What type of cancer will the first approved biologic product treat?

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The first approved biologic product for a first-in-human clinical trial will treat advanced solid tumors.

The Ministry of Health (MOH) has announced that applications for Clinical Trial Import Licences (CTIL) and Clinical Trial Exemptions (CTX) for "first in human" (FIH) clinical trials are now open. This development aligns with the 2021 Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption.
First Biologic Product Approved for FIH Trial

A significant milestone was reached at the 395th Drug Control Authority (DCA) meeting on April 4, 2024, with the approval of the first CTIL for a biologic product intended for FIH clinical trial use. This approval specifically pertains to a biologic product designated for the treatment of advanced solid tumors.
Scope of FIH Trial Applications

According to Norhaliza A Halim, senior director of MOH Pharmaceutical Services, FIH applications can now be submitted for products classified as new chemical entities, herbal products with substantial demand, and biologic products. However, cell and gene therapy products are excluded from this current scope.
Clinical Trial Details and Location

The FIH clinical trial involving this biologic product will be conducted at the Sarawak General Hospital. This trial is set to enroll 48 cancer patients. The Sarawak General Hospital has been accredited by the National Pharmaceutical Regulatory Division (NPRA) as a clinical research site capable of conducting FIH clinical trials, as part of the Phase I Unit Inspection and Accreditation Programme.

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What type of cancer will the first approved biologic product treat?

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