On May 19, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it plans to host a three-part key opinion leader (KOL) webcast series on its portfolio of investigational targeted therapies in hematology (Press release, Syros Pharmaceuticals, MAY 19, 2021, View Source [SID1234580241]). The series will consist of presentations from Syros leaders, as well as KOLs, who will review recent progress for SY-1425 in newly diagnosed higher-risk myelodysplastic syndrome (MDS) and newly diagnosed unfit acute myeloid leukemia (AML) and for SY-2101 in acute promyelocytic leukemia (APL), and discuss the unmet need and evolving treatment landscape in these diseases. Each event will be webcast live on Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following each presentation.

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The Targeted Hematology Portfolio KOL Webcast Series schedule will be as follows:

SY-1425 in Newly Diagnosed HR-MDS:

Date: Wednesday, May 26
Time: 8:30-10:00am ET
Guest Speaker: Amy DeZern, M.D., M.H.S., Director, Bone Marrow Failure and MDS Program and Associate Professor of Oncology, Johns Hopkins University
SY-1425 in Newly Diagnosed Unfit AML:

Date: Tuesday, June 22
Time: 8:30-10:00am ET
Guest Speaker: Daniel Pollyea, M.D., M.S., Associate Professor of Medicine, Clinical Director of Leukemia Services and Robert H. Allen MD Chair in Hematology Research, University of Colorado School of Medicine
SY-2101 in APL:

Date: Tuesday, July 20
Time: 8:30-10:00am ET
Guest Speaker: Farhad Ravandi, M.D., Janiece and Stephen A. Lasher Professor of Medicine, Chief of Section of Acute Myeloid Leukemia, Department of Leukemia at The University of Texas – MD Anderson Cancer Center

On May 19, 2021 Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported positive topline data from the GEMINI phase 1 study of its wholly owned product candidate, SLN124, in healthy volunteers (Press release, Silence Therapeutics, MAY 19, 2021, View Source [SID1234580240]). SLN124, an siRNA which targets TMPRSS6, is in development for the treatment of iron-loading anemia conditions, thalassemia and myelodysplastic syndrome (MDS).

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The GEMINI phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study evaluated the safety and tolerability of SLN124 (1.0, 3.0 and 4.5 mg/kg doses) in 24 healthy volunteers (18 active and 6 placebo). Pharmacokinetic parameters and pharmacodynamic biomarkers of iron metabolism were also measured to assess reduction in iron.

Initial data from the study showed all doses of SLN124 were generally well-tolerated with no serious or severe treatment emergent adverse events (TEAEs) or TEAEs leading to withdrawal. TEAEs did not appear to be dose dependent and the majority were mild, including transient injection site reactions which resolved without intervention.

Notably, up to an approximate four-fold increase in average hepcidin and 50% reduction in plasma iron levels were also observed after a single dose of SLN124. Effects on hepcidin and iron appear to be dose dependent and were still observed at the end of the 8-week study at all dose levels, indicating a sustained and long duration of action.

These clinical data support preclinical findings which demonstrated SLN124 effectively improved red blood cell production and reduced anemia by increasing levels of hepcidin – a key natural regulator of iron balance and distribution in the body. The Company expects to measure red blood cell production and effects on anemia in the ongoing GEMINI II phase 1 study of SLN124 in people with thalassemia and MDS, who unlike healthy volunteers have significantly elevated iron levels.

Mark Rothera, President and CEO of Silence Therapeutics, said: "These data represent the first clinical data from our mRNAi GOLD platform and underscore the promising potential for our technology to deliver precision medicines. We look forward to further data in patients anticipated from both of our wholly owned clinical programs later this year – the GEMINI II study of SLN124 for iron-loading anemia conditions and the APOLLO study of SLN360 for cardiovascular disease due to high lipoprotein(a)."

Giles Campion, M.D., EVP, Chief Medical Officer and Head of Research & Development of Silence Therapeutics, said: "Today’s results confirm the strong preclinical profile of SLN124 in humans – we observed excellent safety, robust gene knockdown expressed by up to an approximate four-fold increase in average hepcidin along with a 50% reduction in serum iron levels and a durable effect which lasted throughout the study. We are encouraged by these data in healthy volunteers and the opportunity for SLN124 to potentially address iron-loading anemia conditions such as thalassemia and MDS."

John Porter, M.D., Professor and Consultant Haematologist, Red Cell Disorders Unit, University College London and University of College London Hospitals, commented: "Despite advances in our understanding of thalassemia and MDS, there are no existing treatments that specifically target the underlying mechanisms of these conditions as a way to improve the degree of anemia. There is a major unmet need for a therapy that can provide safe and continuous control of iron balance and distribution as a way to improve the efficiency of red cell production. I’m encouraged by data from the SLN124 study in healthy volunteers and look forward to further clinical testing."

Silence expects to present full data from the GEMINI phase 1 study of SLN124 in healthy volunteers at an appropriate scientific meeting later this year. In addition, the Company plans to report data from the single-ascending dose portion of the ongoing GEMINI II phase 1 study of SLN124 in people with thalassemia and MDS in the second half of this year. SLN124 has Orphan Drug Designation for both conditions and rare pediatric disease designation for beta thalassemia.

