Herwenda (trastuzumab biosimilar) / EirGenix, Sandoz - LARVOL DELTA

EGC102: Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared with EU-sourced Perjeta® (Pertuzumab) in Patients with HER2-positive Hormone Receptor Negative Early Breast Cancer. (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: EirGenix, Inc.

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

Clarity expands pipeline in breast cancer with Cu-64/67 SAR-trastuzumab: Pre-clinical data published and trastuzumab supply agreement in place (Clarity Pharmaceuticals Press Release) - "Clarity Pharmaceuticals...is pleased to announce the addition of a new asset, 64/67Cu-SAR-trastuzumab, into the Targeted Copper Theranostic (TCT) portfolio. Pre-clinical data on SAR-trastuzumab has recently been published and Clarity has signed a Supply Agreement with EirGenix, Inc. ('EirGenix') for the clinical development and future commercial supply of clinical-grade GMP trastuzumab biosimilar, EG12014. The supply enables the development of a radiolabelled product using Clarity’s SAR Technology....Clarity intends to conduct a Phase 1/2a theranostic study with 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need....Pre-clinical evidence shows dose-response reduction in tumour size and prolonged survival using 67Cu-SAR-trastuzumab compared to trastuzumab alone in a HER2-positive tumour mouse model."

Commercial • New molecule • Preclinical • HER2 Positive Breast Cancer

Taiwan Kangsheng Biosimilar Breast Cancer Treatment Drug 420 mg dosage form applies for Taiwan Drug License [Google translation] (stock.yahoo) - "Tai Kangsheng...announced on the 5th that it has applied for a drug license from Taiwan's TFDA for EG12014 'Yikangping' frozen crystal injection 420 mg. This biosimilar drug is mainly used to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer...The 420 milligrams sent this time belong to biopharmaceuticals that have been reviewed, and their different dosages and packaging have been inspected and registered in different places of origin...In addition, the manufacturer of this preparation is Taiyao Chemical, which is currently undergoing factory inspection by the TFDA."

Filing • Breast Cancer • Gastric Cancer

Taikang Biotech’s second similar breast cancer drug to be licensed in Europe and the United States to finalize at the end of the year, with potential orders of US$1 billion [Google translation] (stock.yahoo) - "Taikang Biotech...held a press conference on the 18th. Chairman Liu Lizheng said that the first breast cancer biosimilar drug Trastuzumab EG12014 150 mg, the US FDA is expected to inspect the third party factory at the end of October. If everything goes well, It is expected to obtain a U.S. drug license before the end of this year, and the second similar breast cancer drug, Pertuzumab (EG1206A), is expected to finalize European and American market authorization by the end of this year....The second R&D product/Pertuzumab biosimilar drug EG1206A has held two scientific consultation meetings with the EMA and one with the FDA before the launch of the Phase III clinical trial. The Phase III clinical trial will open nearly 100 acceptance points, it is expected to be completed clinically in one and a half years, and the first patient will be admitted in the first quarter of next year."

EMA approval • FDA approval • New P3 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Tai Kangsheng breast cancer biosimilar drug EG12014 factory inspection FDA response still needs improvement [Google translation] (stock.yahoo) - "Taikang Biotech...announced on October 10 that after the drug license application for the 150 mg dosage form of the breast cancer biosimilar EG12014 (Trastuzumab Biosimilar, also called EGI2014), the US FDA factory inspection results showed that the filling factory still needs to improve the follow-up progress...Tai Kangsheng stated that the content of this complete reply letter is only related to the production defects of the entrusted third-party manufacturers, but it is clearly stated that this defect has nothing to do with product quality, clinical efficacy, safety and biosimilarity (Biosimilarity)....The main demand in the US market is 420 mg packaging dosage. This solution will be considered and is currently in progress. 420 mg product, and the 150 mg and 420 mg products will be launched in the United States together after approval as originally planned, ensuring that this important drug can be brought to American patients as soon as possible."

CRL • Gastric Cancer • HER2 Positive Breast Cancer

Focus stocks: Taikang Biotech’s CDMO business continues to grow, and breast cancer biosimilar drugs will obtain certification in the United States by the end of the year [Google translation] (stock.yahoo) - "The breast cancer biosimilar drug EG12014 150 mg frozen crystal injection, which is the most concerned about the market, is expected to have the opportunity to complete the review in the fourth quarter and obtain the certificate by the end of the year. In addition, another mainstream dose in the US market, 420 mg, is also expected to be submitted. After the authorized partner Sandoz will complete three batches of validation in Slovakia in the second half of the year, there is a great chance of submitting a drug license application to the FDA in the third quarter of next year, and we will continue to pay attention."

