On February 19, 2026, Japan's Ministry of Health, Labour and Welfare approved the world's first two iPSC cell therapy products—ReHeart for heart failure and Amchepry for Parkinson's disease. This marks that, from Shinya Yamanaka's first creation of iPS cells in 2006 to their true clinical application in 2026, a full 20 years of painstaking exploration has finally reached the critical point of an industrialization explosion.

      In this global race, China's strength should not be underestimated. Zhejiang Tianyuan Biotechnology Co., Ltd., as a pioneer in iPS cell technology research and application in China, has achieved internationally leading levels in multiple core technologies, particularly in the safety of cardiomyocyte transplantation, cell cryopreservation and recovery rates, and pacemaker cell organoids, demonstrating a "front-running" posture.

I. Forward-Looking Layout Lays the Cornerstone for Clinical Safety and Commercialization

Dr. Chen Junjie, Chief Technology Officer of Tianyuan Biotechnology, has led his team to a series of milestone breakthroughs in the field of iPS cell technology.

      Eliminating the risk of arrhythmia at the source——through precise regulation of signaling pathways, the generation of non-target pacemaker cells is completely suppressed while simultaneously accelerating the maturation of left ventricular cardiomyocytes. After transplantation, the cells can perfectly integrate into the recipient heart's electrophysiological rhythm, fundamentally eliminating the greatest clinical safety hazard.

      Redefining industry efficiency standards——a self-developed cryoprotective system enables the efficient cryopreservation of ventricular progenitor cells, raising the recovery rate from the industry average of 30% to over 90%. This leap not only solves logistics challenges but also makes the large-scale production of "ready-to-use" cell drugs possible, building a strong cost moat.

II. Leading in "Organoids": Pacemaker Cell Differentiation Research Surpasses Japan

      If Japan's ReHeart product focuses on myocardial repair, then Tianyuan Biotechnology's layout in the field of cardiac electrophysiological reconstruction has greater technical depth—it has successfully produced highly biomimetic sinoatrial node organoids (pacemaker cell organoids) through iPSC.

      These organoids can sense physiological signals and generate rhythmic impulses, and are expected to replace traditional electronic pacemakers, providing patients with bradycardia a lifelong solution that requires no battery replacement and causes no foreign body rejection. It is worth noting that, globally, only a handful of teams have truly advanced pacemaker cell organoids to the large animal testing stage, and Tianyuan Biotechnology has already achieved substantive progress in this specialized track—in this particular direction, it is even ahead of Japan's existing R&D pipeline.

III. Large Animal Testing Progressing Smoothly, Just One Step Away from Clinical Application

      At present, Tianyuan Biotechnology's core cardiomyocyte differentiation project has fully entered the large animal testing stage. As the most critical validation step before an Investigational New Drug (IND) application, preliminary data have demonstrated outstanding tissue integration capability and effects on improving cardiac function. This means that, if subsequent progress goes smoothly, Tianyuan Biotechnology's products are expected to enter clinical trials in the near future, benefiting patients.

      At the same time, China's domestic iPSC cell therapies are also accelerating overall: for example, the iPSC-derived cardiomyocyte product HiCM-188 has entered Phase II clinical trials, and the 4-year follow-up results of the world's first iPSC heart failure clinical study have confirmed long-term safety and efficacy. Tianyuan Biotechnology's technological breakthroughs will undoubtedly inject new vitality into China's regenerative medicine industry.

IV. Strong Alliance: Collaborative Innovation Between In-House Teams and Top-Tier Platforms

      The reason Tianyuan Biotechnology has been able to achieve these breakthroughs first is by no means accidental. Behind it lies the day-and-night dedication of its own scientist team, the collaborative support of top international experts, and the strong domestic technical support system—national and regional platforms such as the Institute of Science and Technology of the National Health Commission, the National Stem Cell Translational Resource Bank, and the Medical School of Ningbo University.

      This innovation ecosystem of "enterprise as the main body, platform as the support, and multi-party collaboration" allows Tianyuan Biotechnology to stand on the shoulders of giants, see further, and run faster.

      Zhejiang Tianyuan Biotechnology Co., Ltd. not only represents the future of regenerative medicine industrialization, but also an investment opportunity full of potential. With the rapid development of regenerative medicine technology and the gradual release of market potential, Tianyuan Biotechnology has proven with its hardcore technology that it possesses the strength to lead.

      Tianyuan Biotechnology is turning the vision of "making the impossible possible, turning the possible into value, and turning value into universal benefit" into reality through concrete action. We sincerely invite investors from around the world to join hands with Tianyuan Biotechnology in creating a new era of regenerative medicine. Join Tianyuan to explore new frontiers of regenerative medicine together and grasp the future pulse of life and health. For more information on Tianyuan Biotechnology's technical details and cooperation opportunities, please contact us.

      Founded in 2017, Zhejiang Tianyuan Biotechnology Co., Ltd. is a national high-tech enterprise dedicated to the integrated development of cell R&D, production, operations, and services. It holds valuable resource banks including an HLA umbilical cord matching bank, an iPS seed cell bank, and a tumor cell bank, and serves as a formulating unit for the group standard on immune function assessment methods under the National Health Commission. The company has jointly established a Metabolic and Immune Monitoring Joint Laboratory with the Institute of Science and Technology of the National Health Commission, and also serves as the Ningbo Storage Center of the National Stem Cell Translational Resource Bank and the Achievement Translation Center of the Institute of Science and Technology of the National Health Commission, among other important research and service platforms.