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

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Minimal residual disease • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Neoadjuvant Pertuzumab Biosimilar HLX11 Versus Reference Pertuzumab for Early-stage or Locally Advanced Breast Cancer: A phase 3 Equivalence Trial. (PubMed, Clin Cancer Res) - "Compared with EU-pertuzumab, neoadjuvant HLX11 demonstrated a similar tpCR rate and no clinically meaningful differences in other efficacy endpoints, safety, PK, or immunogenicity in BC."

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

HLX11: A Pertuzumab Biosimilar. (PubMed, BioDrugs) - "No new safety or immunogenicity concerns were observed following a switch from neoadjuvant reference pertuzumab to adjuvant HLX11. The role of reference pertuzumab in the management of HER2-positive breast cancer is well established, and HLX11 provides an effective biosimilar alternative for patients requiring pertuzumab therapy."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

The Committee adopted a positive opinion by consensus recommending the granting of a marketing authorization, together with the CHMP assessment report and translation timetable. (European Medicines Agency) - CHMP Final Minutes of the meeting on 23 - 26 Feb 2026: CHMP confirmed that all previously identified issues in the application for the treatment of breast cancer in adults had been addressed.

CHMP • Breast Cancer • Oncology

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11 (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

HENLIUS…announced that Shanghai Henlius Biologics, a wholly-owned subsidiary of the Company, received the 'Notice of GMP Compliance Inspection for Pharmaceuticals' issued by Shanghai Medical Products Administration (iis.aastocks.com) - "...The drug substance (DS) east line, drug product (DP) production line and packaging line of HANBEIYOU (pertuzumab injection) in biopharmaceutical production base of the Company in Songjiang district, Shanghai successfully passed the compliance inspection for the Good Manufacturing Practice conducted by Shanghai Medical Products Administration."

Commercial • HER2 Positive Breast Cancer

Henlius…announced that the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY) has been approved by the National Medical Products Administration (NMPA). (Henlius Press Release) - "It is indicated for neoadjuvant and adjuvant treatment of HER2-positive early-stage breast cancer and for the treatment of metastatic breast cancer, covering all indications approved in the Chinese Mainland for the reference pertuzumab injection.....Data from its pivotal Phase 3 equivalence trial (NCT05346224) were also selected for a mini oral presentation at the 2025 ESMO Congress....Henlius is also developing HLX319, the first domestic fixed-dose subcutaneous injection of pertuzumab and trastuzumab, which has completed its first subject dosing in a Phase 1 clinical trial (HLX319-001) in China."

China approval • HER2 Positive Breast Cancer

Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis (clinicaltrials.gov) - P3 | N=562 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

BUDGET IMPACT AND COST CALCULATOR MODEL FOR POHERDY® (PERTUZUMAB-DPZB) IN THE TREATMENT OF HER2-POSITIVE BREAST CANCER (ISPOR 2026) - "OBJECTIVES: To estimate the budget impact of POHERDY®, a pertuzumab biosimilar, from the perspective of the Brazilian private healthcare payer. The CCM identified patient weight distribution and IV infusion duration as key drivers. Weight-based IV dosing resulted in lower costs for lighter patients, whereas fixed-dose SC regimens became slightly more favorable in higher-weight patients. Deterministic sensitivity analyses confirmed drug pricing and biosimilar uptake as the most influential parameters, with savings maintained across scenarios."

HEOR • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

HENLIUS…announced that the marketing authorization application for its self-developed POHERDY (pertuzumab) 420mg/14mL injection has been approved by the European Commission. (iis.aastocks.com) - "The approval signifies that POHERDY has obtained centralized marketing authorization in all European Union member states as well as Iceland, Liechtenstein and Norway. The approved indications cover all indications of the reference pertuzumab that have been authorized in Europe."

EMA approval • HER2 Positive Breast Cancer

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

EAY131-J: Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Poherdy, intended for the treatment of breast cancer. (European Medicines Agency) - "Poherdy is indicated for use in combination with trastuzumab and chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence; the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence."

CHMP • HER2 Positive Breast Cancer

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center

Minimal residual disease • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

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