Korea:196170

Alteogen Receives European Commission Approval for Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

* EYLUXVI® is the second biosimilar approved for Alteogen following the launch of the Herceptin® biosimilar in China through its partner Qilu Pharmaceutical. DAEJEON, South Korea, Sept. 17, 2025 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the European Commission (EC) has ...

2025-09-17 15:40 1944

Alteogen Receives Positive CHMP Opinion for Aflibercept Biosimilar, 'EYLUXVI® (ALT-L9)'

* CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing EYLUXVI® to the reference product Eylea® * Upon approval, EYLUXVI® will be Alteogen's second biosimilar product, following a Herceptin® biosimilar by Alteogen's license partner Qilu Pharm...

2025-07-28 14:00 1841

Alteogen enters into an Exclusive License Agreement to Develop and Commercialize Subcutaneous ENHERTU® Enabled by Alteogen's Hybrozyme™ Technology

DAEJEON, South Korea, Nov. 10, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the company has entered into an exclusive license agreement with Daiichi Sankyo (TSE: 4568). Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteo...

2024-11-11 08:07 2227

Alteogen Receives Ministry of Food and Drug Safety (MFDS) Approval for Tergase®

* Tergase® poised to capture a fair share of the global hyaluronidase market. DAEJEON, South Korea, July 8, 2024 /PRNewswire/ -- Alteogen Inc.  (KOSDAQ:196170) announced that the Ministry of Food and Drug Safety (MFDS) of Korea approved its New Drug Application (NDA...

2024-07-08 21:00 2802

Altos Biologics Files for Approval of Aflibercept Biosimilar

DAEJEON, South Korea, July 1, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ: 196170) announced on July 1st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept bi...

2024-07-02 08:00 3593

Alteogen's Tergase® (Novel Recombinant Human Hyaluronidase Injection) Shows Excellent Immunogenicity Profile

Alteogen expects Tergase® will replace commercially available animal-derived hyaluronidase products and their significant disadvantages.  Compared with other commercially available hyaluronidase products, Tergase® showed no incidence of anti-drug antibodies (ADA).  The occurrence of ADA is known ...

2023-09-05 20:00 1876

Altos Biologics, a Subsidiary of Alteogen, Completed Patient Enrollment in Global Phase 3 Clinical Trial of Eylea® Biosimilar in Neovascular Age-related Macular Degeneration

* Altos Biologics, a subsidiary of Alteogen, is actively engaged in Eylea®  Biosimilar (ALT-L9) clinical development and licensing-out discussions. * Early 2024 projected for Phase 3 completion and product launch in Europe expected after obtaining approval in the first half of 2025. DAEJEON, So...

2023-02-22 22:00 3013