Hengrui Pharma’s Ruikang Trastuzumab for Injection Wins Clinical Trial Approval
November 26, 2025
Source: drugdu
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Beijing Business Today, Nov. 25 – Hengrui Pharmaceuticals announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA) for Ruikang Trastuzumab for Injection, approving the monotherapy clinical trial in patients with HER2-amplified solid tumors.
According to the announcement, Ruikang Trastuzumab for Injection binds to and is internalized by HER2-expressing tumor cells. Within the tumor cell lysosomes, the toxin is released through protease cleavage, inducing cell cycle arrest and triggering tumor cell apoptosis. The released toxin exhibits high membrane permeability, enabling a bystander killing effect that further enhances anti-tumor efficacy. Ruikang Trastuzumab for Injection was approved for marketing in China in May 2025, indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have previously received at least one line of systemic therapy.
Reference：https://finance.eastmoney.com/a/202511253574356329.html
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