Speech by the Chairman of Jiuzhitang Maker

As spring returns and the warmth of the season gradually spreads, all things begin to renew. Filled with the joy of harvest and brimming with the spirit of forward momentum, we’ve steadily stepped across the threshold of the new year, welcoming 2021—a year full of boundless hope. On the occasion of the vibrant Spring Festival, the entire Jiuzhitang Maker team extends our heartfelt gratitude to everyone from all walks of life who have shown enduring care and support for our company. We also send our warmest New Year wishes to friends near and far, along with sincere greetings and best wishes to our dedicated employees—those who work tirelessly, collaborate passionately, and celebrate every victory together—as well as to their families.

2020 was an extraordinary year, as a sudden pandemic placed unprecedented challenges across industries—yet it also presented Jiuzhitang Maker with both opportunities and hurdles. Amid the raging crisis, all employees at Jiuzhitang Maker rallied together with unwavering determination, staying focused and working tirelessly to achieve inspiring milestones. The company has since earned prestigious accolades such as "Zhongguancun Golden Seed Enterprise" and "Top 50 Most Innovative Biopharmaceutical Companies in China 2020," while also becoming one of the first batch of science-and-technology-based SMEs selected by China’s Ministry of Science and Technology. Additionally, Jiuzhitang Maker received special funding from Daxing District for its innovative efforts in combating COVID-19, established a branch of its postdoctoral research workstation, and successfully secured approval—and launched—a groundbreaking clinical trial for a new stem-cell-based drug, conducted jointly with Beijing Tiantan Hospital. These achievements have ushered in a new chapter for Jiuzhitang Maker.

On February 19, 2020, the clinical trial application for a new stem-cell drug jointly conducted by Jiuzhitang Maker and Tiantan Hospital was approved, marking "three industry firsts" in China's stem-cell drug sector: it became the first clinical trial to utilize imported stem cells; the first to target a major neurological indication with stem-cell therapy; and, following the National Medical Products Administration's resumption of accepting applications for stem-cell clinical trials, the first study to employ bone marrow-derived mesenchymal stem cells. This milestone holds significant importance for the development of China's stem-cell industry.

In September 2020, amid the severe COVID-19 situation and heightened aviation restrictions in the U.S., Jiuzhitang Maker successfully completed the import of stem cells required for its clinical trial, ensuring the smooth initiation of the study. Jiuzhitang Maker also became the first domestic company to receive customs approval for importing stem-cell-based pharmaceutical products intended for clinical trials.

On January 12, 2021, the kickoff meeting for China's first Phase I/IIa clinical trial (the ASSIST Study) using imported stem cells to treat ischemic stroke—initiated by Jiuzhitang Maker—was held online at Beijing Tiantan Hospital, Affiliated to Capital Medical University, the leading institution of the trial. This marked the official launch of the clinical study. This trial is the first-ever clinical trial evaluating stem cell therapy for cerebrovascular diseases conducted in accordance with the new version of the "Good Clinical Practice Guidelines for Drug Clinical Trials," since stem cells have been regulated as pharmaceuticals under national policy. The trial holds significant importance not only for advancing the clinical application of stem cells in the treatment of cerebrovascular disorders but also for potentially transforming the broader management system governing stem cell therapies.

In 2020, Jiuzhitang Maker's partner, Stemedica, received U.S. FDA approval for an emergency IND application to use bone marrow-derived mesenchymal stem cells in treating 14 severe and critically ill COVID-19 patients, demonstrating remarkable therapeutic efficacy. In September, Stemedica’s Investigational New Drug (IND) application for a Phase II clinical trial evaluating the use of stem cells to treat COVID-19 patients was approved by the U.S. Food and Drug Administration (FDA).

"Plum blossoms bloom fragrant only after enduring the bitter cold; true jade is polished through constant refinement. As we look ahead to 2021, new goals have been set, and a fresh journey has begun. Facing entirely new challenges and opportunities, we—standing firmly in the midst of this powerful current—are fully prepared to ride the wave."

The road ahead may be long and challenging, but let’s never forget our original aspirations. We’ll embody the Jiuzhitang Maker spirit through concrete actions—driven by a strong sense of dedication and responsibility, backed by expertise and unwavering confidence. With every achievement, we’ll ignite the dreams burning deep within us, passionately continuing to write new chapters of growth and progress. And as we thrive, we’ll pave the way for Jiuzhitang Maker to achieve even greater, well-deserved glory.

The New Year's bells have already rung—let’s step into 2021 with confidence and excitement, ready to embrace the year ahead!

Zhang Quancheng, Chairman of Jiuzhitang Maker