On April 17, 2023 Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) reported that the U.S. Food and Drug Administration (FDA) has accepted the companies’ supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) with the KarMMa-3 study that investigated the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody (Press release, 2seventy bio, APR 17, 2023, View Source [SID1234630135]). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023. Data from KarMMa-3 were published in The New England Journal of Medicine on February 10, 2023.

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"Our continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "This FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients."

"Positive results from our Phase 3 KarMMa-3 study demonstrate a significant clinical benefit of Abecma across lines of care in triple-class exposed multiple myeloma," said Steve Bernstein, M.D., chief medical officer, 2seventy bio. "The acceptance of the sBLA brings us closer to expanding the benefits of Abecma to myeloma patients earlier in their treatment course."

Additional Regulatory Acceptances Granted to Bristol Myers Squibb

The European Medicines Agency (EMA) has also validated Bristol Myers Squibb’s Type II variation application for Abecma based on the KarMMa-3 study. Validation of the application confirms the submission is complete and begins the procedure and scientific assessment.

In addition, Japan’s Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Abecma based on the KarMMa-3 study.

"The KarMMa-3 study has shown the clear clinical benefit of Abecma over existing standard of care regimens and, if approved, the potential for this anti-BCMA CAR T cell therapy to become a standard of care earlier in the treatment course for relapsed and refractory multiple myeloma," said Adam Lenkowsky, senior vice president, head of Major Markets, Bristol Myers Squibb. "These global regulatory acceptances of BMS’ applications represent important additional progress across three regions with significant patient need in triple-class exposed multiple myeloma."

The three regulatory applications were based on interim results from the pivotal, Phase 3, open-label, global, randomized, controlled KarMMa-3 study evaluating Abecma compared with standard combination regimens. The study enrolled patients who were treated with an immunomodulatory agent, a proteasome inhibitor, and daratumumab, which are the most commonly used standard treatments in multiple myeloma. Growing use of daratumumab in frontline and early-line relapse has led to an increasing unmet need for patients following treatment with the three most common classes of antimyeloma agents, for whom there is no clear treatment paradigm and often very poor outcomes with current standards of care. Results of the KarMMa-3 study showed treatment with Abecma demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and overall response rate, and safety results were consistent with the well-established and generally predictable safety profile of Abecma. Based on results from KarMMa-3, Abecma is the first and only CAR T cell therapy to demonstrate superiority over standard regimens in a randomized, controlled Phase 3 trial designed to evaluate patients with triple-class exposed relapsed and refractory multiple myeloma.

Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding cytokine release syndrome, neurologic toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome and Prolonged Cytopenia. Abecma is also approved in the European Union, Switzerland, the United Kingdom, Japan, Canada, and Israel for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after three to four or more prior lines of therapy.

About KarMMa-3

KarMMa-3 (BB2121-MM-003, NCT03651128) is a pivotal, Phase 3, open-label, global, randomized, controlled trial evaluating Abecma compared to standard regimens in patients with relapsed and refractory multiple myeloma who have received two to four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and daratumumab and were refractory to the last treatment regimen. Patients were randomized to receive Abecma or standard regimens that consisted of combinations that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen by investigators based on their most recent treatment regimen. The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. Key secondary endpoints include overall response rate and overall survival.

About Abecma

Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.

The companies’ broad clinical development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS
WARNINGS AND PRECAUTIONS:

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA in 85% (108/127) of patients. Grade 3 or higher CRS occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 – 23 days) and the median duration of CRS was 7 days (range: 1 – 63 days). The most common manifestations included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache. Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Fifty four percent (68/127) of patients received tocilizumab (single dose: 35%; more than 1 dose: 18%). Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median time to resolution of 5 days (range: 1 – 61 days). The median duration of neurotoxicity was 6 days (range: 1 – 578) in all patients including 3 patients with ongoing neurotoxicity. Thirty-four patients with neurotoxicity had CRS with onset in 3 patients before, 29 patients during, and 2 patients after CRS. The most frequently reported manifestations of CAR T cell-associated neurotoxicity include encephalopathy, tremor, aphasia, and delirium. Grade 4 neurotoxicity and cerebral edema in 1 patient, Grade 3 myelitis, and Grade 3 parkinsonism have been reported with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient developed fatal multi-organ HLH/MAS with CRS and another patient developed fatal bronchopulmonary aspergillosis with contributory HLH/MAS. Three cases of Grade 2 HLH/MAS resolved. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4 – 9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care.

