2025-08-01

Hunan Releases Cell and Gene Regulations: Critically Ill Patients to Gain Access to Expanded Cell-Gene Product Therapies

On July 31, 2025, the 17th meeting of the Standing Committee of the 14th Hunan Provincial People's Congress voted to adopt the "Hunan Province Regulations on Promoting the Cell and Gene Industry," which will officially come into effect on October 1, 2025. The regulations explicitly state that cell and gene products demonstrating phased achievements may be given priority for expanded use or extended clinical trials.

2025-05-27

New progress in Jiuzhitang Maker's clinical trial for stem cell therapy of pulmonary alveolar proteinosis draws attention.

The road ahead is long and arduous, but Jiuzhitang Maker fully understands that stem-cell drug development still faces numerous challenges. Yet, the company will seize this forum as a pivotal opportunity to reaffirm its confidence, ramp up R&D investments, continuously optimize resource integration, and strengthen collaborative partnerships. Together, we’ll accelerate the translation of groundbreaking stem-cell research into tangible clinical applications, bringing patients with pulmonary alveolar proteinosis more treatment options and renewed hope—and ultimately contributing significantly to the growth of the stem-cell pharmaceutical industry.

2025-05-08

Stem Cell "Dual Track": The Differences and Synergies Between IIT and IND

The "dual-track" regulatory model for stem cells provides a diversified pathway for stem cell research and application in China. IIT studies offer flexibility for early-stage exploration, while IND studies ensure rigorous safeguards for bringing drugs to market. Together, these approaches drive forward innovation and expand the potential for practical applications of stem cell technology. Looking ahead, as more stem-cell-based therapies gain approval and enter the market, this regulatory framework will continue to support the healthy growth of China's stem cell industry.

2025-04-16

Jiuzhitang Maker makes its debut at the 2025 Wuzhen Health Conference, paving the way for innovative advancements in the stem cell field.

This year's conference, themed "Towards Spring: Internal and External Drivers Amidst Transformation," brought together the leading players of China's health industry ecosystem, creating a remarkable annual showcase of the pharmaceutical and healthcare sectors. As a standout in the stem-cell field, Jiuzhitang Maker demonstrated its exceptional expertise at the event, highlighting the vibrant spirit of innovation and heritage that has long defined the time-honored pharmaceutical brand, Jiuzhi堂. This performance not only injected fresh energy into the industry but also sparked meaningful reflection on its future trajectory.

2025-04-02

Common Challenges in Stem Cell Drug Development and Industrialization — The CMC Pharmaceutical Perspective

As the inaugural article in our series on stem cell-based drug development, this piece will focus on the key milestones in stem cell drug research and innovation. Our aim is to spark discussion and inspire practitioners by offering practical insights and guidance, ultimately working together to accelerate the advancement of stem cell drug development and its commercialization.

2025-02-20

Zhengzhou Airport Economic Zone Releases Full Text of "Nine Measures for Cells"! Supporting the High-Quality Aggregation and Development of the Cell and Gene Therapy Industry

Piloting a "risk-based classification and access management" system for cell and gene therapies at the Central Plains Medical Science City, this initiative will clarify the pathways for translating cell and gene therapy technologies into clinical applications, as well as establish transparent pricing and fee structures. It also aims to encourage real-world studies and foster innovative regulatory models for emerging biomedical technologies. For newly approved cell and gene therapy-related medical service price items, healthcare institutions are encouraged to promptly file and begin implementing these services.

2025-02-18

The Tianjin Municipal People's Government General Office has issued a document supporting the exploration and implementation of a tiered and categorized system for cell and gene therapies.

Support the Tianjin Free Trade Zone in innovating cell and gene therapy management models, strive for national pilot policies, and explore the implementation of a tiered and categorized system for cell and gene therapies.

2025-01-21

People's Daily: The stem cell market is projected to surpass 25 billion yuan, with more than 30 companies already making strategic moves in this space.

Although currently only one product has been approved domestically, there are still many companies actively developing stem cell therapies. According to an incomplete tally by the People's Daily Health Client, more than 30 companies received approval in 2024 to proceed with clinical trials for new drugs, including well-known firms such as Tasly, Jiuzhitang Maker, Qilu Cell, and Quansheng Bio. These therapies primarily target conditions affecting the blood system, cardiovascular system, nervous system, respiratory system, and autoimmune disorders.

2025-01-03

Big news! China's first stem-cell therapy drug approved for market.

The approval of "Amy Maitosai" marks a significant milestone in China’s stem-cell therapy field. This breakthrough not only offers hope to patients who urgently need effective treatment options but also represents an important step forward for China’s stem-cell therapies in both clinical application and commercialization.