China Clears IND for SEED Therapeutics’ First-in-Class Cancer Drug in Global Trial Push
News November 19, 2025

China Clears IND for SEED Therapeutics’ First-in-Class Cancer Drug in Global Trial Push

KING OF PRUSSIA, PA — SEED Therapeutics announced that China’s National Medical Products Administration has cleared the Investigational New Drug application for ST-01156, enabling Chinese sites to participate in the ...

KING OF PRUSSIA, PA – SEED Therapeutics, a biotechnology company focused on developing innovative therapies, has reached a significant milestone in its global clinical trial program. The company announced that China's National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for ST-01156, a first-in-class cancer drug candidate. This clearance paves the way for Chinese clinical sites to join the ongoing global trial evaluating the safety and efficacy of ST-01156.

This decision by the NMPA represents a major step forward for SEED Therapeutics, allowing them to broaden the scope of their clinical research and potentially accelerate the development of this promising new treatment. The inclusion of Chinese patients in the study is crucial for ensuring the drug's effectiveness and safety across a diverse population. It also speaks to the growing importance of the Chinese market in global pharmaceutical development.

ST-01156 is designed as a first-in-class therapy, suggesting it utilizes a novel mechanism of action to combat cancer. While details on the specific type of cancer being targeted and the precise mechanism of action were not immediately available, the "first-in-class" designation implies that ST-01156 tackles the disease in a fundamentally new way, offering potential benefits over existing treatments. This novel approach could be particularly important for patients who have not responded well to traditional therapies or have developed resistance to them.

The global trial, now incorporating sites in China, aims to evaluate the drug's safety profile and determine its effectiveness in treating the targeted cancer. Clinical trials are a rigorous process, involving multiple phases, designed to assess whether a new drug is safe and effective before it can be approved for widespread use. The participation of Chinese clinical sites will contribute valuable data to this process, potentially leading to faster regulatory approval and ultimately, making the drug available to patients in need.

SEED Therapeutics' announcement underscores the company's commitment to bringing innovative cancer therapies to patients worldwide. With the IND clearance in China, the company is well-positioned to advance the clinical development of ST-01156 and potentially make a significant impact on the treatment landscape for the targeted cancer. Further updates on the trial's progress are anticipated as the study continues.
Category: World