Sihuan Pharmaceutical Holdings Group Ltd., together with its subsidiaries and SignalChem Lifesciences Corporation today announced that Sihuan Pharmaceutical Holdings Group Ltd subsidiary company Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu") and SignalChem Lifesciences Corporation ("SignalChem") have entered into an exclusive collaboration and licensing agreement for the clinical development and commercialization of SLC-391, a potent and selective AXL targeting inhibitor, in the Greater China region.
Under the terms of the agreement, Xuanzhu will pay to SignalChem an upfront fee of thirteen million US dollars (US$13,000,000). Additional development milestones and royalties have also been committed. The exclusive rights for SLC-391 for the field of oncology is for the Greater China region (Mainland China, Hong Kong, Macau and Taiwan).
AXL is a member of TAM (Tyro3, AXL, Mer) family of receptor tyrosine kinases. AXL along with its ligand GAS6 (growth arrest-specific gene 6) is highly expressed and activated in many malignant tumors, such as acute myeloid leukemia, kidney, pancreatic, breast, lung and ovarian cancer, etc. As one of the crucial signaling pathways promoting tumor growth and metastasis, immune escape and drug resistance, GAS6-AXL pathway is considered to be an attractive target for cancer treatment and has attracted widespread attention.
"The agreement with SignalChem will further advance Xuanzhu's pipeline in the solid tumor and hematoma space. The results from preclinical and phase 1 clinical development demonstrated SLC-391 superiority not only as SLC-391 has prominent single-agent activities in multiple solid and hematological tumors but also can potentially be administered with a variety of drugs under development at Xuanzhu. Both parties will use their respective resources to accelerate the clinical approval of SLC-391 in China," said Ms. Xu Yanjun, Chairman of Xuanzhu. "Xuanzhu will continue to expand its efforts to develop and commercialize innovative drugs in the oncology field."
"Xuanzhu Biopharmaceutical, a subsidiary of Sihuan Pharmaceutical, is a highly innovative and progressive company," commented by Mr. Jun Yan, the Chairman and President of SignalChem, "We are very pleased to establish a partnership with Xuanzhu. This licensing agreement is of great significance for SignalChem to further validate and expand SLC-391's clinical superiority. This agreement will accelerate SLC-391's development timeline to reach the market and provide more effective treatment alternatives for patients with cancer." Mr. Jun Yan added, "the size of the agreement, including upfront, milestone and royalties, with Xuanzhu may be one of the largest agreements signed in Canada with a Chinese bio-pharma company for the Chinese territory rights, and we are looking forward to reaching all anticipated objectives. Furthermore, SignalChem will continue its efforts to expand and accelerate clinical development with SLC-391 for wider indications in even more geographic territories."
SLC-391 is a potent, highly selective and orally bioavailable small molecule AXL inhibitor. Preclinical investigational data shows SLC-391 is a superior AXL inhibitor and has the potential to become a first-in-class inhibitor. Phase I clinical study is currently underway in Canada. SignalChem has established a collaboration with Merck (MSD) to evaluate the efficacy of SLC-391 in combination with Keytruda® (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC). In pre-clinical studies, SLC-391 demonstrated strong efficacy as a single agent or in combination with other approved drugs in multiple animal models for cancer. SLC-391 will be developed to undisclosed cancer indications as a single agent or in combination with other therapies.
Xuanzhu Biopharmaceutical Co., Ltd., a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., is an innovative biopharmaceutical company rooted in China with a global perspective, focusing on tumors, metabolic diseases, infections, and other fields. It has a layout of the entire industry chain from drug discovery, preclinical research, clinical development, and production commercialization. Xuanzhu's strengths reside in its detailed knowledge and expertise in the clinical development and regulatory approval processes in China. Xuanzhu has a clinical and regulatory team of over 300 people bringing expertise from numerous multinational pharmaceutical companies including J&J, Lilly, Merck, Novartis, Pfizer, and Roche. This combined with the most extensive sales and marketing capability in China, places Xuanzhu as the premier partner for those companies with innovative assets desiring to enter the China domestic market.
About SignalChem Lifesciences Corporation
SignalChem Lifesciences Corporation, headquartered in Richmond, British Columbia, Canada, is a clinical-stage company developing novel targeted therapies for oncology. Its unique business model has been built upon four important pillars: Drug Discovery and Development, the Bioreagents and Research Services business, In-Vitro Diagnostic Reagent Development and Plant Biosynthesis Systems. We at SignalChem are a group of scientists with extraordinary expertise and experience in protein engineering and drug discovery who are working together cohesively to provide the best products and services to our customers around the world and to maximize the efficiency of our own drug discovery efforts.
Xuanzhu Forward-Looking Statements
These statements are only predictions based upon our current expectations and projections about future events. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Xuanzhu to be materially different from those expressed or implied by such forward-looking statements. Although Xuanzhu has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. You should not rely on forward-looking statements as a prediction of future events.
The assumptions used in the preparation of this statement although considered reasonable by Xuanzhu at the time of preparation, may prove to be incorrect. Recipients are cautioned that the information is based on assumptions as to many factors and that actual results may vary from the results projected and such variations may be material. Accordingly, readers should not place undue reliance on any forward-looking statements contained herein. Xuanzhu does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.
SignalChem's Forward-Looking Statements
These statements contain forward-looking statements, including statements about SignalChem's business strategy, product development, regulatory matters, manufacturing plans, and intellectual property plans. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. SignalChem's business is subject to numerous risks and uncertainties. SignalChem has never commercialized any drug products and it is uncertain whether its product candidates under development will become effective treatments. SignalChem's product candidates are still in an early stage of development, have not completed clinical development and have not received regulatory approval for commercialization. SignalChem may not actually achieve the plans, projections, or expectations set forth in its forward-looking statements. Actual results or events could differ materially from the plans, projections, and expectations set forth in its forward-looking statements, as a result of the risks affecting its business.
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