Global Rights

China-US-EU pipeline targeting global core markets

Pipeline Name
Indications
Preclinical
IND
Phase I clinical
Phase II clinical
Phase III clinical
NDA Application
Listed for sale
sbk002

sbk002 is a Class 1 innovative drug for the secondary prevention of atherosclerotic thrombotic events, such as in patients with myocardial infarction, ischemic stroke, or peripheral arterial disease. It demonstrates enhanced safety, reduced hepatic and renal burden, and minimized drug-drug interactions.

China: Accepted by the CDE in December 2025.
United States: sbk002 received FDA IND approval on February 1, 2025.
European Union: Plans to submit an MAA application to the EMA in 2026.

Acute Ischemic Stroke
Acute Coronary Syndrome
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK001

SBK001 is a Class 1 innovative drug with a novel compound structure for the treatment of acute lung injury (ALI) and expectoration. It improves clinical treatment safety, achieves better efficacy, and provides more treatment options for patients with respiratory diseases.

China: Phase II clinical trials have completed enrollment.
United States/European Union: Registration evaluation is currently underway.

Expectorant
Lung Injury
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK007

SBK007 is a Class 1 innovative drug with a novel compound structure, targeting two indications: treatment of acute urticaria in adults and relief of symptoms related to allergic rhinitis (seasonal and perennial). It is a new, highly effective third-generation antihistamine anti-allergy drug.


China: Phase I clinical trials for acute urticaria in adults have been completed, and Phase II clinical trials for seasonal allergic rhinitis have been initiated.
United States: Plans to submit an IND application to the FDA in 2026.

Acute Urticaria
Allergic Rhinitis
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK009

SBK009 can effectively inhibit ADP-induced platelet aggregation with favorable safety and tolerability, making it a promising new option for antiplatelet therapy.

China: SBK009 for injection has received clinical trial approval (IND) from the National Medical Products Administration (NMPA) for antiplatelet therapy during the perioperative period of PCI.
United States: Plans to submit an IND application to the FDA in 2026.

Emergency Treatment for Acute Coronary Syndrome
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK013

SBK013 is a Class 1 innovative drug with a novel compound structure, intended for the prevention of arterial and venous thromboembolic diseases. It aims to compete with existing anticoagulants by addressing the shortcomings of current treatment options and providing a more effective solution for the prevention and treatment of thrombotic diseases.


China: SBK013 received clinical trial approval (IND) from the National Medical Products Administration (NMPA) on March 6, 2025, with plans to submit an IND application for new indications in 2026.
United States: Plans to submit an IND application to the FDA in 2026.

Stroke
Thrombosis Prevention
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
China Rights

Five China-Exclusive Pipeline Products

Pipeline Name
Indications
Preclinical
IND
Phase I clinical
Phase II clinical
Phase III clinical
NDA Application
Listed for sale
SBK008

SBK008 is a Class 1 innovative drug with a novel compound structure. It effectively improves neurological deficits while significantly ameliorating cognitive dysfunction, making it a promising new option for the treatment of acute ischemic stroke.

Mild Ischemic Stroke
Moderate Ischemic Stroke
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK011

SBK011 is a diagnostic reagent specifically designed for the OGTT test. Its launch will successfully fill the gap in commercially available reagents in this field in China, providing a new solution for diabetes screening and diagnosis, and significantly enhancing the standardization and convenience of diabetes diagnosis and treatment.

Shibeikang plans to submit a New Drug Application (NDA) in 2026.

Blood glucose index testing
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK010

SBK010 is a Class 2 innovative drug with an improved formulation for the treatment of ischemic stroke. It demonstrates excellent therapeutic efficacy while significantly improving patient compliance.

 

Mild Ischemic Stroke
Moderate Ischemic Stroke
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK012

SBK012 is a Class 2 innovative drug with an improved formulation for the treatment of acute ischemic stroke. It has successfully overcome the limitations of existing medications, completed clinical trials with favorable data across all evaluation metrics.

Shibeikang plans to submit a New Drug Application (NDA) in 2026.

Mild Ischemic Stroke
Moderate Ischemic Stroke
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK014

SBK014 is an improved formulation designed to enhance medication compliance in pediatric patients or adult patients with dysphagia. It improves ease of swallowing, enhances taste, provides more precise dosing for pediatric patients requiring weight-based administration, and offers greater convenience.

Anti-infection
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SBK017

SBK017 is a Chemical Class 2 new drug, an improved formulation designed for patients with dysphagia.

Ischemic cardio-cerebrovascular disease caused by arteriosclerosis
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales
SHLQ  Syrup

SHLQ Syrup is an approved Class 2 chemical new drug (GYZZ H20240034) indicated for sedation and hypnosis in children prior to surgical examinations or procedures. As China's first commercially available pediatric-specific SHLQ Syrup formulation, it significantly improves medication safety and compliance in children.

 

SHLQ Syrup included in NRDL on Nov 28, 2024

Hypnosis
Anticonvulsant
Sedation for Examinations and Preoperative Procedures
Preclinical
IND
Phase I
Clinical
Phase II
Clinical
Phase III
Clinical
NDA
Application
Listed
Sales