The Group is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. (軒竹生物科技有限公司) (“XuanzhuBiopharm”) of the Group has successfully received investigational new drug (IND) approval from the National Medical Products Administration (the “NMPA”) of the People’s Republic of China (the “China”) for its application of a highly active and selective AXL-targeted inhibitor capsule XZB-0004 (SLC-391) in clinical trial on advanced solid tumors and hematological malignancies. Xuanzhu Biopharm has entered into collaboration with SignalChem Lifesciences Corporation (“SignalChem”) in September 2021, introducing in the exclusive development and commercialization rights in the Greater China region.
SLC-391 is a potent, highly selective and orally bioavailable small molecule AXL-targeted inhibitor. The current pre-clinical investigational data shows SLC-391 is a “Best-in-Class” inhibitor with 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 jointly 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 compounds have demonstrated good efficacy in various animal models, including NSCLC, colon cancer, chronic myeloid leukemia (CML) and acute myeloid leukemia (“AML”) models. Therapeutic synergy in combination with other approved therapies has been demonstrated in various 2models. Pre-clinical and phase I clinical results have shown that SLC-391 not only has single agent efficacy in multiple solid tumor and hematological tumor trials, but also has the potential to be used in combination with a number of drugs under development from Xuanzhu Biopharm to treat some refractory tumors.
Lung cancer is the second most prevalent type of cancer in China, with NSCLC being the most common in lung cancer, accounting for 84% of all diagnosed lung cancer cases with a very low 5-year overall survival rate of only 24%, ranging from 61% for localised NSCLC to 6% for metastatic NSCLC. AML is a refractory myeloid hematopoietic stem/progenitor cell malignancy with a high clinical recurrence rate, and is one of the most common but lethal types of leukemia. According to data from American Cancer Society (ACS), there were approximately 60,530 new leukemia cases and 23,100 leukemia deaths in the U.S. in 2020, including 19,940 new cases of AML and 11,180 deaths from AML.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group Ltd., said: “In China, with the approval and launch of targeted drugs such as BCL2 inhibitor Venetoclax in 2020, new treatment option has been brought to patients who cannot tolerate strong induction chemotherapy. SLC-391 has significant market potential for clinical drug combination in treating the NSCLC. It will have a positive impact on the Group's operating results in the future.”
ABOUT AXL INHIBITOR
AXL inhibitor is a highly selective, oral, small molecule product. As a member of the TAM (Tyro3, AXL and Mer) family of tyrosine protein kinases, AXL, along with its ligand GAS6, is highly expressed and activated in many malignant tumors, such as the AML, kidney cancer, pancreatic cancer, breast cancer, lung cancer and ovarian cancer, etc. The GAS6-AXL signaling pathway, as one of the crucial signaling pathways promoting tumor growth and metastasis, tumor immune escape and drug resistance, is considered to be a new target for cancer treatment.
ABOUT XUANZHU BIOPHARM
Xuanzhu Biopharm is the innovative drug research subsidiary of Sihuan Pharmaceutical, a large domestic pharmaceutical and medical aesthetic group. After nearly 10 years of construction and development, the company has gathered an outstanding team of nearly 400 led by returned scientists. The company owns the ability to research and develop innovative drugs independently, forms a complete R&D system, with complete drug development and industrialization capabilities, and does not rely on license-in and CRO, with the ability to innovate and produce continuously. Xuanzhu Biopharm owns two first-class innovative drug R&D platforms for both small molecular and large molecular, and is dedicated to the development of category 1.1 innovative drugs for small molecular and bio-macromolecular. It currently has more than 25 innovative drugs in pipeline under development, focusing on tumors, metabolism, digestion, and other fields. Among them, Xuanzhu Biopharm has a full coverage on major targets of breast cancer, and thus becomes one of the companies in China with the most comprehensive coverage in breast cancer therapeutic areas. The R&D of Xuanzhu Biopharm is progressing rapidly, with the NMPA accepted its NDA for Anaprazole Sodium for the treatment of duodenal ulcer. In addition, it has nearly 10 products in clinical stage. The pipeline layout is complete and balance in long, medium, and short terms, with strong capability to innovate continuously, in order to ensure that at least 1–2 products could apply for IND every year in the future. Riding on the commercialization capabilities of its parent company Sihuan Pharmaceutical, Xuanzhu Biopharm is now transforming from a Biotech company to a Biopharm company, and is gradually becoming a company with excellent R&D and industrialization capabilities.
ABOUT SIHUAN PHARMACEUTICAL
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical is an international pharmaceutical and medical aesthetics company led by innovation, with an independent and leading research and development technology platform, a rich global product pipeline, strong product registration capability, a full dosage form production platform with high efficiency and low cost and a mature and excellent sales system. Adhering to the overall strategic goal for the “full promotion of a two-wheel drive strategy of its medical aesthetics and biopharmaceutical businesses”, Sihuan Pharmaceutical endeavors to build itself into a leading medical aesthetics and biopharmaceutical company in China.