Tanvex BioPharma, Inc. (“Tanvex” or “the Company”, TWSE: 6541), the biosimilar-focused biopharmaceutical company and CDMO, today announced that its Board of Directors has appointed Stephen Lam as the Company’s Chief Executive Officer, effective September 5th, 2024. Stephen succeeds Henry Chen, who shall remain the Chairman until the closing of Tanvex’s strategic alliance with Bora Pharmaceuticals […]

Tanvex BioPharma Inc. (TWSE: 6541) announced that the Board of Directors approved the acquisition of Bora Biologics Co., Ltd. (“Bora Biologics”), a CDMO subsidiary of Bora Pharmaceuticals (“Bora”). This strategic alliance will bring together Bora’s extensive CDMO capabilities and total service culture with Tanvex’s scale, development expertise and USFDA-approved commercial-scale facility in San Diego, California, […]

SAN DIEGO, August 19, 2024 (Newswire.com) – Tanvex BioPharma USA, Inc. (“Tanvex” or the “Company”), a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, recently announced that the U.S. Food and Drug Administration (FDA) approved NYPOZI™ (filgrastim-txid), the Company’s biosimilar referencing Neupogen®,1 to treat chemotherapy-induced neutropenia in cancer patients. The […]

Tanvex BioPharma, Inc. (TWSE: 6541) announced that US Food and Drug Administraion (FDA) has accepted its trastuzumab (TX05) BLA resubmission which was resubmitted in July. This moves Tanvex a step closer toward a BLA approval from FDA. The BsUFA date is in early January of 2025. TX05, a biosimilar product of Herceptin, is the second […]

Tanvex BioPharma, Inc. (TWSE: 6541) which holds Taiwan’s first biosimilar drug marketing authorization issued by the US Food and Drug Administration (FDA), resubmits the biologics license application (BLA) for trastuzumab (TX05) to the US FDA, a biosimilar product of Herceptin, on July 06, 2024 (Taiwan Time). TX05 is the second biosimilar drug product independently developed […]

Tanvex BioPharma, Inc. (TWSE: 6541) announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of NYPOZI (TX01) and approved the biologics license application (BLA) on June 28, 2024. “This milestone has moved the company beyond being a clinical/developmental stage company to a commercial company in the U.S.”, said […]