After Biotech’s failure, the domestic Trop-2 ADC drug reported to be launched...

On May 12, the CDE official website showed that Genting Pharmaceuticals submitted a listing application for Trop-2 ADC product-Trodelvy (gosartuzumab for injection) for metastatic triple-negative breast cancer that has received at least 2 therapies in the past (MTNBC) Adult patients.

Screenshot from CDE official website

Introduction to Trop-2 target

Trop-2 is called human trophoblast cell surface antigen 2.

Trodelvy is a first-in-class anti-Trop-2 antibody drug conjugate (ADC).

Trodelvy was approved by the FDA on April 22, 2020 for the treatment of adult patients with metastatic triple-negative breast cancer who have previously received more than two therapies.

This approval is based on an international, open-label, phase III ASCENT study, enrolling a total of 529 unresectable locally advanced or metastatic TNBC patients who have previously received at least two therapies.

The results showed that the study reached the primary and key secondary endpoints: Compared with the chemotherapy group, the Trodelvy group had a statistically significant improvement in PFS (median PFS: 4.

In terms of safety, the toxicity profile of Trodelvy is consistent with the toxicity profile shown on the previous FDA-approved label.

TNBC accounts for about 10% to 15% of breast cancer cases.

Current status of domestic Trop2 R&D

On March 4 this year, Biotech announced the termination of the Phase II ADC drug BAT8003.

However, the Trop2 project independently developed by two domestic companies is undergoing clinical trials, namely: Kelun’s SKB264 and Shanghai Junshi Biotechnology’s JS108.

Colum

Antibody-conjugated drug (ADC) is the key layout of Kelun Pharmaceuticals.

SKB264 achieves a high toxin load through a new coupling method.

SKB264 was approved by the U.

Jun Shi

In December 2019, Junshi Biotechnology obtained the rights and interests of Duoxi Biologics DAC-002 in Japan, South Korea and other Asian countries at a price of 30 million yuan in advance + 270 million yuan in milestone amount.

In July 2020, Junshi Biotech's JS108 (DAC-002) was approved and issued by the National Medical Products Administration in the "Drug Clinical Trial Approval Notice", allowing it to carry out clinical trials for the treatment of advanced solid malignant tumors.

After decades of accumulation of ADC drugs, it has finally begun to show an explosive trend.

Reference source:

1.
Trerotola M, Cantanelli P, Guerra E, et al.
Upregulation of Trop-2 quantitatively stimulates human cancer growth.
Oncogene.
2013;32(2): 222-233.