Viral Reactivation: CMV infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: In the clinical study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months.

Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support.

Hypogammaglobulinemia: Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

On April 17, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it has completed enrolment and treatment of patients for the Phase 2 clinical trial of its investigational anticancer product DEP cabazitaxel (Press release, Starpharma, APR 17, 2023, View Source;mc_eid=bf52dd3418 [SID1234630129]). Encouraging efficacy signals, including significant tumour shrinkage and substantial tumour biomarker reductions, have been observed in multiple cancer types, including prostate cancer, ovarian cancer, gastro-oesophageal cancer, cholangiocarcinoma and head and neck cancer, following treatment with DEP cabazitaxel.

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Developed by Starpharma, DEP cabazitaxel is a patented, dendrimer nanoparticle version of the chemotherapy drug, cabazitaxel, which is marketed as Jevtana and widely used in the treatment of prostate cancer. Unlike standard cabazitaxel, DEP cabazitaxel is highly water soluble, does not contain toxic detergent-like excipients associated with anaphylaxis, and avoids the need for patients to pre-medicate with steroids. DEP cabazitaxel is one of three clinical-stage anticancer products developed by Starpharma, with a fourth being clinically developed by Starpharma’s partner, AstraZeneca, and others in preclinical development.

In the Phase 2 trial of DEP cabazitaxel, a total of 76 patients were enrolled across sites in the United Kingdom and Australia, with the final patient having now completed treatment. In the latter part of the trial, patient enrolment was focused on certain hard-to-treat cancers, including platinum-resistant ovarian and gastro-oesophageal cancers where encouraging efficacy signals have been observed. Given the challenges faced by patients with these tumours and the advanced nature of their disease, multiple patients who were recruited into the trial subsequently failed clinical, laboratory or radiological screening, which impacted recruitment rates in the latter stage of the trial.

Starpharma previously reported preliminary results from the prostate cancer cohort of the Phase 2 trial of DEP cabazitaxel and presented these at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2022. As previously announced[1], DEP cabazitaxel showed multiple potential benefits for patients with metastatic Castration-Resistant Prostate Cancer (mCRPC), including longer progression-free survival (PFS) and a lower incidence of key side effects than conventional cabazitaxel (Jevtana). The median PFS for DEP cabazitaxel in this cohort was 3.9 months[2], which is more than 30% longer than the 2.9 months[3] reported for standard cabazitaxel. mCRPC patients treated with DEP cabazitaxel also experienced a lower incidence of severe (Grade 3 or 4) treatment-related adverse events (7.5%2), compared to published data on standard cabazitaxel (39.7%)3. No mCRPC patients experienced severe hypersensitivity reactions and patients were not required to have steroid pre-medication, in contrast to standard cabazitaxel. In addition, only two mCRPC patients required prophylactic G-CSF[4], which is commonly required in prostate cancer patients treated with Jevtana.

Having now completed dosing of patients in the DEP cabazitaxel trial, Starpharma and its specialist clinical research organisation are now focused on follow-up and finalising the patient data set and quality control processes. At this stage, Starpharma expects to report top-line results from the Phase 2 clinical trial of DEP cabazitaxel during Q3 CY23, following the final requisite data verification and review. In parallel, licensing activities and discussions for DEP cabazitaxel are ongoing as part of the Company’s DEP commercialisation strategy.

Dr Jackie Fairley, CEO of Starpharma, commented: "We are pleased to have completed enrolment and treatment of patients in Starpharma’s Phase 2 clinical trial of DEP cabazitaxel. DEP cabazitaxel demonstrated longer progression-free survival in the prostate cancer cohort as well as a lower incidence of key side effects in patients[5] in comparison with published data on standard cabazitaxel treatment. We look forward to reporting data from other patient cohorts.

"We would like to express our gratitude to the patients who participated in this trial, as well as our appreciation for the contributions made by our clinical investigators and the clinical teams. Thank you to all involved for your dedication to developing improved oncology medicines for patients."

