Hong Kong, 27 July, 2022 - Sihuan Pharmaceutical Holdings Group Ltd. together with Xuanzhu Biopharmaceutical Co., Ltd. (“Xuanzhu Biopharm”), a non-whollyowned subsidiary of the Company, are pleased to announce that the National Medical Products Administration (“NMPA”) of the People’s Republic of China (“China”) has accepted the application for marketing of fulvestrant injection. It is the first application for marketing of antioncology drug that Xuanzhu Biopharm submitted and this application has been accepted, which remarks the new milestone of Xuanzhu Biopharm’s anti-oncology drugs from research and development to commercialization.
Fulvestrant is one of the blockbuster drugs in the anti-oncology pipeline of AstraZeneca, with global sales peaking at over US$1 billion in 2018. Fulvestrant was introduced into China in 2010 and is now a Category B drug under the 2021 National Reimbursement Drug List. According to IQVIA data, its sales to sample public hospitals exceeded RMB570 million in 2021. With the growth of the breast cancer treatment market, sales of fulvestrant are expected to further increase in volume.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holding Group, said: “Fulvestrant injection is clinically indicated for the treatment of estrogen receptor positive (ER+) locally advanced or metastatic breast cancer. This blockbuster product will be used in combination with CDK4/6 inhibitor Birociclib, another blockbuster product of Xuanzhu Biopharm, to treat advanced breast cancer. The combination of fulvestrant with CDK4/6 inhibitor can significantly improve the survival benefit of patients. The future launch of fulvestrant injection will further enhance the Group’s strength in the field of oncology treatment."
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 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 accepting 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 enterprise 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.
This announcement is being made by the Group on a voluntary basis to update the investing public on the Group’s latest business development, and does not constitute, and is not intended to be, an advertisement regarding the use of any medicine, surgical appliance, treatment or orally consumed product.