The Group is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. (軒竹生物科技股份有限公司)(“Xuanzhu Biopharm”), a non-wholly owned subsidiary of the Group, entered into an exclusive licensing agreement in June 2022 with Shanghai SPH New Asia Pharmaceutical Co., Ltd. (“New Asia Pharmaceutical”), a non-wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. (“Shanghai Pharma”), for the exclusive license of the active pharmaceutical ingredient (the “API”) and formulation of two new anti-infection drugs of Xuanzhu Biopharm, Benapenem and Plazomicin, in the Greater China Territory (including mainland China, Hong Kong SAR, Macau SAR and Taiwan) (the “Greater China Territory”).
Under the terms of the licensing agreement, New Asia Pharmaceutical will obtain exclusive rights of the API and formulation of the above mentioned two drugs in the Greater China Territory, including all rights in licensing, research and development (“R&D”), production and commercialization, and will become the marketing authorization holder (MAH) of the two drugs in the Greater China Territory. Xuanzhu Biopharm will receive an upfront payment of RMB21 million and will be eligible to receive milestone payments of up to RMB419 million (including R&D registration, patent extension and sales milestone payments), as well as tiered royalties on sales of up to two digits.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, “the collaboration will leverage the strong product development, production and sales strengths of our business partners Shanghai Pharma and New Asia Pharmaceutical in the anti-infection field, and form a good commercial synergy with New Asia Pharmaceutical’s pipeline under development and sale, to maximize the future commercial value of the two products. The two parties will in the future further explore diversified cooperation models, in order to build up a good and long-term partnership. “
About Benapenem
Benapenem API and Benapenem for Injection are the class 1.1 carbapenem antibiotic new drug independently developed by Xuanzhu Biopharm of the Group, which are intended for the treatment of complicated urinary tract infections and community-acquired pneumonia. Phase II clinical trials have been completed in China for the indication of complicated urinary tract infections, and phase III clinical trials will be initiated soon. The clinical and pre-clinical results obtained so far have shown that the products have good antibacterial activity and safety profile, long half-life period, and support qd administration, which is significantly better than similar drugs on the market.
About Plazomicin
Plazomicin API and Plazomicin for Injection are the new generation of semi-synthetic aminoglycoside antibiotics developed by the U.S. company Achaogen, Inc. They produce antibacterial effect mainly through binding to bacterial 30S ribosomal subunits, and are used to treat severe infections caused by multi-drug resistance (MDR) gram-negative bacteria and enterobacteriaceae. The products were approved by the U.S. Food and Drug Administration (FDA) in June 2018 for the indication in end-line therapy of treatment of complicated urinary tract infections caused by the enterobacteriaceae and are intended to be used in the end-line therapy of bloodstream infections. In December 2019, the Group’s subsidiary Xuanzhu Biopharm has acquired all ownership interests and related intellectual property rights of the products in the Greater China Territory.
About New Asia Pharmaceutical
New Asia Pharmaceutical, a non-wholly owned subsidiary of Shanghai Pharmaceutical, is one of the largest antibiotic pharmaceutical company in China. The company was formed through the strategic asset restructure and integration of three of the largest antibiotic product manufacturers under the former Shanghai Pharmaceutical (Group), namely Xinya Pharmaceutical, Xianfeng Pharmaceutical and Disi Pharmaceutical. The company’s three brands: “Yazi” brand, “Sanhua” brand and “Sixing” brand, cover a wide range of anti-infection drugs, and have developed a complete industrial chain that integrates R&D, raw materials, formulations and sales.
About Xuanzhu Biopharm
Xuanzhu Biopharm is the innovative drug subsidiary of Sihuan Pharmaceutical, a large domestic pharmaceutical and medical aesthetic group. After 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 heavily 3 rely on license-in and CRO. 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 balanced 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 medical aesthetic and pharmaceutical company led by innovation, with an independent and leading R&D 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.