HONG KONG, Oct 17, 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 new drug application ("NDA") of Birociclib (XZP-3287, CDK4/6 inhibitor) ("Birociclib"), a class 1 innovative drug independently developed by the Group's non-wholly owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu Biopharm"), has been accepted by the National Medical Products Administration (the "NMPA") of China. Specifically, Birociclib is used as a single agent for the treatment of locally advanced or metastatic adult breast cancer patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (Her2) negative who have received two or more endocrine treatments and one chemotherapy treatment in the past metastatic stage and have disease progression.

Birociclib is the only CDK4/6 inhibitor in China that has conducted clinical research to verify the clinical efficacy of a single agent. For HR+/Her2- patients with locally advanced or metastatic breast cancer who have received two or more endocrine treatments and one or more chemotherapy in the metastatic stage and have disease progression, the ORR of Birociclib monotherapy assessed by the Independent Review Committee (IRC) was 30.0%, the median DoR was 14.78 months, the median PFS was 9.17 months, and the median OS was 29.01 months. Compared with monochemotherapy and novel antibody-drug conjugate ("ADC") drug therapy (ORR: 8.1%~21%; median PFS: 2.6~5.5 months; median OS: 8.0~17.8 months), it shows better treatment response rate, longer remission duration, progression free survival, and better overall survival, with better long-lasting treatment benefits. In addition, compared to intravenous chemotherapy drugs, Birociclib, as an oral drug, is safer, more convenient and more accessible for patients with advanced tumors.

Birociclib is an oral small molecule CDK4/6 inhibitor independently developed by Xuanzhu Biopharm. Based on innovative technology and design, Birociclib has good enzymatic inhibitory activity against CDK4 and CDK6, higher selectivity for CDK4, and good inhibitory effect on CDK2. In clinical research, Birociclib has shown significant anti-tumor effect. Both monotherapy and combinational therapy with endocrine have shown good effectiveness in patients with HR positive and Her2 negative advanced breast cancer, exhibiting good safety and tolerance, which can achieve continuous dosing. At present, the NDA application of Birociclib's monotherapy and combinational therapy with fulvestrant in the treatment of advanced breast cancer have both been accepted by NMPA.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, "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 https://www.sihuanpharm.com/

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