XuanZhu Pharma

What XuanZhu Pharma does

XuanZhu Pharma is a China-based, innovation-driven biopharmaceutical company founded in 2008 and listed on the Hong Kong Stock Exchange (02575.HK) in October 2025. It is the innovation drug flagship subsidiary of Sihuan Pharmaceutical Holdings Group (0460.HK) and operates three core technology platforms — a Small Molecule Drug R&D Platform, a Biologics R&D Platform (covering monoclonal antibodies, bispecific antibodies, bispecific ADCs, and fusion proteins, anchored by the proprietary Mab-Edit and Mebs-Ig platforms), and a Clinical Development Platform. The company has built a 20+ asset pipeline spanning digestive diseases, oncology, and NASH, with three NMPA-approved commercial products: Anaprazole Sodium Enteric-coated Tablets (安久卫®, China's first independently developed PPI, approved June 2023 and included in the National Reimbursement Drug List from January 2024), Bireociclib Tablets (轩悦宁®, a CDK2/4/6 inhibitor for HR+/HER2- breast cancer, dual-indication NMPA approval in May 2025 plus a first-line AI-combination indication in March 2026), and Dirozalkib Tablets (轩菲宁®, a next-generation ALK inhibitor for ALK-positive NSCLC, approved August 2025).

The company makes money through a hybrid model combining direct commercialization in China and out-licensing for international markets. In China, XuanZhu has built its own professional sales teams for digestive and oncology therapeutic areas, supplemented by distribution partnerships; all three products are or will be covered under China's National Medical Insurance Catalog. International revenue is generated via exclusive licensing and supply agreements, most notably the April 2026 deal with Boston Oncology covering Bireociclib and Dirozalkib across 20+ MENA countries (upfront plus cumulative milestone payments exceeding USD 100 million plus royalties on net sales), prior Eurasian Economic Union licensing for Bireociclib, and a 2022 deal with Shanghai Pharma Shangya Xinya for 百纳培南 and Plazomicin in Greater China (up to RMB 440 million in deal value plus tiered royalties). The company also conducts co-development collaborations, including a 2023 clinical partnership with Innovent Biologics combining KM501 (HER2 bispecific ADC) with Sintilimab.

Name

XuanZhu Pharma

Legal name

轩竹生物科技股份有限公司

Website

https://xuanzhubio.com

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

251–500 employees

Short description

XuanZhu Pharma is a Hong Kong-listed (02575.HK) Chinese biopharmaceutical company developing innovative small molecule and biologic drugs for digestive diseases, oncology, and NASH, with three NMPA-approved products and a 20+ asset pipeline.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industries

Gastroenterology Specialty Pharmaceuticals (HLAIACAE), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

Keywords

• Biopharmaceutical products
• Oncology drug development
• Digestive disease therapeutics
• Small molecule drugs
• Innovative pharmaceuticals

Headquarters

HQ city

Hebei

HQ country

China

HQ region

Asia

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Product Sales: Revenue from commercialized products including 安奈拉唑钠肠溶片 (Anaprazole), 吡洛西利片 (Bireociclib), and 地罗阿克片 (Dirozalkib). The company has established professional sales teams for digestive and oncology products.
2. Licensing and Milestone Payments: XuanZhu receives upfront payments and cumulative regulatory and commercial milestone payments exceeding USD 100 million from Boston Oncology for MENA region licensing of Bireociclib and Dirozalkib, plus royalty payments on net sales.
3. Technology Licensing: Licensing revenue from out-licensing products such as 百纳培南 (up to RMB 266M) and Plazomicin (up to RMB 174M) to Shanghai Pharma Shangya Xinya, plus gradient sales royalties.
4. Royalties and Supply Fees: Revenue from supplying products to licensees at agreed pricing for commercial development activities in licensed territories.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

XuanZhu Pharma is an innovation-driven Chinese biopharmaceutical company that develops, manufactures and commercializes novel drugs for digestive diseases, oncology, and NASH. It operates three core technology platforms (Small Molecule Drug R&D, Biologics R&D, and Clinical Development) supporting more than 20 pipeline assets, and has secured NMPA approvals for three Class 1 innovative drugs: Anaprazole Sodium Enteric-coated Tablets (a proton pump inhibitor), Bireociclib Tablets (a CDK4/6 inhibitor for HR+/HER2- breast cancer), and Dirozalkib Tablets (an ALK inhibitor for NSCLC).

