Xuanzhu Biopharmaceutical Co. Ltd. (轩竹生物科技股份有限公司) (China)

The company is limited liability company established in the PRC on September 5, 2018, and converted into a joint stock company with limited liability on November 22, 2021, formerly known as Xuanzhu Biopharmaceutical Limited Liability Company. The company is listed in the Stock Exchange of Hong Kong on October 15, 2025 with Main Board.
The company and its subsidiaires are principally engaged in research, development and distributed the biopharmaceutical product in China. The company had over ten drug assets under active development covering digestive diseases, oncology and NASH. The company had successful developed of four drug candidates that were subsequently transferred and/or out-licensed to leading pharmaceutical companies.
HISTORY
2008 - The company commenced the operations through Shandong Xuanzhu.
The company initiated the business regarding the R D of innovative drugs and started to build up in-house small molecule drug R D platform.
2012 - Sihuan Pharm acquired the remaining equity interest in Shandong Xuanzhu and Shandong Xuanzhu became a wholly-owned subsidiary of Sihuan Pharm, mainly focusing on the R D of innovative drugs.
2013 - The company obtained the IND approval of KBP-3571 (Anaprazole Sodium) for its phase 1 clinical trial.
2017 - The company obtained the IND approval of XZP-3287 (Bireociclib).
2018 - The Company was established in Hainan Province, China and became the holding company of Group upon completion of the intra-group restructuring.
The company obtained the IND approval of XZP-3621.
2020 - The company commenced a phase 3 clinical trial of KBP-3571 (Anaprazole Sodium) for the treatment of DU in China.
The company accelerated the development of biological drug R D platform by acquiring the biologics business of Beijing Combio Pharmaceutical Inc.
2021 - The company completed the Series A and Series B Financings.
The company was converted into a joint stock limited company under the name of Xuanzhu Biopharmaceutical Co., Ltd.
The company commenced a phase 3 clinical trial of XZP-3287 (Bireociclib) in China in combination with fulvestrant in treating HR+/HER2-advanced BC.
The company obtained approval from the NMPA for conducting phase 3 clinical trial of XZP-3621 in China for the first-line treatment of patients with ALK-positive advanced NSCLC.
The company commenced a phase 3 clinical trial of XZP-3287 (Bireociclib) in China in combination with aromatase inhibitor in treating advanced HR+/HER2- BC.
2022 - The company commenced a phase 2 clinical trial of KBP-3571 (Anaprazole Sodium) for RE in adults in China.
The company entered into two out-licensing and collaboration agreements with Shanghai SPH New Asia Pharmaceutical Co., Ltd., to out-license certain patents and know-how owned by relating to KBP-5081, a Class 1 innovative benapenem candidate, and XZP-P803, a plazomicin candidate.

2023 - KBP-3571 (Anaprazole Sodium) obtained drug registration approval from the NMPA for the treatment of DU, becoming the first commercialized product, which was subsequently included in the NRDL.
The NDA applications of XZP-3287 (Bireociclib)'s monotherapy and combinational therapy with fulvestrant in the treatment of advanced BC were filed and accepted by the NMPA.
2024 - The NDA application of XZP-3621 in the first-line treatment of patients with ALK- positive advanced NSCLC was filed and accepted by the NMPA.
The company entered into an out-licensing and technology transfer agreement with Livzon Group Livzon Pharmaceutical Factory to grant certain patents, know-how and interests related to XZP-5849, a PDE5 inhibitor candidate.
2025 - The company obtained NDA approvals for XZP-3287 as a monotherapy and in combination with fulvestrant for HR+/HER2- advanced BC from the NMPA.
The NDA application of XZP-3287 in combination with aromatase inhibitor (AI) was filed and accepted by the NMPA.
The company received the NDA approval for XZP-3621 as the first-line treatment of patients with ALK-positive advanced NSCLC.