We are unafraid to face the biggest challenges in therapeutic innovation. With our robust pipeline that includes multiple assets with innovative mechanisms of action, we are daring to take on difficult-to-treat diseases. Diseases with low survival rates. Diseases with limited treatment options. Diseases where treatments are exorbitantly expensive. And we won’t rest until we can get innovative medicines into the hands of those who need them the most.
Indication:
KRAS-G12D inhibitor for advanced solid tumors harboring the KRAS 12D mutation1,2
Targeting the KRAS G12D mutant as potential therapy in cancer is urgently needed
KRAS protein is a small membrane-bound GTPase, acting as a switch for a multitude of cellular signaling functions
An inhibitor of KRAS, the most frequently mutated oncogene, which plays a predominant role in driving initiation and progression of cancers
Since KRAS G12D mutant exists in many cancer cell types, this program will evaluate patients with multiple advanced solid tumors, focusing on CRC, pancreatic cancer, and NSCLC
References: 1. Indini A, Rijavec E, Ghidini M, et al. Targeting KRAS in solid tumors: current challenges and future opportunities of novel KRAS inhibitors. Pharmaceutics. 2021;13(5):653. 2. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
A HER2 antibody-drug conjugate (ADC) molecule targeting tumor-specific antigen HER21
The role of HER2-targeted drugs in cancers other than breast and gastric remains unclear, emphasizing the need for ongoing research in these areas
A human epidermal growth factor receptor 2 (EGFR2; HER2; ErbB2)–targeting ADC, comprised of humanized anti-HER2 IgG1 monoclonal antibody and a DNA topoisomerase I inhibitor
Has demonstrated an anti-tumor effect in preclinical studies
With HER2 being over-expressed by many cancer cell types, SHR-A1811 is being evaluated in patients with HER2 expressing or mutated advanced solid tumors, with focus on breast cancer, gastric or gastroesophageal carcinoma, and non-squamous cell lung cancer
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
HER3-targeting antibody-drug conjugate (ADC) in advanced solid tumors1
The therapeutic potential of targeting the HER3 receptor has not been completely identified. There are currently no approved HER3-targeted therapies
A HER3; ErbB3–targeting ADC, comprised of fully humanized anti-HER3 IgG1 monoclonal antibody, an enzyme-cleavable linker, and a proprietary DNA topoisomerase I inhibitor
Has demonstrated a positive signal in preclinical studies
Currently being evaluated in patients with HER3-expressing advanced solid tumors, with focus on non-small cell lung, breast, colorectal, and head and neck cancers
Reference: 1. Data on file. Luzsana Biotechnology., 2022.
Indication:
A Nav 1.8 channel blocker for chemotherapy-induced peripheral neuropathy (CIPN)1,2
CIPN is regarded as one of the most common drug-induced neuropathies and has an increasing patient population with no approved therapies
A Nav 1.8 channel blocker developed for addressing management of chronic pain post-chemotherapy
Has shown efficacy in preclinical studies
Robust clinical development program for chronic pain indications
References: 1. Salat K. Chemotherapy-induced peripheral neuropathy: part 1—current state of knowledge and persepctives for pharmacotherapy. Pharmacol Rep. 2020;72(3):486-507. 2. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
Trop-2 targeting antibody-drug conjugate (ADC) for solid tumors that highly express Trop-21,2
The expression level of Trop-2 in a variety of tumor tissues is significantly higher than in normal tissues
An ADC comprised of a humanized anti–Trop-2 IgG1 monoclonal antibody, an enzyme-digestible linker, and a DNA topoisomerase I inhibitor
Demonstrated antitumor effect in pre-clinical studies with significant inhibition of several types of cancer cells
Currently being studied in patients with advanced solid tumors, specifically advanced lung, breast, and bladder cancers with a high rate of Trop-2 expression
References: 1. Zaman S, Jadid H, Denson AC, Gray JE. Targeting Trop-2 in solid tumors: future prospects. Onco Targets Ther. 2019;12:1781-1790. 2. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
Claudin 18.2 antibody-drug conjugate (ADC) for tumors over-expressing Claudin 18.21
It is estimated that 30% to 40% of patients with gastric and pancreatic cancers express the Claudin 18.2 protein. Currently, however, there are no approved treatments that target the novel Claudin 18.2 protein
An ADC comprised of a humanized anti-CLDN18.2 IgG1 monoclonal antibody, an enzyme-digestible linker, and a DNA topoisomerase I inhibitor
Preclinical studies demonstrated an antitumor effect
Currently being studied in patients with advanced solid tumors, specifically in advanced CLDN18.2+ gastric and pancreatic cancers
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
A thrombopoietin receptor (TPO-R) agonist for the treatment of chemotherapy-induced thrombocytopenia (CIT)1
There are currently no drugs approved in the US or EU for the treatment of CIT
An oral non-peptide TPO-R agonist that stimulates megakaryocyte proliferation and differentiation and promotes platelet production
Has demonstrated pharmacological activity in the preclinical setting and early phase 1 and 2 studies
Efficacy and safety are currently being evaluated in a placebo-controlled, phase 3 study (CIT-301) for CIT in the United States and European Union
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
A PARP inhibitor in first-line metastatic castration-resistant prostate cancer (mCRPC)1
There are no approved PARP inhibitors for the treatment of mCRPC in the front-line setting
An inhibitor of human poly (ADP-ribose) polymerase (PARP) with demonstrated anti-tumor activity in preclinical studies
SHR-3162 + abiraterone + prednisone is being evaluated in a placebo-controlled, phase 3 study as first-line treatment for mCRPC
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
PD-1 inhibitor in advanced hepatocellular carcinoma (HCC)1
In the current treatment landscape of HCC, immunotherapy is still in its early stages compared to other tumors
Humanized anti-PD1 IgG4 monoclonal antibody with high affinity with human PD-1
43 studies have been initiated with camrelizumab as of May 2021
Granted orphan drug designation for the treatment of HCC by the FDA
A randomized, open-label, international, multicenter, phase 3 study of camrelizumab + rivoceranib vs sorafenib as first-line therapy in patients with advanced HCC is currently ongoing with final data readout anticipated later in 2022
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
An androgen receptor (AR) antagonist with potential to establish a new treatment modality in metastatic castration-resistant prostate cancer (mCRPC)1
In today’s treatment of high-risk localized prostate cancer, there are no approved AR antagonists in the neoadjuvant/adjuvant setting
A pure AR antagonist with strong antagonistic activity and no agonist activity on AR
In first-in-human phase 1/2 study for mCRPC, SHR-3680 was shown to be safe and well tolerated with encouraging anti-tumor activity
SHR-3680 + androgen deprivation therapy is being evaluated in a phase 3 study as a once-daily neoadjuvant/adjuvant treatment for patients with high-risk localized prostate cancer who are candidates for radical prostatectomy
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
Indication:
A new long-acting insulin option for Type 1 and 2 diabetes1
Despite insulin therapy developments in recent years, barriers remain for initiation and optimal maintenance in practice
A long-acting basal insulin with stable antidiabetic effect
Encouraging results from early-phase studies
Currently being evaluated in multiple phase 3 clinical studies for the treatment of both type 1 and type 2 diabetes
Reference: 1. Data on file. Luzsana Biotechnology, Inc., 2022.
*Oncology supportive care.
†Metabolics drug.
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