Product
Overview

NeuClone is developing a deep pipeline of analytically proven biosimilars across a range of indications, aimed at both developed and rest-of-world (RoW) markets.

 

The eight disclosed products we are developing in partnership with Serum Institute of India represent a combined global market of over $60 billion.

 

Below are the reference product details of these eight biosimilars.

Herceptin

INN name

Trastuzumab

 

Reference Product Indications

HER2 overexpressing breast and gastric cancer.

 

Mechanism of Action

HER2/neu receptor antagonist

 

Global Sales (USD)

2020: $4.0 billion

 

Patient Numbers

Roughly 20% of breast and gastric cancers are HER2-positive[11][12]. Breast cancer is the second most common cancer in the world with approximately 1.7 million new cases diagnosed per year.[13]

 

Development Status

Phase I clinical trial completed. All primary and secondary endpoints successfully achieved.

Preclinical analytical and toxicokinetic studies demonstrated high biosimilarity.

Stelara

INN name

Ustekinumab

 

Reference Product Indications

Plaque psoriasis

Psoriatic arthritis

Crohn’s disease

Ulcerative colitis

 

Mechanism of Action

IL-12 and IL-23 antagonist

 

Global Sales (USD)

2020: $8.0 billion

 

Patient Numbers

The prevalence of psoriasis is between 1.5% and 5% in most developed countries.[14] 7.4 million adults in the U.S. live with psoriasis.[15]

 

Development Status

Phase I clinical trial in progress. All subjects have received dosing.

Preclinical analytical and toxicokinetic studies demonstrated high biosimilarity.

Prolia/XGEVA

INN name

Denosumab

 

Reference Product Indications

Increasing bone mass in osteoporosis

Treatment-induced bone loss

Multiple myeloma and solid tumour metastases to bone

Giant cell tumour of bone

Hypercalcemia of malignancy

 

Mechanism of Action

RANK ligand inhibitor

 

Global Sales (USD)

2020: $5.1 billion

2024E: $6.0 billion[20]

 

Patient Numbers

Over 200 million people worldwide suffer from osteoporosis.[19]

 

Development Status

Process development and scale-up activities in progress.

Synagis

INN name

Palivizumab

 

Reference Product Indications

Prevention of lower respiratory tract disease in premature babies and other infants at risk of RSV infection

 

Mechanism of Action

RSV protein F glycoprotein inhibitor

 

Global Sales (USD)

2020: $1.1 billion

 

Patient Numbers

RSV causes roughly 34 million cases of acute respiratory illness in children under 5 years of age globally.[18]

 

Development Status

Process development and scale-up activities in progress.

Perjeta

INN name

Pertuzumab

 

Reference Product Indications

HER2-positive metastatic and early breast cancer. Approved for use in combination with trastuzumab.

 

Mechanism of Action

HER2 (subdomain II)

 

Global Sales (USD)

2020: $4.2 billion

2024E: $5.9 billion[20]

 

Patient Numbers

Roughly 20% of breast cancers are HER2-positive[12]. Breast cancer is the second most common cancer in the world with approximately 1.7 million new cases diagnosed per year [13].

 

Development Status

Process development and scale-up activities in progress.

Opdivo

INN name

Nivolumab

 

Reference Product Indications

Ten oncology indications including melanoma, lung cancer and renal cell carcinoma.

 

Mechanism of Action

Programmed death receptor-1 (PD-1)-blocking antibody.

 

Global Sales (USD)

2020: $7.9 billion

2024E: $10.5 billion [22]

 

Patient Numbers

There were approximately 2 million new cases of lung cancer and 300,000 new cases of melanoma worldwide in 2018 [23],[24]

 

Development Status

Process development and scale-up activities in progress.

Keytruda

INN name

Pembrolizumab

 

Reference Product Indications

Over ten oncology indications including melanoma, lung cancer and renal cell carcinoma.

 

Mechanism of Action

Programmed death receptor-1 (PD-1)-blocking antibody.

 

Global Sales (USD)

2020: $14.4 billion

2024E: $22.3 billion [22]

 

Patient Numbers

There were approximately 2 million new cases of lung cancer and 300,000 new cases of melanoma worldwide in 2018 [23],[24]

 

Development Status

Process development and scale-up activities in progress.

Humira

INN name

Adalimumab

 

Reference Product Indications

Rheumatoid arthritis

Juvenile idiopathic arthritis

Psoriatic arthritis

Ankylosing spondylitis

Crohn’s disease

Ulcerative colitis

Plaque psoriasis

Hidradenitis suppurativa

Uveitis

 

Mechanism of Action

TNF-α blocker

 

Global Sales (USD)

2020: $20.4 billion

 

Patient Numbers

The global prevalence of Rheumatoid Arthritis is roughly 17 million.[16] Inflammatory bowel disease (comprising ulcerative colitis and Crohn’s disease) affects over 1.6 million people in the U.S. alone.[17]

 

Development Status

Selection of clone with potential to achieve >3 g/L titre.

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