Hercessi (trastuzumab-strf) / Fosun Pharma, Intas, Eurofarma - LARVOL DELTA

Real-World Efficacy of HLX02-Based Neoadjuvant Therapy in HER2-Positive Breast Cancer: Clinical Insights and Future Directions. (PubMed, Breast J) - "Background: The efficacy of HLX02, a trastuzumab biosimilar, in combination with chemotherapy for treating metastatic breast cancer (BC) has been established as equivalent to the reference Herceptin...Dual HER2 blockade with HLX02 and pertuzumab was associated with a numerically improved pCR rate (62.16%)...The lower pCR rate in HR-positive patients highlights the need for additional strategies. Combining CDK4/6 inhibitors with anti-HER2 therapy presents a promising approach for HR-positive HER2-positive patients, warranting further clinical validation."

Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Efficacy and Safety of Biosimilar Trastuzumab (HLX02) in Patients with HER2-positive Advanced Breast Cancer: A Retrospective Real-world Analysis (Frontiers) - "This study was designed to evaluate the real-world safety and efficacy of HLX02 in patients with HER2-positive metastatic breast cancer (MBC), as well as assessed the effectiveness of switching from trastuzumab originator (Herceptin) to HLX02 during treatment.Between April 2021 and October 2022, all patients with HER-2-positive MBC who received at least one cycle of HLX02 at Fudan University Shanghai Cancer Center were included in a retrospective analysis....The follow-up ranged from 0.7 to 40.2 months, the effectiveness rates were 57.5% in the naïve group and 54.5% in the switched group, respectively (P=0.751). The estimated median progression-free survival (PFS) were 13.70 (95% CI: 8.634-18.766) months and 14.70 (95% CI: 6.684-22.716) months in the naive and switched groups, respectively (P=0.192). Multivariate cox regression analysis suggested that brain metastasis and the current number of treatment lines were independent predictors of MBC PFS."

Real-world evidence • HER2 Positive Breast Cancer

Real-world outcomes of first-line treatment with HLX02 versus reference trastuzumab plus pertuzumab in HER2-positive metastatic breast cancer. (PubMed, Oncologist) - "The real-world data suggested that both HLX02 and RTZ, when combined with pertuzumab and various chemotherapy regimens, offer comparable efficacy and safety as first-line treatments for HER2-positive advanced breast cancer patients in China."

Clinical • Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Optimizing neoadjuvant treatment in HER2-positive breast cancer: the role of HER2, HR, PD-L1 expression and regimen selection. (PubMed, Future Oncol) - "The intravenous formulation (Herceptin) or subcutaneous formulation (Herceptin Hylecta) of the original trastuzumab drug, as well as the biosimilar drugs (Hanquyou) produced in China, showed similar efficacy, while Nab-Paclitaxel demonstrated potential benefits in overall patient. HER2 3+, PD-L1 CPS > 27.5 and HR-negative are independent predictors of pCR. The TCbHP and THP regimens have comparable efficacy, and both are superior to the AC-THP regimen."

IO biomarker • Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

Comparison of the efficacy, safety, and cost-effectiveness of trastuzumab biosimilar HLX02 and the originator combined with pertuzumab and chemotherapy in the neoadjuvant treatment of patients with HER-2-positive breast cancer (PubMed, Zhonghua Zhong Liu Za Zhi) - "The HLX02 regimen showed a lower cost-effectiveness ratio (586.48 vs. 604.96) and reduced trastuzumab treatment costs during neoadjuvant therapy compared to HST [tpCR:(31 208.37±2 191.00) CNY vs. (33 224.49±2 741.00) CNY; non-tpCR: 33 030.05±5 787.00) CNY vs. (33 412.50±4 203.00) CNY, P＜0.05]. In the neoadjuvant treatment of early-stage HER-2-positive breast cancer, HLX02 combined with pertuzumab and chemotherapy demonstrates similar efficacy and safety to the trastuzumab originator, while offering a significant cost advantage."

Clinical • HEOR • Journal • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial. (PubMed, Breast) - P3 | "Long-term efficacy and safety were consistent with the previous findings. No clinically meaningful differences between HLX02 and reference trastuzumab were demonstrated."

Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Shanghai Henlius Extends Promotional Partnership with Jiangsu Fosun (Nasdaq) - "Shanghai Henlius Biotech has announced the renewal of its Promotional Services Agreement with Jiangsu Fosun, extending the partnership for an additional year through 2025. This agreement involves promotional activities for their product HANQUYOU in various regions of China, with adjustments to fees and designated areas. The transactions are categorized as continuing connected transactions under the Listing Rules, necessitating reporting and review without requiring independent shareholder approval."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer

Contemporary patterns of Medicare Utilization and Spending on Herceptin and its Biosimilars in Breast Cancer. (SABCS 2024) - "The six FDA approved Herceptin biosimilars are: Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, and Hercessi. There has been a significant decline in Herceptin utilization and spending, accompanied by a shift towards biosimilars; reflecting changing trends in HER2-positive breast cancer treatments. Kanjinti and Trazimera, in particular, experienced substantial increases in spending, dosage units, claims, and beneficiaries, indicating growing acceptance and usage. Despite these increases, total spending and claims for Herceptin remain higher than for its biosimilars."

