CBX - China Biotech XYZ

Beigene has submitted the IND application for its anti-EGFR×c-MET×c-MET tri-specific antibody BG-T187 in China. This marks the company's first in-house tri-specific antibody entering the clinical stage. In NSCLC, BeiGene has strategically targeted numerous molecular pathways, including PD-1, TIGIT, TIM3, LAG3, OX40, PanKRASi, HPK1, PRMT5i, B7H3 ADC, CEA ADC, and EGFR degrader. BG-T187 EGFR is a critical biomarker for the diagnosis and treatment of non-small cell lung cancer (NSCLC). Beigene had not previously targeted this pathway, but they have now discovered therapeutic approaches beyond single inhibitors, such as TsAb and degraders. Prevalence of EGFRm in NSCLC BG-T187 is an anti-EGFR×c-MET×c-MET tri-specific antibody that is registered as a monotherapy or in combo with the other therapeutic agents (not disclosed) in the phase 1 trial ( NCT06598800 ).  In 2023, Beigene submitted a patent (WO2024153168) covering anti-cMET antibodies, including multispecific antibodies such as the...

Beigene has submitted the IND application for the PRMT5 (Protein arginine methyltransferase 5) inhibitor BGB-58067 in China. This aligns with the plan to enter the clinic in Q4 2024. BGB-58067 BGB-58067 is a second-generation MTA-cooperative PRMT5 inhibitor with brain-penetrating and good intracranial efficacy. MTAP-deletion lung cancer and GI cancers are the target diseases for the PRMT5 inhibitor. 2nd generation PRMT5 inhibitor BG PRMT5i In 2019 and 2023, Beigene filed patents for PRMT5 inhibitors, providing several examples. Patents [Update]  In September 2024, Beigene registered a phase 1 trial ( NCT06589596 ) of BGB-58067 monotherapy in solid tumors patients. The potential of combining PRMT5 inhibitor with IO therapy (anti-PD-1, etc.) may be explored. PRMT5 Inhibitors in China Currently, no PRMT5 inhibitors are under investigation in the clinical stage. SIM0272 , discovered by Simcere, was terminated from the phase 1 trial as an R&D strategy adjustment.  GTA182 GT...

 InnoCare has initiated the global phase 3 trial of orelabrutinib plus bendamustine and rituximab in patients with 1L MCL. Seeking opportunities in the United States In 2020, the China NMPA authorized the first market approval of Orelabrutinib for rrMCL and rrSSL/CLL. Then, in 2023, Orlabrutinib became the first BTK inhibitor for rrMZL in China. As announced at the 2024 J.P. Morgan Healthcare Conference, more than 30,000 patients have received Orelabrutinib, leading to an increase in annual sales to approximately 671 million RMB (equivalent to 93 million USD) at a rate of 18.5%. Orelabrutinib The United States is a dream destination for Chinese domestic biopharma, including InnoCare. According to InnoCare's presentation, they plan to submit an NDA seeking approval for rrMCL in the US in Q3 2024 . However, the FDA has become more strict in recent years regarding confirmatory trials for drugs that have conditional approvals. This action was taken because the promised trials we...

 Beigene has registered a Phase 1 clinical trial ( NCT06233942 ) of BG-C9074, an anti-B7H4 antibody-drug conjugate (ADC), as monotherapy or in combination with tislelizumab: enrolling approximately 150 patients with pretreated solid tumors. The study (still no IND application submission in China yet) is estimated to start in May 2024, which is in line with the target for 2024 H1. BG-C9074 According to the Beigene slide deck, BG-C9074, a novel B7-H4-targeted ADC with a drug-to-antibody ratio (DAR) of 6 , is designed to balance efficacy and toxicity, utilizing DualityBio ADC technology.  BG-C9074 The efficacy of BG-C9074 was evaluated in a B7-H4 low/heterogeneous PDX model, as measured by tumor volume reduction. The 10 mpk dose resulted in a greater degree of tumor shrinkage compared to the 3 mpk dose. B7-H4 low/heterogeneous PDX model In addition to BG-C9074, Beigene plans to initiate another ADC targeting B7-H3 with stable DAR8 and a strong bystander effect. ------------...