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

Comparison of the efficacy and safety of HLX-02 plus pertuzumab versus HLX-02 plus pyrotinib in neoadjuvant therapy for HER2-positive breast cancer. (PubMed, Ther Adv Med Oncol) - "Participants were divided into two treatment groups: those receiving docetaxel, carboplatin, HLX‑02 plus pertuzumab (TCbHP group), and those receiving docetaxel, carboplatin, HLX‑02 (a trastuzumab biosimilar) plus pyrotinib (TCbHPy group). Both HLX‑02‑based neoadjuvant regimens exhibited comparable efficacy in achieving pCR in patients with HER2‑positive breast cancer. These findings indicate that HLX‑02, whether combined with pertuzumab or pyrotinib, represents a viable neoadjuvant strategy."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor • HER-2

A best-in-class HER2xHER2 novel biparatopic antibody-drug conjugate with an efficacious, low-toxicity design that maximizes antibody functionality (AACR 2026) - "When combined with HLX02 (a trastuzumab biosimilar), HLX22 increases internalization of HER2 homodimers and HER2/EGFR heterodimers, reducing cell proliferation signals. This combination shows stronger antitumor effects than HLX02 plus HLX11 (a pertuzumab biosimilar) both in vitro and in vivo...Preliminary toxicology in cynomolgus monkeys was assessed at 60 mg/kg, administered every three weeks for three cycles. The HER2xHER2 biparatopic ADC demonstrated superior internalization efficiency than KN026 (a HER2-targeted bispecific antibody) and trastuzumab deruxtecan in BT474 and NCI-N87 cell lines... We have developed a potential best-in-class HER2xHER2 novel biparatopic ADC that exhibits a superior therapeutic index, antibody-mediated signaling blockade. The preclinical findings support clinical development in breast and gastric cancers, with the hope that the improved therapeutic index of this agent confers survival benefit."

ADC • Gastric Cancer • Oncology • Solid Tumor • EGFR

Comparative efficacy and safety of the trastuzumab biosimilar HLX02 versus originator trastuzumab in the neoadjuvant THP-EC regimen for early-stage HER2-positive breast cancer: a real-world study. (PubMed, Expert Opin Biol Ther) - "Safety profiles, including cardiac toxicity, were similar between groups. HLX02 demonstrated equivalent efficacy and safety to the originator trastuzumab in this setting, representing a cost-effective treatment alternative."

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

Henlius Reports 2025 Results: Sustained Growth in Both Revenue and Profit, Advancing Innovation Validation and Global Operations (The Manila Times) - "The Company's flagship product, serplulimab (trade name: Hetronifly in Europe), continued to deliver global commercial momentum. During the reporting period, it recorded global sales revenue of RMB 1.4926 billion, representing a year-on-year increase of 13.7%...Its core product HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) achieved global sales revenue of RMB 2.9645 billion, up 5.5% year-on-year...HANNAIJIA (neratinib) generated sales revenue of RMB 0.3012 billion, representing a year-on-year increase of 564.2%...HANBEITAI (bevacizumab) generated sales revenue of RMB 0.3564 billion, up 80.8%."

Sales • Colorectal Cancer • Gastric Cancer • HER2 Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

ASCO GI 2026 | Henlius Accelerates Global Phase 3 Head-to-Head Development of HLX22 as First-Line Treatment for HER2-Positive Gastric Cancer (Henlius Press Release) - "Median OS was not reached (95% CI: 16.2, NE) compared with 16.4 months (95% CI: 10.7, NE) in the control group (HR = 0.60; 95% CI: 0.28–1.21). Median PFS was not reached (95% CI: 16.2, NE) versus 8.3 months (95% CI: 5.7–21.4), respectively (HR=0.20; 95% CI: 0.09–0.54). These results indicate an 80% reduction in the risk of disease progression or death, substantially exceeding historical trials, and provided important support for the design and implementation of the phase 3 head-to-head HLX22-GC-301 study."

P2 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Efficacy and Safety of Different Treatment Regimens for Previously Untreated Patients with HER2-positive Advanced Gastric Cancer: A Meta-Analysis of Randomized Controlled Trials. (PubMed, J Gastrointest Cancer) - "No first-line regimen significantly improved OS or PFS in HER2-positive advanced gastric cancer. However, HLX22-based and immune-combination strategies show potential clinical value-particularly in enhancing ORR-and merit further investigation."

Clinical • Journal • Retrospective data • Review • Gastric Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of neoadjuvant treatment of trastuzumab and pyrotinib plus dalpiciclib in HR-negative/HER2-positive breast cancer: an exploratory, open-label phase II study. (PubMed, Int J Surg) - "In patients with HR-HER2 + EBC, the neoadjuvant therapy with trastuzumab, pyrotinib and dalpiciclib has promising activity and manageable toxicity. Further investigation is needed."

Journal • P2 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Henlius Keeps Steady Growth in H1 2025: Overseas Product Profits Soar 200%+, Innovation Fuels Global Reach (PRNewswire) - "The company's core innovative product serplulimab (trade name: HANSIZHUANG in China, Hetronifly in Europe)...has recorded a global sales revenue of RMB597.7million during the reporting period....Henlius' core breast cancer product HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe)...has recorded a global sales revenue of RMB1.4442 billion in the first half of 2025."

Sales • Esophageal Squamous Cell Carcinoma • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Efficacy and safety of biosimilar trastuzumab (HLX02) in patients with HER2-positive advanced breast cancer: a retrospective real-world analysis. (PubMed, Front Oncol) - "HLX02 demonstrated favorable efficacy and safety in real-world practice comparable to those observed in previous HLX02 studies. Switching between trastuzumab originator and biosimilar for MBC treatment had no impact on efficacy and did not increase safety risks."

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

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