Medicare • Reimbursement • US reimbursement • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

First Shipment of Henlius Trastuzumab to U.S. (Henlius Press Release) - "On November 29, 2024, Henlius' independently developed and produced trastuzumab biosimilar, HANQUYOU (trade name: HERCESSI in the U.S. and Zercepac in Europe), departed from Henlius’ Songjiang First Plant, heading to the U.S. This milestone marks the company’s first commercial supply to North America, representing a significant breakthrough in its global expansion."

Biosimilar launch • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

HER2 dual-targeted therapy: Henlius' HLX22 Phase II study was featured on the cover of Cell's Med [Google translation] (Henlius Press Release, Med) - P2 | N=150 | NCT04908813 | Sponsor: Shanghai Henlius Biotech | "Recently, the comprehensive medical flagship journal Med 2024...has officially launched its 10th issue of Volume 5, 2024. The cover of this issue features Henlius' innovative anti-HER2 monoclonal antibody HLX22 combined with Hanquyou...and chemotherapy for the first-line treatment of HER2-positive advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer in a Phase II clinical study (HLX22-GC-201)....'The study showed that this treatment regimen significantly prolonged the patient's progression-free survival (PFS) and enhanced the anti-tumor response, and had a good safety profile, which confirmed the clinical benefits of dual HER2 targeting.'"

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

HER2 dual-targeted therapy: Henlius' HLX22 Phase II study was featured on the cover of Cell's Med [Google translation] (Henlius Press Release, Med) - P2 | N=150 | NCT04908813 | Sponsor: Shanghai Henlius Biotech | "Recently, the comprehensive medical flagship journal Med 2024...has officially launched its 10th issue of Volume 5, 2024. The cover of this issue features Henlius' innovative anti-HER2 monoclonal antibody HLX22 combined with Hanquyou...and chemotherapy for the first-line treatment of HER2-positive advanced or metastatic gastric/gastroesophageal junction (G/GEJ) cancer in a Phase II clinical study (HLX22-GC-201)....'The study showed that this treatment regimen significantly prolonged the patient's progression-free survival (PFS) and enhanced the anti-tumor response, and had a good safety profile, which confirmed the clinical benefits of dual HER2 targeting.'"

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Dual HER2 inhibition: Is two better than one? (PubMed, Med) - "present data from a randomized frontline phase II trial in HER2+ gastroesophageal cancers exploring dual targeting of HER2 with HLX22 (a novel HER2-specific antibody) with HLX02 (a trastuzumab biosimilar) and capecitabine/oxaliplatin chemotherapy. While the objective response and progression-free survival are encouraging, the future development of the combination in a crowded HER2 space remains unclear."

Journal • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer (PRNewswire) - "Accord BioPharma, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved a 420mg strength of HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. This milestone, together with FDA approval of a 150mg strength of HERCESSI earlier this year, paves the way for the company to commercially launch its first biosimilar in the U.S. in early 2025....FDA approval was granted based on...two Phase 1 comparative single-dose pharmacokinetic (PK) studies conducted in healthy volunteers (HLX02-HV01 and HLX02-HV02), and a supportive Phase 3, double-blind, randomized clinical efficacy and safety compafrability study in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel (HLX02-BC01)."

Biosimilar launch • Evidence highlight • FDA approval • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Latest Results of…HANQUYOU Released at 2024 ESMO (Henlius Press Release) - P2 | N=216 | NCT04917900 | "Patients with previously untreated non-metastatic HER2-positive BC were assigned to receive six neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus HLX02 (8 mg/kg loading dose, followed by 6 mg/kg) and Nab-P (260 mg/m2) q3w....From December 2020 to August 2023, a total of 214 patients were enrolled and completed neoadjuvant therapy and surgery. The pCR rate was 62.96% (95% CI, 55.65% -69.86%, p=. 001). The most common grade 3-4 adverse events were diarrhea (34.7%) and neutropenia (6.5%). Of 95 patients who underwent CTCs analysis, 63 (66.3%) achieved pCR. CTCs count was significantly reduced at P1 compared to that of at P0 (3.06±3.38 vs.0.84±1.53 FU/5ml, p<.001). Patients with pCR have larger nuclei size at P0 (95% CI, 1.02-1.38; P =. 04), less count (95% CI, 1.49-8.28; P =. 03) and lower membrane intensity (95% CI,0.93-0.98; P =. 03) at P1 to those with non-pCR..."

