Shanghai Pharmaceuticals Holding Co Class H ((SHPMF)) announced an update on their ongoing clinical study.
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Study Overview: Shanghai Pharmaceuticals Holding Co. is conducting a randomized, double-blind, placebo-controlled Phase II/III study to evaluate the safety and efficacy of SPH4336 combined with letrozole in the first-line treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer. This study aims to provide a new therapeutic option for patients with this type of breast cancer, potentially improving treatment outcomes.
Intervention/Treatment: The study tests SPH4336 tablets, an experimental drug, combined with letrozole, against a placebo combined with letrozole. SPH4336 is administered orally at 400mg once daily, while letrozole is given at 2.5mg once daily, both in 28-day cycles.
Study Design: The study employs a randomized, parallel intervention model with triple masking involving participants, investigators, and outcomes assessors. The primary purpose is treatment, aiming to assess the effectiveness of the drug combination in a controlled environment.
Study Timeline: The study began on February 16, 2023, and is currently recruiting participants. The last update was submitted on August 15, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
Market Implications: This study update could influence Shanghai Pharmaceuticals’ stock performance positively if the results demonstrate significant efficacy and safety, potentially boosting investor confidence. The study’s outcome may also impact the competitive landscape in the breast cancer treatment market, where innovation is highly valued.
The study is ongoing, with further details available on the ClinicalTrials portal.