On November 9, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 9, 2020, View Source [SID1234570387]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"We are excited to have US WorldMeds in full control of our SYMJEPI product now that the transition from Sandoz has been completed. We expect to see the full impact of this transition going forward and I expect 2021 to be the breakout year for this product. We and our commercial partner eagerly await the FDA’s decision on our ZIMHI NDA which has a target PDUFA date of November 15th. We remain very excited about the remainder of this year and beyond."

Product Updates

SYMJEPI (epinephrine) Injection

On July 1, 2020, Adamis’ new commercial partner, USWM began promoting SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products through its field sales force in the U.S. USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians. The transition of sales and distribution from Sandoz to USWM was completed on October 31, 2020 and now USWM is fully responsible for sales and distribution of SYMJEPI.

The company’s Australian partner, Emerge Health, which was acquired by Chiesi Farmaceutica in June, continues to work through the regulatory process with the Therapeutic Goods Administration (TGA) in Australia and the company expects a decision from the TGA sometime in the first half of 2021.

ZIMHI (naloxone) Injection

The FDA has provided a target action date (PDUFA) of November 15, 2020 with respect to the company’s resubmitted New Drug Application (NDA) relating to ZIMHI. The company continues to work with its commercial partner, as USWM prepares for the commercial launch of ZIMHI.

Tempol

Since licensing this product, the company has made some progress on the development of Tempol. Unfortunately, few therapies have been successful so far for the treatment of COVID-19. In preliminary results from a study in collaboration with Stanford University, Tempol inhibits the release of multiple cytokines from activated immune cells of COVID-19 patients. This new data now provides the additional scientific rationale needed to conduct clinical studies in early COVID-19 patients with Tempol. We are currently identifying sites that could conduct this trial. With the additional data from this study, the company continues to explore its options for government and other forms of funding to potentially support additional testing of Tempol.

Discussions with various groups continue to evolve on the funding and design of a large clinical study to examine the effects of Tempol for the treatment of radiation induced dermatitis. One of these groups, which was previously under the direction Dr. Stephen Hahn (current FDA commissioner), conducted successful clinical studies of Tempol for the treatment of radiation induced alopecia.

Drug Outsourcing Facility

Year to date, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the COVID-19 outbreak. Revenues decreased by approximately 21% for the nine months ended September 30, 2020, compared to the same period in the prior year.

Third Quarter Financial Results

Revenues were approximately $4.3 million and $5.9 million for the three months ended September 30, 2020 and 2019, respectively. This decrease in revenues of approximately 27% year over year was primarily due to the COVID-19 pandemic which has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians’ offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC’s customers for certain of USC’s products.

Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were approximately $5.8 million and $5.3 million, respectively.

Research and development expenses were approximately $1.7 million and $3.3 million for the three months ended September 30, 2020 and 2019, respectively. The decrease was primarily due to completing work on ZIMHI and a decrease in development costs of our other product candidates.

Cash and equivalents at the end of the third quarter was approximately $12.4 million. This amount includes proceeds from an equity offering completed in September which provided net proceeds of approximately $10.7 million.

Targeted Milestones

●FDA approval and U.S. commercial launch of ZIMHI;
●Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
●Ex-US partnerships for SYMJEPI and ZIMHI.

Conference Call

Adamis will host a conference call and live webcast on Monday, November 9, 2020 at 2:00 pm Pacific Time to discuss its financial and operating results for the third quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-855-327-6838

TOLL/International Dial-in: 1-604-235-2082

Conference ID: 10011804

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on November 9, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 10011804.

On November 9, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the third quarter ended September 30, 2020 (Press release, TapImmune, NOV 9, 2020, View Source [SID1234570386]).

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"This quarter, our Company reached a significant milestone by initiating our first Marker-sponsored study—a Phase 2 trial of zelenoleucel or MT-401, our lead MultiTAA-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We have enrolled the first patient in the safety lead-in portion of the trial, and are in the process of scheduling the donor in order to manufacture the product."

Continued Mr. Hoang: "During this unprecedented time, we have made significant progress by enrolling additional clinical sites for our AML trial, advancing our manufacturing process, reducing production time by 50% and improving the potency of our MT-401 product, and entering the final phase of the construction of our new in-house cGMP manufacturing facility. I am extremely proud of the dedication and resolve that our team has shown during these challenging months. I want to acknowledge their hard work across the organization that went into achieving these milestones."