Commercial • FDA filing • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

[Announcement] The U.S. Food and Drug Administration (FDA) has officially accepted the drug license review application for the biosimilar drug EG12014 (Trastuzumab Biosimilar) 150 mg frozen crystal injection submitted by Sandoz, the authorized partner of Taikang Biotech. [Google translation] (stock.yahoo) - "The U.S. Food and Drug Administration (FDA) has officially accepted the drug license review application for the biosimilar drug EG12014 (Trastuzumab Biosimilar) 150 mg frozen crystal injection submitted by Sandoz, the authorized partner of Taikang Biotechnology...Use: Treat early breast cancer, metastatic breast cancer and metastatic gastric cancer....EG12014 (Trastuzumab Biosimilar) in patients with HER2-positive early breast cancer."

FDA approval • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Taikang Biotech’s breast cancer drug FDA drug license review review starts in Q4, CDMO performance is improving and outlook is optimistic [Google translation] (stock.yahoo) - "Sandoz, the authorized partner of Taikang Biotechnology (6589), has submitted a drug license application review to the US FDA for EG12014 150 mg frozen crystal injection in June. The review is expected to be completed in the fourth quarter, Chairman Liu Lizheng said, it is very important to pass the review this time, as it affects whether the plan to submit another dose of 420 mg injection for drug license application in the third quarter of next year can proceed as scheduled...The other dose is 420 mg. Sandoz expects to complete three confirmed batches in Slovakia in the second half of this year....and launch it in 2026. The mainstream in the US market is 420 mg."

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

[Announcement] Sandoz, the authorized partner of Taikang Biotech, proposed the biosimilar drug EG12014 (Trastuzumab Biosimilar) 150 mg frozen crystal injection and submitted a drug license application review to the US FDA. [Google translation] (stock.yahoo) - "Sandoz, the authorized partner of Taikang Biotech, proposed the biosimilar drug EG12014 (Trastuzumab Biosimilar) 150 mg frozen crystal injection and submitted a drug license application review to the US FDA...on June 13, 2024, U.S. time....Use: Treat early breast cancer, metastatic breast cancer and metastatic gastric cancer. EG12014 (Trastuzumab Biosimilar) in patients with HER2-positive early breast cancer."

FDA filing • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Popular Stock - Taiwan Kangsheng's revenue surges, legal support [Google translation] (stock.yahoo) - "Tai Kangsheng is developing a Herceptin biosimilar drug EG12014 for the treatment of breast cancer. The U.S. drug license application is still filling in the missing parts such as freeze-drying equipment. The market expects that after completing the supplements, it can obtain the U.S. drug license in the second half of the year, and there will be a milestone by then. Jin Keyi notes; the second-generation EG1206A will also have opportunities for external licensing before the end of the year."

FDA approval • Licensing / partnership • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Breast cancer ranks first among female cancers in Taiwan for 19 consecutive years! Taikang Biotechnology took ten years to develop the first biosimilar drug. Zeng Xinying said on the platform, 'I hope breast cancer will one day become a chronic disease.' [Google tranlation] (Business Today) - "Before the Lunar New Year, Taikang Biotech (6589) released the epoch-making achievement of ten years of investment, the breast cancer drug EG12014. This is the first biosimilar drug independently developed by a Taiwanese pharmaceutical company and obtained marketing approval....EG12014 has obtained drug certificate from the Food and Drug Administration of the Ministry of Health and Welfare and European marketing authorization from the European Commission (EC), and is expected to obtain the U.S. FDA drug certificate in the second to third quarter of 2024."

BLA • Non-US regulatory • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Taikang Biotechnology’s breast cancer treatment drug EG12014 is launched, which will boost the global operation scale [Google translation] (Yahoo News) - "Taikang Biotech...held a launch conference for the breast cancer treatment drug EG12014 on the 27th; EG12014 is the first HER2 breast cancer drug independently developed and produced by a local pharmaceutical company in Taiwan and applied for global marketing approval."

Biosimilar launch • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

TAIKANG’S BREAST CANCER BIOSIMILAR DRUG HAS BEEN APPROVED BY THE EUROPEAN COMMISSION FOR MARKETING [Google translation] (EirGenix Press Release) - "Taikang Biotech...licensed the biosimilar drug EG12014 (Trastuzumab Biosimilar 150 mg, intravenous use) for breast cancer and gastric cancer to Sandoz AG. Last night on 11/16, it received the marketing authorization approval from the European Commission (EC). Officially used and sold in the European market. EG12014 is indicated for the treatment of human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and metastatic gastric cancer, which is the same indication as the EMA-approved control biologic drug Herceptin."

European regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Tai Kangsheng CDMO plans to return to growth next year; EG1 will be supplemented by the end of 2014 [Google translation] (MoneyDJ) - P1 | N=135 | NCT05471648 | Sponsor: EirGenix, Inc. | "Affected by the vaccine stock solution and the general environment, Taikang Biotech (6589)'s professional drug manufacturing (CDMO) business declined significantly in the first eight months...As for the self-owned drugs, the date for the replacement of the anti-breast cancer drug EG12014 has been postponed to the end of this year. If everything goes well, it will be certified in the third quarter of next year. The other EG1206A will strive to be authorized before the second quarter of next year....The market is paying more attention to the progress of the more competitive EG1206A. With phase I clinical data showing positive results, it plans to launch phase III trials in the third quarter of next year and complete authorization before the second quarter."

Commercial • New P3 trial • P1 data • Breast Cancer • Oncology • Solid Tumor

Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive (EIN News) - "On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Herwenda, intended for the treatment of HER2-positive breast and gastric cancer. The applicant for this medicinal product is Sandoz GmbH....Herwenda will be available as a 150 mg powder for concentrate for solution for infusion."

European regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors. (ASCO 2023) - P1/2 | "BDC-1001 incorporates a trastuzumab biosimilar (EG12014) conjugated to a proprietary TLR7/8 agonist using a non-cleavable linker and a cell membrane-impermeable payload. An international phase 1/2 study was initiated to evaluate the safety of BDC-1001 ± nivolumab (nivo) and to identify the recommended phase 2 dose (RP2D) considering PK/PD analyses and preliminary efficacy... BDC-1001 mono and combo were well-tolerated. Targeted serum exposure levels were achieved, and encouraging clinical activity was noted in heavily pretreated pts with various HER2 positive tumors, especially in the 20 mg/kg q2w cohorts. Immune biomarker changes from plasma and tumor were consistent with MoA of this ISAC."

Clinical • IO biomarker • Metastases • P1/2 data • Tumor mutational burden • Cardiovascular • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Solid Tumor • Ventricular Tachycardia • HER-2

EGC002: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer (clinicaltrials.gov) - P3 | N=807 | Completed | Sponsor: EirGenix, Inc. | Active, not recruiting ➔ Completed

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

A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 (EirGenix Trastuzumab) with Herceptin® as Neoadjuvant Treatment in Combination with Anthracycline/Paclitaxel-based Systemic Therapy in Patients with HER2-positive Early Breast Cancer (EBCC 2022) - " Neoadjuvant phase: 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintece dose: 6 mg/kg) and paclitaxel (175 mg/m2) every 3 weeks for 4 cycles. This study demonstrated that EG12014, a proposed trastuzumab biosimilar, matches reference trastuzumab in terms of efficacy, safety, PK and immunogenicity."

Clinical • Combination therapy • P3 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 • ER • HER-2 • PGR

A phase III, randomized, multicenter, double-blind study to compare efficacy and safety of EG12014 (EirGenix trastuzumab) with Herceptin ® as neoadjuvant treatment in combination with anthracycline/paclitaxel-based systemic therapy in patients with HER2-positive early breast cancer - a multinational phase III study conducted during the COVID-19 pandemic (SABCS 2021) - P3 | " Neoadjuvant phase : 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m 2 ) and cyclophosphamide (600 mg/m 2 ) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) and paclitaxel (175 mg/m 2 ) every 3 weeks for 4 cycles. EG12014 has shown equivalent efficacy to Herceptin in regard to clinical response (pCR) and has also demonstrated a similar safety profile. The impact of the COVID-19 pandemic has been comparable between the two treatment arms. The influence of the pandemic on this clinical study has been relatively low considering timing and the participating countries."

Clinical • Combination therapy • P3 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 • ER • HER-2 • PGR

EGC002: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer (clinicaltrials.gov) - P3 | N=807 | Active, not recruiting | Sponsor: EirGenix, Inc. | Unknown status ➔ Active, not recruiting | Trial completion date: Jan 2022 ➔ Sep 2022

Combination therapy • Enrollment closed • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Sandoz submits Marketing Authorization Application for proposed biosimilar trastuzumab to EMA (GlobeNewswire) - "Sandoz...announced that it has submitted a Marketing Authorization Application for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the European Medicines Agency (EMA)."

European regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA (GlobeNewswire) - "Sandoz...announced the submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) developed by EirGenix, Inc. to the US Food and Drug Administration (FDA)....Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data."

BLA • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov) - P2; N=1250; Not yet recruiting; Sponsor: ECOG-ACRIN Cancer Research Group

Clinical • New P2 trial • 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 • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • ER • PGR

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy (clinicaltrials.gov) - P2; N=1250; Recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • 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 • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • ER • PGR

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov) - P3; N=312; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting

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