About Thalassemia and Myelodysplastic Syndrome (MDS)
Thalassemia and MDS are both rare diseases that prevent a person from producing enough healthy red blood cells. Low levels of healthy red blood cells, known as anemia, result in less oxygen being delivered to different parts of the body. This can cause symptoms such as excessive tiredness and weakness. It can also lead to other serious health problems, such as heart disease. People living with thalassemia or MDS can also store too much iron in their bodies, leading to a phenomenon called ‘iron overload’, which damages organs such as the heart and liver.

Both conditions are typically treated with regular blood transfusions, which add to the problem of iron overload. Iron chelation therapy removes excess iron from the body using special medicines. While it helps reduce the amount of iron in the blood for people with thalassemia or MDS, it does not treat the underlying cause of the condition or stop it from progressing. There is, therefore, a need for therapies that directly address the biological drivers of disease.

About SLN124
SLN124 is a gene ‘silencing’ therapy – one that is designed to temporarily block a specific gene’s message that would otherwise trigger an unwanted effect. In this case, SLN124 aims to temporarily ‘silence’ TMPRSS6, a gene that prevents the liver from producing a particular hormone that controls iron levels in the body – hepcidin. As hepcidin increases, it is hoped that iron levels in the blood will decrease, which could in turn allow more healthy red blood cells to be produced, thereby improving anemia. In preclinical studies, SLN124 has shown positive effects on improving levels of red blood cells and reducing harmful iron levels.

SLN124 is now being studied in the GEMINI clinical trial program. GEMINI II is a phase 1 study to investigate the effects of SLN124 in people with thalassemia or myelodysplastic syndrome (MDS), whose bodies produce fewer healthy red blood cells than normal and who can store too much iron in their bodies. For more information on the GEMINI II study, please click here.

On May 19, 2021 Genmab A/S (Nasdaq: GMAB) reported that In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons (Press release, Genmab, MAY 19, 2021, View Source [SID1234580239]).

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The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab shares by the company’s managerial employees and their closely associated persons.

On May 19, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it launched an anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Press release, Chugai, MAY 19, 2021, View Source [SID1234580237]). Polivy had been approved by the Ministry of Health, Labour and Welfare (MHLW) on March 23, 2021 and was listed on the national health insurance (NHI) reimbursement price list today.

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"We are very pleased to launch Polivy as a new treatment for relapsed or refractory DLBCL," said Chugai’s President and CEO Dr. Osamu Okuda. "R/R DLBCL represents a high unmet medical need given the limited treatment options. We are committed to providing information in order to promote appropriate use of this first-in-class anti-CD79b antibody-drug conjugate (ADC) so that we may contribute to better treatment for patients."

The approval is based on data including the results from a multicenter overseas phase Ib/II clinical study (GO29365) that evaluated the efficacy and safety of Polivy in combination with bendamustine and rituximab (BR therapy) compared to BR therapy alone, and a multicenter, single-arm Japanese phase II study (JO40762/P-DRIVE study) that evaluated the efficacy and safety of Polivy in combination with BR therapy in R/R DLBCL.

A double-blind, placebo-controlled global phase III study (GO39942/POLARIX study) is ongoing for untreated DLBCL to examine the efficacy and safety of Polivy in combination with rituximab plus cyclophosphamide, doxorubicin, prednisolone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP).

[Reference information]
Chugai Obtains Approval for Polivy for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press release issued by Chugai on March 23, 2021)
View Source

Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese Phase II study for Relapsed or Refractory Diffuse Large B-cell Lymphoma (Press release issued by Chugai on February 13, 2020)
View Source

Approval information

Product name:
Polivy Intravenous Infusion 30 mg
Polivy Intravenous Infusion 140 mg

Generic name: polatuzumab vedotin (genetical recombination)

Intended uses or indications: Relapsed or refractory diffuse large B-cell lymphoma

Dosage and administration:
The usual adult dosage is 1.8 mg/kg (body weight) polatuzumab vedotin (genetical recombination) administered by intravenous infusion every 3 weeks for 6 doses, in combination with bendamustine hydrochloride and rituximab (genetical recombination). If the first infusion is well tolerated after 90 minutes, subsequent infusions may be administered over a shorter time of at least 30 minutes. Reduce the dose as necessary in accordance with the patient’s condition.

Date of approval: March 23, 2021

Date of NHI reimbursement price listing: May 19, 2021

Date of launch: May 19, 2021

Drug price:
Polivy Intravenous Infusion 30 mg JPY 298,825/vial
Polivy Intravenous Infusion 140 mg JPY 1,364,330/vial

About GO29365 study1)
GO29365 is a global, phase Ib/II study evaluating the safety and tolerability of Polivy in combination with bendamustine and rituximab (BR therapy) or obinutuzumab (BG therapy) in R/R follicular lymphoma or DLBCL. In the phase II randomized part of the study with 80 DLBCL patients, the efficacy and safety of Polivy in combination with BR therapy were studied compared to BR therapy alone. The primary endpoint was complete response at the point of primary response assessment as evaluated by an independent assessment committee using PET-CT. Patients received six cycles of treatment, spaced three weeks apart.