PROGRAM UPDATES

MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell Product Candidate for AML

Phase 2 AML Trial
The Company initiated the safety lead-in portion of its Phase 2 study of zelenoleucel (MT-401) in patients with acute myeloid leukemia (AML) following an allogeneic stem cell transplant in both the adjuvant and active disease settings. The Company anticipates treating the first patient by Q1 2021. The safety lead-in is expected to enroll a total of six patients: three of which will be treated with MT-401 manufactured with a legacy reagent, and the remaining three to be treated with study drug manufactured with a new reagent from an alternate supplier.

Marker has activated four clinical sites and is in the start-up phase with additional clinical sites to enroll patients for the safety lead-in portion of the AML trial. The Company has also received commitments from additional clinical sites to participate in the Phase 2 AML trial following the safety lead-in phase and anticipates activating a total of approximately 20 sites.

The study remains on partial clinical hold pending the review of final data and subsequent acceptance of certificates of analysis for the new reagent by the U.S. FDA. The Company received the remaining reagent from the alternate supplier in Q3 2020 and is currently conducting the comparability analyses between the previous and new reagents, as required by FDA. Marker intends to submit all required data to FDA by Q1 2021 to enable removal of the partial clinical hold.

Over the past year, the Company has continued to streamline and simplify the MT-401 manufacturing process. The technical improvements include a 50% reduction in manufacturing time, a 95% reduction in the number of required operator interventions, and significant improvement in the consistency and reproducibility of the manufacturing process, while yielding a significant increase in the number of T cells available for patient administration. The Company expects the new process to yield a measurably improved product, with superior T cell phenotype and antigen specificity as compared to the original process. The new process improvements have been updated in the CMC section of the IND and will be used for all patients in the Marker AML clinical trial.

BUSINESS UPDATES

Construction of the cGMP manufacturing facility has entered its final phase. The facility, located in Houston near the George Bush Intercontinental Airport, will be used to support the manufacture of study drug for Marker’s Phase 2 AML trial and for future hematological and solid tumor trials, in addition to the potential commercialization of any approved products. The construction is expected to be completed by year-end with clinical activities to be initiated in the first half of 2021.
THIRD QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance: At September 30, 2020, Marker had cash and cash equivalents of $27.0 million. The Company raised $2.2 million through the previously executed $30 million common stock purchase agreement with Aspire Capital Fund, LLC. The remaining $27.8 million available to Marker from Aspire Capital along with current cash available, funds operations into Q1 2022.

R&D Expenses: Research and development expenses were $4.8 million for the quarter ended September 30, 2020, compared to $3.1 million for the quarter ended September 30, 2019.

G&A Expenses: General and administrative expenses were $2.6 million for the quarter ended September 30, 2020, compared to $2.5 million for the quarter ended September 30, 2019.

Net Loss: Marker reported a net loss of $7.4 million for the quarter ended September 30, 2020, compared to a net loss of $5.5 million for the quarter ended September 30, 2019.

Conference Call and Webcast

The Company will host a webcast and conference call to discuss its third quarter 2020 financial results and provide a corporate update today at 5:00 PM EST.

The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics Third Quarter 2020 Earnings Call."

The archived webcast will be available for replay on the Marker website following the event.

On November 9, 2020 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the third quarter ended September 30, 2020 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, NOV 9, 2020, View Source [SID1234570385]).

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"A powerful current of progress propels our enterprise, as exemplified by the recent FDA acceptance for review of our NDA for avacopan for the treatment of ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We ready ourselves for the bright prospect of changing the treatment paradigm in ANCA vasculitis, while also pursuing the rest of our avacopan pipeline-in-a-drug strategy. To that end, we expect to announce topline data from avacopan in C3G by the end of this year, and we are also on track to start clinical development of avacopan in lupus nephritis and initiate a pivotal Phase III trial of avacopan in patients with severe hidradenitis suppurativa in 2021. Beyond that — let’s not forget — our orally-administered small molecule checkpoint inhibitor CCX559, designed to be a next generation cancer treatment, is also slated to enter the clinic in the first half of 2021."

Dr. Schall continued, "The marked progress that we have generated in recent quarters at ChemoCentryx continues to drive us toward our goal of becoming a fully-integrated company that provides new kinds of therapies for the most critical diseases. History shows that our unique discovery and development platform has generated not just avacopan but multiple drug candidates for the highest need indications. We will always follow where the science leads, continuing to focus on the areas of the greatest need and greatest promise for patients, and also with the greatest potential reward for our shareholders."