Differentiator

Problem solved

Functional benefit

Brands

• 轩悦宁® (Xuanyuening®): Brand name for Bireociclib Tablets (吡洛西利片), China's first approved CDK2/4/6 inhibitor for HR+/HER2- advanced breast cancer.
• 轩菲宁® (Xuanfeining®)
• 安久卫® (Anjiuv®)

Products and services

• Anaprazole Sodium Enteric-coated Tablets (安奈拉唑钠肠溶片, brand 安久卫®) A novel proton pump inhibitor with only 3.5% CYP2C19 metabolism, reducing drug-drug interactions and offering improved efficacy for patients with acid-related digestive diseases such as duodenal ulcers.
• Bireociclib Tablets (吡洛西利片, brand 轩悦宁®) A CDK4/6 inhibitor (XZP-3287) for HR+/HER2- advanced breast cancer, China's first and only single-agent late-line CDK4/6 inhibitor with CNS penetration capability and improved efficacy for endocrine-resistant and brain metastasis patients.
• Dirozalkib Tablets (地罗阿克片, brand 轩菲宁®) A next-generation ALK inhibitor (XZP-3621) with strong inhibition of resistance mutations including G1202R and I1171N, addressing unmet needs in ALK-positive NSCLC patients who develop resistance to first/second-generation inhibitors.
• KM501 (HER2 Bispecific ADC) A HER2 bispecific epitope bispecific antibody ADC drug candidate under Phase I clinical development for HER2-positive/mutated solid tumors, with potential best-in-class characteristics.
• KM602 (CD80 Fc Fusion Protein) China's first CD80 Fc fusion protein candidate under Phase I clinical development, functioning as an immune activator for advanced solid tumors.
• XZP-5610 A NASH pipeline drug candidate under Phase I clinical development for treatment of non-alcoholic steatohepatitis.
• XZP-6019 A NASH pipeline drug candidate in IND-stage development for non-alcoholic steatohepatitis.
• 百纳培南 (Bainanapinem) A self-developed Class 1.1 carbapenem antibiotic licensed to Shanghai Pharmaceuticals Shangya Xinya for development and commercialization in China (including Hong Kong, Macau, and Taiwan).
• Plazomicin An aminoglycoside derivative antibiotic out-licensed to Shanghai Pharmaceuticals Shangya Xinya for development and commercialization in China.