In addition to this DEP cabazitaxel trial completing enrolment and treatment of patients, Starpharma’s Phase 2 monotherapy trials of DEP docetaxel and DEP irinotecan are in the final stages, with commercial discussions for these products also underway.

On April 17, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the initiation of an open-label Phase II trial evaluating eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II agonist, in combination with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting (Press release, Immutep, APR 17, 2023, View Source [SID1234630128]).

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The investigator-initiated study (EFTISARC-NEO) will be primarily funded by the Maria Skłodowska-Curie National Research Institute of Oncology with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. Immutep will provide efti at no cost as well as technical support. The trial will be led by Co-Principal Investigators, Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Skłodowska-Curie National Research Institute of Oncology.

Dr. Paweł Sobczuk, stated: "We are excited to begin this chemotherapy-free study combining radiotherapy with the novel immunotherapy, eftilagimod alpha, and pembrolizumab. Given efti’s synergistic effects with immune checkpoint inhibitors and its ability to arm, activate, and proliferate cytotoxic T cells with radiotherapy-induced cancer antigens, this combination has a strong foundation to drive effective immunity against soft tissue sarcoma, a rare and aggressive disease in immense need of new therapeutic approaches."

Efti’s targeting and unique activation of antigen-presenting cells (e.g., dendritic cells, monocytes) via MHC Class II molecules leads to broad adaptive and innate immunity to fight cancer, including proliferation of CD8+ cytotoxic T cells that can be armed with radiotherapy-induced tumour antigens. The combination of efti with radiotherapy and the anti-PD-1 therapy KEYTRUDA (pembrolizumab) has the potential to generate a robust anti-tumour immune response in the immunosuppressed tumour microenvironment (TME) of STS. This is the first time efti will be tested in the neoadjuvant setting, which importantly will provide access to tumour tissue prior to and after treatment, where the impact of this novel triple combination on the TME can be assessed.

Immutep CEO, Marc Voigt added: "Efti’s unique potential to help safely drive superior clinical efficacy for cancer patients, with and without the use of chemotherapy, is attracting increasing attention from industry and academia. We are delighted to see efti and pembrolizumab, which together have led to deep and durable responses in several difficult-to-treat advanced solid tumours, being combined with radiotherapy for the first time and hope this approach can make a difference for soft tissue sarcoma patients who have limited treatment options."

Soft tissue sarcoma (STS) represents a high unmet medical need with a poor prognosis for patients. The incidence of STS varies in different regions, with approximately 23,400 cases annually and a crude incidence of 4.7 per 100,000 in Europe, according to the RARECARE project. In the United States, the number of new STS cases is estimated to be 13,400 annually with 5,140 deaths, according to the American Cancer Society.

The dosing of the first patient is anticipated in the first half of calendar year 2023.

On April 17, 2023 Patrys reported that its deoxymab platform has been further strengthened by the granting of two new patents by the US Patent and Trademark Organisation (US PTO), providing expanded intellectual property protection until 2039 (Press release, Patrys, APR 16, 2023, View Source [SID1234630168]).

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The first patent, co-filed with Yale University, is the first US patent to be granted specifically for PAT-DX1 and PAT-DX3, the humanised forms of the original 3E10 antibody. The second patent covers the combination of deoxymabs with nanocarriers that can potentially provide a powerful new approach for treating cancer.

Patrys’ CEO and Managing Director, Dr James Campbell said:

"The granting of these two patents provides Patrys with robust intellectual property covering both the humanised form of the antibody and its conjugated form. The Company has multiple patents granted in the United States and other major jurisdictions which cover a broad range of applications for using deoxymabs to treat cancer and deliver therapeutic payloads. As well as expanding Patrys’ patent estate, these new patents provide the intellectual property coverage to enable the Company or potential partners or licensees to invest in development programs for these applications.

On April 16, 2023 As a global innovative biopharmaceutical company, Henlius reported that it is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 5 products launched in China (Press release, Henlius Biopharmaceuticals, APR 16, 2023, View Source [SID1234630134]). Leveraging the differentiated competitive edges of its products, Henlius adopts meticulous management model and precise market strategies to optimize the commercialization layout and further extend its market reach. In the first quarter of 2023, Henlius’revenue climbed 97.2% to RMB995.7 million. With expanding sales of its flagship products including HANQUYOU and HANSIZHUANG, the company has shown continous revenue growth.