Key Highlights

In September, the FDA accepted for review the Company’s New Drug Application (NDA) for avacopan in the treatment of ANCA-associated vasculitis and set July 7, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date. The NDA included data from the global, Phase III ADVOCATE trial.
In November, the Company’s Kidney Health Alliance partner Vifor Fresenius Medical Care Renal Pharma announced that their marketing authorization application (MAA) for avacopan in the treatment of ANCA-associated vasculitis has been validated by the European Medicines Agency (EMA). Approval is expected in the second half of 2021.
The results of the Phase III ADVOCATE trial of avacopan for the treatment of ANCA-Associated Vasculitis were shared in oral presentations at Kidney Week 2020, the annual meeting of the American Society of Nephrology (ASN), and ACR Convergence 2020, the annual meeting of the American College of Rheumatology (ACR).
In October, the Company announced topline data from the randomized, double-blind, placebo-controlled, multi-center Phase II AURORA clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS) in patients with moderate or severe disease. Avacopan at 30 mg BID demonstrated a statistically significant higher response than placebo in the pre-specified Hurley Stage III (severe) HS patients and the Company plans to advance avacopan into Phase III development for the treatment of severe HS.
The Company expects to announce topline data from the ACCOLADE trial of avacopan for patients with C3 Glomerulopathy (C3G) by year end 2020.
The Company remains on track to initiate clinical studies of avacopan in lupus nephritis and its orally administered checkpoint inhibitor, CCX559, for cancer in the first half of 2021.
Third Quarter 2020 Financial Results

Revenue was $5.1 million for the third quarter of 2020, compared to $10.6 million for the same period in 2019. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations under its alliance agreements. The decrease from 2019 to 2020 was primarily attributable to lower costs incurred in 2020 due to the completion of the avacopan ADVOCATE Phase III pivotal trial.

Research and development expenses were $18.6 million for the third quarter of 2020, compared to $18.1 million for the same period in 2019. The increase from 2019 to 2020 was primarily attributable to professional fees associated with the preparation of the NDA submission for avacopan for the treatment of ANCA vasculitis and higher research and drug discovery expenses, including those tied to the advancement of CCX559, the Company’s orally administered checkpoint inhibitor. These increases were partially offset by lower expenses due to the completion of the avacopan ADVOCATE Phase III pivotal trial and the CCX140 LUMINA-1 Phase II clinical trial in 2019.

General and administrative expenses were $10.4 million for the third quarter of 2020, compared to $6.1 million for the same period in 2019. The increase from 2019 to 2020 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the third quarter of 2020 was $24.1 million, compared to net loss of $12.9 million for the same period in 2019.

Total shares outstanding at September 30, 2020 were approximately 69.1 million shares.

Cash, cash equivalents and investments totaled $485.8 million at September 30, 2020 and the Company projects to end 2020 with cash and investments in excess of $460 million.

Conference Call and Webcast

The Company will host a conference call and webcast today, November 9, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 7147318. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On November 9, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2020 and recent company developments (Press release, TG Therapeutics, NOV 9, 2020, View Source [SID1234570384]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "This has been a very exciting few months for TG especially sharing the first ever data from the UNITY-CLL Phase 3 trial last week showing that the trial met its primary endpoint of improvement in progression-free survival, as well as data from the UNITY-NHL trial which supported our NDA submission for umbralisib monotherapy. These data sets add to the growing body of evidence suggesting that umbralisib has a differentiated safety profile and support our long-term vision of U2 as a potential backbone for future combination therapies." Mr. Weiss continued, "With PDUFA goal dates in February 2021 and June 2021 now set for our umbralisib NDA for the treatment of relapsed/refractory MZL and FL, respectively, our team is hard at work ensuring we are prepared for a successful launch in these indications. With a healthy balance sheet which includes a proforma cash position of approximately $325 million as of September 30, 2020, we are focused on preparing a BLA/NDA submission for U2 in CLL and importantly delivering on our remaining milestones for the year including topline results from our ULTIMATE I & II Phase 3 trials of ublituximab in MS."

