About us
Company profile

Rooted in China with global vision

Very few domestic high-tech biomedical technology enterprises with the development, industrialization and commercialization ability of small molecular chemical drugs and macromolecular biological drug

In 2012, after Sihuan wholly acquired 100% equity, XZenith became the innovative drug subsidiary of Sihuan Pharmaceutical, a large domestic pharmaceutical group. The company began operating independently in 2018. And in 2020, it won the A round of strategic investment of national funds such as Future Industry Investment Fund II and Metropolitan Industrial Investment Fund. At the beginning of 2021, acquisition and integration of Beijing Combio( macromolecular biological pharmaceutical company). The B round of financing was successfully completed at the end of the same year.

After 10 years of incubation and construction of the Sihuan, XZenith has formed a complete new drug research and development system, with a whole industrial chain platform from the source of new drug approval, design discovery, pre-clinical pharmacological efficacy evaluation, CMC process development and pilot scale amplification, clinical development, registration and application, to industrialization and commercialization. Focusing on oncology, digestion, NASH and other fields, and committed to the development of class 1.1  innovative drugs.

Marketing
Global IP
Comprehensive development capability to NDA from the early stage
Commercial production and sales capacity
  • Drug
    discovery
    Project approval evaluation

    Innovativeness

    Market demand

    Competitiveness

    Feasibility

    Risk control

     
    High throughput screening
    AI&Drug discovery
  • Validation /
    In vitro
    verification
    Biological mechanism study Enzymes and cell activity study
  • Preclinical
    development
    Efficacy evaluation
    Pharmacookinetic evaluation
    Toxicologic study
    Drug safety screening
    Pathology test
    Process development
  • Clinical
    development
    Phase I-III clinical
    Study and develop quality standards
    Post-marketing safety evaluation
  • Production
    Market
    Self-built small molecule and macromolecule production base
    Build a professional sales team in the field of digestion and oncology, combined with the distribution model, in order to quickly open the market
  • Drug
    discovery
    Project approval evaluation

    Innovativeness

    Market demand

    Competitiveness

    Feasibility

    Risk control

     
    High throughput screening
    AI&Drug discovery
  • Validation /
    In vitro
    verification
    Biological mechanism study Enzymes and cell activity study
  • Preclinical
    development
    Efficacy evaluation
    Pharmacookinetic evaluation
    Toxicologic study
    Drug safety screening
    Pathology test
    Process development
  • Clinical
    development
    Phase I-III clinical
    Study and develop quality standards
    Post-marketing safety evaluation
  • Production
    Market
    Self-built small molecule and macromolecule production base
    Build a professional sales team in the field of digestion and oncology, combined with the distribution model, in order to quickly open the market
Marketing
Global IP
Comprehensive development capability to NDA from the early stage
Commercial production and sales capacity
development history
Development History
2012

Sihuan pharmaceutical wholly-owned holding XZenith.

Benapenem has obtained phase I clinical approval documents.

2013

Two Class 1 innovative drugs have awarded the national major innovative drug innovation and technology Project.

Two Class 1 innovative drugs have obtained phase I clinical approval documents.

2014

Anaprazole Sodium initiates a phase I clinical trial.

2016

Intellectual property management system certification.

ISO9001 Quality Management System Certification.

Four Class 1 innovative drugs have obtained clinical approval documents.

2017

Birociclib has obtained clinical approval documents.

2018

Anaprazole Sodium and Benapenem have obtained phase II-III clinical

approval documents, and have started phase II clinical trial.

Birociclib initiates a phase II/III clinical trial.

XZP-3621 has obtained clinical approval documents.

Establish our own clinical development team.

2019

XZP-3621 initiates a phase I clinical trial.

2020

Anaprazole Sodium initiates a phase III clinical trial.

SDIC Investment Promotion led the investment in XZenith.

Open the biotech to biopharma conversion.

2021

Anaprazole Sodium submits NDA applications, and is accepted.

Birociclib (Combined with fulvestrant) initiates a phase III clinical trial.

XZP-3621 is approved for a Phase III clinical trial.

Three Class 1 innovative drugs have obtained clinical approval documents.

Two Class 1 innovative drugs initiate clinical trial.

Merger and acquisition and integration of biological pharmaceutical company Beijing Combio.

The potential unicorn company and China's digital medical new species company.

Sunshine Insurance Group led the investment in a Series B round of financing.

Start the construction of the production base of the Shijiazhuang headquarters.

2022

Anaprazole Sodium (the new indications) initiates a phase II clinical trial.

Birociclib (Combined with AI) initiates a phase III clinical trial.

XZP-3621 initiates phase II/III clinical trial.

Fulvestrant submits NDA applications.

Two Class 1 innovative drugs are approved for clinical trial.

Submit 1 IND applications.

Intellectual property management system certification.

For Bainapenem, we have reached an exclusive licensing cooperation with SPH.

2023

Anaprazole Sodium has been approved for marketing.

The results of Birociclib in Phase II study were presented at ASCO, and Phase III clinical study reached the primary endpoint.

Forbes China Unicorn Enterprise, China Unicorn Enterprise.

Hebei Province innovative small and medium-sized enterprise, Hebei Province science and technology small and medium-sized enterprise.

Three Class 1 innovative drugs are approved for clinical trial.

2012
2013
2014
2016
2017
2018
2019
2020
2021
2022
2023
Management team
Leadership Team
First-class international team led by senior experts in the industry
Yanjun XU
Chairman
CK.Shih
Chief Science Officer and Vice Chairman
Jiakui Li
General Manager of Shandong XZenith
Xiaodong Zhu
General Manager of Combio
  • Yanjun XU
    Chairman
  • CK.Shih
    Chief Science Officer and Vice Chairman
  • Jiakui Li
    General Manager of Shandong XZenith
  • Xiaodong Zhu
    General Manager of Combio
HONOR & QUALIFICATION
Honor and Qualification

XZenith has been committing to the development of class 1.1 innovative drugs and adhering to innovation driven. Undertaking corporate social responsibility, to boost the development of new drugs in China and  serve human health as its own responsibility.


Learn more
Industrial planning
Industry Chain
Cultural concept
Corporate Culture
  • Mission

    Innovation

    To boost the development of new drugs in China and serve human health

  • Vision

    Innovation leads the future

    Innovative pharmaceutical enterprises rooted in China and with a global vision

  • Values

    Innovation and responsibility

    Integrity and overcoming difficulties

    Preciseness and cooperation

  • Social Responsibility

    Promoting medical development
    Building up health attitudes
    Strengthening community construction