Pusintin (bevacizumab biosimilar) / BioDlink - LARVOL DELTA

Bevacizumab biosimilar candidate TAB008 compared to Avastin in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study. (PubMed, J Cancer Res Clin Oncol) - P3 | "TAB008 is similar to Avastin in terms of efficacy, safety, and pharmacokinetic parameters, with comparable immunogenicity."

Clinical • Journal • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=549 | Completed | Sponsor: TOT Biopharm Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TOT BIOPHARM Announces NMPA Granted Marketing Approval for Pusintin (TAB008, Bevacizumab Injection) in China (PRNewswire) - "TOT BIOPHARM International Company Limited...announced its self-developed Pusintin® (TAB008, bevacizumab injection) has been officially granted approval by the National Medical Products Administration ('NMPA') for marketing in mainland China (i.e., excluding Hong Kong, Macau and Taiwan regions) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer....The results from pharmaceutical studies, non-clinical studies, and clinical studies proved that Pusintin® has similar PK characteristics with the originator drug and presents clinically equivalent with highly similarity in safety and immunogenicity."

Non-US regulatory • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology

TOT BIOPHARM Anounces 2021 Interim Results (Yahoo Finance) - "Major milestones of key products in clinical trial...TAB008: the Group expects to receive approval for marketing of the drug by end of 2021."

Non-US regulatory • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Shengde Holding's sustainable cash flow model spawns the group's biotech unicorn [Goolge translation] (Yahoo News) - "Toyo Pharmaceutical focuses on innovation The development and commercialization of anti-tumor drugs and therapies, and is committed to becoming a competitive CDMO company in mainland China and a leading company in the ADC field. Its operating strategies have three:Consolidate the CDMO business: accelerate the promotion of monoclonal antibody biosimilar TAB008 , TAB014, TAA013, TOZ309 and other products on the commercialization process, after the project is sold, focus on the CDMO business."

Commercial • Oncology

TOT BIOPHARM Announces A Number of Key Anti-Tumor Drugs Have Entered the Pivotal Clinical Stage in 2020 (PharmiWeb) - “TAB008 (anti-VEGF mAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted...It is expected to be approved for marketing in 2021.”

Non-US regulatory • P3 data • Non Small Cell Lung Cancer • Oncology

Looking at the underestimated Toyo Pharmaceutical-B (1875.HK) from the ADC drug R&D wave? [Google translation] (jrj.com) - "According to SPDB International's rNPV valuation calculation, the share prices of its core products TAB008 and TAA013 are 5.6 and 3.5 Hong Kong dollars, respectively, and the overall valuation is 9.1 Hong Kong dollars per share. As of March 7, the company's stock price was 4.1 Hong Kong dollars. In other words, the current market valuation only reflects the value of TAB008 biosimilar drugs, and does not reflect the company's leading advantage in ADC."

Stock price • Oncology

[VIRTUAL] Biosimilar TAB008 compared with bevacizumab in advanced non:squamous, non-small cell, EGFR wildtype lung cancer patients (ESMO Asia 2020) - "Patients received 4-6 (3 week)cycles of paclitaxel/carboplatin plus TAB008 or Avastin® at 15mg/kg intravenously, followed by 7.5mg/kg maintenance dose until disease progression, unacceptable toxicity, or death. Legal entity responsible for the study: TOT BIOPHARM. Funding: TOT BIOPHARM."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Biosimilar TAB008 compared with bevacizumab in advanced nonsquamous, nonsmall cell, EGFR wildtype lung cancer patients (ESMO Asia 2020) - "Patients received 4-6 (3 week)cycles of paclitaxel/carboplatin plus TAB008 or Avastin® at 15mg/kg intravenously, followed by 7.5mg/kg maintenance dose until disease progression, unacceptable toxicity, or death. TAB008 is similar to bevacizumab(Avastin®) in terms of efficacy, safety, and pharmacokinetic parameters. TOT BIOPHARM."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

