On July 6, 2020, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereafter referred to as "Jiuzhitang Maker") signed a Clinical Trial Agreement with Beijing Tiantan Hospital, Affiliated to Capital Medical University (hereafter referred to as "Tiantan Hospital"), marking the imminent launch of China's first clinical trial using an imported stem-cell-based new drug to treat ischemic stroke.

This trial is a multicenter, double-blind, randomized, placebo-controlled Phase I/IIa study designed to evaluate the safety, tolerability, and preliminary efficacy of a single injection of ischemia-tolerant human bone marrow mesenchymal stem cells in patients with ischemic stroke. The principal investigator is Professor Wang Yongjun, Executive Vice President of Tiantan Hospital, Deputy Director of the National Clinical Research Center for Neurological Diseases, and Director of the National Medical Quality Control Center for Neurological Diseases. The study population primarily consists of patients clinically diagnosed with ischemic stroke more than 6 months ago, who require assistance from others to walk or are unable to independently perform basic daily activities.

The formal signing of this cooperation agreement marks a substantive step toward actively advancing clinical stem cell research collaboration between the two parties, and also represents a significant milestone in Meiko’s 2020 new drug development plan.

Ischemia-Tolerant Human Mesenchymal Stem Cells (it-hMSC)

The ischemic-tolerant human bone marrow mesenchymal stem cell (it-hMSC) product used in this clinical trial was manufactured by Stemedica Cell Technologies, Inc. (hereafter referred to as "Stemedica") in the United States. Derived from the bone marrow of healthy, young adult donors, this product was cultivated throughout the process under low-oxygen conditions that closely mimic the body's natural physiological environment—resulting in superior performance compared to stem cells cultured under standard, high-oxygen conditions. Life Technologies has even described it as "best-in-class."

This stem cell product boasts strong proliferative capabilities, helping to minimize hypoxia-induced tissue damage, reduce cellular apoptosis, and suppress inflammation. Additionally, the product demonstrates exceptional tolerance toward ischemic tissues, promoting the differentiation of neural precursor cells into neurons within the ischemic striatum, continuously recruiting proliferating cells, and enhancing neurovascular remodeling. As a result, this innovative therapy holds significant promise for the treatment of ischemic stroke.

Both China and the U.S. have strong clinical foundations.

In the United States

In 2019, the Yonghe Qihang Fund, under Jiuzhitang, participated in an investment in the U.S.-based company Stemedica Cell Technologies Inc., which successfully completed a Phase I/IIa clinical trial in the U.S. using its it-hMSC product to treat ischemic stroke. The results demonstrated that it-hMSC therapy was well-tolerated, with patients receiving the treatment showing significant improvements in mental status, depression levels, and ability to perform daily activities—providing preliminary evidence of the effectiveness of stem cell therapy. These groundbreaking findings were published in September 2019 in "Stroke," a leading international journal specializing in stroke research.

In China

In 2019, Jiuzhitang Maker’s preclinical study on "Human Bone Marrow Mesenchymal Stem Cell Therapy for Acute Stroke," conducted using this product, received funding from Beijing's Major Science and Technology Project.

On February 19, 2020, Jiuzhitang Maker’s application for a clinical trial of a stem-cell-based new drug, submitted to the Center for Drug Evaluation (CDE) under the National Medical Products Administration, was approved. This marks the sixth IND application for a stem-cell research-oriented new drug approved by the CDE. Prior to Meike’s IND, the previous five approved INDs all involved domestically produced stem cells sourced from materials such as umbilical cords and autologous fat, with therapeutic applications ranging from knee osteoarthritis and diabetic foot ulcers to graft-versus-host disease. Notably, this is the first time a clinical trial using stem cells has been approved specifically for treating major neurological conditions.

it-hMSC holds promise in bringing new hope to stroke patients.

Ischemic stroke is characterized by high incidence, high disability rates, and a significant mortality rate. According to the latest Global Burden of Disease Study (GBD), China ranks first globally with an overall lifetime stroke risk of 39.9%, meaning that roughly 2 out of every 5 Chinese people will experience a stroke in their lifetime. Moreover, stroke is also the leading cause of years of life lost due to disease in China. Data from the "2019 China Health Statistics Highlights" reveal that in 2018, cerebrovascular diseases accounted for more than 20% of all deaths among Chinese residents—highlighting that at least 1 in every 5 fatalities was attributable to stroke.

Additionally, among stroke patients, only 30%–40% achieve full recovery or experience only mild functional impairments, while 50%–70% suffer severe disabilities such as blindness, aphasia, or persistent limb paralysis, placing a tremendous burden on both the patients and their families and causing profound physical and emotional suffering.

As a specialized treatment for stroke, stem cells have demonstrated promising therapeutic outcomes. According to data from the ClinicalTrials website, as of now, a total of 59 Phase I, II, and III clinical trials focusing on stem cell therapy for ischemic stroke have been conducted worldwide—among them is the clinical trial conducted by Stemedica.

Although 16 stem-cell drugs have already been approved for global markets, there are still no stem-cell therapies specifically targeting ischemic stroke. Building on the successful completion and promising results of the Phase I/IIa clinical trial conducted in the U.S., this study aims to further investigate the therapeutic potential of it-hMSC in treating ischemic stroke—offering renewed hope to the millions of patients worldwide who continue to suffer from this debilitating condition.

Dedicated to launching China's first stem-cell-based drug

In 2018, Jiuzhitang initiated and established Zhuhai Hengqin Jiuzhitang Yonghe Investment in Stemedica, and simultaneously invested in founding Jiuzhitang Maker—the sole entity in China entrusted with Stemedica's stem cell technology.

Jiuzhitang Maker has acquired world-class production technologies—such as advanced stem cell isolation and purification, as well as stable in vitro expansion and culture—through technology transfer. They also boast extensive and comprehensive clinical translation experience with ischemia-tolerant human bone marrow mesenchymal stem cells (it-hMSC) and ischemia-tolerant human neural stem cells (it-hNSC), positioning them to become the first company in China to launch a stem cell-based drug. Ultimately, Jiuzhitang Maker is committed to driving the industrialization and large-scale production of domestically developed stem cell therapies in China.

Jiuzhitang Maker has completed construction of Beijing's first large-scale allogeneic stem cell R&D and production facility at the Daxing Biomedical Base in Beijing, meeting cGMP standards set by China, the U.S., and the EU. This facility also stands as the largest and most advanced stem cell production and R&D base in the Beijing region, featuring an operational and production area of approximately 4,500 square meters. Its production platform includes four independent B+A clean zones, enabling the manufacturing of clinical-grade stem cells that comply with both Chinese and U.S. pharmaceutical regulatory requirements for drug submissions.

Responding to the Belt and Road Initiative, the China-Kazakhstan Regenerative Medicine Cooperation Center has been established in Horgos.

Responding to the Belt and Road Initiative, Jiuzhitang Group has partnered with Kazakhstan’s ALTACO Company to jointly establish the Jiuzhitang-ALTACO International Medical Center at the China-Kazakhstan Khorgos International Border Cooperation Center. This center serves as an innovative collaboration platform for international stem cell research and clinical translation. The International Medical Center officially opened in September 2019, focusing its scientific research and clinical development efforts on ischemia-tolerant mesenchymal stem cells produced by Stemedica.