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NDA/BLA

Drug

Target

Modality

Discovery

Preclinical

IND-enabling

Phase 1

Phase 2

Phase 3

 Immuno-Oncology

PD-L1

mAb

PD-L1 x CTLA-4

STING

TGFBR

BsAb

Agonist

Inhib

EGFR

mAb*

HER2

ADC

TROP2

ADC

VEGFR2

 Targeted Oncology

CLDN 18.2

ADC

Inhib

RET

AXL

Inhib

Inhib

A2A/A2BR

SHP2

Inhib

Non-Oncology

mAb*

Agonist

KOR

JAK1/2

HBV CAM

Inhib

FXIa

Inhib

FXIa

mAb

PPAR

Inhib

TSLP

Inhib

*Biosimilar

mAb

LAG-3

mAb

A167
A289
A337
A140
A166
SKB264
A168
SKB315
A336

A167

A167 is a monoclonal antibody targeting PD-L1. Currently, the BLA has been filed to NMPA in China for two solid tumor indications. Combo studies are also being planned.

A289

A289 is a monoclonal antibody targeting LAG-3. Preclinical studies showed that the drug was well tolerated and demonstrated efficacy as monotherapy and in combination with ICI. Phase 1 dose-escalation study is ongoing in China, with combo studies being planned.

A337

A337 is a bispecific antibody targeting PD-L1 and CTLA-4. The affinities of both arms were modified to improve safety, while preclinical studies showed higher antitumor activity compared to anti-PD-L1 or anti-CTLA-4 alone. Phase 1 dose-escalation study is ongoing in China, with combo studies being planned. 

A296 

A296 is a non-CDN small molecule agonist of Stimulator of Interferon Genes (STING). Preclinical studies showed promising induction of innate anti-tumor immune response. Phase 1 study is planned to be initiated in China in Q2 2022.

A435

A435 is a small molecule inhibitor targeting Transforming Growth Factor β (TGFβ). Preclinical studies showed promising anti-tumor activity in various mouse models as monotherapy and in combo with ICI.

A295

A295 is a small molecule dual inhibitor of adenosine receptors A2AR and A2BR. Preclinical studies showed good anti-tumor activity in various mouse models, especially in combination with chemotherapy. 

A140

A140 is a monoclonal antibody targeting epidermal growth factor receptor (EGFR) in development as a cetuximab biosimilar. Preclinical and clinical studies showed comparability to reference product Erbitux. Phase 3 study is current recruiting patients in China. 

A166

A166 is a third-generation antibody-drug conjugate (ADC) that incorporates an anti-HER2 antibody conjugated to highly potent auristatin-based payload, via site-specific conjugation and cleavable Val-Cit linker. Phase 1 studies in the US and China showed promising response in breast cancer patients and a favorable safety profile. Phase 2 pivotal study is ongoing in China. 

SKB264

SKB264 is a third-generation antibody-drug conjugate (ADC) that incorporates an anti-TROP2 antibody conjugated to highly potent topoisomerase I inhibitor, via site-specific conjugation and highly stable linker. Phase 2 studies are planned for the US and China, recruiting patients with locally advanced and/or metastatic solid tumors and refractory to available therapies. Based on preclinical and Phase 1 studies, SKB264 demonstrated promising efficacy in various solid tumors with improved safety profile compared to other TROP2 ADCs.

SKB315

SKB315 is a third-generation antibody-drug conjugate (ADC) that incorporates an anti-Claudin 18.2 antibody conjugated to highly potent topoisomerase I inhibitor, via site-specific conjugation and highly stable linker. Preclinical studies showed promising anti-tumor activity in various solids tumors overexpressing Claudin 18.2. Phase 1 study is ongoing in China. 

A168

A168 is a monoclonal antibody targeting vascular endothelial growth factor receptor 2 (VEGFR2) that was in development as a biosimilar. Preclinical studies showed comparability to reference product Cyramza. A Phase 1 study in China has been completed. 

A400

A400 is a small molecule inhibitor of Rearranged during Transfection (RET) fusions in development to treat various solid tumors. Preclinical studies showed comparable efficacy to approved RET inhibitors in various RET-mutated tumor mouse models. Phase 1a study is ongoing in China. 

A416

A416 is a small molecule inhibitor targeting receptor tyrosine kinase AXL. Preclinical studies showed good anti-tumor activity in various solid tumors. IND-enabling studies are currently underway.

A380

A380 is a small molecule inhibitor of Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2) in development to treat various solid tumors. Preclinical studies showed good anti-tumor activity in various solid tumors. IND-enabling studies are currently underway.

A277

A277 is a small molecule agonist of kappa opioid receptor (KOR) in development to treat chronic pain and pruritus. Preclinical and clinical studies showed significant reduction of post-op pain and severity of pruritus symptoms. Phase 2 study is ongoing in China for both indications.

A223

A223 is a small molecule dual inhibitor of JAK 1/2 in development to treat rheumatoid arthritis and related autoimmune disorders. Preclinical and clinical studies showed greater reduction of RA symptoms and better PK and safety profile compared with other JAK inhibitors. Phase 2 study is ongoing in China.

A204

A204 is a HBV capsid assembly modulator (CAM) that was in development to treat chronic Hepatitis B infection. Preclinical studies showed significant reductions in HBsAg and HBeAg in AAV-HBV mouse model. Phase 1a study showed favorable PK and safety profile in healthy volunteers.  

A336

A336 is a novel humanized antibody targeting Factor XI and FXIa in development to treat clotting disorders. Preclinical studies showed significant prevention of thromboembolism without major hemorrhagic adverse effects. Phase 1 dose-escalation study is ongoing in China. 

A186

A186 is a small molecule inhibitor of Factor XIa in development to treat clotting disorders. Preclinical studies showed significant reduction of thrombus formation in various AV-shunt animal models. IND is expected to be filed to NMPA in Q2 2022.

A278

A278 is a small molecule pan-PPAR inhibitor that was in development to treat Non-Alcoholic Steatohepatitis (NASH). Preclinical studies showed significant reduction of liver steatosis and fibrosis in MCD-induced NASH mouse model. IND-enabling studies have been completed. 

A157

A157 is a fusion protein agonist of thrombopoietin (TPO) that was in development as a biosimilar. Preclinical studies showed comparability to reference product Nplate. IND-enabling studies have been completed.

A378

A378 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP) for asthma and related respiratory diseases. Preclinical studies showed comparable efficacy to approved anti-TSLP therapies and favorable PK profile. IND has been filed in China. 

A296
A435
A295
A400
A416
A380
A277
A223
A204
A186
A278
A157
A378

©2023 by KLUS Pharma Inc.

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