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Jiuzhitang Maker's clinical trial application for a new stem-cell drug has been accepted.
2019-11-20
On November 18, 2019, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. received acceptance from the National Medical Products Administration’s Center for Drug Evaluation for its clinical trial application of a new stem-cell-based drug. With this milestone, Jiuzhitang Maker, which boasts advanced stem-cell production technologies developed in the U.S., has taken its first significant step toward entering the stem-cell pharmaceutical market.
Application Number: JXSL1900126
Drug Name: Ischemia-Tolerant Human Allogeneic Bone Marrow Mesenchymal Stem Cells
According to the announcement on the website of the National Medical Products Administration's Center for Drug Evaluation, the center has currently received 12 clinical trial applications for stem cell therapies from 11 companies, with 4 of them having been approved by implication. Notably, the clinical trial application submitted by Jiuzhitang Maker marks the first time the Center has accepted a request for a clinical trial involving imported stem cell products.
In 2018, the Zhuhai Hengqin Jiuzhitang Yonghe Qihang Fund—established by Jiuzhitang—invested in the U.S.-based Stemedica Cell Technology Inc. At the same time, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. was founded as the sole Chinese partner entrusted with Stemedica's stem cell technology. Leveraging Stemedica’s globally recognized, cutting-edge clinical-grade stem cell production platform, Jiuzhitang Maker has mastered the core technologies essential for scaling up, standardizing, and ensuring full traceability in stem cell manufacturing.
Stemedica, a U.S.-based company, has developed stem cells that meet US FDA cGMP standards. The company has already initiated six clinical trials in the United States, with two of them having completed Phase I/IIa studies for specific indications. Notably, the Phase I/IIa trial evaluating human bone marrow-derived mesenchymal stem cells for ischemic stroke successfully achieved both its primary and secondary endpoints, providing initial evidence of safety and efficacy. In October 2019, the study’s findings were published in *Stroke*, a leading international journal specializing in stroke research.
In the future, Jiuzhitang Maker will also collaborate with Stemedica to conduct multi-center clinical trials in China, accelerating the pace of bringing stem-cell therapies to market.
Hint: After Medico's clinical trial application is accepted, it will still need to undergo review by the Drug Review Center of the National Medical Products Administration. Whether approval will ultimately be granted remains highly uncertain. Given the unique nature of drug development, the process—from clinical trial application to commercial production and market launch—typically spans a long timeline with numerous steps, many unpredictable factors along the way, and inherent uncertainties in both timing and outcomes at each stage.
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