TAA013 / BioDlink - LARVOL DELTA

Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023) - "Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35,..."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

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) - “TOZ309 (temozolomide capsule): Pre-approval registration inspection was completed, and it is expected to be approved for marketing in the first half of 2021. TAA013 (anti-HER2 ADC) (HER2-positive breast cancer): Phase III clinical trials were initiated in June 2020 with the first patient enrolled in July, and it is currently at the stage of clinical recruitment. It is planned to be launch in the market in 2023.”

Launch non-US • Non-US regulatory • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology