On January 18, the American Cancer Comprehensive Network (NCCN) guidelines were updated to include BeiGene's self-developed BTK inhibitor Baiyueze (zebutinib) in the recommended treatment regimen for patients with primary chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) without del (17p); at the same time, the guidelines are recommended for CLL/17p-free CLL/LD.; Second-line treatment of patients with SLL and first-line/second-line/follow-up treatment of patients with DL(17p) CLL/SLL have also shifted zebutinib from other recommended regimens to the preferred treatment regimen, and BeiGene's clinically recommended status in this important indication for CLL has increased significantly.
Zebutinib is the first indigenously developed new anti-cancer drug approved by the FDA in mainland China, and it is also the first new drug to be recommended by the NCCN guidelines of the United States and the clinical guidelines of China's CSCO, and the drug has been approved in 43 countries or regions around the world.
At the same time, another self-developed core product of BeiGene, has obtained positive clinical data for the combination therapy of reillizumab (PD-1), and the global layout is expected to bring differentiated advantages. On January 19, 2022, BeiGene partner Leap Therapeutics announced that positive data have been obtained from the DisTinGuish Phase II clinical trial of tirerizumab plus DKK1 monoclonal antibody DKN-01 combined for the treatment of gastric cancer, which will be reported in detail at the ASCO GI meeting.
Just on January 24, BeiGene announced that RATIONALE 305, a phase 3 clinical trial of tirelizumab plus chemotherapy versus placebo + chemotherapy for the first-line treatment of locally advanced, unresectable or metastatic gastric or gastroesophageal-conjunctive (G/GEJ) adenocarcinoma, has yielded positive results. In the interim analysis, terelizumab combined with chemotherapy achieved the primary endpoint of overall survival (OS) in patients expressing PD-L1.
According to the latest disclosure of BeiGene, the company has conducted or completed 17 registered clinical trials of Bai Zean (terelizumab) in China and globally, including 13 Phase 3 clinical trials and 4 key Phase 2 clinical trials.
The company said that with the gradual completion of the entire industry chain capacity, beiGene's achievements from Biotech to Biopharma have initially emerged. In terms of R&D, the company has initially completed the construction of the whole industry chain in 2021, and most of the research and development links no longer rely on CRO, but are promoted through the internal global R & D team. In terms of BD, the company expanded its cooperation with Novartis in December 2021, and the two parties will jointly develop and commercialize the company's TIGIT antibody Ociperlimab in North America, Europe and Japan, with a potential total transaction value of up to nearly $3 billion, once again demonstrating Novartis' recognition of the commercial value of the company's product. At present, Ociperlimab has been carried out in the United States to clinical Phase III trials, and the development progress is in the first echelon of the TIGIT track, and the market potential is huge. (Li Gongsheng)
![Yahong Pharmaceutical: APL-1202 and Bai Zean combined neoadjuvant therapy completed the world's first drug administration in the United States[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)