Securities Times reporter: Wang Xiaowei

The Jiuzhitang Yonghe Qihang Fund, initiated by Jiuzhitang, signed an investment agreement on the 14th with Stemedica Cell Technology Co., Ltd., based in San Diego’s Biotech Valley in the U.S. Under the terms of the agreement, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. (hereafter referred to as Jiuzhitang Maker) will introduce cutting-edge stem cell production technologies and a state-of-the-art preparation platform from a globally leading stem cell company. Over the next 3 to 5 years, Jiuzhitang Maker plans to establish a commercial-grade stem cell production facility meeting both U.S. and EU cGMP standards at the Beijing Daxing Biopharmaceutical Industry Base. This strategic move marks Jiuzhitang, a century-old traditional Chinese medicine enterprise, officially entering the rapidly growing field of stem cell drug research, clinical development, and industrialization.

Strategic Transformation

Industry insiders highlight that stem cell technology holds groundbreaking significance for the advancement of human medicine, prompting countries worldwide to position stem cells as a strategic emerging industry crucial for enhancing their global competitiveness in the health sector. In the U.S. alone, listed companies on the Nasdaq with stem cell-related stocks boast a combined market value exceeding $30 billion. By 2020, the global stem cell market is projected to reach $400 billion, while China’s stem cell market is expected to grow to as much as 120 billion RMB. Meanwhile, in 2016, China released the "Healthy China 2030" Planning Outline, identifying regenerative medicine—led by stem cell technology—as a key pillar driving the future evolution of medical science and healthcare.

Li Zhenguo, Chairman of Jiuzhitang Co., Ltd., told a reporter from the Securities Times that the company aims to leverage its strong position in the traditional Chinese medicine industry while capitalizing on cutting-edge international stem-cell technologies. By seamlessly integrating China's time-honored traditional medical practices with pioneering stem-cell biotechnology, Jiuzhitang seeks to forge a unique path of innovation for this iconic Chinese pharmaceutical enterprise. To accelerate its R&D process and secure a competitive edge in China’s rapidly growing stem-cell pharmaceutical market, Jiuzhitang has established the Yonghe Qihang Fund, which has already invested in Stemedica Cell Technology Inc., a leading U.S.-based company in stem-cell innovation. Concurrently, Jiuzhitang has set up Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd., serving as the exclusive Chinese partner entrusted with adopting and advancing Stemedica’s groundbreaking stem-cell technologies. Through this strategic collaboration, Jiuzhitang (Meike) has successfully introduced Stemedica’s globally advanced stem-cell production techniques and manufacturing platforms, enabling large-scale, scalable expansion of stem cells—a critical breakthrough that addresses key technical hurdles in turning stem cells into viable pharmaceutical products.

According to incomplete statistics, there are currently 13 stem-cell drugs approved globally. China, however, has yet to approve any stem-cell therapies. That said, in recent years, China has significantly accelerated its pharmaceutical system reforms, introducing a series of policies aimed at encouraging innovation in drug development. The CFDA has also gradually released a set of guidelines specifically addressing the technical aspects of stem-cell research, further refining the regulatory framework. As a result, the agency has resumed accepting applications for clinical trials involving stem cells, effectively opening the door for stem-cell-based medicines to enter the market.

It is reported that Jiuzhitang is currently constructing an allogeneic stem cell production facility in Beijing's Daxing District, designed to meet both U.S. and EU cGMP standards. This facility will be dedicated to the manufacturing of human bone marrow-derived mesenchymal stem cells and neural stem cells. The platform spans a total area of 4,500 square meters and is expected to become operational in 2019. Once fully operational, it will enable the production of 900,000 consistent, highly active therapeutic-grade stem cells from a single donated bone marrow sample—marking a significant leap forward in the scalable expansion of stem cells, thereby addressing a critical technical hurdle in turning stem cells into viable pharmaceutical products. Building on Stemedica Corporation’s existing advancements in the U.S., Jiuzhitang (Meike) plans to continuously innovate and advance clinical trials across key therapeutic areas, including neurology, cardiovascular and cerebrovascular diseases, endocrinology, and orthopedics. Currently, the company is finalizing documentation and preparing for regulatory submissions, with plans to file with the CFDA within the year.

Initiate the clinical trial

It is reported that Jiuzhitang (Meike) will collaborate with top-tier domestic hospitals to conduct multi-center clinical trials. Building on the promising clinical results achieved by Stemedica in the U.S., the company plans to advance stem-cell research focused on neurological and cardiovascular diseases, ultimately paving the way for the early launch of stem-cell therapies in China.

Meanwhile, Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd. has also signed cooperation agreements with Mexico’s Novastem Cell Technology Company and Kazakhstan’s ALTACO Cell Technology Company, respectively, to jointly establish an international stem cell research and development platform.

Among them, Kazakhstan is a key node in the Belt and Road Initiative, and Kazakhstan’s ALTACO Company has been Stemedica’s long-term partner in the country. As the applicant, ALTACO has conducted multiple stem cell clinical trials in Kazakhstan using Stemedica’s stem cells. Just earlier this month, Kazakhstan’s Ministry of Health signed documents approving a mesenchymal stem cell therapy protocol specifically for acute myocardial infarction, marking the official entry of stem cell treatment into the commercialization phase in Kazakhstan. This marks the first stem cell therapy program approved across Central Asia’s five countries. Industry experts believe that this milestone will serve as an important model for the future development of stem cell technology in Central Asia and the Middle East.

Coinciding with Jiuzhitang's official entry into the stem cell field, the "Global Stem Cell Industry Development Summit Forum" was held in Beijing on the same day. Professor Aaron Ciechanover, the 2004 Nobel laureate, and Dr. Joseph Maroon, an international expert in clinical stem cell research, among others, attended the forum and delivered keynote speeches.