In February 2021, Haisco Pharmaceutical Group Co., Ltd. and Starton Therapeutics Inc. (hereinafter referred to as 'Starton') of the United States signed the 'Development and Commercial License for Olanzapine Transdermal Patch (hereinafter referred to as 'STAR-OLZ') Agreement' (hereinafter referred to as the 'cooperation agreement'), STAR-OLZ is under development and is committed to becoming the first approved product for PIINV.

According to the cooperation agreement, Starton awarded Haisco to develop, register and commercialize STAR-OLZ in mainland China for its research on weekly olanzapine transdermal drug delivery system, which is intended to be used for nausea and vomiting caused by tumor chemotherapy. Exclusive rights.

STAR-OLZ is a once-a-week transdermal drug delivery system (TDS), intended to treat nausea and vomiting (CINV) caused by chemotherapy and nausea and vomiting (PIINV) caused by PARP inhibitors.

STAR-OLZ has completed the human bioavailability study on 36 healthy volunteers. In this study, it was found that STAR-OLZ can provide the target therapeutic level of olanzapine within 7 days, has a good tolerance to the skin, adheres to the skin within the dosing interval and is easy to remove, and is compatible with ZYPREXA (Oanzapine tablets) has a lower overall sedative side effect intensity compared with oral administration. The study achieved all clinical target endpoints and goals.

A number of randomized controlled studies have shown that in the prevention of CINV, olanzapine is superior to NK-1 receptor antagonists in controlling nausea, and is not inferior to NK-1 receptor antagonists in controlling vomiting. The NCCN guidelines recommend olanzapine for CINV, but the current olanzapine label does not include indications for nausea and vomiting.

PARP inhibitor is a long-term cancer treatment agent that can cause nausea in more than 70% of patients. There are currently no drugs approved for PIINV. STAR-OLZ is under development and is committed to becoming the first approved product for PIINV. Currently STAR-OLZ is still under research and has not yet been approved for marketing, and currently no transdermal olanzapine patch has been approved globally.

The company has been deeply involved in the field of tumor and vomiting for several years, and has successfully developed and commercialized products for the prevention of nausea and vomiting, including dolasetron mesylate injection and palonosetron hydrochloride injection. At present, the two products have occupied a considerable market share in the field of tumor vomiting. The introduction of STAR-OLZ this time is expected to further improve and enrich the company's product line in the field of tumor antiemetics.

Introduction to Starton

The goal of Starton (www.startontx.com) is to have a positive impact on the lives of cancer patients by safely and effectively developing products based on current treatment models. The company is a clinical-stage biotechnology company dedicated to changing the standards of existing care treatments. The company focuses on transdermal patches, screens the best-selling drugs that have been approved for many years, develops new dosage forms or new indications based on its rich clinical use basis and data, and reduces the drug development time through the 505(b)2 application route And development risk.

Contact:

Tel: + 86-0893-7834870

Email: haisco@haisco.com

Web: http://www.haisco.com

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