Policy & Regulation
Kintor Pharmaceutical receives Chinese regulatory approval for ALK-1 antibody and Nivolumab combination therapy clinical trial
12 October 2021 -

Kintor Pharmaceutical Limited (HKEX: 9939), a clinical-stage biotechnology company, announced on Monday that it has received approval from the National Medical Products Administration of China (NMPA) for the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo) combination therapy, intended for the treatment of systemic therapy naive patients with advanced hepatocellular carcinoma.

The company received an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer Inc. in February 2018.

The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC commenced on 7 May 2019 in Taiwan, China (Taiwan phase II clinical trial), to evaluate the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO GI 2021 (held between 15 – 17 January 2021), and showed positive efficacy and safety results.

On 11 February 2021, the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by the United States Food and Drug Administration.

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