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First Drug Holdings disclosed that SY-5007, a selective RET inhibitor, conducts pivotal clinical trials

 Last Update: 2023-02-02
 Source: Internet
 Author: User

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gene therapy process

lung cancer icd

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Recently, First Drug Holdings (Beijing) Co.
, Ltd.
received feedback from the Center for Drug Evaluation (CDE) of the National Medical Products Administration on the conditional approval of its selective RET inhibitor SY-5007, based on the safety and efficacy data of SY-5007 at the current stage I.
, CDE agreed that SY-5007 will be conditionally approved for marketing
in the future using phase II.
single-arm clinical trials.

Accordingly, the Company will rapidly initiate a pivotal Phase II clinical trial
of SY-5007 for patients with RET-positive non-small cell lung cancer (NSCLC) after standard therapy.

SY-5007 is the first domestic innovative drug to enter the clinical stage for RET targets, and it is also one of the domestic selective RET inhibitors with the
fastest clinical progress.
Phase I clinical trial data show that SY-5007 has potent and long-lasting anti-tumor activity, and has shown good clinical activity and tolerability in patients with multiple solid tumors with RET gene variants, such as advanced NSCLC and MTC, which is expected to provide precise treatment options for domestic RET-positive tumor patients and significantly improve the accessibility of patients
.

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