Aurobindo Pharma shares soared in the early trade after its subsidiary CuraTeQ Biologics broadcasted favourable results in the phase-3 clinical trial of Trastuzumab biosimilar.

The breast cancer biosimilar invention, BP02 (Trastuzumab or biosimilar to Herceptin), established by the wholly owned subsidiary Curateq Biologics Private Limited, has met its principal endpoint in the Phase-3 clinical trial, according to Aurobindo Pharma report.

BP02 has revealed equal efficacy to Herceptin based on its clinical response (overall response rate, ORR), demonstrating a similar safety profile.

This Phase-3 study is a multi-centre, randomised, double-blinded study concerning females with metastatic HER2- positive breast cancer.

The trial was carried out to determine product correspondence amid efficacy vis-à-vis EU-sourced Herceptin. The trial also associated pharmacokinetics, safety, and immunogenicity of BP02 vs originators product, it added.
The results confirmed that BP02 met equivalence to Herceptin in clinical answers, and the safety profiles of the two treatment arms were analogous during the treatment phase.

Earlier, CuraTeQ accomplished a randomised, double-blind, parallel three-arm Phase-1 study (BP02-101) in healthy offers with BP02 and Herceptin sourced from the US and the EU.

On July 3, the company’s entity entered into a plan with Viatris Inc for a total value of $48 million about the transfer from Viatris Inc of certain advertising and manufacturing-related authorisations subject to sanction from applicable regulatory authorities and third parties.

The arrangement also anticipates participation in the supply system with certain marketing and manufacturing-related authorisations and sharing of the net economic benefits by Viatris to such group entity of the company.
At 9:28 am, Aurobindo Pharma was trading at Rs 716.30, up Rs 3.65, or 0.51% on the BSE.

The share moved a 52-week high of Rs 741.40 and a 52-week low of Rs 397.30 on June 28, 2023, and February 3, 2023, respectively. It trades 3.39% below its 52-week high and 80.29% above its 52-week low.