Recent Developments and Highlights

ASH 2020 Presentations:
• Four abstracts have been accepted for presentation at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held virtually December 5 – 8, 2020, including:
• Results from the UNITY-NHL Phase 2 marginal zone lymphoma (MZL) and follicular lymphoma (FL) umbralisib monotherapy cohorts
• Results from the UNITY-CLL Phase 3 trial evaluating the combination of umbralisib and ublituximab (U2) in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL)
• Two triple therapy presentations, one evaluating the combination of U2 plus venetoclax in CLL, and a another evaluating the combination of U2 plus TG-1701, our BTK inhibitor, in patients with B-cell malignancies
• Abstracts were made available last week and a call was held with leading investigators from our trials to review the data included in these abstracts. A replay from this call is available on our corporate website at View Source

UNITY-NHL: Umbralisib Monotherapy Marginal Zone Lymphoma & Follicular Lymphoma Cohorts
• In July 2020, we announced the publication of preclinical data describing the unique immunomodulatory effects of umbralisib in Blood Advances, a Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).
• In August 2020, the U.S Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for umbralisib as a treatment for patients with previously treated MZL and FL. The NDA was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021.

UNITY-CLL: Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia
• In October, the FDA granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL, which could potentially expedite the development and regulatory review of U2. The application for Fast Track was based on data from the UNITY-CLL Phase 3 Study.

Key Objectives for Remainder of 2020 and Early 2021

Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis
Present full data from the UNITY-CLL Phase 3 trial and from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at ASH (Free ASH Whitepaper) 2020 as well as data from our triple therapy combinations of U2 plus venetoclax and U2 plus 1701, our BTK inhibitor
Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
Complete enrollment in ULTRA-V Phase 2b trial
Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801

Financial Results for the Three and Nine Months Ended September 30, 2020

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $45.8 million and $114.8 million for the three and nine months ended September 30, 2020, respectively, compared to $56.5 million and $118.8 million for the three and nine months ended September 30, 2019, respectively. The decrease in R&D is primarily attributable to a decrease in manufacturing costs for ublituximab and umbralisib, offset by an increase in milestone payments made during the three and nine months ended September 30, 2020. We expect our R&D expenses to decrease during the remainder of 2020 as costs associated with our main pivotal clinical trials continue to decline, partially offset by expenses associated with the expected NDA/BLA filing for U2 in CLL.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $11.6 million and $25.4 million for the three and nine months ended September 30 2020, respectively, as compared to $2.3 million and $6.6 million for the three and nine months ended September 30, 2019, respectively. The increase in other G&A expenses is primarily due to increased personnel and other general and administrative costs, associated with preparations for a potential commercial launch. We expect G&A expenses to increase modestly during the remainder of 2020 in preparation for potential launch.

Net Loss: Net loss was $87.2 million and $191.2 million for the three and nine months ended September 30, 2020, respectively, compared to a net loss of $61.9 million and $133.3 million for the three and nine months ended September 30, 2019, respectively. The net loss for the nine months ended September 30, 2020 included approximately $15 million of one-time milestone expenses related to our license agreements. Excluding non-cash compensation, the net loss for the three and nine months ended September 30, 2020 was approximately $58.8 million and $144.4 million, respectively, compared to a net loss of $59.9 million and $127.6 million for the three and nine months ended September 30, 2019, respectively.

Cash Position and Financial Guidance: Cash and cash equivalents were $254.2 million as of September 30, 2020. Pro forma cash, cash equivalents and investment securities as of September 30, 2020 are approximately $328 million, after giving effect to $74.0 million of net proceeds from the utilization of the Company’s ATM sales facility during the fourth quarter of 2020. The Company believes its cash and cash equivalents on hand as of September 30, 2020, along with the additional capital raised in the fourth quarter of 2020, will be sufficient to fund the Company’s planned operations well into 2022.

On November 9, 2020 EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) reported that the Biologics License Application (BLA) for QARZIBA▼ (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA) for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease (Press release, BeiGene, NOV 9, 2020, View Source [SID1234570383]). High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.

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"Dinutuximab beta represents an important biologic, which is already available to patients with high-risk neuroblastoma in Europe," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "For pediatric patients fighting this disease in China, we are hopeful that dinutuximab beta will soon be available as a new treatment option. Our collaboration with EUSA and the progress thus far demonstrate our joint commitment to bringing high-quality therapies to the people who need them."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "This milestone brings us and BeiGene closer to delivering on our promise of bringing innovative cancer and rare disease therapies to patients around the world. We look forward to working with BeiGene and the NMPA to potentially make dinutuximab beta available in China."

About QARZIBA▼ (dinutuximab beta)

QARZIBA▼ is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).