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Thursday, 8 June 2023, 21:18 HKT/SGT

Source: Sihuan Pharmaceutical Holdings Group Ltd.
Xuanzhu Biopharm, a subsidiary of Sihuan Pharmaceutical, progresses at full speed in innovative research and development, Presents major research results of birociclib, the start product, at the international stage in ASCO

HONG KONG, June 8, 2023 - (ACN Newswire) - Sihuan Pharmaceutical Holdings Group Ltd. (the "Company" or "Sihuan Pharmaceutical", together with its subsidiaries, the "Group", HKEX stock code: 0460) is pleased to announce that the Group recently attended the 59th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, the United States with its major research results, which demonstrated the efficacy of the innovative CDK4/6 inhibitor birociclib independently developed by Xuanzhu Biopharm, its subsidiary, in the treatment of HR+/HER2- metastatic breast cancer after monotherapy and combination therapy (including endocrine therapy and chemotherapy), which was highly recognized by the industry worldwide and further validated the corporate value of Xuanzhu Biopharm.

The CDK4/6 inhibitor with a novel structure for HR+/HER2-advanced breast cancer, which was independently developed by Xuanzhu Biopharm, an innovative pharmaceutical subsidiary of Sihuan Pharmaceutical, is also the first CDK4/6 inhibitor in mainland China to conduct a registration clinical trial for monotherapy final-line treatment, and has significant advantages. Being able to present the latest clinical progress at the ASCO annual meeting is a great recognition by the international academic community of Xuanzhu Biopharm's global innovation and R&D capabilities.

In the drug design of birociclib, Xuanzhu Biopharm has differentially constructed a unique molecular structure through the analysis of molecule-protein binding, and coupled with the leading technology, it can inhibit CDK6 moderately while inhibiting CDK4 potently, effectively reducing the side effects of the drug. Preclinical studies have shown that birociclib has a unique pharmacokinetic profile that can effectively pass the blood-brain barrier and is expected to be effective in patients with brain metastases from breast cancer. Therefore, birociclib, as an innovative CDK4/6 inhibitor developed by a domestic company, is expected to gain global presence with its excellent monotherapy efficacy, safety and tolerability, and the potential for additional combination therapy. The excellent clinical results disclosed by Xuanzhu Biopharm at the ASCO annual meeting highlighted the development potential of birociclib.

Through the Group's innovation-oriented research and development, the indications covered by birociclib have been further expanded, enabling the drug to capture the emerging opportunities in the blue ocean market in China and globally, thereby providing more options for cancer treatment in the future and better benefiting patients worldwide. In addition, the latest excellent clinical results show that birociclib is now at a critical stage of development, with positive results in both monotherapy and combination therapy, reliable safety and efficacy, and significant clinical relevance and differential advantage. In the future, Sihuan Pharmaceutical is expected to explore the maximization of value of this major product. With the huge market space of breast cancer treatment sector and excellent product efficacy, the drug will be able to capture market share rapidly and contribute to the development of the Company at full speed.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, "In recent years, Sihuan Pharmaceutical has successfully transformed into a two-pronged business model of "Innovation + Medical Aesthetics". We have over 40 medical aesthetics products and over 50 innovative drugs, many of which have already entered the harvesting stage. This shows that the R&D and commercialization process of the Group's pipeline is progressing in an orderly manner, and the presentation of our major research results at the international stage means that our innovation capability has been widely recognized by international biopharmaceutical peers, and proves that the Company is growing in a more certain manner. In the future, driven by strong R&D capabilities and systematic competitive advantages, the Group will strive to become a company with excellent investment value and growth potential."

Currently, Xuanzhu Biopharm has over 10 products approved to conduct clinical trials, and over 10 drug candidates in the preclinical development stage. The pipeline layout is complete and balanced in long, medium, and short terms, with strong capability to innovate continuously, and another ALK/ROS1 dual-target inhibitor is also in phase III clinical trials. For biological drugs, KM501, a bispecific antibody drug conjugate, KM257, a bispecific antibody drug, and KM602, a CD80 fusion protein drug, have all entered phase I clinical trials.

In fact, Xuanzhu Biopharm has been making breakthroughs in breast cancer treatment in recent years and continues to deepen and expand its research scope, covering the whole range of breast cancer targets through self-development and product introduction, in order to capture the first-mover advantage in this specialized sector. Under the strategy of focusing on breast cancer treatment, clinical efficacy differentiation and R&D progress are the comparative advantages of Xuanzhu Biopharm, which also provide Sihuan Pharmaceutical with more drug development directions and a more extensive market.

Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, Sihuan Pharmaceutical Holdings Group Ltd. ("Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX: 0460) is an international medical aesthetic and biopharmaceutical company led and driven by innovation, with a leading independent production, and R&D technology platform, a rich global product pipeline and a mature and excellent sales system. Focusing on high-growth therapeutic areas such as medical aesthetics, oncology, metabolism, diabetes, cardiovascular and cerebrovascular, modern Chinese medicine and industrial hemp, it adheres to its overall strategic objective of "Adhering to the full-speed promotion of a two-wheeled strategy of Sihuan medical aesthetics and biopharmaceuticals" to build a leading medical aesthetics and biopharmaceutical company in China.

For more information about Sihuan Pharmaceutical, please visit the Company's website at

Topic: Press release summary
Source: Sihuan Pharmaceutical Holdings Group Ltd.

Sectors: BioTech, Healthcare & Pharm
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