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

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

CIRCULATING TUMOR CELL COUNT FOR ASSESSING THE EFFICACY OF NEOADJUVANT ALBUMIN-BOUND PACLITAXEL PLUS TRASTUZUMAB (HLX02) AND PYROTINIB MALEATE IN HER2-POSITIVE, STAGE II-III BREAST CANCER (GBCC 2024) - "CTC count enables the evaluation of the neoadjuvant therapeutic efficacy of albumin-bound Paclitaxel plus Trastuzumab (HLX02) and Pyrotinib Maleate in HER2-positive, stage II-III breast cancer. Variations in CTC count across different clinical stages and Ki67 levels may reveal the effect of different clinical parameter and biomarkers on neoadjuvant therapy response. The value of CTCs in predicting the long-term survival of these patients needs further analysis."

Circulating tumor cells • Clinical • Tumor cell • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Fuhong Hanlin (02696.HK) first quarter operating income increased by 35.5% year-on-year [Google translation] (iis.aastocks.com) - "Fuhong Hanlin...announced that its operating income in the first quarter was approximately RMB 1.349 billion (the same below), a year-on-year increase of 35.5%....Among them, Hanquyou (trastuzumab injection, European trade name: Zercepac, American trade name: HERCESSI) achieved sales revenue of approximately 671 million yuan in China; Hansizhuang (serplulimab injection) achieved sales revenue in China Domestic sales revenue is approximately 334 million yuan"

Sales • Breast Cancer • Esophageal Squamous Cell Carcinoma • HER2 Breast Cancer • HER2 Positive Breast Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of HERCESSI (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab) for the Treatment of Several Forms of HER2-Overexpressing Cancer (PRNewswire) - "The studies include two Phase 1 comparative single-dose PK equivalence studies conducted in healthy volunteers (HLX02-HV01 and HLX02-HV02), and a supportive Phase 3, double-blind, randomized clinical efficacy and safety comparability study in patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel (HLX02-BC01)....A 420mg-strength version of HERCESSI is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024."

BLA • PDUFA date • Breast Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

HLX02 (TRASTUZUMAB-STRF, PROPRIETARY NAME IN THE UNITED STATES: HERCESSI) FOR THE TREATMENT OF ADJUVANT BREAST CANCER, METASTATIC BREAST CANCER AND METASTATIC GASTRIC CANCER APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) (iis.aastocks.com) - "The board of directors of the Company...is pleased to announce that, recently, Accord has received an approval letter from the FDA for HLX02 (trastuzumab-strf) with a strength of 150mg/vial, indicated for (1) adjuvant treatment of HER2-overexpressing breast cancer; (2) the treatment of HER2-overexpressing metastatic breast cancer; and (3) the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The proprietary name approved for HLX02 in the United States is HERCESSI. Accordingly, HLX02 (trastuzumab for injection) is the first product of the Company approved by the FDA for marketing in the United States....The FDA approval is primarily based on the review of a series of study data of HLX02 (trastuzumab for injection), known as HANQUYOU in mainland China (excluding Hong Kong, Macau and Taiwan regions, same as below), versus the reference product, Herceptin, including analytical similarity and clinical studies, etc."

BLA • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Henlius 2023 Annual Results: Revenue surpassed RMB5.39 billion with a net profit RMB546 million, first full-year profitability achieved (PRNewswire) - "Henlius' core oncology product HANQUYOU...is now reimbursed nationally in countries including China, the UK, France, and Germany....Its marketing applications in the...Canada have also been accepted and expected to be approved for marketing in 2024."

Canadian regulatory • Reimbursement • Gastric Cancer • HER2 Positive Breast Cancer