---
title: "RemeGen Wins Fifth China Approval for Flagship ADC in Urothelial Cancer"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/282374325.md"
description: "RemeGen Co. Ltd. has received approval from China's National Medical Products Administration for its antibody-drug conjugate Disitamab Vedotin, in combination with Toripalimab, as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma. This marks the drug's fifth approved indication in China, supported by a Phase III trial demonstrating improved survival rates over traditional chemotherapy. The approval enhances RemeGen's position in the oncology market and expands treatment options for patients. Analysts rate RemeGen's stock (HK:9995) as a Buy with a price target of HK$124.00."
datetime: "2026-04-10T14:38:59.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/282374325.md)
  - [en](https://longbridge.com/en/news/282374325.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/282374325.md)
---

# RemeGen Wins Fifth China Approval for Flagship ADC in Urothelial Cancer

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An announcement from RemeGen Co. Ltd. Class H ( (HK:9995) ) is now available.

RemeGen has secured approval from China’s National Medical Products Administration for a new indication of its flagship antibody-drug conjugate Disitamab Vedotin, in combination with immunotherapy drug Toripalimab, as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma, marking the drug’s fifth approved indication in China. The approval, supported by a large Phase III trial showing significantly improved survival and response rates over platinum-based chemotherapy across the full spectrum of HER2 expression with a favorable safety profile, strengthens RemeGen’s position in the competitive oncology market and expands treatment options for patients with a high-burden, historically hard-to-treat cancer type in China.

The most recent analyst rating on (HK:9995) stock is a Buy with a HK$124.00 price target. To see the full list of analyst forecasts on RemeGen Co. Ltd. Class H stock, see the HK:9995 Stock Forecast page.

**More about RemeGen Co. Ltd. Class H**

RemeGen Co., Ltd. is a China-based biopharmaceutical company specializing in the research, development and commercialization of innovative antibody-drug conjugates and other targeted oncology therapies. Its lead product Disitamab Vedotin is China’s first domestically developed HER2-targeting ADC, aimed at treating multiple solid tumors including gastric, urothelial and breast cancers, with a focus on high-incidence, high-unmet-need indications in China and globally.

**Average Trading Volume:** 4,409,670

**Technical Sentiment Signal:** Buy

**Current Market Cap:** HK$78.08B

Find detailed analytics on 9995 stock on TipRanks’ Stock Analysis page.

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