On January 12, 2021, the first-ever Phase I/IIa clinical trial in China using imported stem cells to treat ischemic stroke—titled ASSIST—was officially launched, initiated by Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereinafter referred to as "Jiuzhitang Maker"). As of now, Phase I is progressing smoothly, and we are now recruiting 45 patients with ischemic stroke to voluntarily enroll in the Phase IIa clinical trial.

This is a Phase II, multicenter, double-blind, randomized, placebo-controlled study (ASSIST) evaluating the safety, tolerability, and preliminary efficacy of a single injection of ischemia-tolerant human allogeneic bone marrow mesenchymal stem cells (itMSCs) in patients with ischemic stroke. This trial was conducted in two phases: the first phase was an open-label dose-escalation study, and the second phase involved a double-blind, placebo-controlled study.

The ischemia-tolerant allogeneic human bone marrow mesenchymal stem cell (itMSCs) product used in this clinical trial was manufactured by Stemedica Cell Technologies, Inc. (hereafter referred to as "Stemedica"), a company in which the Zhuhai Hengqin Jiuzhitang Yonghe Qihang Equity Investment Fund has invested. Founded in 2005, Stemedica obtained a manufacturing license from the California state government in 2010 and has been operating under GMP-compliant conditions for over 10 years to date. Has secured 10 FDA-approved INDs, covering multiple therapeutic areas such as neurology, cardiology, respiratory medicine, and dermatology.

Stemedica's ischemia-tolerant allogeneic human bone marrow mesenchymal stem cell (itMSCs) product Cultured throughout the entire process under simulated real human physiological conditions (hypoxic conditions), These stem cells exhibit superior performance compared to those cultured under normoxic conditions, and their manufacturing processes and quality systems comply with both U.S. FDA and cGMP requirements.

In 2019, Stemedica completed a Phase I/IIa clinical trial in the U.S. using the same product to treat ischemic stroke. The results showed that ischemic-tolerant human allogeneic bone marrow mesenchymal stem cells (itMSCs) therapy was well-tolerated and safe. Patients treated with these cells demonstrated significant improvements in mental status, depression levels, and ability to perform daily activities, providing preliminary evidence of the efficacy of stem cell therapy. The trial findings were published in September 2019 in *Stroke*, a leading international journal specializing in stroke research.

On January 29, 2023, Stemedica announced its ischemia-tolerant allogeneic human bone marrow mesenchymal stem cell (itMSCs) product. Initiating an "IIB/III, multicenter, randomized, double-blind, placebo-controlled study" under IND in the U.S.

Men and women aged 18 and older;

The medical history reveals that the most recent clinical diagnosis of ischemic stroke occurred more than 6 months ago.

MRI results at the time of first diagnosis and upon enrollment both indicated ischemic stroke with associated functional impairments.

There was no substantial improvement in neurological function or functional deficits during the 2 months prior to being selected for the study.

There is a severe neurological impairment related to the diagnosis outlined in Article 2, resulting in the subject requiring assistance from others to walk or being unable to independently perform basic daily living activities.

NIHSS score of 6–20 at the time of selection;

Life expectancy exceeds 12 months;

Before treatment, the patient received standard medical care for secondary prevention of ischemic stroke, including, but not limited to, appropriate measures to control blood pressure and cholesterol levels, as well as the use of antiplatelet or anticoagulant medications—unless contraindicated.

Can understand and provide a signed informed consent form, or allow the designated legal guardian or spouse to voluntarily make the above decision on behalf of the participant.

Patients reasonably expect to receive standard medical care for secondary prevention of ischemic stroke and to participate in all scheduled, safe follow-up appointments.

No severe organ dysfunction.

Note: During your participation in the study, you will undergo a health checkup conducted by hospital specialists. You must meet all specified requirements and receive approval from the physician overseeing this research project before being eligible for enrollment. The final interpretation rights belong to the research department.

In 2018, the Zhuhai Hengqin Jiuzhitang Yonghe Qihang Fund—established by Jiuzhitang—invested in the U.S.-based company Stemedica, and also set up Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. in Beijing. Currently, the two companies are jointly developing stem-cell therapies for stroke treatment.

Jiuzhitang Maker owns A large-scale stem cell R&D and production facility compliant with cGMP standards from China, the United States, and the European Union , the total office and production area is approximately 4,800 m², including the production platform There are 4 independent B+A cleanrooms. Capable of consistently producing high-quality, highly safe products with excellent batch-to-batch consistency. Clinically-grade stem cells that meet Chinese and U.S. drug regulatory requirements , which has taken shape within the industry “Jiuzhitang Maker = Higher-Quality Stem Cells” Its excellent reputation has earned the trust of several renowned Grade-III hospitals across the country, as well as high recognition from authoritative national authorities.