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At 5:30 a.
m.
Beijing time on January 10, 2023, John V.
Smith, co-founder, chairman and CEO of BeiGene.
Mr.
Oyler attended the 41st J.
P.
Morgan Healthcare Annual Meeting
Conference) gave a presentation on Redefining Global
Biotech
。 The report showcases BeiGene's growth achievements since its inception in 2010, and unveils the company's latest pipeline and key growth plans
for 2023 and beyond.
Image source: Screenshot of BeiGene's speech report
The report notes that 2010~2020 was a productive first decade
for BeiGene.
During this period, the company has independently developed a new generation of BTK selective inhibitor zebratinib, anti-PD-1 monoclonal antibody tislelizumab, PARP inhibitor pamiparib and other innovative products, and these three new anti-tumor drugs have been approved for marketing
.
In addition, the company's innovative therapies for targets such as BRAF, TIM-3, OX40, TIGIT, Bcl-2, and PI3Kd have also entered different stages of clinical development
.
BeiGene said in the report that the company has entered a new era
of drug discovery in its second decade of existence.
Among them, a number of innovative drugs developed by the company have entered the clinical stage before 2023, including HPK-1 inhibitors, TYK2 allosteric inhibitors, second mitochondrial derived cysteine protease activators (SMAC) mimics, chimeric degradation activating compounds (CDAC) targeting BTK, CEA/4-1BB bispecific antibodies, etc.
; In 2023, at least 4 new molecular entities (NMEs) in the company's pipeline will see important progress; After 2024, BeiGene expects 10 new molecules to enter the clinic every year, including CDAC, bispecific/trispecific antibodies, mRNA therapy, CAR-NK and other cell therapies.
.
.
Image source: Screenshot of BeiGene's speech report
To date, BeiGene has reached nearly 20 industry collaborations with a number of companies; Nearly 50 projects of products under development are in the clinical and commercial stage, of which 16 products have been approved (including independent research and development and cooperative introduction products); In addition, the company has more than 60 preclinical programs, most of which have the potential
to become "first-in-class" new drugs.
According to the report, BeiGene's pipeline pipeline is expected to reach several important milestones in 2023, as follows
.
BTK inhibitor zebrutinib: In the first half of 2023, the US FDA will make a decision on the marketing application for a new indication for the treatment of lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL); It is expected to be approved for treatment-naïve CLL/SLL indications in China; FURTHER COMMUNICATE
WITH FDA AND EMA ON THE EFFICACY RESULTS OF THE HEAD-TO-HEAD STUDY ALPINE TRIAL.
In addition, the product is expected to be approved in Canada and Australia for the treatment of CLL/SLL patients
in 2023.
Anti-PD-1 monoclonal antibody tislelizumab: In the first half of 2023, the FDA will make a decision on the marketing application of this product for the second-line treatment of esophageal squamous cell carcinoma (ESCC); It is expected to be approved in China for the first-line treatment of gastric cancer and ESCC for two new indications
.
In the second half of 2023, it is expected to be approved in China for the first-line treatment of hepatocellular carcinoma (HCC), and submit a new indication application for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and gastric cancer.
It is expected to be approved in Australia for non-small cell lung cancer (NSCLC) and second-line treatment of ESCC; It is expected to be approved in the EU for the indication of NSCLC and second-line treatment of ESCC
.
In addition, the product is also expected to submit a first-line treatment of gastric cancer and ESCC in the United States and a marketing application for first-line treatment of gastric cancer, ESCC and nasopharyngeal cancer in the European Union in 2023.
Submission of new drug applications for first- and second-line treatment of
ESCC in Japan.
▲BeiGene's internal R&D pipeline (Image source: Screenshot of BeiGene's speech report)
▲BeiGene's internal R&D pipeline (Image source: BeiGene speech report screenshot) ▲▲Bcl-2 inhibitor BGB-11417: In the second half of 2023, a global pivotal trial in combination with zebratinib for the first-line treatment of CLL will be initiated, and data from ongoing clinical studies is expected to be available
.
Anti-TIGIT antibody osperlimab: data from Phase 2 clinical studies targeting multiple indications are expected and AdvanTIG, a Phase 3 study for the first-line treatment of NSCLC, is completed
302 patients recruited
.
Chimeric degradation-activating compound BGB-16673 targeting BTK: Early data
from Phase 1 studies will be obtained.
Anti-OX40 monoclonal antibody BGB-A445: obtain the recommended dose of Phase 2 (RP2D) for single-agent and combination clinical trials
.
HPK1 inhibitor BGB-15025: RP2D was obtained for clinical trials of two monotherapies, followed by a dose-expansion trial
in combination with tislelizumab.
Anti-LAG-3 antibody LBL-007: RP2D was obtained for clinical trials
of combination therapy.
Other early plans: Initiation of 15 new tumor immune combinations in 6 trials using tislelizumab, combination therapies including innovative products targeting targets such as LAG3, OX40, TIM3, TIGIT and HPK1, intended to treat multiple new tumor types, including head and neck squamous cell carcinoma, colorectal cancer, bladder cancer, renal cell carcinoma, melanoma, etc
.
According to the report, BeiGene will continue to advance the global development
of core products and other pipeline in progress in 2023 and beyond.
The company's vision is to create impactful medicines that make them affordable and accessible to more cancer patients around the world
.
In addition to BeiGene, many other companies will be speaking at this year's J.
P.
Morgan Healthcare Annual Conference, and Medical Guanlan will continue to report in
the coming days.
