---
title: "Sihuan’s Xuanzhu Unit Posts Strong Phase III Lung Cancer Data for ALK Inhibitor Dirozalkib"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/283291980.md"
description: "Sihuan Pharmaceutical's subsidiary, Xuanzhu Biopharm, announced promising Phase III trial results for its ALK inhibitor dirozalkib in treating ALK-positive advanced non-small cell lung cancer. The trial demonstrated that dirozalkib significantly improved median progression-free survival compared to crizotinib, along with better response rates and safety profiles. This strengthens Xuanzhu's oncology portfolio and supports Sihuan's innovative drug strategy. The company is focused on developing first-in-class medicines and has a market cap of HK$13.53B, with a year-to-date price performance of 17.89%."
datetime: "2026-04-20T04:08:01.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/283291980.md)
  - [en](https://longbridge.com/en/news/283291980.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/283291980.md)
---

# Sihuan’s Xuanzhu Unit Posts Strong Phase III Lung Cancer Data for ALK Inhibitor Dirozalkib

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The latest announcement is out from Sihuan Pharmaceutical Holdings Group ( (HK:0460) ).

Sihuan Pharmaceutical’s non-wholly-owned subsidiary Xuanzhu Biopharm has reported Phase III data for its next-generation ALK inhibitor dirozalkib (Xuan Fei Ning) in first-line treatment of ALK-positive advanced non-small cell lung cancer in China. The multicenter, randomized trial compared dirozalkib with crizotinib in 275 patients, assessing progression-free survival as the primary endpoint along with key response and safety measures.

The study showed dirozalkib more than doubled median progression-free survival versus crizotinib, significantly improving objective response, duration of response and disease control while delivering strong intracranial tumor responses and markedly lower brain progression risk. With a favorable safety and tolerability profile and prior regulatory approval in China for untreated ALK-positive advanced NSCLC, the robust results bolster the clinical value and competitive positioning of dirozalkib, enhancing Xuanzhu Biopharm’s oncology franchise and supporting Sihuan Pharmaceutical’s broader innovative drug strategy.

**More about Sihuan Pharmaceutical Holdings Group**

Sihuan Pharmaceutical Holdings Group is a Bermuda-incorporated pharmaceutical company listed in Hong Kong, operating through subsidiaries such as Xuanzhu Biopharm. Xuanzhu Biopharm, also Hong Kong-listed, is an innovative China-based drug developer focused on major diseases in digestion, oncology and non-alcoholic steatohepatitis, with dual small-molecule and biopharmaceutical R&D platforms and a pipeline spanning small molecules, biologics and ADCs.

The group concentrates on discovering, developing, producing and commercializing first-in-class and best-in-class innovative medicines backed by proprietary intellectual property. Xuanzhu’s capabilities across independent R&D, manufacturing and sales are aimed at addressing unmet clinical needs and strengthening its position as a leading innovative pharmaceutical player in China with a growing global outlook.

**YTD Price Performance:** 17.89%

**Average Trading Volume:** 35,639,862

**Technical Sentiment Signal:** Buy

**Current Market Cap:** HK$13.53B

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