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HANQUYOU Continues to Soar

In the first quarter of 2023, Henlius’ core anti-tumour product HANQUYOU (trastuzumab, trade name in Europe: Zercepac, trade name in Australia: Tuzucip and Trastucip) extended its strong momentum, soaring by 66.7%, to RMB538.6 million.

HANQUYOU, indicated for the treatment of HER2-positive breast cancer and gastric cancer, is the first product sold and promoted in Chinese mainland by the company’s in-house commercialisation team. The 150mg/60mg dual dosage and preservative-free formulation of HANQUYOU sets it apart, leading clinical practices and providing a personalized and cost-effective treatment option for breast cancer patients of any weight. In 2022, the 24,000L production capacity of Songjiang First Plant was approved to commence the commercial production of HANQUYOU, being a driving force behind the production increase and the accerlerated commercialisation of HANQUYOU. Furthermore, Henlius continues to expand the sales network of HANQUYOU. As at the end of 2022, the copany had more than 550 sales agents for HANQUYOU, with the goal of penetrating the Chinese mainland markets with efficiency far exceeding the industry average.

HANQUYOU is the first China-developed mAb approved both in China and Europe. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. In February 2023, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA), which will further expand the product’s footprint in major markets of biologics in the U.S. and Europe. In addition, Henlius has aggressively pursued international commercialization of HANQUYOU, actively collaborating with global partners to bring its therapeutics to patients in the United States, Canada, Europe, and other emerging markets, covering about 100 countries and regions. Up to now, HANQUYOU has launched in over 30 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Singapore, Argentina and Saudi Arabia.

HANSIZHUANG Sees Unbated Growth

In the first quarter of 2023, the company’s first innovative product, HANSIZHUANG (serplulimab) achieved a domestic sales revenue of RMB249.8 million. Notably, HANSIZHUANG realized a monthly sales of over RMB100 million in March 2023 in Chinese mainland, starting a new stage of its sales growth as well as providing strong momentum for the product’s commercialization.

HANSIZHUANG was launched in China in March 2022，and has been approved for 3 indications including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC) so far. As the world’s first anti-PD-1 monoclonal antibody (mAb) for the first-line treatment of SCLC, HANSIZHUANG set a record for SCLC immunotherapy with a median OS (overall survival) of 15.8 months. With its outstanding quality and clinical efficacy, HANSIZHUANG has earned wide recognitions from the market and has seen rapid sales uptick. At the beginning of the product’s commercialisation, an amazing "Henlius speed" has been demonstrated in the first deliveries and the first prescriptions of HANSIZHUANG, which also indicated the company’s strong commercial operation and execution. As of the end of 2022, its sales team has been expanded to approximately 400 people. With a rich experience in oncology and meticulous management model, the team has covered over 23,000 healthcare providers from nearly 1000 domestic hospitals. Looking forward, the company will continue to accelerate the market coverage and penetration of HANSIZHUANG in the areas of lung cancer, gastrointestinal and gynecological tumours.

In March 2023, the European Medicines Agency (EMA) has validated the Marketing Authorization Application(MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC. Another patient has also been dosed in a head-to-head bridging trial of HANSIZHUANG versus first-line standard of care atezolizumab for ES-SCLC in the U.S. The company also plans to submit a Biologics License Application (BLA) for HANSIZHUANG in the U.S. in 2024. Meanwhile, the company continues to explore the combination therapies between HANSIZHUANG and self-developed products such as HANBEITAI, HLX07 (anti-EGFR mAb), HLX26 (anti-LAG-3 mAb), HLX208 (BRAF V600E small molecule inhibitor) and HLX60 (anti-GARP mAb) to provide better therapies for the patients, more than 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications.

Looking forward, Henlius will continue to delve into the area of oncology, auto-immune and other diseases. While maximizing the commercial value of biosimilars at home and abroad, Henlius will actively explore innovation drugs and tackle unmet clinical needs by leveraging its in-house R&D capabilities supplemented by external cooperation and license-in, so as to consolidate the best-in-class capabilities of "integrated research, manufacturing and commercialisation", and achieve steady development as a larger, international and more profitable Biopharma to provide more affordable and better therapies for patients worldwide.