---
title: "InSilico Medicine Wins China IND Nod for AI-Discovered IPF Drug Rentosertib"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/284467539.md"
description: "InSilico Medicine has received Investigational New Drug approval from China's Center for Drug Evaluation for its inhaled solution Rentosertib, aimed at treating idiopathic pulmonary fibrosis. This is the 13th program from its AI-driven pipeline to reach clinical trials, highlighting the effectiveness of its Pharma.AI platform. The approval allows for a Phase I trial involving 80 subjects. Rentosertib, a small-molecule TNIK inhibitor, holds U.S. Orphan Drug and China Breakthrough Therapy Designations, potentially enhancing InSilico's position in AI-enabled drug discovery."
datetime: "2026-04-29T00:19:18.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/284467539.md)
  - [en](https://longbridge.com/en/news/284467539.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/284467539.md)
---

# InSilico Medicine Wins China IND Nod for AI-Discovered IPF Drug Rentosertib

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The latest update is out from InSilico Medicine Cayman TopCo ( (HK:3696) ).

InSilico Medicine has received Investigational New Drug approval from China’s Center for Drug Evaluation for its self-developed inhaled solution of Rentosertib (ISM001-055) to treat adult idiopathic pulmonary fibrosis. This marks the 13th program from the company’s AI-driven pipeline to reach the clinical trial stage, underscoring the growing productivity of its Pharma.AI platform.

The approval clears the way for a Phase I trial assessing safety, tolerability and pharmacokinetics in about 80 subjects through both healthy volunteer and patient cohorts. Rentosertib, a potentially first-in-class small-molecule TNIK inhibitor that already holds U.S. Orphan Drug Designation and China Breakthrough Therapy Designation for IPF, could enhance InSilico’s competitive position in AI-enabled drug discovery and signal a maturing late-stage pipeline for stakeholders if early data prove positive.

**More about InSilico Medicine Cayman TopCo**

InSilico Medicine Cayman TopCo is a Cayman Islands–incorporated biotechnology company focused on developing small-molecule drugs using its proprietary generative AI platform, Pharma.AI. The group builds an AI-driven pipeline targeting difficult diseases, positioning itself at the intersection of artificial intelligence and pharmaceutical innovation.

**Average Trading Volume:** 3,139,147

**Current Market Cap:** HK$40.5B

For a thorough assessment of 3696 stock, go to TipRanks’ Stock Analysis page.

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