P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Phase II study of pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer (ESMO 2024) - P2 | "In women with HER2-positive, stage II-III BC, the neoadjuvant regimen pyrotinib plus Nab-P and HLX02 effectively promoted pCR of tumor and presented an acceptable tolerability. Personalized monitoring of CTCs during neoadjuvant therapy of early BC may aid in real-time assessment of treatment response and help predict pCR."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTCs • HER-2

Henlius Maintains Patient-Centric Focus, Drives Sustainable Growth, and Accelerates Overseas Expansion in 2024 H1 (Henlius Press Release) - "HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB1.4743 billion, RMB677.8 million and RMB86.7 million, respectively. In addition, the company received sales revenues of RMB227.0 million and RMB13.6 million based on the collaboration with partners for HANLIKANG (rituximab)..."

Sales • Colorectal Cancer • Esophageal Cancer • Follicular Lymphoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Neuroendocrine Tumor • Small Cell Lung Cancer

Henlius Trastuzumab Receives Approval in Canada (Henlius Press Release) - "Shanghai Henlius Biotech...has received marketing approval (Notice of Compliance) from the Health Canada for HLX02 (trade name: HANQUYOU in China, HERCESSI in U.S., Zercepac in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved under the trade name of Adheroza in Canada for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer...HLX02....was granted approval by the Health Canada based on a comprehensive package of analytical, non-clinical and clinical study data submitted by Henlius. Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study."

Canada approval • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024 (Henlius Press Release) - "2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC)...and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC)..."

Biomarker • P2 data • P3 data • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. (PubMed, Med) - P2 | "Adding HLX22 to HLX02 and XELOX prolonged PFS and enhanced antitumor response in the first-line treatment of HER2-positive gastric cancer, with manageable safety."

Clinical • Journal • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Dual targeting non-overlapping epitopes in HER2 domain IV substantially enhanced HER2/HER2 homodimers and HER2/EGFR heterodimers internalization leading to potent antitumor activity in HER2-positive human gastric cancer. (PubMed, J Transl Med) - "These results suggested that the application of non-competing antibodies HLX22 and HLX02 targeting HER2 subdomain IV together may be of substantial benefit to gastric cancer patients who currently respond suboptimal to trastuzumab therapy."

Journal • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • EGFR • FGFR • HER-2 • mTOR • PI3K • STAT3 • TGFB1

The efficacy and safety of trastuzumab biosimilar HLX02 compared with reference trastuzumab plus pertuzumab in combination with chemotherapy as the first-line treatment for HER2 positive metastatic breast cancer: A real-world study in China. (ASCO 2024) - "5%), including nab-paclitaxel (44...3%), docetaxel (41... The real-world data suggest similar efficacy and safety of HLX02 and RTZ plus pertuzumab with different chemotherapy regimens as the first-line treatment for patients with HER2-positive advanced breast cancer patients in China. Overall, the PFS was consistent with the CLEOPATRA trial in both groups, and there was no new safety signal."

Clinical • Combination therapy • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Palliative care • Solid Tumor • HER-2

HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study (ESMO-GI 2024) - P2 | "The improved survival and antitumor response brought by the addition of HLX22 to HLX02 + XELOX as first-line therapy were maintained with manageable safety in HER2-positive G/GEJ cancer patients."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • HER-2

Henlius Trastuzumab Begins its Journey to Saudi Arabia (Henlius Press Release) - "On June 6, 2024, Henlius' independently developed and produced product, HANQUYOU...left Henlius’ Xuhui Facility, heading to Saudi Arabia, with the expectation of being the first Chinese monoclonal antibody (mAb) biosimilar to hit the market in the Middle East. This milestone signifies the company’s first commercialized delivery to the Middle East and North African (MENA) countries and is a testament to the exclusive commercial partnership formed with the international partner Intas and its subsidiary Accord, covering parts of Europe, North America, certain areas of MENA, and CIS countries."

Biosimilar launch • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of neoadjuvant trastuzumab, pyrotinib, and dalpiciclib without chemotherapy in early-stage HR-negative/HER2-positive breast cancer: An open-label, single-arm phase II trial. (ASCO 2024) - "Eligible patients received trastuzumab (HLX02, 8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks intravenously) for 15 weeks, plus pyrotinib (240 mg daily orally) and dalpiciclib (125 mg daily orally for 3 weeks, followed by 1 week off) for 16 weeks. In patients with HR-negative/HER2-positive EBC, a dual HER2-targeted combination of pyrotinib and trastuzumab, along with dalpiciclib in the absence of chemotherapy showed promising efficacy with encouraging pCR and ORR rates, as well as a favorable safety profile in the neoadjuvant setting. Clinical trial information: Chi-CTR-2200060748."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Henlius to Showcase at BIO 2024 (Henlius Press Release) - "From June 3-6, 2024, the 2024 Biotechnology Innovation Organization International Convention...will be held in San Diego Convention Center, California, USA....During BIO 2024, the company will be at Booth #1719 with 5 launched products, including HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name: HERCESSI in the U.S and Zercepac in Europe) and its innovative product HANSIZHUANG, the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer."

Clinical • Breast Cancer • Chronic Lymphocytic Leukemia • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Cell Lung Cancer • Solid Tumor