CBX - China Biotech XYZ

 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...

Dizal Pharma has initiated a phase 2 study ( CTR20240120 ) of DZD8586, a fully blood-brain barrier (BBB) penetrable LYN/BTK dual inhibitor, for the treatment of CLL/SLL in China. The sponsor aims to enroll an estimated 155 patients with rr-CLL/SLL. The patients in the three groups will receive DZD8586 at doses of 25 mg, 75 mg, and 100 mg. https://doi.org/10.1038/nchembio.502 Recently, Dizal highlighted various results from preclinical and clinical studies of DZD8586. As DZD8586 inhibits both LYN and BTK simultaneously, it demonstrated anti-proliferative effects in cell lines expressing C481X and pirtobrutinib resistance mutations . Additionally, DZD8586 exhibited potent cell growth inhibition and induced cell death in a variety of DLBCL cell lines. Moreover, it demonstrated profound tumor growth inhibition in both CNS tumor models, attributed to its specific blood-brain barrier (BBB) penetration. DZD8586 demonstrated consistent results in the early human study . The dose escalation a...