[VIRTUAL] Biosimilar TAB008 compared with bevacizumab in advanced nonsquamous, nonsmall cell, EGFR wildtype lung cancer patients (ESMO Asia 2020) - "Patients received 4-6 (3 week)cycles of paclitaxel/carboplatin plus TAB008 or Avastin® at 15mg/kg intravenously, followed by 7.5mg/kg maintenance dose until disease progression, unacceptable toxicity, or death. TAB008 is similar to bevacizumab(Avastin®) in terms of efficacy, safety, and pharmacokinetic parameters. TOT BIOPHARM."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Toyo Pharmaceutical-B (01875) first announced the results of TAB008 (bevacizumab injection) Phase III study at ESMO ASIA [Google translation] (Sina Corp) - "On November 22, TOTI Pharmaceutical-B ( 4.06 , -0.01 , -0.25% ) (01875) will be displayed in the form of an electronic poster (E-Poster) at the 2020 European Society of Medical Oncology Asia Annual Meeting (ESMO ASIA) The results of the Phase III clinical study of its self-developed bevacizumab biosimilar TAB008 (proposed trade name: Puxintin®, Pusintin®)."

P3 data • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology

The results of the Phase III study of Tojoo's bevacizumab injection will be announced soon [Google translation] (Sina Corp) - "The 2020 European Society of Medical Oncology Asia Annual Meeting (ESMO ASIA) will be held in the form of an online conference from November 20 to 22. At this ESMO conference, Toyo Pharmaceutical (1875.HK) will publish in the form of a poster Phase III clinical study data of TAB008 (proposed trade name: Pu Xin Ting®)."

P3 data • Oncology

TOYO's first self-developed biologic drug TAB008 is declared for listing and has commercial production advantages [Google translation] (Eastmoney.com) - "Toyo Pharmaceutical's first self-developed biologic drug TAB008 has been declared for commercialization and its advantages in commercial production."

Commercial • Oncology

The new drug listing application for TAB008's antibody drug TAB008 was accepted by the China Food and Drug Administration [Google translation] (ON.CC (BVI) LTD) - "Toyo Pharmaceuticals ( 01875 ) announced that the new drug listing application (this NDA) of the antibody drug TAB008 independently developed by the group in mainland China has been accepted by the National Medical Products Administration (NMPA)."

Non-US regulatory • Oncology

Shengde Q1 earns 0.51 yuan per share and reinvests (money.udn.com) - "In the field of medicine, Toyao Pharmaceutical Co., Ltd. has successfully achieved the Phase III clinical trial of its biologically similar drug TAB008. Follow-up will actively promote the application of mainland China's drug certificate. After the interview, the test results will provide the key design basis for the subsequent phase III clinical trials."

Clinical • Oncology

TOT BIOPHARM self-developed biological drug TAB008 (pusintin) meets primary endpoint in phase III clinical trial (PipelineReview) - P3, N=NA; "TOT BIOPHARM International Company Limited...is pleased to announce that the randomized Phase III clinical trial of TAB008 (Pusintin) has recently reached the predefined primary endpoint. The Company will continue to push forward the new drug application (NDA) of TAB008 (Pusintin) as scheduled."

NDA • P3 data • Oncology

A Phase I, Randomized, Single-Dose Study Evaluating the Biosimilarity of TAB008 to Bevacizumab in Healthy Volunteers. (PubMed, Front Pharmacol) - "Anti-drug antibody generation was reported once only in each group, and neutralizing antibody (Nab) analysis was negative upon follow-up. TAB008 attained pharmacokinetic similarity to bevacizumab, and was safe and well tolerated."

Clinical • Journal

A phase I, randomized, single-dose study evaluating the biosimilarity of TAB008 to bevacizumab in healthy volunteers (Frontiers) - P1, N=100; "TAB008 group and 22 (44.0%) subjects in the Avastin® group. TEAEs related to the study drug were reported for 19 (38.8%) subjects in the TAB008 group and 19 (38.0%) subjects in the Avastin® group. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 TEAEs were reported for 1 (2.0%) subject in the TAB008 group and 3 (6.0%) subjects in the Avastin® group."

P1 data

Tot Bio, Junshi pair bevacizumab biosimilar with PD-1 for HCC (GBI Health) - "China-based biotechs Tot Biopharm Co., Ltd, and Shanghai Junshi Biosciences Co., Ltd, (HKX.1877) agreed to pair Tot's TAB008, a biosimilar of Roche’s anti-VEGF monoclonal antibody (mAb) bevacizumab (Avastin), in combination with Junshi Bio’s toripalimab (JS001), an innovative recombinant human programmed death-1 (PD-1) monoclonal antibody (mAb). The combination therapy will be tried out as a treatment for advanced hepatocellular carcinoma (HCC). No financial details relating to the partnership were disclosed."

Licensing / partnership