Poherdy (pertuzumab-dpzb) / Fosun Pharma, Organon - LARVOL DELTA

Neoadjuvant HLX11 versus European Union (EU)-sourced pertuzumab in human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-negative early or locally advanced, breast cancer (BC): A double-blind, randomised phase III equivalence study (ESMO Asia 2025) - P3 | "Enrolled patients were randomised 1:1 to receive 4 cycles of intravenous (IV) HLX11 (HLX11 arm) or reference pertuzumab (EU-pertuzumab arm) plus trastuzumab and docetaxel every 3 weeks (Q3W). HLX11 showed equivalent efficacy and comparable safety, immunogenicity and PK to the EU-sourced pertuzumab, supporting HLX11 as a potential pertuzumab biosimilar."

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

FDA approves new interchangeable biosimilar to Perjeta (FDA) - "Poherdy is a HER2/neu receptor antagonist indicated for the following: use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease...use in combination with trastuzumab and chemotherapy as: neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence....The recommended initial pertuzumab-dpzb dose is 840 mg administered as a 60-minute intravenous infusion, then followed every three weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes."

FDA approval • HER2 Positive Breast Cancer

European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta (pertuzumab) Biosimilar Candidate HLX11 (Businesswire) - "Shanghai Henlius Biotech...and Organon...today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications....The submission was based on a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study (NCT05346224)..."

EMA filing • Evidence highlight • HER2 Positive Breast Cancer • HER-2

HLX11-BC301: A Study to Evaluate the Efficacy and Safety of HLX11 Vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=900 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Trial primary completion date: Nov 2024 ➔ May 2024

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Henlius Headlines | Fosun Henlius's Pertuzumab Biosimilar HLX11's US Marketing Authorization Application Accepted by FDA [Google translation] (Henlius Press Release) - "...Henlius...announced that the company's independently developed Perjeta (pertuzumab) biosimilar HLX11's biologics license application (BLA) was accepted by the U.S. Food and Drug Administration (FDA)...This submission is mainly based on a series of comparative studies with the original pertuzumab, including analytical similarity studies and two clinical comparative studies. One of the clinical studies is a randomized, double-blind, single-dose, parallel-controlled, four-arm Phase I clinical trial conducted in healthy male subjects in China....The other clinical trial is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial, which aims to compare the efficacy and safety of HLX11 with the original pertuzumab commercially available in the European Union for neoadjuvant treatment of patients with HER2-positive, HR-negative early or locally advanced breast cancer."

FDA filing • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer

China NMPA Accepts Henlius' NDA for HLX11, an Pertuzumab Biosimilar Candidate (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11, in combination with trastuzumab and chemotherapy, as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, and in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease....The filing was based on data from a series of head-to-head studies of HLX11 in comparison with reference pertuzumab, including analytical studies of similarities, phase 1 clinical studies and international multicenter phase 3 clinical studies."

China filing • HER2 Positive Breast Cancer

Henlius Biopharmaceuticals (02696): The international multicenter Phase 3 clinical study of HLX11 for neoadjuvant treatment of HER2-positive and HR-negative early or locally advanced breast cancer has achieved the primary endpoint [Google translation] (Sina Corp) - P3 | N=900 | NCT05346224 | Sponsor: Shanghai Henlius Biotech | "This study is a multicenter, randomized, double-blind, parallel-controlled Phase 3 clinical trial designed to compare the efficacy and safety of HLX11 and the original Perjeta (pertuzumab) as part of the overall treatment regimen for the neoadjuvant treatment of patients with HER2-positive, HR-negative early or locally advanced breast cancer. Eligible subjects were randomly divided into two groups in a 1:1 ratio to receive HLX11 or the original Perjeta (pertuzumab) combined with trastuzumab and docetaxel once every three weeks for a total of four cycles. The primary endpoint of the study was the overall pathological complete response (tpCR) rate assessed by an independent review committee (IRC)....The primary endpoint of this study has been achieved."

P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

Henlius Maintains Patient-Centric Focus, Drives Sustainable Growth, and Accelerates Overseas Expansion in 2024 H1 (Henlius Press Release) - "In the first half of 2024, HANLIKANG, the first biosimilar launched in China...The company also plans to submit marketing applications for...HLX11 (pertuzumab biosimilar) in China and the U.S. in the second half of 2024."

China filing • FDA filing • Launch non-US • Oncology

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

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=900 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates (Businesswire) - "Organon...announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan....The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy® (ipilimumab, HLX13)."

Licensing / partnership • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Giant Cell Tumor of Bone • HER2 Breast Cancer • HER2 Positive Breast Cancer • Melanoma • Microsatellite Instability • Oncology • Renal Cell Carcinoma • Solid Tumor

HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects. (PubMed, BioDrugs) - P1 | "The PK, safety, and immunogenicity of HLX11 were highly similar to those of reference pertuzumab (US-, EU-, CN-approved products). The established bioequivalence supports further clinical trials of HLX11 in cancer treatment."

Journal • PK/PD data • Breast Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial primary completion date: Dec 2023 ➔ Nov 2024

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=160 | Completed | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Jul 2021 | Trial primary completion date: Oct 2020 ➔ Jul 2021

Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Shanghai Henlius Biotech

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1; N=160; Not yet recruiting; Sponsor: Shanghai Henlius Biotech

Clinical • New P1 trial