About JO40762 (P-DRIVE) study
JO40762 (P-DRIVE) is an open label, single-arm study investigating Polivy in combination with BR therapy in 35 patients with R/R DLBCL. Primary endpoint is investigator’s assessment of CRR by PET-CT at the timing of primary response assessment. Patients received six cycles of treatment, spaced three weeks apart.

About Polivy
Polatuzumab vedotin was developed by Roche using Seattle Genetics’ ADC technology. It is a first-in-class anti-CD79b antibody-drug conjugate (ADC), comprising the anti-CD79b humanized monoclonal antibody and a tubulin polymerization inhibitor attached together using a linker. The CD79b protein is expressed specifically in the majority of B-cells, making it a promising target for the development of new therapies2,3). Polatuzumab vedotin binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to suppress the effects on normal cells4,5). Polatuzumab vedotin was granted accelerated approval in the US in June 2019 and conditional marketing authorization in the EU in January 2020, respectively.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is one of the histologic subtypes of non-Hodgkin’s lymphoma (NHL), which is categorized as an aggressive disease that progresses on a monthly basis. DLBCL is the most common form of NHL, accounting for 30-40 percent of NHL, which is equivalent to about 23,000-32,000 patients6-10). DLBCL frequently occurs in middle-aged and older people, mainly in their 60’s11). The median age at diagnosis has been reported to be 6412).

The combination of rituximab and chemotherapy is the standard therapy for untreated DLBCL; however, recurrence has been observed in about 40% of patients due to insufficient therapeutic effect13). In addition, although autologous stem cell transplantation (ASCT) is recommended for eligible patients with recurrent or refractory DLBCL, ASCT cannot be performed in about half of these patients due to failure of salvage chemotherapy prior to ASCT14). Furthermore, no standard therapy has been established for patients ineligible for ASCT due to reasons including age or complications15). Therefore, more useful new treatment options for relapsed or refractory DLBCL are in great need.

Salvage chemotherapy: Salvage chemotherapy or salvage therapy is used to treat patients with hematologic malignancy who experienced no therapeutic effects (refractory), or recurrence/relapse of the disease. Applicable treatment may vary depending on the type of cancer. Combination therapies of multiple drugs including anticancer agents16) are generally used.

Trademarks used or mentioned in this release are protected by law.

On May 19, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review (Press release, BeiGene, MAY 19, 2021, View Source [SID1234580236]). The Prescription Drug User Fee Act (PDUFA) target action date is September 19, 2021.

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"This is our first regulatory submission in MZL, a serious disease diagnosed in more than 2,000 patients every year in the U.S., with no clear standard of care. In clinical trials, BRUKINSA has demonstrated promising efficacy and tolerability in MZL and presents a potential new option for MZL patients," said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. "We look forward to continuing our communications with the FDA in the coming months as we work on advancing the broad global development program for our potentially best-in-class BTK inhibitor."

Clinical data in the sNDA submission include results from the single-arm, open-label, multicenter, Phase 2 MAGNOLIA trial (NCT03846427) in patients with relapsed or refractory (R/R) MZL as presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, with supportive data from a global Phase 1/2 trial (NCT02343120) in patients with B-cell malignancies. The submission also includes pooled safety data from 847 patients with B-cell malignancies treated with BRUKINSA in seven clinical trials.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); and
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021).
To-date, more than 30 marketing authorization applications in multiple indications have been submitted outside of the United States and China, covering countries in the European Union and more than 20 other countries.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher bleeding events including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 2% of patients treated with BRUKINSA monotherapy. Bleeding events of any grade, including purpura and petechiae, occurred in 50% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 23% of patients treated with BRUKINSA monotherapy. The most common Grade 3 or higher infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%), and anemia (8%) based on laboratory measurements, were reported in patients treated with BRUKINSA monotherapy.

Monitor complete blood counts during treatment and treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 9% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was skin cancer (basal cell carcinoma and squamous cell carcinoma of skin), reported in 6% of patients. Advise patients to use sun protection.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter have occurred in 2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 0.6% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for at least 1 week after the last dose. Advise men to avoid fathering a child during treatment and for at least 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions in > 10% of patients who received BRUKINSA were neutrophil count decreased (53%), platelet count decreased (39%), upper respiratory tract infection (38%), white blood cell count decreased (30%), hemoglobin decreased (29%), rash (25%), bruising (23%), diarrhea (20%), cough (20%), musculoskeletal pain (19%), pneumonia (18%), urinary tract infection (13%), hematuria (12%), fatigue (11%), constipation (11%), and hemorrhage (10%). The most frequent serious adverse reactions were pneumonia (11%) and hemorrhage (5%).

Of the 118 patients with MCL treated with BRUKINSA, 8 (7%) patients discontinued treatment due to adverse reactions in the trials. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (3.4%). One (0.8%) patient experienced an adverse reaction leading to dose reduction (hepatitis B).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For co-administration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid co-administration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATION

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.