asian resources to accelerate clinical data generation, providing valuable experience and insights to the industry while showcasing Transcenta's practical capabilities and professional expertise in promoting global R&D of innovative drugs.

About Transcenta Group

Transcenta Group is a clinical-stage biopharmaceutical company with comprehensive capabilities in biologic drug discovery, research and development, process development, and manufacturing.

Headquartered in Suzhou, Transcenta has successfully established a global business footprint: with drug discovery, clinical, and translational research centers in Suzhou, a process and product development center as well as a drug manufacturing base in Hangzhou, and clinical development centers in China, the United States, and Europe. Transcenta is developing a diversified product pipeline comprising dozens of novel biologics, covering oncology and certain non-oncology indications such as orthopedic and renal diseases.

For more information about Transcenta, please visit the company website: www.transcenta.com or LinkedIn profile: Transcenta. If you are interested in exploring capital partnership opportunities, please contact us via ir@transcenta.com to discuss potential collaborations.

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