The organization reaffirmed its "buy" rating on BEIGENE (06160) and is optimistic about its strong tumor drug development pipeline.
20/12/2024
GMT Eight
Recently, BEIGENE (06160) held an investor conference call to introduce important data presentations at the American Society of Hematology (ASH) and the San Antonio Breast Cancer Symposium (SABCS). Subsequently, TD Cowen reiterated a "buy" rating for BEIGENE, maintaining a target price of $260.00, which was in line with the consensus of many analysts who believed that the stock had potential for upward movement.
The institution emphasized BEIGENE's recent presentations at scientific meetings, particularly praising the strength of its oncology drug development pipeline. BEIGENE's progress at the American ASH annual meeting and the San Antonio Breast Cancer Symposium was especially impressive, showcasing promising data.
In terms of hematologic malignancies, TD Cowen analysts stated that BEIGENE's BTK inhibitor zanubrutinib, BCL-2 inhibitor sonroctoclax, and BTK CDAC (chimeric degrader activating compound) BGB-16673, these three cornerstone drugs provided the best treatment options, further solidifying the company's leading position in the field of hematologic malignancies.
It is understood that zanubrutinib has been approved in over 70 countries with the widest range of indications. In the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients (including high-risk patients (17p/TP53)), zanubrutinib has shown sustained efficacy compared to first-generation BTK inhibitors, once again demonstrating its "best in class" strength. At the 2024 ASH annual meeting, BEIGENE presented 5-year follow-up data from the SEQUOIA study, showing that zanubrutinib used in the treatment of newly diagnosed CLL patients could reduce the risk of disease progression or death by 71% compared to bendamustine combined with rituximab, further solidifying its leading position in the treatment of newly diagnosed and relapsed/refractory CLL patients.
At the same time, BEIGENE's BCL-2 inhibitor sonroctoclax also demonstrated the potential of being "best in class", with over 1,300 patients already enrolled. According to BEIGENE, the combination of zanubrutinib and sonroctoclax has shown enormous potential for first-line treatment of CLL - with a median follow-up time of 19.4 months, the overall response rate (ORR) reached 99%, the best undetectable minimal residual disease (uMRD) rate reached 92%, and overall tolerability was good. This combination therapy is expected to provide better efficacy than the fixed-dose V-O regimen.
In terms of BTK CDAC, BEIGENE's BGB-16673 is currently the fastest progressing hematologic malignancy degrader in clinical development. Data from the Phase 1/2 CaDAnCe-101 study showed that BGB-16673 had good overall tolerability in patients who had received multiple prior treatments. Good anti-tumor activity was also observed in patients with high-risk features (including those with BTK inhibitor resistant mutations and those who had previously been treated with covalent BTK inhibitors, non-covalent BTK inhibitors, and BCL2 inhibitors). These early data suggest that BGB-16673 has the potential to be a "best in class" treatment choice for CLL patients and other BTK-driven B-cell malignancies. Based on the data from relevant studies, BEIGENE has planned a head-to-head study of BGB-16673 and ibrutinib.
It is reported that the combination of these three products will solidify BEIGENE's leadership position in the CLL field, while the different combinations between different molecules have the potential to become the best combination therapy options to meet various treatment needs. In the future, core drugs will continue to expand into new indications with significant unmet medical needs, such as acute myeloid leukemia/myelodysplastic syndrome, multiple myeloma, Richter's transformation, and diffuse large B-cell lymphoma.
In terms of solid tumors, BEIGENE's BGB-43395 is a novel CDK4 inhibitor with the potential to be "best in class", exhibiting early safety and tolerability data at the SABCS poster presentation. In the first year of clinical research, BGB-43395 has already enrolled over 120 patients, with Phase 1a data showing good safety and tolerability for its use in HR+/HER2- breast cancer treatment. TD Cowen analysts stated that the preliminary pharmacokinetic and safety data, as well as early efficacy indicators, were encouraging, demonstrating BEIGENE's strong potential in addressing various types of cancer. In the field of breast cancer and gynecologic tumors, in addition to small molecule CDK inhibitors, BEIGENE's pipeline products also include ADCs and novel BCL2 inhibitors.
Over the past few years, BEIGENE has built a deep and differentiated drug portfolio in the field of solid tumors, gradually expanding from immunotherapy to a diversified pipeline focusing on disease types. By 2025, BEIGENE is expected to maintain strong momentum in breast cancer, lung cancer, and gastrointestinal cancer. BEIGENE stated that multiple clinical molecules will read out a large amount of data in the next 12 months, including CDK4 inhibitors, CDK2 inhibitors, Pan-KRAS inhibitors, EGFR CDAC, PRMT5 inhibitors, MAT2A inhibitors, B7H4 ADC, CEA ADC, FGFR2B ADC, etc.
Currently, BEIGENE's research pipeline has diversified treatment modalities and technological platforms, and with its "fast concept validation" strategy and leading clinical execution speed, it is driving numerous innovative new molecular entities into clinical trials. It is reported that the company has a reserve of 69 pre-clinical pipelines, covering small molecules (CDACs, traditional small molecules), large molecules (bispecific/multispecific, ADCs, etc.), as well as cell therapies and mRNA.