TX05 (trastuzumab biosimilar) / Tanvex BioPharma - LARVOL DELTA

Taifu’s breast cancer biosimilar drug TX05 fails again in court with the US FDA [Google translation] (money.udn.com) - "Taifu-KY...announced on the 6th that the anti-breast cancer biosimilar drug TX05 (Herceptin Biosimilar) developed by the company has not yet passed the U.S. Food and Drug Administration (FDA) marketing inspection due to inspection issues at the downstream filling and packaging factory. Registration (BLA) review, Taifu will negotiate with downstream manufacturers to improve and respond to the FDA...However, Taifu's stock price on the 6th was not affected by the negative news of the failure of the TX05 drug in the United States....Tanvex announced that its subsidiary Tanvex BioPharma USA, Inc received a notification (CRL) from the U.S. Food and Drug Administration (FDA) on January 3, 2025, West Coast time. According to the content of the CRL, the biosimilar drug TX05 was blocked by downstream filling and packaging plants. There are still unfinished matters to be improved, so it has not yet passed the listing inspection registration (BLA) review on January 3, 2025, West Coast time."

CRL • Gastric Cancer • HER2 Positive Breast Cancer

Taifu-KY subsidiary received an official letter from the FDA stating that it accepted the drug license application for the biosimilar drug TX05 [Google translation] (MoneyDJ) - "Tanvex BioPharma USA, Inc., a subsidiary of Tanvex-KY-, announced that the U.S. FDA has officially accepted the drug license application data application for the biosimilar drug TX05 (Herceptin Biosimilar)."

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

Analysis of therapeutic monoclonal antibodies by imaged capillary isoelectric focusing (icIEF). (PubMed, Anal Methods) - "We also tested the method's performance using multiple lots of another IgG1 mAb, commercially available as Herceptin (trastuzumab). Additionally, we designed and assessed native and denaturing platform icIEF methods for 11 other marketed mAbs, with pIs ranging from 6.0 (eculizumab) to 9.22 (tocilizumab)."

Journal

[Announcement] Tanvex BioPharma USA, Inc., a subsidiary of Tanvex-KY, has submitted drug license application materials for the biosimilar drug TX05 (Herceptin Biosimilar) to the U.S. Food and Drug Administration (FDA) [Google translation] (stock.yahoo) - "Purpose: Subsidiary Tanvex BioPharma USA, Inc. has submitted drug license application materials for the biosimilar drug TX05 (Herceptin Biosimilar) to the U.S. Food and Drug Administration (FDA)...Usage: Same as the reference drug Herceptin, except that the main indication is breast cancer, it also includes gastric cancer...Accumulated R&D expenses invested: Based on the possibility of future international cooperation on the TX05 product or due to trade secret considerations....In order to protect the rights and interests of the company and investors, it will not be disclosed publicly."

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

Taifu-KY moves forward with both feet to expand revenue as soon as possible; no additional capital increase is required this year [Google translation] (MoneyDJ) - "Reorganizing its positioning, macromolecular drug manufacturer Taifu-KY...actively reduced unnecessary waste in the first half of the year, expanded its business opportunities in professional drug manufacturing (CDMO), and confirmed its strategy of advancing with its own product lines. CEO Chen Linzheng...said that the U.S. drug license application for TX01 is in the final stage, and he hopes to obtain the certificate and launch it as soon as possible. In addition, TX05 will also be supplemented as soon as possible, and there is no need to apply for a capital increase this year...As for its own products, Chen Linzheng said that TX01 is in the final stage of drug license review. The good news is that according to the latest response from the FDA, it is possible that injection and drip dosage forms will be marketed together again....It is estimated that the supplements will be completed before the middle of the third quarter."

Commercial • FDA event • FDA filing • Breast Cancer • Gastric Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

'Biomedical Stocks' Taifu focuses on the listing of TX01 and TX05 to expand CDMO capacity Google translation] (stock.yahoo) - "Taifu-KY (6541) held a briefing today (1) afternoon. Chairman Chen Linzheng emphasized that the core strategy of focusing on biosimilars and deploying CDMOs remains unchanged. With its technological advantages, in the future, it will focus more on maximizing the value of TX 01 and TX 05 after they are launched, while expanding CDMO service capacity and reaching new milestones....Taifu Biotechnology is currently awaiting notification of the final review conclusion from the U.S. FDA for its TX 01 drug marketing inspection and registration review application. According to communications with the U.S. FDA, all received positive responses. The company said it hopes to share the news with everyone soon."

Commercial • FDA event • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Comparative analysis of Herceptin N-Linked glycosylation by HILIC-FLD and LC-MS/MS methods. (PubMed, J Pharm Biomed Anal) - "However, despite these differences, both methods demonstrated a strong correlation in relative glycan proportions. This study contributes to the comprehensive analysis of Herceptin's glycosylation, offering insights into the influence of analytical methods on glycan quantification and providing valuable information for the biopharmaceutical industry."

Journal

TX05-03e: Adjuvant treatment following neoadjuvant treatment and surgical resection in TX05-03, a trial comparing the safety, efficacy, and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ EBC. (ASCO 2022) - P3 | "The rates of DFS, OS, AEs and immunogenicity were comparable in subjects randomized to TX05/TX05, TRA/TRA or TRA/TX05 for neoadjuvant/adjuvant treatment and continue to support the conclusion of biosimilarity of TX05 to the reference product. The change from TRA to TX05 for adjuvant treatment has no detectable impact on safety or treatment outcome."

Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 (clinicaltrials.gov) - P3 | N=338 | Completed | Sponsor: Tanvex BioPharma USA, Inc. | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

"#Tanvex submits #TX05 #BLA to #FDA https://t.co/ghZO1rufPn" (@1stOncology)

[VIRTUAL] Trial comparing the safety, efficacy and immunogenicity of trastuzumab biosimilar candidate (TX05) with originator trastuzumab in HER2+ early breast cancer (ESMO 2021) - P3 | "Treatment included four 3-week cycles of epirubicin and cyclophosphamide followed by four 3-week cycles of paclitaxel and TX05 or TRA. The pCR risk ratio was within the predefined equivalence margins, confirming therapeutic equivalence of TX05 and Herceptin. Secondary endpoints including ORR, safety and immunogenicity were comparable and support the conclusion of biosimilarity."

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO (Center for Biosimilars) - P3, N=809; NCT03556358; Sponsor: Tanvex BioPharma; “A phase 3 study of a trastuzumab biosimilar candidate (TX05) and reference product (Herceptin) has demonstrated equivalence in patients with human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer, according to findings presented at the European Society for Medical Oncology Congress 2021…Secondary end points were objective response rate (ORR), immunogenicity, safety, and tolerability…ORR was also highly similar between the TX05 (84.3%) and TRA (85.0%) groups, and findings for patients with complete response, partial response, and stable disease were also highly similar between cohorts.”

P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology

"Tanvex Presents Positive Findings for Trastuzumab #Biosimilar Candidate Referencing #Herceptin at #ESMO21 https://t.co/AcMRwcrQPi" (@BiosimCenter)

Oncology

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 (clinicaltrials.gov) - P3; N=338; Active, not recruiting; Sponsor: Tanvex BioPharma USA, Inc.; Enrolling by invitation ➔ Active, not recruiting

Clinical • Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov) - P3; N=809; Completed; Sponsor: Tanvex BioPharma USA, 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

Taifu TX05 breast cancer drug successfully solved blindness in the United States [Google translation] (Yahoo News) - "Taifu also brings good news, announcing that the TX05 breast cancer drug has successfully solved the blindness in the third phase. Apply for a drug certificate to the FDA and the US Food and Drug Administration will be listed in the United States as soon as 2023....the results of the phase III clinical trial of breast cancer drugs were released, confirming that the blindness was successfully solved in the United States....It is expected to report to the FDA in June. Apply for a drug certificate and it will be listed in the United States as early as 2023."

BLA • P3 data • Breast Cancer • Oncology

Taifu Dongzuo Zhao Yutian: Breast Cancer Drugs Get 300 Million USD in Sales within Three Years (udn.com) - "Taifu-KY (6541) Dong Zuo Yutian Zhao said today (21) that Taifu 's breast cancer biosimilar drug TX05...will apply to the U.S. Food and Drug Administration ( FDA ) for a drug certificate in the middle of this year . TX05 The initial sales in the US market were US$300 million (approximately NT$8.5 billion), and the company will also successfully turn losses into profits due to this drug."

FDA event • Sales • Breast Cancer • Oncology

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov) - P3; N=809; Active, not recruiting; Sponsor: Tanvex BioPharma USA, Inc.; Trial primary completion date: Jun 2020 ➔ Nov 2020

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

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 (clinicaltrials.gov) - P3; N=330; Enrolling by invitation; Sponsor: Tanvex BioPharma USA, Inc.; Trial completion date: Nov 2021 ➔ Feb 2022; Trial primary completion date: Aug 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Taifu-KY completed the capital increase before the end of KY. The company obtained the key process patent of the two drugs [Google translation] (money.udn.com) - "...obtained key process patents for its two self-developed drugs TX05 and TX16, and the chances of success in subsequent challenges to the original patents have greatly increased....Taifu's TX05 Phase III human clinical trial has been completed on October 21st, US time. It is expected to eliminate blindness in the first quarter of next year and submit a drug certification application to the US Food and Drug Administration (FDA) in the middle of next year. It will be launched in 2022; TX16 is going to undergo Phase III clinical testing. The legal person estimates that Taifu's TX-01 and TX-05 are expected to start sales in the third quarter of next year. The two drugs are expected to contribute more than 10 million US dollars in revenue."

Biosimilar launch • BLA • Patent • Sales • Trial status • Oncology

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov) - P3; N=809; Active, not recruiting; Sponsor: Tanvex BioPharma USA, Inc.; Recruiting ➔ Active, not recruiting

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

Taifu Biotech's TX05 phase III clinical trial completed (Yahoo News) - "Taifu Biotech...announced that its TX05 human phase III clinical trial, which began at the end of 2017, has been closed...the number of subjects in this clinical trial was 800, and the subjects were Adult women with early breast cancer who are diagnosed with HER2 (type 2 human epidermal growth factor receptor) positive."

Trial completion

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 (clinicaltrials.gov) - P3; N=330; Enrolling by invitation; Sponsor: Tanvex BioPharma USA, Inc.

Clinical • New P3 trial

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer (clinicaltrials.gov) - P3; N=800; Recruiting; Sponsor: Tanvex BioPharma USA, Inc.; Trial completion date: Mar 2020 ➔ Dec 2020; Trial primary completion date: Feb 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date