Quantifiable outcome

• Bireociclib single-agent: mPFS 11 months, OS 29 months in late-line HR+/HER2- breast cancer (BRIGHT-1 study)
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature7 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Boston Oncology CGT Holding Co. LimitedcoreChannel Partner/ Reseller/ Distributor · 9 April 2026Exclusive licensing and supply agreement for Bireociclib (吡洛西利片) and Dirozalkib (地罗阿克片) in Middle East and North Africa (MENA) region covering 20+ countries. XuanZhu receives upfront payment, cumulative milestone payments exceeding USD 100 million, and royalty payments on net sales. XuanZhu will supply products at agreed pricing for commercial development.
• Innovent Biologics (信达生物)coreStrategic or Co-development Partner · 28 December 2023Clinical research collaboration for KM501 (HER2 bispecific ADC) combined with Sintilimab (PD-1 inhibitor, marketed as Tyvyt). XuanZhu leads Phase Ib clinical study in China while Innovent provides Sintilimab for the combination therapy trial evaluating safety and preliminary efficacy in various solid tumors.
• Shanghai Pharma Shangya Xinya (上药新亚)coreChannel Partner/ Reseller/ Distributor · 16 June 2022Exclusive licensing agreement for 百纳培南 (carbapenem antibiotic) and Plazomicin (aminoglycoside derivative) in China region including Hong Kong, Macau, and Taiwan. Deal value up to RMB 266 million and RMB 174 million respectively plus gradient sales royalties. Rights include sublicensing, use, manufacturing, import, development, packaging, distribution, and sales.
• SignalChem LifesciencescoreStrategic or Co-development Partner · 1 November 2021Acquired exclusive rights for high-selectivity AXL inhibitor (XZB-0004/SLC-391) in Greater China. XZB-0004 is in Phase I clinical trial in China and is partnered with Merck overseas for Phase II trial in combination with PD-1 (Keytruda) for NSCLC and AML. The compound received FDA IND approval for 1b/2 phase trial.
• HB Therapeutics (USA)minorStrategic or Co-development Partner · 1 August 2021Joint development of protein degradation platform targeting three First-in-Class undruggable targets, expanding molecular glue pipeline through collaboration.
• Eurasian Economic Union PartnersminorChannel Partner/ Reseller/ DistributorExclusive licensing agreement for Bireociclib in Eurasian Economic Union five countries (previous separate agreement).

Scale indicators10 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Hutchmed (China) Limited: Hong Kong-listed Chinese biopharma developing innovative small molecule and biologic oncology drugs with global commercialization ambitions. Highly comparable in target therapies (oncology focus), HKEX listing status, and China-to-global commercialization strategy.
• BeiGene, Ltd. China-rooted global oncology biopharma with multiple approved drugs including Brukinsa and tislelizumab. Comparable as Chinese-origin innovative oncology drug developer with both domestic and international commercial operations.
• Innovent Biologics: Leading Chinese biologics innovator with approved PD-1 inhibitor sintilimab (Tyvyt). XuanZhu is an active clinical development partner with Innovent (KM501 + sintilimab combination trial), and both compete in the same innovative oncology biologics space.
• Akeso, Inc. Hong Kong-listed Chinese biopharma specializing in bispecific antibodies and immuno-oncology. Comparable as Chinese innovative biologics developer with HKEX listing and similar bispecific ADC/fusion protein technology focus.
• Cstone Pharmaceuticals: Hong Kong-listed Chinese biopharma focused on immuno-oncology and targeted therapies. Comparable in oncology focus, HKEX listing, and China-domestic commercialization strategy.
• Junshi Biosciences: Shanghai-headquartered biopharma with multiple approved oncology products including toripalimab (PD-1). Comparable as innovative Chinese biopharma with approved commercial products and licensing partnerships for international expansion.
• Hansoh Pharmaceutical Group: Hong Kong-listed leading Chinese innovative pharma with broad oncology, CNS, and specialty pipeline. Comparable in focus on innovative small molecule and biologic drugs with NRDL-included commercial products.
• Livzon Pharmaceutical Group: Major Chinese pharmaceutical company that has licensed a PDE5 inhibitor candidate from XuanZhu. Comparable as innovative Chinese pharma with digestive and specialty therapeutic areas, and has in-licensed XuanZhu assets.

Broad incumbents

• Shanghai Pharmaceuticals Holding: China's largest pharmaceutical distributor and one of the top pharma groups. Subsidiary Shanghai Pharma Shangya Xinya has exclusive licensing agreements with XuanZhu for two products, making it both a partner and broad-market comparable in China's pharma ecosystem.
• Jiangsu Hengrui Pharmaceuticals: China's largest innovative pharma company with broad oncology, anesthesia, and specialty drug portfolios. Comparable as a dominant Chinese innovative pharma with NRDL-included products, though much larger and more diversified than XuanZhu.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries4 records

Funding overview

Funding rounds2 records

Investors14 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about XuanZhu Pharma