Sandoz AG received a positive CHMP opinion for the biosimilar drug EG12014 licensed from EirGenix, Inc.

Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab

https://www.sandoz.com/news/media-releases/sandoz-receives-positive-chmp-opinion-breast-and-gastric-cancer-biosimilar-trastuzumab

2023-09-18

Associated News

EIRGENIX ACHIEVES THE FOURTH MILESTONE OF ITS TRASTUZUMAB BIOSIMILAR LICENSING AGREEMENT

2021/07/21

HONG HAI/FOXCONN FOUNDER TERRY GUO ANNOUNCES INVESTMENT TO ACCELERATE EIRGENIX’S GLOBAL EXPANSION

2021/04/06

POSITIVE PHASE III CLINICAL RESULTS FOR EIRGENIX'S PROPOSED TRASTUZUMAB BIOSIMILAR

2021/03/23

EIRGENIXは日本市場を拡大するために、日本の会社と長期供給契約の締結について

2021/03/02

VSTRIP® COVID-19 ANTIGEN RAPID TEST VALIDATED AND APPROVED IN INDIA!

Vstrip® COVID-19 Antigen Rapid Test Validated and Approved in India!

2020/09/26

EIRGENIX ACHIEVES THE THIRD MILESTONE OF ITS TRASTUZUMAB BIOSIMILAR LICENSING AGREEMENT

2020/09/11

EIRGENIX RECEIVES 2020 BIOPROCESSING EXCELLENCE IN GREATER CHINA REGION AWARD!

2020/07/07

EIRGENIX ACHIEVES THE SECOND MILESTONE OF ITS BIOSIMILAR TRASTUZUMAB - LICENSING AGREEMENT

2020/03/09

EIRGENIX RECEIVES APPROVAL FROM JAPAN'S PMDA

2020/02/03

EIRGENIX COLLECTS ITS INITIAL SIGNING FEE DAYS BEFORE ITS OFFICIAL IPO

2019/06/27

EIRGENIX INC. ANNOUNCES 3-DAY STOCK OPTION BIDDING AHEAD OF ITS LATE-JUNE IPO

2019/06/10

EIRGENIX HOLDS ITS PRE-IPO PRESS CONFERENCE

2019/05/29

EIRGENIX SIGNS TRASTUZUMAB BIOSIMILAR LICENSE AGREEMENT WITH NOVARTIS SANDOZ

2019/04/30

EIRGENIX AWARDED FOR ITS INNOVATION AT THE NATIONAL INDUSTRIAL INNOVATION AWARDS

2019/04/10

EIRGENIX, INC. WINS BEST BIOPROCESS EXCELLENCE IN TAIWAN AWARD

2019/02/27

EIRGENIX, INC. OFFICIALLY OPENS ITS NEW WORLD-CLASS COMMERCIAL MASS PRODUCTION FACILITY

2019/01/23

EIRGENIX'S PHASE III CLINICAL TRIAL OF EG12014 HAS ENROLLED FIRST PATIENT

2018/10/30

CANCER THERAPEUTIC DRUG EG12014 IS APPROVED FOR PHASE III CLINICAL TRIAL

2018/05/22

EIRGENIX IS AWARD TOP 145 OF THE TECHNOLOGY FAST 500 COMPANIES IN ASIA PACIFIC (APAC)

2018/05/09

EIRGENIX RECEIVED "ASIA'S BEST CMO"

2018/01/31

EIRGENIX RECEIVED THE ACCREDITATION CERTIFICATE OF FOREIGN DRUG MANUFACTURER FROM JAPAN

2017/11/08

EIRGENIX HELD THE WHOLE NEW "PROTEIN DRUG COMMERCIAL PRODUCTION PLANT" BEAM-RAISING CEREMONY

2017/10/19

CANCER THERAPEUTIC DRUG EG12014 PASSED THE DOUBLE-BLINDED PHASE I CLINICAL TRIAL

2017/05/02

EIRGENIX RECEIVED "GRAND WINNER OF BEST BIOPROCESS EXCELLENCE IN TAIWAN"

2017/02/16

EIRGENIX HELD THE WHOLE NEW "PROTEIN DRUG COMMERCIAL PRODUCTION PLANT" GROUNDBREAKING CEREMONY

2016/12/30

2015 TAIWAN BIO-MEDICAL AND NEW AGRICULTURAL INDUSTRY DRAFT COMPETITION AWARDS CEREMONY

2015/09/24

EIRGENIX AND FORMOSA LABORATORIES COLLABORATE TO ESTABLISH A PLATFORM FOR ADC CMC INTEGRATION SERVIC

2014/06/23

EIRGENIX DEVELOPS AND MANUFACTURES BIOLOGICS

2013/12/06

EG12014'S PHASE III CLINICAL TRIAL INTERIM RESULTS PUBLISHED AT SAN ANTONIO BREAST CANCER SYMPOSIUM

2021/12/08

BIOLOGICS LICENSE APPLICATION (BLA) SUBMITTED TO U.S FDA FOR EIRGENIX'S TRASTUZUMAB BIOSIMILAR

2021/12/18

MARKETING AUTHORIZATION APPLICATION (MAA) SUBMITTED FOR EIRGENIX'S TRASTUZUMAB BIOSIMILAR TO EMA

2021/12/21

EIRGENIX ACHIEVES THE FIFTH MILESTONE OF ITS TRASTUZUMAB BIOSIMILAR LICENSING AGREEMENT

2022/01/26

EIRGENIX COMPLETES NEOADJUVANT TREATMENT AND SURGERY FOR LAST PATIENT IN PHASE III CLINICAL TRIAL

2020/11/08

EirGenix Completed Its NTD 5.03 Billion Private Placement on the Fifteenth of October

2021/10/15

EIRGENIX'S REVENUE REACHES A RECORD HIGH IN JUNE

2019/07/10

EirGenix rated top 5% Corporate Governance Evaluation at TPEx after second year of the IPO

2022/05/04

EirGenix's Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives

2023/05/01

National Pharmaceutical Technology & Research Development (PTRD) "Gold Award" !

2023/11/22

EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC

2023/11/17

EirGenix Inc. Achieves Major Milestone: Breast Cancer Biosimilar Candidate -EG1206A Receives Favorable Response Regarding Phase III Clinical Trial Waiver

On September 24, EirGenix (6589) announced that it has received positive feedback from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) during scientific consultations regarding the waiver of Phase III clinical trials for its breast cancer biosimilar candidate, EG1206A (Pertuzumab biosimilar). Consequently, the company has officially terminated the on-going Phase III clinical trial for EG1206A. This decision accelerates the global marketing authorization applications (BLA/MAA) for the product and reduces the originally planned product development expenses. Receiving positive feedback from regulatory agencies reflects EirGenix’s long-standing expertise in biosimilar development and marks a significant milestone in the company’s expansion in the biosimilar market.

2025/10/22

EirGenix Signed The Commercial Licensing Agreement for Its Second HER2 Biosimilar Asset EG1206A

2025/11/12

EirGenix Signs Licensing and Commercialization Agreement with Japanese Pharmaceutical Company for EG1206A in Japan

2026/06/30